144 results on '"Prymula R"'
Search Results
2. Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons A Randomized Clinical Trial
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Dbaibo G, Amanullah A, Claeys C, Izu A, Jain VK, Kosalaraksa P, Rivera L, Soni J, Yanni E, Zaman K, Acosta B, Ariza M, Arroba Basanta ML, Bavdekar A, Carmona A, Cousin L, Danier J, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Gonzales MLA, Hacimustafaoglu M, Hughes SM, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinón-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Szymanski H, Ulied A, Woo W, Schuind A, Innis BL, and Flu4VEC Study Group
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seasonal variation ,healthcare utilization ,vaccine efficacy ,influenza ,disease attenuation - Abstract
Background: We evaluated an inactivated quadrivalent influenza vaccine (IIV4) in children 6-35 months of age in a phase III, observer-blind trial. Methods: The aim of this analysis was to estimate vaccine efficacy (VE) in preventing laboratory-confirmed influenza in each of 5 independent seasonal cohorts (2011-2014), as well as vaccine impact on healthcare utilization in 3 study regions (Europe/Mediterranean, Asia-Pacific and Central America). Healthy children were randomized 1:1 to IIV4 or control vaccines. VE was estimated against influenza confirmed by reverse transcription polymerase chain reaction on nasal swabs. Cultured isolates were characterized as antigenically matched/mismatched to vaccine strains. Results: The total vaccinated cohort included 12,018 children (N = 1777, 2526, 1564, 1501 and 4650 in cohorts 1-5, respectively). For reverse transcription polymerase chain reaction confirmed influenza of any severity (all strains combined), VE in cohorts 1-5 was 57.8%, 52.9%, 73.4%, 30.3% and 41.4%, respectively, with the lower limit of the 95% confidence interval >0 for all estimates. The proportion of vaccine match for all strains combined in each cohort was 0.9%, 79.3%, 72.5%, 24.1% and 28.6%, respectively. Antibiotic use associated with influenza illness was reduced with IIV4 by 71% in Europe, 36% in Asia Pacific and 59% in Central America. Conclusions: IIV4 prevented influenza in children 6-35 months of age in each of 5 separate influenza seasons in diverse geographical regions. A possible interaction between VE, degree of vaccine match and socioeconomic status was observed. The IIV4 attenuated the severity of breakthrough influenza illness and reduced healthcare utilization, particularly antibiotic use.
- Published
- 2020
3. Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement
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Abu-Raya, B. Maertens, K. Edwards, K.M. Omer, S.B. Englund, J.A. Flanagan, K.L. Snape, M.D. Amirthalingam, G. Leuridan, E. Damme, P.V. Papaevangelou, V. Launay, O. Dagan, R. Campins, M. Cavaliere, A.F. Frusca, T. Guidi, S. O'Ryan, M. Heininger, U. Tan, T. Alsuwaidi, A.R. Safadi, M.A. Vilca, L.M. Wanlapakorn, N. Madhi, S.A. Giles, M.L. Prymula, R. Ladhani, S. Martinón-Torres, F. Tan, L. Michelin, L. Scambia, G. Principi, N. Esposito, S. World Association of Infectious Diseases Immunological Disorders (WAidid) the Vaccine Study Group of the European Society of Clinical Microbiology Infectious Diseases (EVASG)
- Abstract
Immunization during pregnancy has been recommended in an increasing number of countries. The aim of this strategy is to protect pregnant women and infants from severe infectious disease, morbidity and mortality and is currently limited to tetanus, inactivated influenza, and pertussis-containing vaccines. There have been recent advancements in the development of vaccines designed primarily for use in pregnant women (respiratory syncytial virus and group B Streptococcus vaccines). Although there is increasing evidence to support vaccination in pregnancy, important gaps in knowledge still exist and need to be addressed by future studies. This collaborative consensus paper provides a review of the current literature on immunization during pregnancy and highlights the gaps in knowledge and a consensus of priorities for future research initiatives, in order to optimize protection for both the mother and the infant. © Copyright © 2020 Abu-Raya, Maertens, Edwards, Omer, Englund, Flanagan, Snape, Amirthalingam, Leuridan, Damme, Papaevangelou, Launay, Dagan, Campins, Cavaliere, Frusca, Guidi, O'Ryan, Heininger, Tan, Alsuwaidi, Safadi, Vilca, Wanlapakorn, Madhi, Giles, Prymula, Ladhani, Martinón-Torres, Tan, Michelin, Scambia, Principi and Esposito.
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- 2020
4. COVID-19 Antigen Testing: Better than We Know?
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Tomaskova H, Jakub Mrázek, Jezo E, Kloudova A, Homza M, Janosek J, Prymula R, Svagera Z, and Zelená H
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Text mining ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Medicine ,Computational biology ,business ,Antigen testing - Published
- 2020
5. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study
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Vesikari, T., Karvonen, A., Prymula, R., Schuster, V., Tejedor, JC, Cohen, R., Meurice, F., Han, HH, Damaso, S., and Bouckenooghe, A.
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Rotarix (Vaccine) -- Health aspects ,Rotavirus infections -- Prevention ,Rotavirus infections -- Research ,Viral vaccines -- Health aspects ,Viral vaccines -- Research ,Infants (Newborn) -- Diseases ,Infants (Newborn) -- Prevention ,Infants (Newborn) -- Research - Published
- 2007
6. The occurrence of microscopic fungi in air samples from a transplant intensive care unit
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Vackova, M, Buchta, V., Prymula, R., Cerman, J., Kuvatova, A., Hamal, P., Raclvasky, V., and Chlibek, R.
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Cross infection -- Research ,Intensive care units -- Research ,Contamination (Technology) -- Research ,Nosocomial infections -- Research ,Fungi -- Research ,Construction and materials industries ,Health ,Research - Abstract
Abstract Contamination of the air by fungi at the Transplant Intensive Care Unit (ICU) of the University Hospital in Hradec Kralove was investigated in 2004. Air samples were taken from [...]
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- 2006
7. Persistence of bactericidal antibodies following booster vaccination with 4CMenB at 12, 18 or 24months and immunogenicity of a fifth dose administered at 4years of age-a phase 3 extension to a randomised controlled trial
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Iro, MA, Snape, MD, Voysey, M, Jawad, S, Finn, A, Heath, PT, Bona, G, Esposito, S, Diez-Domingo, J, Prymula, R, Odueyungbo, A, Toneatto, D, Dull, P, Pollard, AJ, and European Men B Vaccine Study Group
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Male ,Time Factors ,4CMenB ,Booster dose ,Neisseria meningitidis ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine ,030212 general & internal medicine ,Czech Republic ,Immunogenicity ,Venous blood ,11 Medical And Health Sciences ,Antibodies, Bacterial ,Vaccination ,Infectious Diseases ,Italy ,Child, Preschool ,Molecular Medicine ,Female ,medicine.medical_specialty ,Blood Bactericidal Activity ,Toddler ,Immunization, Secondary ,Meningococcal Vaccines ,Meningococcal vaccine ,03 medical and health sciences ,030225 pediatrics ,Internal medicine ,Virology ,Immunology and Microbiology(all) ,Humans ,MenW ,Reactogenicity ,Antigens, Bacterial ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Vaccine ,Public Health, Environmental and Occupational Health ,Infant ,Complement System Proteins ,06 Biological Sciences ,veterinary(all) ,United Kingdom ,Spain ,Immunology ,Antibody Formation ,07 Agricultural And Veterinary Sciences ,business - Abstract
Background4CMenB is immunogenic in infants and toddlers. We assessed persistence of human complement serum bactericidal activity (hSBA) following a fourth dose administered at 12, 18 or 24 months and characterised the antibody response to a fifth dose administered at 4 years of age.MethodsA phase 3, open label, multi-centre extension to a randomised controlled trial conducted in four countries (number of centres): Czech Republic (nineteen), Italy (four), Spain (four) and the United Kingdom (four). Four-year-old children who were either 4CMenB-naïve or had previously received a variety of 3-dose infant priming schedules and a booster vaccine as toddlers (follow-on group) were recruited. Venous blood samples were obtained to determine hSBA against four reference strains; acting as targets to assess immunity to each of the vaccine antigens, NadA (5/99), fHbp (H44/76), PorA (NZ98/254), and NHBA (M10713) at baseline (prior to vaccination, all participants) and one month following a dose of 4CMenB for all vaccine-naïve and follow-on participants primed with the 2, 3, 4 schedule, and a third of follow-on participants primed with a 2, 4, 6 month schedule.ResultsAt baseline (prior to vaccination), the proportion of participants (n = 468) with hSBA titers ⩾ 5 was similar across all followon groups: 89–100% against 5/99; 12–35% for H44/76; 8–12% for NZ98/254 and 53–80% for M10713 compared with 5%, 0%, 0%; and 60% respectively, for the vaccine-naïve controls (n = 206). Following a dose of 4CMenB at 4 years of age, this increased to 100% (5/99), 97–100% (H44/76), 80–95 % (NZ98/254) and 84–100% (M10713) (n = 210), compared with 89%, 70%, 24%, and 76% respectively for vaccine-naïve controls (n = 192).ConclusionWaning of protective antibodies occurred 12–36 months after toddler booster regardless of age at boost. This was least marked against target strains 5/99 and M10713. A robust memory response occurred after a booster dose given at 4 years of age.
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- 2017
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8. Epidemiology of Streptococcus pneumoniae causing acute otitis media in young children in the Czech Republic
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Prymula, R., Kriz, P., Motlova, J., and Chrobok, V.
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- 2004
9. The use of foam substances for disinfection
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Chlibek, R., Hartmanova, M., Severa, J., Prymula, R., and Splino, M.
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Foamed materials -- Usage ,Anti-infective agents -- Usage ,Construction and materials industries ,Health ,Usage - Abstract
Abstract Foams provide another method of applying disinfectant under laboratory and field conditions. They can act as anti-epidemic measures for the prevention of infectious diseases by stopping spread in a [...]
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- 2006
10. Corrigendum to 'Persistence of bactericidal antibodies following booster vaccination with 4CMenB at 12, 18 or 24months and immunogenicity of a fifth dose administered at 4years of age-a phase 3 extension to a randomised controlled trial' [Vaccine 35 (2017) 395-402]
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Iro, MA, Snape, MD, Voysey, M, Jawad, S, Finn, A, Heath, PT, Bona, G, Esposito, S, Diez-Domingo, J, Prymula, R, Odueyungbo, A, Toneatto, D, Dull, P, Pollard, AJ, and European Men B Vaccine Study Group
- Published
- 2017
11. Persistence of bactericidal antibodies following, booster vaccination with 4CMenB at 12, 18 or 24 months and immunogenicity of a fifth dose administered at 4 years of age-a phase 3 extension to a randomised controlled trial (vol 35, pg 395, 2017)
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Iro MA, Snape MD, Voysey M, Jawad S, Finn A, Heath PT, Bona G, Esposito S, Diez-Domingo J, Prymula R, Odueyungbo A, Toneatto D, Dull P, Pollard AJ, and European Men B Vaccine Study Group
- Published
- 2017
12. Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules
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Sadarangani, M, Sell, T, Iro, MA, Snape, MD, Voysey, M, Finn, A, Heath, PT, Bona, G, Esposito, S, Diez-Domingo, J, Prymula, R, Odueyungbo, A, Toneatto, D, Pollard, AJ, and European MenB Vaccine Study Group
- Abstract
BACKGROUND: One schedule for the capsular group B meningococcal vaccine 4CMenB is 2 doses that are administered 2 months apart for children aged 12-23 months, with a booster dose 12-24 months later. Our objective was to provide data on persistence of human serum bactericidal antibody (hSBA) titres in children up to 4 years of age after initial doses at 12-24 months, and immunogenicity of a booster dose at 48 months of age compared with vaccine-naive children. METHODS: Children previously immunized, as part of a randomized controlled trial, with 2 doses of 4CMenB vaccine at 12-24 months of age received a booster at 4 years of age. Vaccine-naive age-matched toddlers received 2 doses of 4CMenB. Human serum bactericidal antibody titres against reference strains H44/76, 5/99, NZ98/254 and M10713 were evaluated before and after innoculation with 4CMenB vaccine in 4-year-old children. RESULTS: Of 332 children in the study, 123 had previously received 4CMenB and 209 were vaccine-naive controls. Before the booster, the proportions of participants (previously vaccinated groups compared with controls) with hSBA titres of 1:5 or more were as follows: 9%-11% v. 1% (H44/76), 84%-100% v. 4% (5/99), 0%-18% v. 0% (NZ98/254) and 59%-60% v. 60% (M10713). After 1 dose of 4CMenB in previously immunized children, the proportions of participants achieving hSBA titres of 1:5 or more were 100% (H44/76 and 5/99), 70%-100% (NZ98/254) and 90%-100% (M10713). INTERPRETATION: We found that waning of hSBA titres by 4 years of age occurred after 2 doses of 4CMenB vaccine administered at 12-24 months, and doses at 12-24 months have a priming effect on the immune system. A booster may be necessary to maintain hSBA titres of 1:5 or more among those children with increased disease risk. Trial registration: ClinicalTrials.gov, no. NCT01717638
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- 2017
13. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial
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Gossger, N, Snape, Md, Yu, Lm, Finn, A, Bona, G, Esposito, S, Principi, N, Diez Domingo, J, Sokal, E, Becker, B, Kieninger, D, Prymula, R, Dull, P, Ypma, E, Toneatto, D, Kimura, A, Pollard, Aj, Giaquinto, Carlo, and the European MenB Vaccine Study Group
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Male ,Pediatrics ,medicine.medical_specialty ,Context (language use) ,Meningococcal Vaccines ,Meningococcal vaccine ,Neisseria meningitidis ,Serum Bactericidal Antibody Assay ,Drug Administration Schedule ,medicine ,Humans ,Immunization Schedule ,Vaccines ,Vaccines, Synthetic ,Reactogenicity ,Tetanus ,business.industry ,Diphtheria ,Infant ,General Medicine ,medicine.disease ,Poliomyelitis ,Vaccination ,Meningococcal Infections ,Antibody Formation ,Female ,Pertactin ,business - Abstract
CONTEXT: In the absence of an effective vaccine, serogroup B Neisseria meningitidis (MenB) remains a major cause of invasive disease in early childhood in developed countries. OBJECTIVE: To determine the immunogenicity and reactogenicity of a multicomponent MenB vaccine (4CMenB) and routine infant vaccines when given either concomitantly or separately. DESIGN, SETTING, AND PARTICIPANTS: Phase 2b, multicenter, open-label, parallel-group, randomized controlled study of 1885 infants enrolled at age 2 months from August 2008 to July 2010 in Europe. INTERVENTION: Participants were randomized 2:2:1:1 to receive (1) 4CMenB at 2, 4, and 6 months with routine vaccines (7-valent pneumococcal and combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, Haemophilus influenzae type b vaccines); (2) 4CMenB at 2, 4, and 6 months and routine vaccines at 3, 5, and 7 months; (3) 4CMenB with routine vaccines at 2, 3, and 4 months; or (4) routine vaccines alone at 2, 3, and 4 months. MAIN OUTCOME MEASURES: Percentage of participants with human complement serum bactericidal activity (hSBA) titer of 1:5 or greater against 3 MenB strains specific for vaccine antigens (NZ98/254, 44/76-SL, and 5/99). RESULTS: After three 4CMenB vaccinations, 99% or more of infants developed hSBA titers of 1:5 or greater against strains 44/76-SL and 5/99. For NZ98/254, this proportion was 79% (95% CI, 75.2%-82.4%) for vaccination at 2, 4, and 6 months with routine vaccines, 86.1% (95% CI, 82.9%-89.0%) for vaccination at 2, 4, and 6 months without routine vaccines, and 81.7% (95% CI, 76.6%-86.2%) for vaccination at 2, 3, and 4 months with routine vaccines. Responses to routine vaccines given with 4CMenB were noninferior to routine vaccines alone for all antigens, except for the responses to pertactin and serotype 6B pneumococcal polysaccharide. Fever was seen following 26% (158/602) to 41% (247/607) of 4CMenB doses when administered alone, compared with 23% (69/304) to 36% (109/306) after routine vaccines given alone and 51% (306/605) to 61% (380/624) after 4CMenB and routine vaccines administered together. CONCLUSION: A 4CMenB vaccine is immunogenic against reference strains when administered with routine vaccines at 2, 4, and 6 or at 2, 3, and 4 months of age, producing minimal interference with the response to routine infant vaccinations. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00721396.
- Published
- 2016
14. Persistence of bactericidal antibodies following infant serogroup B meningococcal immunization (4CMenB) and booster dose response at 12, 18 or 24 months of age
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Snape, MD, Pollard, AJ, Voysey, M, Finn, A, Bona, G, Esposito, S, Principi, N, Diez-Domingo, J, Sokal, E, Kieninger, D, Prymula, R, Dull, PM, Kohl, I, Barone, M, Wang, H, and Toneatto, D
- Abstract
Background: A serogroup B meningococcal vaccine (4CMenB) is licensed for infant use in countries including Canada, Australia and those of the European Union. Data on serum bactericidal antibody (hSBA) waning and the ideal timing of a ‘toddler’ booster dose are essential to optimise vaccine utilization. Methods: An open-labeled, multicenter phase-2b follow-on European study conducted from 2009 to 2012. Participants previously receiving 4CMenB with routine vaccines at 2,4,6 or 2,3,4 months (246Con and 234Con) or at 2,4,6 months intercalated with routine vaccines (246Int) received a booster dose at 12, 18 or 24 months. 4CMenB-naïve ‘Control’ participants aged 12, 18 or 24 months received two doses of 4CMenB two months apart. Results: 1588 participants were recruited. At 12 months, prior to any booster doses, the proportions with hSBA titers ≥ 1:5 for strain 44/76-SL (testing vaccine component fHBP) were 73% (120/165) for the ‘246Con’ group, 85% (125/147) for ‘246Int’, 57% (51/90) for ‘234Con’ and 13% (26/199) for Controls. For strain 5/99 (NadA) proportions were ≥ 96% (all 4CMenB-recipients) and 1% (Controls). For strain NZ98/254 (PorA) these were 18-35% (4CMenB-recipients) and 1% (Controls). By 24 months, 4CMenB-recipient proportions were 13%–22% (44/76-SL), 82%-94% (5/99) and 7-13% (NZ98/254) and in Controls ≤ 4%. Following a 12-month booster-dose ≥ 95% of previously immunized participants had titers ≥1:5 (all strains). Conclusions: A 4CMenB booster-dose can overcome waning hSBA titers after early-infant immunization. Administration at 12 months could help to maintain immunity during an age of high risk, and the persistence of this response requires further study.
- Published
- 2016
15. Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement: Report on an international workshop
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Arciniega, J., Wagner, L., Prymula, R., Sebo, P., Isbrucker, R., Descampe, B., Chapsal, J.M., Costanzo, A., Hendriksen, C., Hoonaker, M., Nelson, S., Lidster, K., Casey, W., and Allen, D.
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education ,Article - Abstract
The ‘International Workshop on Alternatives to the Murine Histamine Sensitization Test for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST’ was held on 24 August 2014, in Prague, Czech Republic, as a satellite meeting to the 9 th World Congress on Alternatives and Animal Use in the Life Sciences. Participants discussed the progress and challenges associated with the development, validation, and implementation of in vitro assays as replacements for the histamine sensitisation test (HIST) for acellular pertussis vaccines. Discussions focused on the consistency approach, the necessary framework for regulatory acceptance of a harmonised method, and recent international efforts towards the development of in vitro assays to replace the HIST. Workshop participants agreed that acceptable alternatives to the HIST should be based on ADP ribosylation-mediated cell intoxication and therefore that the CHO cell clustering assay, which measures cell intoxication, should be further pursued and developed as a possible replacement for the HIST. Participants also agreed to continue ongoing multinational discussions involving national and international standardisation authorities to reach consensus and to organise collaborative studies in this context for assay characterisation and calibration of reference materials.
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- 2016
16. A phase II randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II)
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Prymula, R., Esposito, Susanna Maria Roberta, Zuccotti, G. V., Xie, F., Toneatto, D., Kohl, I., and Dull, P. M.
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meningococcal ,infants ,serogroup B ,vaccination ,antipyretics - Published
- 2014
17. Immunogenicity and Tolerability of Recombinant Serogroup B Meningococcal Vaccine Administered With or Without Routine Infant Vaccinations According to Different Immunization Schedules A Randomized Controlled Trial
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Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, Kieninger D, Prymula R, Dull P, Ypma E, Toneatto D, Kimura A, Pollard AJ, and European MenB Vaccine Study Group
- Abstract
Context In the absence of an effective vaccine, serogroup B Neisseria meningitidis (MenB) remains a major cause of invasive disease in early childhood in developed countries. Objective To determine the immunogenicity and reactogenicity of a multicomponent MenB vaccine (4CMenB) and routine infant vaccines when given either concomitantly or separately. Design, Setting, and Participants Phase 2b, multicenter, open-label, parallel-group, randomized controlled study of 1885 infants enrolled at age 2 months from August 2008 to July 2010 in Europe. Intervention Participants were randomized 2: 2: 1: 1 to receive (1) 4CMenB at 2, 4, and 6 months with routine vaccines (7-valent pneumococcal and combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, Haemophilus influenzae type b vaccines); (2) 4CMenB at 2, 4, and 6 months and routine vaccines at 3, 5, and 7 months; (3) 4CMenB with routine vaccines at 2, 3, and 4 months; or (4) routine vaccines alone at 2, 3, and 4 months. Main Outcome Measures Percentage of participants with human complement serum bactericidal activity (hSBA) titer of 1: 5 or greater against 3 MenB strains specific for vaccine antigens (NZ98/254, 44/76-SL, and 5/99). Results After three 4CMenB vaccinations, 99% or more of infants developed hSBA titers of 1: 5 or greater against strains 44/76-SL and 5/99. For NZ98/254, this proportion was 79% (95% CI, 75.2%-82.4%) for vaccination at 2, 4, and 6 months with routine vaccines, 86.1% (95% CI, 82.9%-89.0%) for vaccination at 2, 4, and 6 months without routine vaccines, and 81.7% (95% CI, 76.6%-86.2%) for vaccination at 2, 3, and 4 months with routine vaccines. Responses to routine vaccines given with 4CMenB were noninferior to routine vaccines alone for all antigens, except for the responses to pertactin and serotype 6B pneumococcal polysaccharide. Fever was seen following 26% (158/602) to 41% (247/607) of 4CMenB doses when administered alone, compared with 23% (69/304) to 36% (109/306) after routine vaccines given alone and 51% (306/605) to 61% (380/624) after 4CMenB and routine vaccines administered together. Conclusion A 4CMenB vaccine is immunogenic against reference strains when administered with routine vaccines at 2, 4, and 6 or at 2, 3, and 4 months of age, producing minimal interference with the response to routine infant vaccinations.
- Published
- 2012
18. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial
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De Martino, Maurizio, Galli, Luisa, Azzari, Chiara, Gossger, N., Snape, M. D., Yu, L., Finn, M., Bona, G., Esposito, S., Principi, N., Diez Domingo, J., Sokal, E., Becker, B., Kieninger, D., Prymula, R., and Dull, P.
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diphtheria pertussis poliomyelitis tetanus Haemophilus influenzae type b hepatitis B vaccine - Published
- 2012
19. Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for influenza vaccination in children
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Usonis, V, Anca, I, André, F, Chlibek, R, Ivaskeviciene, I, Mangarov, A, Mészner, Z, Prymula, R, Simurka, P, Tamm, E, Tesović, Goran, and Central European Vaccination Advisory Group
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CEVAG ,recommendations ,influenza vaccination ,children - Abstract
Background Influenza vaccination in infants and children with existing health complications is current practice in many countries, but healthy children are also susceptible to influenza, sometimes with complications. The under-recognised burden of disease in young children is greater than in elderly populations and the number of paediatric influenza cases reported does not reflect the actual frequency of influenza. Discussion Vaccination of healthy children is not widespread in Europe despite clear demonstration of the benefits of vaccination in reducing the large health and economic burden of influenza. Universal vaccination of infants and children also provides indirect protection in other high-risk groups in the community. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for the vaccination of infants and children against influenza. The aim of CEVAG is to encourage the efficient and safe use of vaccines to prevent and control infectious diseases. Summary CEVAG recommends the introduction of universal influenza vaccination for all children from the age of 6 months. Special attention is needed for children up to 60 months of age as they are at greatest risk. Individual countries should decide on how best to implement this recommendation based on their circumstances.
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- 2010
20. The seroprevalence of the 'total' anti-HAV antibody in the Czech UNPRO Forces (1991-1995)
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Jiří Beran, Douda, P., Gál, P., Rychlý, R., Prymula, R., and Splino, M.
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Adult ,Military Personnel ,Seroepidemiologic Studies ,Humans ,Hepatitis Antibodies ,Hepatovirus ,Hepatitis A ,Middle Aged ,Hepatitis A Antibodies ,Czech Republic - Abstract
Viral hepatitis A is a common disease particularly in developing countries. That disease is endemic and it is always associated with poor standards of sanitation. All staff and troops in the U.N. (United Nations) are vaccinated by the Havrix vaccine. Till 1995 we did not vaccinate the Czech troops which have operated in the area of the former Yugoslavia. The main goal of this study was to obtain data about the seroprevalence of hepatitis A antibody among the Czech U.N. troops before their departure to the conflict area. The serum samples were investigated by the MEIA (Microparticle Enzyme Immunoassay) method in the fully automated system for immunoassays IMx in the Military Institute of Health in Ceské Budĕjovice. We use the HAVAB investigation kits of the Abbott company. We obtained 884 serum samples (military staff of the Czech U.N. troops in Yugoslavia) in the years 1991-1995. In the laboratory we excluded 19 of the samples due to the small amount (less than 50 ul) or hemolysis. We investigated 865 of them (1991--65, 1992--296, 1993--265, 1994--35, 1995--204). The staff was divided into four age cohorts by ten years (20-29, 30-39, 40-49, 50-59), where the distribution of percentage was 32.6%, 43.6%, 22.5%, and 1.3% respectively. The positive samples were 287 (average seroprevalence was 33.2%, CI 30.1%-36.3%), the negative ones were 578 (66.8%). The seroprevalence 18.1% (CI 13.6%-22.6%), 36.1% (CI 31.3%-40.9%), 47.1% (CI 40.1%-54.1%), 72.7% (CI 46.4%-99.0%) in the age cohorts. The results show relatively low seroprevalence of the anti-HAV antibody in all the age cohorts and necessity to vaccinate the Czech UNPROFOR or IFOR units by Havrix before their departure to conflict area.
- Published
- 1996
21. Use of an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) in a clinical trial in 3630 infants
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Vesikari, T., primary, Esposito, S., additional, Prymula, R., additional, Ypma, E., additional, Kleinschmidt, A., additional, Toneatto, D., additional, Kimura, A., additional, and Dull, P., additional
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- 2011
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22. Online survey: knowledge about risks, prevention and consequences of infections with HBV among travellers from four European countries
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Herbinger, K.H., primary, Nothdurft, H.D., additional, and Prymula, R., additional
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- 2011
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23. Očkování a jeho role v prevenci infekčních nemocí Odmítání očkování -- vážný problém veřejného zdravotnictví.
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PRYMULA, R. and BENCKO, V.
- Abstract
Vaccination is one of the most important achievements in the field of prevention of infectious diseases, which in the 19th century were one of the most common causes of death in Europe, and still in the developing world are the major cause of mortality especially in child population. Vaccination is one of the few activities in the area of disease prevention fulfilling all the conditions required by contemporary medicine „based on evidence“ and his questioning is to some extent a fashion, but utterly undesirable phenomena of the postmodern society, emphasizing individual freedom in decision making without the necessary balance its duties and responsibilities, in terms of the principle of solidarity to the society in which he lives. [ABSTRACT FROM AUTHOR]
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- 2014
24. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study.
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Prymula R, Peeters P, Chrobok V, Kriz P, Novakova E, Kaliskova E, Kohl I, Lommel P, Poolman J, Prieels J, and Schuerman L
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- 2006
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25. Anthrax vaccines.
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Splino M, Patocka J, Prymula R, Chlibek R, Splino, Miroslav, Patocka, Jiri, Prymula, Roman, and Chlibek, Roman
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- 2005
26. Concomitant vaccination against hepatitis A and typhoid fever.
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Van Hoecke, C, Lebacq, E, Beran, J, Prymula, R, and Collard, F
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- 1998
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27. Evaluation of reactogenicity and immunogenicity of two influenza vaccines (vaxigrip and fluarix) in the season 1996-1997
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Jiří Beran, Prymula, R., Chlíbek, R., Rychlý, R., Špliňo, M., Douda, P., and Gál, P.
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Adult ,Male ,Military Personnel ,Adolescent ,Vaccines, Inactivated ,Influenza Vaccines ,Reference Values ,Influenza, Human ,Humans ,Female ,Middle Aged ,Czech Republic - Abstract
Influenza is a very serious disease, which causes thousands of deaths all over the world every year. As there is so far no sufficiently effective causal therapy of influenza the main function of vaccination lies in prevention. Influenza is a major problem especially in collective facilities. Therefore, great emphasis is laid in the Czech Republic Army on the vaccination of military groups and on the evaluation of reactogenicity and immunogenicity of the vaccines used. The specific aim of the clinical trial was to evaluate the reactogenicity and immunogenicity of two inactivated split influenza vaccines Fluarix and Vaxigrip in healthy adult volunteers aged 18-60 years with stress on military groups. The study was designed as an open clinical trial with 2 groups each of 100 volunteers in one centre. Randomisation was not conducted so that each group received only the vaccine specified beforehand. Both the inactivated split vaccines evaluated, Vaxigrip and Fluarix are highly immunogenic both against declared and other antigenic variants of influenza. The study has demonstrated a favourable trend in the preparation of influenza vaccines towards a marked reduction of general solicited symptoms as compared with previous years. Despite minute differences in immunogenicity and reactogenicity, the vaccines are generally speaking comparable, and in healthy individuals aged 18-60 years they induce a sufficient protection against the onset and development of influenza. The results of our open clinical trial (without randomisation) have again proved that both manufacturers produce vaccines of a high European standard.
28. University partnership project in health services management education: the driving force behind the Czech Republic Educational Network
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Prymula, R., Pavlicek, J., Petrakova, A., and Jiří Beran
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Hospital Administration ,Health Care Reform ,International Cooperation ,Humans ,Curriculum ,Education, Graduate ,State Medicine ,United States ,Czech Republic
29. Hepatitis A vaccination by Havrix in the Czech U.N. Troops according to data of seroprevalence in 1991-1995
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Jiří Beran, Douda, P., Prymula, R., Gál, P., Rychlý, R., and Špliňo, M.
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Adult ,Male ,Viral Hepatitis Vaccines ,Hepatitis A Vaccines ,Military Personnel ,Seroepidemiologic Studies ,Humans ,Hepatitis Antibodies ,Hepatitis A ,Middle Aged ,Vaccines, Attenuated ,Hepatitis A Virus, Human ,Czech Republic - Abstract
Viral hepatitis A is a common disease, particularly in developing countries. All staff and troops of the U.N. (United Nations) are vaccinated by the Havrix vaccine. Till 1995 we did not vaccinate Czech troops which have operated in the area of former Yugoslavia. The main goal of this study was to obtain data about the seroprevalence of hepatitis A antibody among the Czech U.N. troops before their departure to the conflict area and to optimize the vaccination approach. The serum samples were examined by the MEIA (Microparticle Enzyme Immunoassay) method in the fully automated system for immunoassays IMx in the Military Institute of Health in Ceské Budĕjovice. We used HAVAB kits of Abbott Company. 692 serum samples (military staff of the Czech U.N. troops in Yugoslavia) were examined in 1991-1995. In the laboratory 19 samples were eliminated due to small amounts (less than 50 microliters) or haemolysis. 673 (1991 - 65, 1992 - 296, 1993 - 265, 1994 - 35, 1995 - 12) were investigated. The staff was divided into four age cohorts by decades (20-29, 30-39, 40-49, 50-59); 26.0%, 47.4%, 24.9% and 1.7%, respectively. There were 253 (37.4%) positive samples and 420 (62.6%) negatives ones, ratio 1:1.7. The ratio of the positive and negative samples--immunity rate and seroprevalence--were 1:0.4 (26.2%), 1:0.6 (37.9%); 1:0.9 (46.4%) and 1:2.7 (72.7%), respectively in the age cohorts. The results show a relatively low seroprevalence of the anti-HAV antibody in all the age cohorts and necessity to vaccinate the Czech U.N. troops by the special basic schedule--Havrix 2 x 720 E.U. at the same time. This regimen will be used in the new units that will be stationed in Bosnia. So far 200 persons have been vaccinated in this way.
30. Recommendations for tick-borne encephalitis vaccination from the Central European Vaccination Awareness Group (CEVAG)
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Zavadska D, Anca I, André F, Bakir M, Chlibek R, Cižman M, Ivaskeviciene I, Mangarov A, Mészner Z, Marko Pokorn, Prymula R, Richter D, Salman N, Simurka P, Tamm E, Tešović G, Urbancikova I, and Usonis V
31. Recommendation for vaccination against rotaviral infections in the Czech republic | Doporučení pro očkování proti rotavirovým infekcím v České republice
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Chlíbek, R., Cabrnochová, H., Ambrožová, H., Dvořáková, J., Marešová, V., Kozderka, C., Petr Pazdiora, Prymula, R., Šebková, A., and Vančíková, Z.
32. Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for influenza vaccination in children
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Prymula Roman, Mészner Zsófia, Mangarov Atanas, Ivaskeviciene Inga, Chlibek Roman, André Francis, Anca Ioana, Usonis Vytautas, Šimurka Pavol, Tamm Eda, and Tešović Goran
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Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Background Influenza vaccination in infants and children with existing health complications is current practice in many countries, but healthy children are also susceptible to influenza, sometimes with complications. The under-recognised burden of disease in young children is greater than in elderly populations and the number of paediatric influenza cases reported does not reflect the actual frequency of influenza. Discussion Vaccination of healthy children is not widespread in Europe despite clear demonstration of the benefits of vaccination in reducing the large health and economic burden of influenza. Universal vaccination of infants and children also provides indirect protection in other high-risk groups in the community. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for the vaccination of infants and children against influenza. The aim of CEVAG is to encourage the efficient and safe use of vaccines to prevent and control infectious diseases. Summary CEVAG recommends the introduction of universal influenza vaccination for all children from the age of 6 months. Special attention is needed for children up to 60 months of age as they are at greatest risk. Individual countries should decide on how best to implement this recommendation based on their circumstances.
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- 2010
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33. Opportunity for healthy ageing: lessening the burden of adult pneumococcal disease in Central and Eastern Europe, and Israel.
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Ludwig E, Unal S, Bogdan M, Chlibek R, Ivanov Y, Kozlov R, van der Linden M, Lode H, Mészner Z, Prymula R, Rahav G, Skoczynska A, Solovic I, Uzaslan E, Ludwig, Endre, Unal, Serhat, Bogdan, Miron, Chlibek, Roman, Ivanov, Yavor, and Kozlov, Roman
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The population of the Region (Central Europe, Eastern Europe, and Israel) is ageing, necessitating preventative programmes to maintain a healthy and active lifestyle in older age groups. Invasive pneumococcal disease (including bacteremic pneumonia, bacteremia without a focus, and meningitis) has higher incidence, morbidity and mortality in older adults and is a substantial public health burden in the ageing population. Surveillance in the Region establishes a significant burden in older adults of invasive pneumococcal disease (IPD), which still appears to be under-estimated as compared with other countries, and this warrants an improvement in surveillance systems. The largest proportion of IPD in adults is bacteremic pneumonia. Community-acquired pneumonia (CAP), largely attributable to S. pneumoniae, can be bacteremic or non-bacteremic; the non-bacteremic forms of CAP also represent a significant burden in the Region. The burden of pneumococcal disease can be reduced with programmes of effective vaccination. Recommendations on pneumococcal vaccination in adults vary widely across the Region. The main barrier to implementation of vaccination programmes is low awareness among healthcare professionals on serious heatlh consequences of adult pneumococcal disease and of vaccination options. The Expert Panel calls on healthcare providers in the Region to improve pneumococcal surveillance, optimize and disseminate recommendations for adult vaccination, and support awareness and education programmes about adult pneumococcal disease. [ABSTRACT FROM AUTHOR]
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- 2012
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34. Pneumococcal vaccination for acute otitis media.
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Marchetti F, Bua J, Ventura A, Arguedas A, Soley C, Prymula R, and Schuerman L
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- 2006
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35. Covid-19 antigen testing: better than we know? A test accuracy study.
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Homza M, Zelena H, Janosek J, Tomaskova H, Jezo E, Kloudova A, Mrazek J, Svagera Z, and Prymula R
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- Antigens, Viral, China, Humans, SARS-CoV-2, Sensitivity and Specificity, COVID-19
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Background: Antigen testing for SARS-CoV-2 is considered to be less sensitive than the standard reference method - real-time PCR (RT-PCR). It has been suggested that many patients with positive RT-PCR 'missed' by antigen testing might be non-infectious., Methods: In a real-world high-throughput setting for asymptomatic or mildly symptomatic patients, 494 patients were tested using RT-PCR as well as a single lateral flow antigen test (Ecotest, AssureTech, China). Where the results differed, virus viability was evaluated by cell culture. The test parameters were calculated with RT-PCR and RT-PCR adjusted on viability as reference standards., Results: The overall sensitivity of the used antigen test related to the RT-PCR only was 76.2%, specificity was 97.3%. However, 36 out of 39 patients 'missed' by the antigen test contained no viable virus. After adjusting on that, the sensitivity grew to 97.7% and, more importantly for disease control purposes, the negative predictive value reached 99.2%., Conclusions: We propose that viability testing should be always performed when evaluating a new antigen test. A well-chosen and validated antigen test provides excellent results in identifying patients who are shedding viable virus (although some caveats still remain) in the real-world high-throughput setting of asymptomatic or mildly symptomatic individuals.
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- 2021
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36. Correlation of protection against varicella in a randomized Phase III varicella-containing vaccine efficacy trial in healthy infants.
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Habib MA, Prymula R, Carryn S, Esposito S, Henry O, Ravault S, Usonis V, Wysocki J, Gillard P, and Povey M
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- Antibodies, Viral, Chickenpox Vaccine, Child, Europe, Herpesvirus 3, Human, Humans, Infant, Measles-Mumps-Rubella Vaccine, Vaccines, Combined, Chickenpox prevention & control, Measles
- Abstract
Background: Varicella vaccination confers high and long-lasting protection against chickenpox and induces robust immune responses, but an absolute correlate of protection (CoP) against varicella has not been established. This study models the relationship between varicella humoral response and protection against varicella., Methods: This was a post-hoc analysis of data from a Phase IIIb, multicenter, randomized trial (NCT00226499) conducted in ten varicella-endemic European countries. Healthy children aged 12-22 months were randomized 3:3:1 to receive one dose of measles-mumps-rubella and one dose of varicella vaccine (one-dose group) or two doses of measles-mumps-rubella-varicella vaccine (two-dose group) or two doses of measles-mumps-rubella vaccine (control group) six weeks apart. The study remained observer-blind until completion, except in countries with obligatory additional immunizations. The objective was to correlate varicella-specific antibody concentrations with protection against varicella and probability of varicella breakthrough, using Cox proportional hazards and Dunning and accelerated failure time statistical models. The analysis was guided by the Prentice framework to explore a CoP against varicella., Results: The trial included 5803 participants, 5289 in the efficacy (2266: one-dose group, 2279: two-dose group and 744: control group) and 5235 (2248, 2245 and 742 in the same groups) in the immunogenicity cohort. The trial ended in 2016 with a median follow-up time of 9.8 years. Six weeks after vaccination with one- or two-dose varicella-containing vaccine, more than 93.0% of vaccinees were seropositive for varicella-specific antibodies. Estimated vaccine efficacy correlated positively with antibody concentrations. The fourth Prentice CoP criterion was not met, due to predicted positive vaccine efficacy in seronegative participants. Further modelling showed decreased probability of moderate to severe varicella breakthrough with increasing varicella-specific antibody concentrations (ten-year probability <0.1 for antibody concentrations ≥2-fold above the seropositivity cut-off)., Conclusions: Varicella-specific antibody concentrations are a good predictor of protection, given their inverse correlation with varicella occurrence., Clinical Trial: NCT00226499., Competing Interests: Declaration of Competing Interest Md Ahsan Habib, Stephane Carryn, Ouzama Henry, Stéphanie Ravault, Paul Gillard and Michael Povey are employees of the GSK groups of companies. Md Ahsan Habib, Stephane Carryn, Ouzama Henry, Stéphanie Ravault and Paul Gillard hold shares in the GSK group of companies as part of their employee remuneration. Roman Prymula received grant support from the GSK group of companies. Susanna Esposito received grant support from Abbott and DMG companies; personal fees from MSD company; and grant support and personal fees from the GSK group of companies, Sanofi, Vifor Pharma and Janssen Pharmaceutica. Jacek Wysocki received personal fees from the GSK group of companies during the conduct of the study. Vytautas Usonis received grant from the GSK group of companies during the conduct of the study and as educational grant. All authors have no non-financial interest to declare., (Copyright © 2021 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.)
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- 2021
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37. Ten-year follow-up on efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: Results from five East European countries.
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Prymula R, Povey M, Brzostek J, Cabrnochova H, Chlibek R, Czajka H, Leviniene G, Man S, Neamtu M, Pazdiora P, Plesca D, Ruzkova R, Stefkovicova M, Usonis V, Verdanova D, Wysocki J, Casabona G, and Habib MA
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- Antibodies, Viral, Chickenpox Vaccine adverse effects, Child, Czech Republic, Europe, Follow-Up Studies, Humans, Infant, Measles-Mumps-Rubella Vaccine, Poland, Romania, Slovakia, Vaccines, Combined adverse effects, Measles, Mumps, Rubella prevention & control
- Abstract
Background: We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia., Methods: This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12-22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirmed by viral DNA detection or epidemiological link and clinical assessment) was calculated with 95% confidence intervals using Cox proportional hazards regression model. Immunogenicity was assessed as seropositivity rates and geometric mean concentrations (GMCs). Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded., Results: A total of 3705 children were vaccinated (1590, MMRV group; 1586, MMR + V group; 529, MMR group). There were 663 confirmed varicella cases (47, MMRV group; 349, MMR + V group; 267, MMR group). VE ranged between 95.4% (Lithuania) and 97.4% (Slovakia) in the MMRV group and between 59.3% (Lithuania) and 74% (Slovakia) in the MMR + V group. At year 10, seropositivity rates were 99.5%-100% in the MMRV group, 98%-100% in the MMR + V group and 50%-100% in the MMR control group, and the anti-VZV antibody GMCs were comparable between MMRV and MMR + V groups. The occurrence of solicited and unsolicited AEs was similar across groups and no SAE was considered as vaccination-related. No new safety concerns were identified., Conclusions: Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination., Competing Interests: Declaration of Competing Interest GC, MAH, MP are employees of the GSK group of companies, and GC and MAH hold shares in the GSK group of companies as part of the employee remuneration. DV, JW, MS, RP, VU have received grants from the GSK group of companies during the conduct of the study. JW, MS have received consulting and lecture fees from the GSK group of companies. MS has received non-financial support from the GSK group of companies to attend scientific meetings, outside the submitted work. DV reports to have received personal fees by Biovomed during the conduct of the study. DV moreover reports to have received personal fees from the GSK group of companies, MSD, Sanofi and Pfizer, outside the submitted work. RR reports that her institution received fees during the conduct of the study. DP, GL, HCa, HCz, JB, NM, PP, RC, SM have not received any consulting fees and declare that they have no conflicts of interest and have no non-financial interest to declare., (Copyright © 2021 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.)
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- 2021
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38. Five Antigen Tests for SARS-CoV-2: Virus Viability Matters.
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Homza M, Zelena H, Janosek J, Tomaskova H, Jezo E, Kloudova A, Mrazek J, Svagera Z, and Prymula R
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- Adult, COVID-19 diagnosis, COVID-19 Nucleic Acid Testing, False Negative Reactions, Female, Humans, Male, Mass Screening, Middle Aged, Sensitivity and Specificity, Antigens, Viral analysis, COVID-19 immunology, COVID-19 Testing methods, Microbial Viability, SARS-CoV-2 immunology, Serologic Tests methods
- Abstract
Antigen testing for SARS-CoV-2 (AGT) is generally considered inferior to RT-PCR testing in terms of sensitivity. However, little is known about the infectiousness of RT-PCR positive patients who pass undetected by AGT. In a screening setting for mildly symptomatic or asymptomatic patients with high COVID-19 prevalence (30-40%), 1141 patients were tested using one of five AGTs and RT-PCR. Where the results differed, virus viability in the samples was tested on cell culture (CV-1 cells). The test battery included AGTs by JOYSBIO, Assure Tech, SD Biosensor, VivaChek Biotech and NDFOS. Sensitivities of the ATGs compared to RT-PCR ranged from 42% to 76%. The best test yielded a 76% sensitivity, 97% specificity, 92% positive, and 89% negative predictive values, respectively. However, in the best performing ATG tests, almost 90% of samples with "false negative" AGT results contained no viable virus. Corrected on the virus viability, sensitivities grew to 81-97% and, with one exception, the tests yielded high specificities >96%. Performance characteristics of the best test after adjustment were 96% sensitivity, 97% specificity, 92% positive, and 99% negative predictive values (high prevalence population). We, therefore, believe that virus viability should be considered when assessing the AGT performance. Also, our results indicate that a well-performing antigen test could in a high-prevalence setting serve as an excellent tool for identifying patients shedding viable virus. We also propose that the high proportion of RT-PCR-positive samples containing no viable virus in the group of "false negatives" of the antigen test should be further investigated with the aim of possibly preventing needless isolation of such patients.
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- 2021
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39. Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement.
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Abu-Raya B, Maertens K, Edwards KM, Omer SB, Englund JA, Flanagan KL, Snape MD, Amirthalingam G, Leuridan E, Damme PV, Papaevangelou V, Launay O, Dagan R, Campins M, Cavaliere AF, Frusca T, Guidi S, O'Ryan M, Heininger U, Tan T, Alsuwaidi AR, Safadi MA, Vilca LM, Wanlapakorn N, Madhi SA, Giles ML, Prymula R, Ladhani S, Martinón-Torres F, Tan L, Michelin L, Scambia G, Principi N, and Esposito S
- Subjects
- Clinical Trials as Topic ethics, Consensus, Ethics, Medical, Female, Global Health, Health Impact Assessment, Health Priorities, Humans, Immunogenicity, Vaccine, Maternal Exposure, Pregnancy, Prenatal Exposure Delayed Effects, Research, Risk Assessment, Risk Factors, Vaccination, Vaccines administration & dosage, Vaccines adverse effects, Vaccines immunology, Immunization adverse effects, Immunization ethics, Immunization methods, Immunization trends, Pregnancy Complications, Infectious epidemiology, Pregnancy Complications, Infectious prevention & control
- Abstract
Immunization during pregnancy has been recommended in an increasing number of countries. The aim of this strategy is to protect pregnant women and infants from severe infectious disease, morbidity and mortality and is currently limited to tetanus, inactivated influenza, and pertussis-containing vaccines. There have been recent advancements in the development of vaccines designed primarily for use in pregnant women (respiratory syncytial virus and group B Streptococcus vaccines). Although there is increasing evidence to support vaccination in pregnancy, important gaps in knowledge still exist and need to be addressed by future studies. This collaborative consensus paper provides a review of the current literature on immunization during pregnancy and highlights the gaps in knowledge and a consensus of priorities for future research initiatives, in order to optimize protection for both the mother and the infant., (Copyright © 2020 Abu-Raya, Maertens, Edwards, Omer, Englund, Flanagan, Snape, Amirthalingam, Leuridan, Damme, Papaevangelou, Launay, Dagan, Campins, Cavaliere, Frusca, Guidi, O'Ryan, Heininger, Tan, Alsuwaidi, Safadi, Vilca, Wanlapakorn, Madhi, Giles, Prymula, Ladhani, Martinón-Torres, Tan, Michelin, Scambia, Principi and Esposito.)
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- 2020
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40. Complex Reporting of the COVID-19 Epidemic in the Czech Republic: Use of an Interactive Web-Based App in Practice.
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Komenda M, Bulhart V, Karolyi M, Jarkovský J, Mužík J, Májek O, Šnajdrová L, Růžičková P, Rážová J, Prymula R, Macková B, Březovský P, Marounek J, Černý V, and Dušek L
- Subjects
- COVID-19, Czech Republic epidemiology, Data Mining, Humans, Internet, Pandemics, SARS-CoV-2, Software, Betacoronavirus, Coronavirus Infections epidemiology, Pneumonia, Viral epidemiology
- Abstract
Background: The beginning of the coronavirus disease (COVID-19) epidemic dates back to December 31, 2019, when the first cases were reported in the People's Republic of China. In the Czech Republic, the first three cases of infection with the novel coronavirus were confirmed on March 1, 2020. The joint effort of state authorities and researchers gave rise to a unique team, which combines methodical knowledge of real-world processes with the know-how needed for effective processing, analysis, and online visualization of data., Objective: Due to an urgent need for a tool that presents important reports based on valid data sources, a team of government experts and researchers focused on the design and development of a web app intended to provide a regularly updated overview of COVID-19 epidemiology in the Czech Republic to the general population., Methods: The cross-industry standard process for data mining model was chosen for the complex solution of analytical processing and visualization of data that provides validated information on the COVID-19 epidemic across the Czech Republic. Great emphasis was put on the understanding and a correct implementation of all six steps (business understanding, data understanding, data preparation, modelling, evaluation, and deployment) needed in the process, including the infrastructure of a nationwide information system; the methodological setting of communication channels between all involved stakeholders; and data collection, processing, analysis, validation, and visualization., Results: The web-based overview of the current spread of COVID-19 in the Czech Republic has been developed as an online platform providing a set of outputs in the form of tables, graphs, and maps intended for the general public. On March 12, 2020, the first version of the web portal, containing fourteen overviews divided into five topical sections, was released. The web portal's primary objective is to publish a well-arranged visualization and clear explanation of basic information consisting of the overall numbers of performed tests, confirmed cases of COVID-19, COVID-19-related deaths, the daily and cumulative overviews of people with a positive COVID-19 case, performed tests, location and country of infection of people with a positive COVID-19 case, hospitalizations of patients with COVID-19, and distribution of personal protective equipment., Conclusions: The online interactive overview of the current spread of COVID-19 in the Czech Republic was launched on March 11, 2020, and has immediately become the primary communication channel employed by the health care sector to present the current situation regarding the COVID-19 epidemic. This complex reporting of the COVID-19 epidemic in the Czech Republic also shows an effective way to interconnect knowledge held by various specialists, such as regional and national methodology experts (who report positive cases of the disease on a daily basis), with knowledge held by developers of central registries, analysts, developers of web apps, and leaders in the health care sector., (©Martin Komenda, Vojtěch Bulhart, Matěj Karolyi, Jiří Jarkovský, Jan Mužík, Ondřej Májek, Lenka Šnajdrová, Petra Růžičková, Jarmila Rážová, Roman Prymula, Barbora Macková, Pavel Březovský, Jan Marounek, Vladimír Černý, Ladislav Dušek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 27.05.2020.)
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- 2020
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41. Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine.
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Danier J, Rivera L, Claeys C, Dbaibo G, Jain VK, Kosalaraksa P, Woo W, Yanni E, Zaman K, Acosta B, Amanullah A, Ariza M, Luisa Arroba Basanta M, Bavdekar A, Carmona A, Cousin L, Diaz A, Diez-Domingo J, Cagri Dinleyici E, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Antionette Gonzales L, Hacimustafaoglu M, Hughes SM, Izu A, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinón-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Soni J, Szymanski H, Ulied A, Schuind A, and Innis BL
- Subjects
- Child, Preschool, Female, Hospitalization, Humans, Infant, Influenza Vaccines administration & dosage, Influenza, Human diagnosis, Male, Odds Ratio, Prevalence, Proportional Hazards Models, Public Health Surveillance, Severity of Illness Index, Symptom Assessment, Vaccination, Vaccines, Inactivated administration & dosage, Vaccines, Inactivated immunology, Influenza Vaccines immunology, Influenza, Human epidemiology, Influenza, Human prevention & control
- Abstract
Background: In an exploratory analysis of an inactivated quadrivalent influenza vaccine (IIV4) trial in children 6-35 months without risk factors for influenza, we evaluated clinical presentation of influenza illness and vaccine impact on health outcomes., Methods: This phase III trial was conducted in 13 geographically diverse countries across 5 influenza seasons (2011-2014). Children were randomized 1:1 to IIV4 or control. Active surveillance was performed for influenza-like episodes (ILE); influenza was confirmed by reverse transcription polymerase chain reaction (RT-PCR). The total vaccinated cohort was evaluated (N = 12,018)., Results: 5702 children experienced ≥1 ILE; 356 (IIV4 group) and 693 (control group) children had RT-PCR-confirmed influenza. Prevalence of ILE was similar in RT-PCR-positive and RT-PCR-negative cases regardless of vaccination. Breakthrough influenza illness was attenuated in children vaccinated with IIV4; moderate-to-severe illness was 41% less likely to be reported in the IIV4 group than the control group [crude odds ratio: 0.59 (95% confidence intervals: 0.44-0.77)]. Furthermore, fever >39°C was 46% less frequent following vaccination with IIV4 than with control [crude odds ratio: 0.54 (95% confidence intervals: 0.39-0.75)] in children with breakthrough illness. Health outcome analysis showed that, each year, IIV4 would prevent 54 influenza cases per 1000 children and 19 children would need to be vaccinated to prevent 1 new influenza case., Conclusions: In addition to preventing influenza in 50% of participants, IIV4 attenuated illness severity and disease burden in children who had a breakthrough influenza episode despite vaccination.
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- 2019
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42. Comparison of vaccination coverage of four childhood vaccines in New Zealand and New York State.
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Baumann KE, Paynter J, Petousis-Harris H, Prymula R, Yang YT, and Shaw J
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- Child, Child, Preschool, Communicable Disease Control methods, Female, Humans, Immunization Schedule, Incidence, Male, New York, New Zealand, Rural Population, Urban Population, Viral Vaccines, Diphtheria-Tetanus-Pertussis Vaccine administration & dosage, Hepatitis B Vaccines administration & dosage, Measles-Mumps-Rubella Vaccine administration & dosage, Poliovirus Vaccines administration & dosage, Vaccination Coverage statistics & numerical data
- Abstract
Aim: To ensure that children are vaccinated, different national governments use diverse strategies. We compared childhood vaccination coverage rates between New York State (NYS) and New Zealand (NZ) as the vaccination strategies are different., Methods: We used vaccination records from the NYS Immunisation Information System and the National Immunisation Register of NZ to measure (i) vaccination coverage by school entry and by age six; (ii) coverage of different socio-demographic groups; and (iii) trend in vaccination coverage between 2011 and 2015., Results: We analysed the records of 583 767 NYS children and 269 800 NZ children 7 years of age. NZ children were 3.3-21.5% more likely than NYS children to receive each of the vaccines. Compared to NYS, NZ children were 39.6% more likely to be up-to-date by the start of school and 28.1% more likely to be up-to-date by age 6 years. Both NYS and NZ had statistically significant increases in the proportion of children who were up to date on each vaccine and all vaccines by the start of school and by 6 years of age (P < 0.001)., Conclusions: We identified under-vaccinated groups and examined the point in the vaccine series where children were most vulnerable to being under-vaccinated. This information is useful in targeting future investigations and interventions aimed at mitigating disparities in vaccine coverage. This comparison of regions with different vaccination programmes and policies is important when considering whether the particular vaccination coverage strategies of one region could be adapted and applied for the benefit of another., (© 2018 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)
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- 2019
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43. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial.
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Povey M, Henry O, Riise Bergsaker MA, Chlibek R, Esposito S, Flodmark CE, Gothefors L, Man S, Silfverdal SA, Štefkovičová M, Usonis V, Wysocki J, Gillard P, and Prymula R
- Subjects
- Chickenpox Vaccine administration & dosage, Chickenpox Vaccine adverse effects, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions pathology, Europe, Female, Follow-Up Studies, Humans, Immunization Schedule, Infant, Male, Single-Blind Method, Treatment Outcome, Vaccines, Combined administration & dosage, Vaccines, Combined adverse effects, Vaccines, Combined immunology, Chickenpox prevention & control, Chickenpox Vaccine immunology
- Abstract
Background: The duration of protection provided by varicella vaccines is unclear. We assessed the 10-year vaccine efficacy of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR + V), versus two MMR doses (control vaccine) for the prevention of confirmed varicella., Methods: This was a phase 3b follow-up of an observer-blinded, randomised, controlled trial. In phase a, children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden were randomly assigned by computer-generated randomisation list (3:3:1) to receive two doses of MMRV, one dose of MMR and one dose of varicella vaccine, or two doses of MMR, 42 days apart. Varicella cases were confirmed by detection of viral DNA, or epidemiological link and clinical assessment, by an independent data monitoring committee; disease severity was based on a modified Vázquez scale. Hazard ratios for MMRV and MMR + V versus MMR estimated in the per-protocol cohort using a Cox proportional hazards regression model were used to calculate vaccine efficacy and 95% CI. Serious adverse events were recorded throughout the study in all vaccinated children. Study objectives were secondary and descriptive. The trial is registered at ClinicalTrials.gov, number NCT00226499., Findings: Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. The per-protocol cohort included 2279 children from the MMRV group, 2266 from the MMR + V group, and 744 from the MMR group. From baseline to a median follow-up of 9·8 years, 76 (3%) children in the MMRV group, 469 (21%) in the MMR + V group, and 352 (47%) in the MMR group had varicella. Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V. During phase b, serious adverse events were reported by 290 (15%) of 1961 children in the MMRV group, 317 (16%) of 1978 in the MMR + V group, and 93 (15%) of 641 in the MMR group. There were no treatment-related deaths., Interpretation: The 10-years vaccine efficacy observed, suggests that a two-dose schedule of varicella vaccine provided optimum long-term protection for the prevention of varicella by offering individual protection against all severities of disease and leading to a potential reduction in transmission, as observed in the US experience with universal mass vaccination., Funding: GlaxoSmithKline Biologicals., (Copyright © 2019 Elsevier Ltd. All rights reserved.)
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- 2019
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44. Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naïve Children.
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Claeys C, Chandrasekaran V, García-Sicilia J, Prymula R, Díez-Domingo J, Brzostek J, Marès-Bermúdez J, Martinón-Torres F, Pollard AJ, Růžková R, Carmona Martinez A, Ulied A, Miranda Valdivieso M, Faust SN, Snape MD, Friel D, Ollinger T, Soni J, Schuind A, Li P, Innis BL, and Jain VK
- Subjects
- Antibodies, Neutralizing blood, Antibodies, Viral blood, Child, Preschool, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions pathology, Female, Hemagglutination Inhibition Tests, Humans, Infant, Influenza Vaccines administration & dosage, Male, Neutralization Tests, Vaccines, Inactivated administration & dosage, Vaccines, Inactivated adverse effects, Vaccines, Inactivated immunology, Immunologic Memory, Influenza Vaccines adverse effects, Influenza Vaccines immunology, Influenza, Human prevention & control
- Abstract
Background: It has not yet been demonstrated whether 2 doses of inactivated quadrivalent influenza vaccine (IIV4) prime a booster response in infants. We evaluated the anamnestic immune response to an IIV4 in children 17-48 months of age., Methods: Children were randomized to 2 doses of IIV4 or control in the primary phase III study (NCT01439360). One year later, in an open-label revaccination extension study (NCT01702454), a subset of children who received IIV4 in the primary study (primed group) received 1 IIV4 dose and children who received control in the primary study (unprimed) received 2 IIV4 doses 28 days apart. The primary objective was to evaluate hemagglutination inhibition (HI) antibody titers 7 days after first IIV4 vaccination in the per-protocol cohort (N = 224 primed; N = 209 unprimed). Neutralizing and antineuraminidase antibodies were also measured. Safety was analyzed in the total vaccinated cohort (N = 241 primed; N = 229 unprimed)., Results: An anamnestic response was observed in primed children relative to unprimed controls, measured by age-adjusted geometric mean HI titer ratios against strains homologous (A/H1N1: 9.0; B/Victoria: 3.9) and heterologous (A/H3N2: 2.7; B/Yamagata: 6.7) to those in the primary vaccination series. The anamnestic response in primed children included increases in neutralizing antibodies (mean geometric increase: 5.0-10.6) and antineuraminidase antibodies (4.9-8.8). No serious adverse events related to vaccination were reported., Conclusions: In this study, 2-dose priming with IIV4 induced immune memory that was recalled with 1-dose IIV4 the following year to boost HI, antineuraminidase and neutralizing antibodies, even though the IIV4 strain composition partially changed.
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- 2019
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45. Immunogenicity and safety of 11- and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study.
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Carmona Martinez A, Prymula R, Miranda Valdivieso M, Otero Reigada MDC, Merino Arribas JM, Brzostek J, Szenborn L, Ruzkova R, Horn MR, Jackowska T, Centeno-Malfaz F, Traskine M, Dobbelaere K, and Borys D
- Subjects
- Bacterial Proteins genetics, Carrier Proteins genetics, Diphtheria-Tetanus-Pertussis Vaccine administration & dosage, Female, Haemophilus influenzae, Hepatitis B Vaccines administration & dosage, Humans, Immunization, Secondary, Immunoglobulin D genetics, Infant, Lipoproteins genetics, Male, Pneumococcal Infections immunology, Pneumococcal Vaccines adverse effects, Poliovirus Vaccine, Inactivated administration & dosage, Serogroup, Streptococcus pneumoniae, Vaccines, Combined administration & dosage, Vaccines, Conjugate adverse effects, Vaccines, Conjugate immunology, Antibodies, Bacterial blood, Bacterial Proteins immunology, Carrier Proteins immunology, Immunogenicity, Vaccine, Immunoglobulin D immunology, Lipoproteins immunology, Pneumococcal Infections prevention & control, Pneumococcal Vaccines immunology
- Abstract
Background: We assessed 2 investigational 11- and 12-valent vaccines, containing capsular polysaccharides of 10 serotypes as in the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and CRM
197 -conjugated capsular polysaccharides of serotypes 19A (11-valent) or 19A and 6A (12-valent)., Methods: In this phase II, partially-blind, multicentre study (NCT01204658), healthy infants were randomised (1:1:1:1) to receive 11vPHiD-CV, 12vPHiD-CV, PHiD-CV, or 13-valent CRM197 -conjugate pneumococcal vaccine (PCV13), at 2, 3, and 4 (primary series), and 12-15 months of age (booster dose), co-administered with DTPa-HBV-IPV/Hib. Confirmatory objectives assessed non-inferiority of investigational vaccines to comparators (PHiD-CV for common serotypes; PCV13 for 19A and 6A), in terms of percentage of infants with pneumococcal antibody concentrations ≥0.2 μg/mL and antibody geometric mean concentrations, post-primary vaccination. Reactogenicity and safety were assessed., Results: 951 children received ≥1 primary dose, 919 a booster dose. Pre-defined immunological non-inferiority criteria were met simultaneously for 9/11 11vPHiD-CV serotypes (all except 23F and 19A) and 10/12 12vPHiD-CV serotypes (all except 19A and 6A); thus, non-inferiority objectives were reached. For each PHiD-CV serotype, percentages of children with antibody concentrations ≥0.2 µg/mL were ≥96.7% post-primary (except 6B [≥75.2%] and 23F [≥81.1%]), and ≥98.1% post-booster vaccination. For each PHiD-CV serotype except serotype 1, ≥81.0% and ≥93.9% of children had opsonophagocytic activity titres ≥8, post-primary and booster vaccination. AEs incidence was similar across all groups. SAEs were reported for 117 children (29 in the 11vPHiD-CV group, 26 in the 12vPHiD-CV group, 38 in the PHiD-CV group and 24 in the PCV13 group); 4 SAEs were considered vaccination-related. No fatal events were recorded., Conclusion: Addition of 19A and 6A CRM197 -conjugates did not alter immunogenicity of the PHiD-CV conjugates; for both investigational vaccines post-booster immune responses to 10 common serotypes appeared similar to those elicited by PHiD-CV. Safety and reactogenicity profiles of the investigational vaccines were comparable to PHiD-CV. Clinical trial registry: NCT01204658., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2019
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46. Vaccination of 50+ adults to promote healthy ageing in Europe: The way forward.
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Esposito S, Principi N, Rezza G, Bonanni P, Gavazzi G, Beyer I, Sulzner M, Celentano LP, Prymula R, Rappagliosi A, Sevilla J, and Poland G
- Subjects
- Aged, Communicable Disease Control, Communicable Diseases epidemiology, Congresses as Topic, Decision Making, Europe, Health Resources, Humans, Middle Aged, Vaccination statistics & numerical data, Healthy Aging, Preventive Health Services trends, Vaccination trends
- Abstract
The proportion of the population ≥65 years old is about 17% today and will be about 27% in 2050 worldwide. The problem, however, is not ageing in itself, it is individual disabilities associated with ageing. This manuscript summarizes the consensus points reached during a pan-European meeting on gaps and barriers in making vaccination of adults aged 50+ a reality and on further joint actions in Europe. The shift from childhood to life-long vaccination is essential to prevent disability, morbidity and mortality in the elderly and promote healthy ageing. This vaccination shift is a major challenge in the post-truth, media-based era in countries with dwindling resources for the provision of healthcare. The challenge can be met only by adopting an innovative approach designed to shift the mindset of decision-makers from treatment to prevention. A number of key actions are required and for these actions a European multidisciplinary network including health authorities, medical doctors with different specialties, sociologists, psychologists, pharmaceutical companies and Associations of patients appears mandatory., (Copyright © 2018 Elsevier Ltd. All rights reserved.)
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- 2018
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47. Vaccination in newly arrived immigrants to the European Union.
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Prymula R, Shaw J, Chlibek R, Urbancikova I, and Prymulova K
- Subjects
- Chickenpox prevention & control, Emigrants and Immigrants statistics & numerical data, Humans, Immunization Schedule, Measles prevention & control, Mumps prevention & control, Public Health methods, Refugees statistics & numerical data, Rubella prevention & control, Vaccines therapeutic use, Whooping Cough prevention & control, European Union statistics & numerical data, Vaccination methods
- Abstract
The challenge of assimilating millions of immigrants in the European region each year presents significant socioeconomic issues. Among them is the threat of vaccine preventable diseases (VPDs) disease transmission within immigrant groups and the broader population given the permeability of nation state borders. A total of 3.8 million people immigrated to the European Union (EU) in 2014, among those were 1.6 million non-EU nationals. While vaccines have markedly reduced the transmission of disease, clusters of under-vaccinated individuals potentiate the rapid transmission of once-eradicated or controlled diseases. Immigrants pose a special challenge to host country public health vaccination programmes. Wars in their native countries may have interrupted vaccination programmes, documentation may be unavailable or unreliable, and refugees may present with health issues due to poor sanitation and food during transit. Further, immigrants are often reticent to access health care in the destination country, or may face financial or language barriers. Thus, preventive health care needs may go unaddressed and the first contact with a clinician is for an emergency. Equitable access to acute and preventive health care and services, including immunizations irrespective of individual's immigration status, should be a priority for European region countries. Ensuring appropriate and timely vaccination for immigrants could be accomplished with a universal European region immunization schedule. Priority should be given to highly communicable VPDs such as measles, mumps, rubella, pertussis, diphtheria, varicella and polio., (Copyright © 2017. Published by Elsevier Ltd.)
- Published
- 2018
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48. Immunogenicity and Safety of Primary and Booster Vaccinations of a Fully Liquid DTaP-IPV-HB-PRP-T Hexavalent Vaccine in Healthy Infants and Toddlers in Germany and the Czech Republic.
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Prymula R, Kieninger D, Feroldi E, Jordanov E, B'Chir S, and DaCosta X
- Subjects
- Antibodies, Bacterial blood, Antibodies, Viral blood, Czech Republic, Diphtheria-Tetanus-acellular Pertussis Vaccines administration & dosage, Female, Germany, Haemophilus Vaccines administration & dosage, Hepatitis B Vaccines administration & dosage, Humans, Immunization Schedule, Immunization, Secondary, Infant, Infant, Newborn, Male, Poliovirus Vaccine, Inactivated administration & dosage, Suspensions administration & dosage, Tetanus Toxoid administration & dosage, Vaccination, Vaccines, Combined administration & dosage, Diphtheria-Tetanus-acellular Pertussis Vaccines immunology, Haemophilus Vaccines immunology, Hepatitis B Vaccines immunology, Immunogenicity, Vaccine, Poliovirus Vaccine, Inactivated immunology, Tetanus Toxoid immunology, Vaccines, Combined immunology
- Abstract
To support a fully liquid, diphtheria (D)-tetanus (T)-acellular pertussis (aP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) vaccine in Europe using a 2, 3, 4 month primary series and a booster at 11-15 months of age. Phase III, randomized, observer-blind studies in Germany and the Czech Republic. Participants who had not received HB vaccine were randomized to a 2, 3, 4 month primary series of DTaP-IPV-HB-PRP-T (group 1; N = 266) or a reconstituted DTaP-HB-IPV//PRP-T comparator (group 2; N = 263) and a booster of the same vaccine. Pneumococcal vaccine (PCV13) and rotavirus vaccine were coadministered at 2, 3, 4 months, and the booster was coadministered with PCV13. Noninferiority (group 1 versus group 2) was tested postprimary series for seroprotection rates (anti-HB and anti-PRP) and vaccine response rates (anti-pertussis toxin and anti-filamentous hemagglutinin). Safety was assessed by parental reports. Noninferiority was demonstrated with the lower bound of the 95% confidence interval for the difference (group 1 to group 2) being > -10% for each comparison. Primary series immune responses were high for all antigens and similar in each group. Prebooster antibody persistence was good, and there was a strong anamnestic response, both being similar for the investigational and control vaccines. Responses to PCV13 and rotavirus vaccine were similar in each group. There were no safety concerns. These data support the use of the DTaP-IPV-HB-PRP-T vaccine in a 2, 3, 4 month schedule without a birth dose of HB vaccine, with a booster dose in the second year of life administered with routine childhood vaccines.
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- 2018
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49. Prevention of vaccine-matched and mismatched influenza in children aged 6-35 months: a multinational randomised trial across five influenza seasons.
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Claeys C, Zaman K, Dbaibo G, Li P, Izu A, Kosalaraksa P, Rivera L, Acosta B, Arroba Basanta ML, Aziz A, Cabanero MA, Chandrashekaran V, Corsaro B, Cousin L, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Friel D, Garcia-Sicilia J, Gomez-Go GD, Antoinette Gonzales ML, Hughes SM, Jackowska T, Kant S, Lucero M, Malvaux L, Mares Bermudez J, Martinon-Torres F, Miranda M, Montellano M, Peix Sambola MA, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Salamanca de la Cueva I, Sokal E, Soni J, Szymanski H, Ulied A, Schuind A, Jain VK, and Innis BL
- Subjects
- Child, Preschool, Female, Humans, Infant, Influenza, Human epidemiology, Internationality, Male, Seasons, Single-Blind Method, Influenza Vaccines, Influenza, Human prevention & control
- Abstract
Background: Despite the importance of vaccinating children younger than 5 years, few studies evaluating vaccine prevention of influenza have been reported in this age group. We evaluated efficacy of an inactivated quadrivalent influenza vaccine (IIV4) in children aged 6-35 months., Methods: In this phase 3, observer-blinded, multinational trial, healthy children from 13 countries in Europe, Central America, and Asia were recruited in five independent cohorts, each in a different influenza season. Participants were randomly assigned (1:1) to either IIV4 (15 μg haemagglutinin antigen per strain per 0·5 mL dose; a single dose on day 0 for vaccine-primed children, and two doses, on days 0 and 28, for vaccine-unprimed children) or to one or two doses of a non-influenza control vaccine. Primary endpoints were moderate-to-severe influenza or all influenza (irrespective of disease severity) confirmed by RT-PCR on nasal swabs. Cultured isolates were further characterised as antigenically matched or mismatched to vaccine strains. Efficacy was assessed in the per-protocol cohort and total vaccinated cohort (time-to-event analysis), and safety was assessed in the total vaccinated cohort., Findings: Between Oct 1, 2011, and Dec 31, 2014, 12 018 children were recruited into the total vaccinated cohort (6006 children in the IIV4 group and 6012 children in the control group). 356 (6%) children in the IIV4 group and 693 (12%) children in the control group had at least one case of RT-PCR-confirmed influenza. Of these 1049 influenza strains, 138 (13%) were A/H1N1, 529 (50%) were A/H3N2, 69 (7%) were B/Victoria, and 316 (30%) were B/Yamagata. Overall, 539 (64%) of 848 antigenically characterised isolates were vaccine-mismatched (16 [15%] of 105 for A/H1N1; 368 [97%] of 378 for A/H3N2; 54 [86%] of 63 for B/Victoria; 101 [33%] of 302 for B/Yamagata). Vaccine efficacy was 63% (97·5% CI 52-72) against moderate-to-severe influenza and 50% (42-57) against all influenza in the per-protocol cohort, and 64% (53-73) against moderate-to-severe influenza and 50% (42-57) against all influenza in the total vaccinated cohort. There were no clinically meaningful safety differences between IIV4 and control., Interpretation: IIV4 prevented influenza A and B in children aged 6-35 months despite high levels of vaccine mismatch. Vaccine efficacy was highest against moderate-to-severe disease, which is the most clinically important endpoint associated with greatest burden., Funding: GlaxoSmithKline Biologicals SA., (Copyright © 2018 Elsevier Ltd. All rights reserved.)
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- 2018
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50. Influenza vaccination in the elderly.
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Smetana J, Chlibek R, Shaw J, Splino M, and Prymula R
- Subjects
- Aged, Animals, Humans, Vaccination methods, Aging immunology, Influenza Vaccines immunology, Influenza, Human immunology, Influenza, Human prevention & control
- Abstract
Seasonal influenza is a prevalent and serious annual illness resulting in widespread morbidity and economic disruption throughout the population; the elderly and immunocompromised are particularly vulnerable to serious sequelae and mortality. The changing demographics worldwide to an aging society have important implications for public health policy and pharmaceutical innovations. For instance, primary prevention via immunization is effective in reducing the burden of influenza illness among the elderly. However, the elderly may be insufficiently protected by vaccination due to the immunosenescence which accompanies aging. In addition, vaccine hesitancy among the younger populations increases the likelihood of circulating infectious diseases, and thus concomitant exposure. While it is clear that the development of more immunogenic vaccines is an imperative and worthy endeavor, clinical trials continue to demonstrate that the current influenza vaccine formulation remains highly effective in reducing morbidity and mortality when well matched to circulating strains.
- Published
- 2018
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