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3 results on '"Ghesquiere W"'

1. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older

Author

Cunningham, A. L., Lal, H., Kovac, M., Chlibek, R., Hwang, S. -J., Diez-Domingo, J., Godeaux, O., Levin, M. J., Mcelhaney, J. E., Puig-Barbera, J., Vanden Abeele, C., Vesikari, T., Watanabe, D., Zahaf, T., Ahonen, A., Athan, E., Barba-Gomez, J. F., Campora, L., De Looze, F., Downey, H. J., Ghesquiere, W., Gorfinkel, I., Korhonen, T., Leung, E., Mcneil, S. A., Oostvogels, L., Rombo, L., Smetana, J., Weckx, L., Yeo, W., Heineman, T. C., Athan, E, Cunningham, Al, de Looze, F, Eizenberg, P, Yeo, W, Avelino-Silva, Tj, Neto, Jl, Santos, Rr, Weckx, L, Zerbini, Ca, Gauthier, Js, Ghesquiere, W, Gorfinkel, I, Mcelhaney, Je, Mcneil, Sa, Toma, A, Chlibek, R, Smetana, J, Poder, A, Ahonen, A, Forsten, A, Karppa, T, Korhonen, T, Seppä, I, Vesikari, T, Esen, M, Schwarz, Tf, Leung, E, Desole, Mg, Icardi, G, Pellegrino, A, Staniscia, T, Volpi, A, Ikematsu, H, Watanabe, D, Choi, Ws, Barba-Gomez, Jf, Mascarenas de Los Santos, A, Tinoco, Jc, Brotons, C, Caso, C, Diez-Domingo, J, Narejos Perez, S, Puig-Barberà, J, Rodriguez de la Pinta ML, Berglund, J, Blom, Kb, Liu, B, Pauksens, K, Rombo, L, Hwang, Sj, Thompson, A, Andrews, C, Jackson Downey, H, Freedman, M, Levin, M, Arbi, Mb, Campora, L, Catteau, G, Curran, D, Godeaux, O, Heineman, Tc, Kovac, M, Lal, H, Marion, S, Oostvogels, L, Oujaa, M, Ravault, S, Abeele, Cv, Vastiau, I, Zahaf, T, Junqueira, T, Berndtsson Blom, K, Downey, H, Rodriguez, Ml, Zerbini, C, Heineman, T, Levin, Mj, Puig, J, and Heineman, Tc.

Subjects
Male, Risk, 0301 basic medicine, Subunit, medicine.medical_specialty, Herpes Zoster Vaccine, Neuralgia, Postherpetic, Kaplan-Meier Estimate, Placebo, Herpes Zoster, law.invention, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Internal medicine, 80 and over, medicine, Humans, 030212 general & internal medicine, Aged, Aged, 80 and over, Vaccines, business.industry, Postherpetic neuralgia, General Medicine, Middle Aged, medicine.disease, Vaccine efficacy, Surgery, Clinical trial, 030104 developmental biology, Female, Vaccines, Subunit, Neuralgia, Zoster vaccine, Postherpetic, business, medicine.drug
Abstract

BACKGROUND A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01(B) adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70). METHODS This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1: 1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. RESULTS In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P

Published
2016
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2. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults

Author

Lal, H, Cunningham, A, Godeaux, O, Chlibek, R, Diez Domingo, J, Hwang, S, Levin, M, Mcelhaney, J, Poder, A, Puig, B, J, Vesikari, T, Watanabe, D, Weckx, L, Zahaf, T, Heineman, T, Arya, M, Athan, E, De Looze, F, Seale, J, Yeo, W, Goldani, L, Jacob, W, Luiz Neto, J, dos Santos, R, Zerbini, C, Dutz, J, Ghesquiere, W, Gorfinkel, I, Mcneil, S, Powell, C, Smetana, J, Ahonen, A, Korhonen, T, Seppa, I, Arnou, R, Beytout, J, Saillard, D, Dominicus, R, Esen, M, Plaßmann, G, Schwarz, T, Tyler, K, Hui, D, Leung, E, Pellegrino, A, Volpi, A, Endo, M, Cheong, H, Choi, W, Choo, E, Kim, Y, Lee, J, Park, D, Peck, K, Song, Y, Barba Gómez, J, de Los Santos, A, Tinoco, J, Bayas, J, Caso, C, Roure, J, Via, L, Pérez, S, López, C, Puig Barberà, J, de la Pinta, M, Riera, M, Bengnér, M, Berglund, J, Blom, K, Liu, B, Pauksens, K, Rombo, L, Chen, M, Cheng, H, Liu, C, Mcnally, D, Thompson, A, Andrews, C, Collins, H, Downey, H, Ervin, J, Freedman, M, Hoekstra, J, Hull, S, Marcadis, I, Rankin, B, Van Cleeff, M, Lääketieteen yksikkö - School of Medicine, and University of Tampere

Subjects
Male, Subunit, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, Herpes Zoster Vaccine, Biolääketieteet - Biomedicine, Placebo, Herpes Zoster, Injections, law.invention, Double-Blind Method, Randomized controlled trial, Immunologic, law, Internal medicine, medicine, Humans, Adjuvants, Adverse effect, Aged, Intramuscular, Vaccines, Adjuvants, Immunologic, Female, Injections, Intramuscular, Middle Aged, Treatment Outcome, Vaccines, Subunit, business.industry, General Medicine, Vaccine efficacy, Vaccination, Immunology, Cohort, Zoster vaccine, business, medicine.drug
Abstract

glycoprotein E and the AS01B adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response. METHODS: We conducted a randomized, placebo-controlled, phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults (≥50 years of age), stratified according to age group (50 to 59, 60 to 69, and ≥70 years). Participants received two intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to assess the efficacy of the vaccine, as compared with placebo, in reducing the risk of herpes zoster in older adults. RESULTS: A total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants). During a mean follow-up of 3.2 years, herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 vs. 9.1 per 1000 person-years) in the modified vaccinated cohort. Overall vaccine efficacy against herpes zoster was 97.2% (95% confidence interval [CI], 93.7 to 99.0; P

Published
2015
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3. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older

Author

Cunningham, A.L., Lal, H., Kovac, M., Chlibek, R., Hwang, S.-J., Díez-Domingo, J., Godeaux, O., Levin, M.J., McElhaney, J.E., Puig-Barberà, J., Vanden Abeele, C., Vesikari, T., Watanabe, D., Zahaf, T., Ahonen, A., Athan, E., Barba-Gomez, J.F., Campora, L., de Looze, F., Downey, H.J., Ghesquiere, W., Gorfinkel, I., Korhonen, T., Leung, E., McNeil, S.A., Oostvogels, L., Rombo, L., Smetana, J., Weckx, L., Yeo, W., Heineman, T.C., Cunningham, A.L., Lal, H., Kovac, M., Chlibek, R., Hwang, S.-J., Díez-Domingo, J., Godeaux, O., Levin, M.J., McElhaney, J.E., Puig-Barberà, J., Vanden Abeele, C., Vesikari, T., Watanabe, D., Zahaf, T., Ahonen, A., Athan, E., Barba-Gomez, J.F., Campora, L., de Looze, F., Downey, H.J., Ghesquiere, W., Gorfinkel, I., Korhonen, T., Leung, E., McNeil, S.A., Oostvogels, L., Rombo, L., Smetana, J., Weckx, L., Yeo, W., and Heineman, T.C.

Abstract

Background: A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70). Methods: This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. Results: In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated disease

Published
2016

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