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1. Immunogenicity and reactogenicity of SARS-CoV-2 vaccines in people living with HIV in the Netherlands: A nationwide prospective cohort study.

Author

Kathryn S Hensley, Marlou J Jongkees, Daryl Geers, Corine H GeurtsvanKessel, Yvonne M Mueller, Virgil A S H Dalm, Grigorios Papageorgiou, Hanka Steggink, Alicja Gorska, Susanne Bogers, Jan G den Hollander, Wouter F W Bierman, Luc B S Gelinck, Emile F Schippers, Heidi S M Ammerlaan, Marc van der Valk, Marit G A van Vonderen, Corine E Delsing, Elisabeth H Gisolf, Anke H W Bruns, Fanny N Lauw, Marvin A H Berrevoets, Kim C E Sigaloff, Robert Soetekouw, Judith Branger, Quirijn de Mast, Adriana J J Lammers, Selwyn H Lowe, Rory D de Vries, Peter D Katsikis, Bart J A Rijnders, Kees Brinkman, Anna H E Roukens, and Casper Rokx

Subjects
Medicine
Abstract

BackgroundVaccines can be less immunogenic in people living with HIV (PLWH), but for SARS-CoV-2 vaccinations this is unknown. In this study we set out to investigate, for the vaccines currently approved in the Netherlands, the immunogenicity and reactogenicity of SARS-CoV-2 vaccinations in PLWH.Methods and findingsWe conducted a prospective cohort study to examine the immunogenicity of BNT162b2, mRNA-1273, ChAdOx1-S, and Ad26.COV2.S vaccines in adult PLWH without prior COVID-19, and compared to HIV-negative controls. The primary endpoint was the anti-spike SARS-CoV-2 IgG response after mRNA vaccination. Secondary endpoints included the serological response after vector vaccination, anti-SARS-CoV-2 T-cell response, and reactogenicity. Between 14 February and 7 September 2021, 1,154 PLWH (median age 53 [IQR 44-60] years, 85.5% male) and 440 controls (median age 43 [IQR 33-53] years, 28.6% male) were included in the final analysis. Of the PLWH, 884 received BNT162b2, 100 received mRNA-1273, 150 received ChAdOx1-S, and 20 received Ad26.COV2.S. In the group of PLWH, 99% were on antiretroviral therapy, 97.7% were virally suppressed, and the median CD4+ T-cell count was 710 cells/μL (IQR 520-913). Of the controls, 247 received mRNA-1273, 94 received BNT162b2, 26 received ChAdOx1-S, and 73 received Ad26.COV2.S. After mRNA vaccination, geometric mean antibody concentration was 1,418 BAU/mL in PLWH (95% CI 1322-1523), and after adjustment for age, sex, and vaccine type, HIV status remained associated with a decreased response (0.607, 95% CI 0.508-0.725, p < 0.001). All controls receiving an mRNA vaccine had an adequate response, defined as >300 BAU/mL, whilst in PLWH this response rate was 93.6%. In PLWH vaccinated with mRNA-based vaccines, higher antibody responses were predicted by CD4+ T-cell count 250-500 cells/μL (2.845, 95% CI 1.876-4.314, p < 0.001) or >500 cells/μL (2.936, 95% CI 1.961-4.394, p < 0.001), whilst a viral load > 50 copies/mL was associated with a reduced response (0.454, 95% CI 0.286-0.720, p = 0.001). Increased IFN-γ, CD4+ T-cell, and CD8+ T-cell responses were observed after stimulation with SARS-CoV-2 spike peptides in ELISpot and activation-induced marker assays, comparable to controls. Reactogenicity was generally mild, without vaccine-related serious adverse events. Due to the control of vaccine provision by the Dutch National Institute for Public Health and the Environment, there were some differences between vaccine groups in the age, sex, and CD4+ T-cell counts of recipients.ConclusionsAfter vaccination with BNT162b2 or mRNA-1273, anti-spike SARS-CoV-2 antibody levels were reduced in PLWH compared to HIV-negative controls. To reach and maintain the same serological responses as HIV-negative controls, additional vaccinations are probably required.Trial registrationThe trial was registered in the Netherlands Trial Register (NL9214). https://www.trialregister.nl/trial/9214.

Published
2022
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2. Immunogenicity of an Additional mRNA-1273 SARS-CoV-2 Vaccination in People With HIV With Hyporesponse After Primary Vaccination

Author

Marlou J Jongkees, Daryl Geers, Kathryn S Hensley, Wesley Huisman, Corine H GeurtsvanKessel, Susanne Bogers, Lennert Gommers, Grigorios Papageorgiou, Simon P Jochems, Jan G den Hollander, Emile F Schippers, Heidi S M Ammerlaan, Wouter F W Bierman, Marc van der Valk, Marvin A H Berrevoets, Robert Soetekouw, Nienke Langebeek, Anke H W Bruns, Eliane M S Leyten, Kim C E Sigaloff, Marit G A van Vonderen, Corine E Delsing, Judith Branger, Peter D Katsikis, Yvonne M Mueller, Rory D de Vries, Bart J A Rijnders, Kees Brinkman, Casper Rokx, Anna H E Roukens, Internal medicine, APH - Quality of Care, Infectious diseases, AII - Infectious diseases, APH - Digital Health, APH - Personalized Medicine, Internal Medicine, Virology, Medical Microbiology & Infectious Diseases, and Immunology

Subjects
Infectious Diseases, SDG 3 - Good Health and Well-being, additional dose, nonresponder, COVID-19, HIV, Immunology and Allergy, SARS-CoV-2 vaccines
Abstract

BackgroundThe COVIH study is a prospective coronavirus disease 2019 (COVID-19) vaccination study in 1154 people with HIV (PWH), of whom 14% showed reduced antibody levels after primary vaccination. We evaluated whether an additional vaccination boosts immune responses in these hyporesponders.MethodsThe primary end point was the increase in antibodies 28 days after additional mRNA-1273 vaccination. Secondary end points included neutralizing antibodies, S-specific T-cell and B-cell responses, and reactogenicity.ResultsOf the 66 participants, 40 previously received 2 doses ChAdOx1-S, 22 received 2 doses BNT162b2, and 4 received a single dose Ad26.COV2.S. The median age was 63 years (interquartile range [IQR], 60–66), 86% were male, and median CD4+ T-cell count was 650/μL (IQR, 423–941). The mean S1-specific antibody level increased from 35 binding antibody units (BAU)/mL (95% confidence interval [CI], 24–46) to 4317 BAU/mL (95% CI, 3275–5360) (P < .0001). Of all participants, 97% showed an adequate response and the 45 antibody-negative participants all seroconverted. A significant increase in the proportion of PWH with ancestral S-specific CD4+ T cells (P = .04) and S-specific B cells (P = .02) was observed.ConclusionsAn additional mRNA-1273 vaccination induced a robust serological response in 97% of PWH with a hyporesponse after primary vaccination.Clinical Trials Registration. EUCTR2021-001054-57-N.

Published
2022

3. Correction: Immunogenicity and reactogenicity of SARS-CoV-2 vaccines in people living with HIV in the Netherlands: A nationwide prospective cohort study

Author

Kathryn S. Hensley, Marlou J. Jongkees, Daryl Geers, Corine H. GeurtsvanKessel, Yvonne M. Mueller, Virgil A. S. H. Dalm, Grigorios Papageorgiou, Hanka Steggink, Alicja Gorska, Susanne Bogers, Jan G. den Hollander, Wouter F. W. Bierman, Luc B. S. Gelinck, Emile F. Schippers, Heidi S. M. Ammerlaan, Marc van der Valk, Marit G. A. van Vonderen, Corine E. Delsing, Elisabeth H. Gisolf, Anke H. W. Bruns, Fanny N. Lauw, Marvin A. H. Berrevoets, Kim C. E. Sigaloff, Robert Soetekouw, Judith Branger, Quirijn de Mast, Adriana J. J. Lammers, Selwyn H. Lowe, Rory D. de Vries, Peter D. Katsikis, Bart J. A. Rijnders, Kees Brinkman, Anna H. E. Roukens, and Casper Rokx

Subjects
General Medicine
Published
2023

4. Declining Hepatitis C Virus (HCV) Incidence in Dutch Human Immunodeficiency Virus-Positive Men Who Have Sex With Men After Unrestricted Access to HCV Therapy

Author

Mark A. A. Claassen, Bart J. A. Rijnders, Stephanie Popping, Corine E Delsing, D. W. M. Verhagen, Anton S M Dofferhoff, Charles A. Boucher, Dirk Posthouwer, Marjo E. E. van Kasteren, Wouter F W Bierman, Arne van Eeden, Joop E. Arends, David A. M. C. van de Vijver, Robert Soetekouw, Paul H. P. Groeneveld, Edgar J G Peters, Kamilla D. Lettinga, Sebastiaan J. Hullegie, Eliane M. S. Leyten, Guido E.L. van den Berk, F. N. Lauw, Anne Boerekamps, Frank P. Kroon, Internal medicine, Amsterdam Movement Sciences - Rehabilitation & Development, AII - Infectious diseases, Med Microbiol, Infect Dis & Infect Prev, MUMC+: DA MMI Staf (9), RS: FHML non-thematic output, Internal Medicine, Medical Microbiology & Infectious Diseases, and Virology

Subjects
Male, NETHERLANDS, Gonorrhea, men having sex with men, HIV Infections, Rate ratio, medicine.disease_cause, Health Services Accessibility, Men who have sex with men, Sexual and Gender Minorities, 0302 clinical medicine, HIV Seropositivity, Prospective Studies, 030212 general & internal medicine, acute Hepatitis C, education.field_of_study, Incidence (epidemiology), Incidence, virus diseases, Hepatitis C, Middle Aged, Infectious Diseases, 030211 gastroenterology & hepatology, Adult, Microbiology (medical), medicine.medical_specialty, TRANSMISSION, Hepatitis C virus, Population, HIV-INFECTED MSM, Antiviral Agents, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, SDG 3 - Good Health and Well-being, EPIDEMIC, Internal medicine, medicine, Humans, Homosexuality, Male, education, REINFECTION INCIDENCE, business.industry, HIV, Hepatitis C, Chronic, Models, Theoretical, medicine.disease, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Immunology, direct acting antiviral therapy, Syphilis, hepatitis C, SEXUALLY-TRANSMITTED INFECTION, business
Abstract

Background. Direct-acting antivirals (DAAa) cure hepatitis C virus (HCV) infections in 95% of infected patients. Modeling studies predict that universal HCV treatment will lead to a decrease in the incidence of new infections but real-life data are lacking. The incidence of HCV among Dutch human immunodeficiency virus (HIV)-positive men who have sex with men (MSM) has been high for >10 years. In 2015 DAAs became available to all Dutch HCV patients and resulted in a rapid treatment uptake in HIVpositive MSM. We assessed whether this uptake was followed by a decrease in the incidence of HCV infections.Methods. Two prospective studies of treatment for acute HCV infection enrolled patients in 17 Dutch HIV centers, having 76% of the total HIV-positive MSM population in care in the Netherlands. Patients were recruited in 2014 and 2016, the years before and after unrestricted DAA availability. We compared the HCV incidence in both years.Results. The incidence of acute HCV infection decreased from 93 infections during 8290 person-years of follow-up (PYFU) in 2014 (11.2/1000 PYFU; 95% confidence interval [CI], 9.1-13.7) to 49 during 8961 PYFU in 2016 (5.5/1000 PYFU; 4.1-7.2). The incidence rate ratio of 2016 compared with 2014 was 0.49 (95% CI,.35-.69). Simultaneously, a significant increase in the percentage positive syphilis (+2.2%) and gonorrhea (+2.8%) tests in HIV-positive MSM was observed at sexual health clinics across the Netherlands and contradicts a decrease in risk behavior as an alternative explanation.Conclusions. Unrestricted DAA availability in the Netherlands was followed by a 51% decrease in acute HCV infections among HIV-positive MSM.

Published
2018

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