A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV.
| Autor: | Wilck M; Merck & Co., Inc., Rahway, New Jersey, USA., Barnabas S; Department of Paediatrics, University of Stellenbosch, Cape Town, South Africa., Chokephaibulkit K; Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand., Violari A; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Kosalaraksa P; Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand., Yesypenko S; Odesa Regional Center for Socially Significant Diseases, Odeska Oblast., Chukhalova I; Dnipropetrovsk Regional Medical Center Of Socially Significant Diseases, Dnipro, Ukraine., Dagan R; The Shraga Segal Department of Microbiology, Immunology and Genetics Faculty of Health Sciences of the Ben-Gurion University of the Negev Beer-Sheva, Israel., Richmond P; University of Western Australia, Perth, Australia., Mikviman E; Merck & Co., Inc., Rahway, New Jersey, USA., Morgan L; Merck & Co., Inc., Rahway, New Jersey, USA., Feemster K; Merck & Co., Inc., Rahway, New Jersey, USA., Lupinacci R; Merck & Co., Inc., Rahway, New Jersey, USA., Chiarappa J; Merck & Co., Inc., Rahway, New Jersey, USA., Madhi SA; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Bickham K; Merck & Co., Inc., Rahway, New Jersey, USA., Musey L; Merck & Co., Inc., Rahway, New Jersey, USA. |
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| Jazyk: | angličtina |
| Zdroj: | AIDS (London, England) [AIDS] 2023 Jul 01; Vol. 37 (8), pp. 1227-1237. Date of Electronic Publication: 2023 Mar 17. |
| DOI: | 10.1097/QAD.0000000000003551 |
| Abstrakt: | Objectives: To evaluate the safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in children with HIV. Design: This phase 3 study (NCT03921424) randomized participants 6-17 years of age with HIV (CD4 + T-cell count ≥200 cells/μl, plasma HIV RNA <50 000 copies/ml) to receive V114 or 13-valent PCV (PCV13) in a double-blind manner on Day 1, followed by PPSV23 at Week 8. Methods: Adverse events (AEs), pneumococcal serotype-specific immunoglobulin G (IgG), and opsonophagocytic activity (OPA) were evaluated 30 days after each vaccination. Results: The proportion of participants experiencing at least one AE post-PCV was 78.8% in the V114 group ( n = 203) and 69.6% in the PCV13 group ( n = 204); respective proportions post-PPSV23 were 75.4% ( n = 203) and 77.2% ( n = 202). There were no vaccine-related serious AEs. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) were generally comparable between V114 and PCV13 for shared serotypes at Day 30, and were higher for V114 compared with PCV13 for the additional V114 serotypes 22F and 33F. Approximately 30 days after PPSV23, IgG GMCs and OPA GMTs were generally comparable between the V114 and PCV13 groups for all 15 serotypes in V114. Conclusions: In children with HIV, a sequential administration of V114 followed 8 weeks later with PPSV23 is well tolerated and induces immune responses for all 15 pneumococcal serotypes included in V114. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.) |
| Databáze: | MEDLINE |
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