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
Issued Date
2023-07-01
Resource Type
ISSN
02699370
eISSN
14735571
Scopus ID
2-s2.0-85161941474
Pubmed ID
36939067
Journal Title
AIDS
Volume
37
Issue
8
Start Page
1227
End Page
1237
Rights Holder(s)
SCOPUS
Bibliographic Citation
AIDS Vol.37 No.8 (2023) , 1227-1237
Suggested Citation
Wilck M., Barnabas S., Chokephaibulkit K., Violari A., Kosalaraksa P., Yesypenko S., Chukhalova I., Dagan R., Richmond P., Mikviman E., Morgan L., Feemster K., Lupinacci R., Chiarappa J., Madhi S.A., Bickham K., Musey L. 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. AIDS Vol.37 No.8 (2023) , 1227-1237. 1237. doi:10.1097/QAD.0000000000003551 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/87627
Title
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
Author's Affiliation
Siriraj Hospital
University of the Witwatersrand Faculty of Health Sciences
The University of Western Australia
Ben-Gurion University of the Negev
Faculty of Medicine, Khon Kaen University
Merck & Co., Inc.
Stellenbosch University
Dnipropetrovsk Oblast Medical Centre of Socially Significant Diseases
Odesa Regional Center for Socially Significant Diseases
University of the Witwatersrand Faculty of Health Sciences
The University of Western Australia
Ben-Gurion University of the Negev
Faculty of Medicine, Khon Kaen University
Merck & Co., Inc.
Stellenbosch University
Dnipropetrovsk Oblast Medical Centre of Socially Significant Diseases
Odesa Regional Center for Socially Significant Diseases
Other Contributor(s)
Abstract
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.