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
; 37(8): 1227-1237, 2023 07 01.
Article
in En
| MEDLINE
| ID: mdl-36939067
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, 9âV, 14, 18C, 19A, 19F, 22F, 23F, 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8âweeks later, in children with HIV.DESIGN:
This phase 3 study (NCT03921424) randomized participants 6-17âyears of age with HIV (CD4 + T-cell count ≥200âcells/µl, plasma HIV RNA <50 000âcopies/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 30âdays after each vaccination.RESULTS:
The proportion of participants experiencing at least one AE post-PCV was 78.8% in the V114 group ( n â=â203) and 69.6% in the PCV13 group ( n â=â204); respective proportions post-PPSV23 were 75.4% ( n â=â203) and 77.2% ( n â=â202). 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 30âdays 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 8âweeks later with PPSV23 is well tolerated and induces immune responses for all 15 pneumococcal serotypes included in V114.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pneumococcal Infections
/
HIV Infections
Type of study:
Clinical_trials
Limits:
Child
/
Humans
/
Newborn
Language:
En
Journal:
AIDS
Journal subject:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Year:
2023
Document type:
Article
Affiliation country:
United States