OBJECTIVES: To evaluate 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, and 33F), followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in adults living with HIV.
DESIGN: In this phase 3 study (V114-018; NCT03480802), pneumococcal vaccine-naive adults with HIV (CD4+ count ≥50 cells/μl, plasma HIV RNA < 50 000 copies/ml, receiving antiretroviral therapy) were randomized 1:1 to receive one dose of V114 or licensed 13-valent PCV (PCV13) on Day 1; participants received PPSV23 at Week 8.
METHODS: Adverse events (AEs) and serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were evaluated after each vaccination.
RESULTS: Of 302 participants enrolled, 292 (96.7%) completed the study. Proportions of participants experiencing ≥1 AE were 73.0% and 62.7% in the V114 and PCV13 groups following PCV and 60.7% and 71.6% following PPSV23. Most solicited AEs were of mild or moderate severity and short duration. OPA geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs) were generally comparable between groups for shared serotypes at Day 30 and maintained at Week 12. OPA and IgG responses for additional serotypes in V114 (22F, 33F) were higher following V114 than PCV13 at Day 30 but comparable at Week 12, 30 days post-PPSV23.
CONCLUSIONS: In pneumococcal vaccine-naive adults living with HIV, V114 was well tolerated and induced immune responses for all 15 pneumococcal serotypes. V114 can be followed by PPSV23 8 weeks later to broaden serotype coverage.