Online Abstracts Vaccines - Pneumococcal Vaccines Development C1 Pneumococcal Vaccines Development



HIV infection increases the risk of pneumococcal disease (PD). Sequential vaccination with pneumococcal conjugate vaccine (PCV) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for prevention of PD. V114, an investigational 15-valent PCV, contains all serotypes in PCV13 plus serotypes 22F and 33F. This phase 3 trial evaluated immunogenicity and safety of V114 or PCV13 followed 8 weeks later by PPSV23 in HIV-infected adults.


Eligible HIV-infected adults aged ≥18 years, pneumococcal vaccine naïve and receiving antiretroviral therapy were randomized 1:1 to receive either V114 or PCV13 followed by PPSV23. Randomization was stratified by CD4 cell count. Serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were measured immediately prior and 30 days after each vaccination.


Enrollment of study participants has been completed. Safety outcomes and serotype-specific OPA geometric mean titers and IgG geometric mean concentrations following vaccination with V114 or PCV13 will be summarized by vaccination group (primary). Sub-group analysis will include CD4 strata if there are more than 10 participants per group. Summaries of safety and immunogenicity outcomes following PPV23 will also be provided.


Findings will demonstrate whether immunization with V114 or PCV13 followed by PPSV23 is well-tolerated and immunogenic in HIV-infected adults.