Safety and Immunogenicity of Anti-pneumococcal Vaccines in HIV-infected Pregnant Women

NICHD P1091 was a multi-center, Phase II, randomized, double-blinded, placebo-controlled study of HIV-infected pregnant women on HAART who were in the second or third trimester of pregnancy and of their infants. The study was designed to investigate the safety, reactogenicity, immunogenicity, transplacental antibody transfer, and interference with infant responses to childhood vaccination of maternal vaccination with PCV-10 or PPV-23 by comparison with placebo. Mothers were randomized to receive PCV-10, PPV-23, or placebo in a blinded fashion. They were followed for safety, immunogenicity, and vaccine-specific anti-capsular pneumococcus (PNC) antibody persistence until 24 weeks post-delivery. Women who received placebo were randomized to a second study step and received PCV-10 or PPV-23 at 24 weeks post-delivery. Antibody responses to the vaccine administered 6 months postpartum were measured. All infants received PCV-10 vaccinations per local standard of care.