HIV-infected Pregnant Women Clinical Trial
Official title:
Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women
The purpose of this study was to determine the safety, reactogenicity, immunogenicity, transplacental antibody transfer and interference with infant responses to childhood vaccination of maternal vaccination with pneumococcal conjugate 10-valent vaccine (PCV-10) or pneumococcal polysaccharide 23-valent vaccine (PPV-23) by comparison with placebo.
This was a multi-center, Phase II, randomized, double-blinded, placebo-controlled study of
Human Immunodeficiency Virus (HIV)-infected pregnant women on Highly Active Antiretroviral
Therapy (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 one of three arms and received 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. Women who received placebo but cannot be randomized to a second study step due to
ongoing new pregnancy were enrolled in a third study step and receive open label PCV-10 at
the last study visit; no data were collected on these women and they were not followed after
vaccine administration. All infants received PCV-10 vaccinations per local standard of care.
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