The safety and imMunogeNicity of combined Pertussis-cOntaining vaccine (Tdap) for HIV-infected pregnant WomEn and their newboRns - A Randomized Clinical Trial (WoMANPOWER)

Immunization in pregnancy against pertussis can reduce severe disease in infancy. There are few data on the safety and immunogenicity of vaccines given to pregnant women living with HIV (PWLWH) and their infants.We conducted an observer-blind, randomised, phase II, non-inferiority trial evaluating safety and immunogenicity of a genetically detoxified acellular pertussis containing vaccine in PWLWH in Uganda. Women aged ≥18 years, between 16- and 26- weeks’ gestation were randomised to receive Td (tetanus-diphtheria) or TdaP (Tetanus -Diphtheria - Acellular pertussis) vaccine. Primary immunogenicity endpoints were anti-Pertussis Toxin (PT) and anti-Filamentous Haemagglutinin (FHA) immunoglobulin(IgG) concentrations in infants at delivery and 18 weeks, following three doses of a whole-cell (wP) pertussis containing vaccine.This entry contains the data dictionary. Please contact Professor Kirsty Le Doare for access to the database, at [e-mail].