NCT02717494

Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 347 (actual)
• Sponsor: Westat · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• PNC Vaccine
• HIV-infected Pregnant Women

Interventions

Type	Name	Description
BIOLOGICAL	PPV-23	PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.
BIOLOGICAL	PCV-10	PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.
OTHER	NaCl	NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-11-01
• Completion: 2019-05-01
• First posted: 2016-03-23
• Last updated: 2020-01-18
• Results posted: 2020-01-18

Locations

8 sites across 1 country: Brazil