Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without HIV (PREPARE) — PREPARE

Group B Streptococcal Infection Clinical Trial

Official title:
A Placebo Controlled Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without Human Immunodeficiency Virus (HIV) Infection and Their Infants

Status Active, not recruiting

Clinical Trial Summary

A placebo controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants

Clinical Trial Description

This Phase 2, randomised, placebo controlled, double blinded study will be the first evaluation of the investigational GBS6 in HIV-infected pregnant women. This study will enroll pregnant women with and without HIV to receive GBS6 or Placebo in order to provide an expanded safety and immunogenicity data set (for both pregnant women and their infants) and to support progression of the development of this vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05832502
Study type	Interventional
Source	St George's, University of London
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	October 14, 2022
Completion date	September 30, 2025

View Details

See also
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Completed	`NCT02528981` - Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial	N/A
Recruiting	`NCT01577108` - Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women	Phase 2