NCT05832502

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: St George's, University of London · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Group B Streptococcal Infection

Interventions

Type	Name	Description
DRUG	GBS6	The investigational products are GBS6 and placebo (saline control). The GBS6 dose will be GBS6 20mcg without AlPO4 (equivalent to 240 mcg/mL) 0.5mL dose or 20 mcg CPS/serotype).
DRUG	Placebo	Placebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle

Timeline

• Start date: 2022-10-14
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-04-27
• Last updated: 2024-02-16

Locations

1 site across 1 country: Uganda

Regulatory

• FDA-regulated drug study