NCT05832502View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 14, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Group B Streptococcal Infection
Interventions
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

Trial Locations (1)

Unknown

Makerere University, John Hopkins University, Kawempe

Sponsors

Collaborators (1)

Pfizer
All Listed Sponsors
collaborator

MU-JHU CARE

OTHER

collaborator

Pfizer

INDUSTRY

lead

St George's, University of London

OTHER

NCT05832502 - Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without HIV (PREPARE) | Biotech Hunter | Biotech Hunter