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

NCT05832502 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-02-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • MU-JHU CARE

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Musa sekikubo, Prof · Makerere University - John Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • Uganda

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832502 on ClinicalTrials.gov