UnknownPhase 2

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

Uganda300 participantsStarted 2022-10-14

Plain-language 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

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 to ≤ 40 years of age, inclusive at day of signing the ICF.
. Pregnant at ≥ 27 0/7 to ≤35 6/7 gestation on the day of planned vaccination, verified by ultrasound scan (U/S).
. Low risk, singleton pregnancy, as assessed by the study physician based on ultra-sound scan and previous obstetric history.
. Documented negative HBV surface antigen, HCV antibody, and syphilis tests at screening.
. Documented HIV test during pregnancy undertaken as per the national guidelines.
. If HIV infected pregnant women, stable on ART for at least 3 months prior to study start
. Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.
. Receiving prenatal standard of care including HIV care if applicable at the clin-ics/physician offices/hospital network affiliated with the clinical study site.

Exclusion criteria

. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary mother outcome 1

Timeframe: 7 days following administration of IMP

Primary mother outcome 2

Timeframe: 7 days following administration of IMP

Primary mother outcome 3

Timeframe: Through 1 month following administration of IMP

Primary mother outcome 4

Timeframe: Visit 1 through 12 months post-delivery

Primary Infant outcome 1

Timeframe: Birth to 6 weeks of age

Primary Infant outcome 2

Timeframe: Through 12 months of age

Trial details

NCT IDNCT05832502

SponsorSt George's, University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Group B Streptococcal Infection trials

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 to ≤ 40 years of age, inclusive at day of signing the ICF.
. Pregnant at ≥ 27 0/7 to ≤35 6/7 gestation on the day of planned vaccination, verified by ultrasound scan (U/S).
. Low risk, singleton pregnancy, as assessed by the study physician based on ultra-sound scan and previous obstetric history.
. Documented negative HBV surface antigen, HCV antibody, and syphilis tests at screening.
. Documented HIV test during pregnancy undertaken as per the national guidelines.
. If HIV infected pregnant women, stable on ART for at least 3 months prior to study start
. Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.
. Receiving prenatal standard of care including HIV care if applicable at the clin-ics/physician offices/hospital network affiliated with the clinical study site.

Exclusion criteria

. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.

What they're measuring

Primary mother outcome 1

Timeframe: 7 days following administration of IMP

Primary mother outcome 2

Timeframe: 7 days following administration of IMP

Primary mother outcome 3

Timeframe: Through 1 month following administration of IMP

Primary mother outcome 4

Timeframe: Visit 1 through 12 months post-delivery

Primary Infant outcome 1

Timeframe: Birth to 6 weeks of age

Primary Infant outcome 2

Timeframe: Through 12 months of age