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Blood samples from vaccinated moms could help perfect GBS protection for newborns

NCT ID NCT07562061

Knowledge-focused Sponsor: St George's, University of London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study collects blood from 50 women in Uganda who previously received an experimental group B strep (GBS) vaccine during pregnancy. The blood is used to create quality control panels that help labs accurately measure vaccine-induced antibodies. The goal is to improve testing for GBS vaccines, which aim to prevent serious infections in newborns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this will create reliable test panels to monitor antibody levels after GBS vaccination, helping ensure vaccines work effectively against group B strep infections in newborns.
What could go wrong
This is a small, early-stage lab-focused study (50 participants) that does not test a treatment or vaccine itself. The panels may not fully represent all populations or perform as expected in wider use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women not living with HIV, who received the GBS6 vaccine in the "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" (GBS6) Clinical Trial in Kampala, Uganda.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * HIV-uninfected women who received the GBS6 vaccine during pregnancy and completed the whole period of study participation. * Reachable by phone * Willing and able to provide consent. * Willingness to provide a blood sample. Exclusion Criteria: * Receipt of blood/plasma transfusion in the last 3 months * Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids. * Women who will test positive for Syphilis or HIV at screening * Current alcohol abuse or illicit drug use, or with a psychiatric condition * Major illness of the mother that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in the study, including but not limited to the following: I. heart disease II. severe anaemia (Hemoglobin level less than 7.0g/dL)

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

group B streptococcal infection streptococcal infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Group B strep infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MUJHU Care Ltd, Kampala

    RECRUITING

    Kampala, Uganda