Could a vaccine shield newborns from a deadly bacterial infection?

NCT ID NCT04596878

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests an experimental vaccine called GBS-NN/NN2 against Group B Streptococcus (GBS), a bacteria that can cause serious infections in newborns. The trial includes pregnant women both with and without HIV, giving two doses between 26 and 30 weeks of pregnancy. Researchers will monitor safety and immune responses in mothers and their babies for a year after birth.

What this could mean

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

Active substance
a recombinant protein vaccine against Group B Streptococcus called GBS-NN/NN2, given with an adjuvant
What this could lead to
If successful, this vaccine could prevent life-threatening Group B Strep infections in newborns, especially in areas with high HIV rates.
What could go wrong
This is a Phase 2 trial, so it is still early. The vaccine may not produce enough immunity or could have unexpected side effects in mothers or babies.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

200 people

The number who actually took part.

Started

Nov 2020

Finished

May 2023

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.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Participants at least 18 years old and not older than 40 years of age. 2. Pregnant women who are between 26 weeks and 30 weeks (inclusive) gestation on the planned day of vaccination with a singleton, uncomplicated pregnancy. Gestational age to be determined on the following hierarchal basis with guidance to the GAIA (Global Alignment of Immunisation Safety Assessment in pregnancy) criteria: 1. ultrasound estimate of gestational age, 2. date of last menstrual period 3. fundal height 3. HIV status to be based on rapid, confirmatory test, unless a documented test of the participant being sero-positive for HIV and history documented in the notes. 4. Women living with HIV, HIV viral load \<1000, on antiretroviral therapy for at least 3 months prior to screening and clinically well. 5. Expected to be available for the scheduled clinic visits for the duration of the study, agree to be contacted by telephone during study participation, and is willing to give parental consent for her infant to participate in the study Exclusion Criteria: 1. Women who are hepatitis B surface (HBSAg) and/or hepatitis C (HCV) positive 2. Women who test positive for syphilis as per standard testing 3. Women knowingly carrying, at screening, a malformed or genetically abnormal foetus based on ultrasound 4. Women who have experienced a previous stillbirth prior to going into labour 5. Women with placenta previa 6. Women with documented chronic or pregnancy induced hypertension at screening 7. Women with 1+ protein in urine and hypertension defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) at ≥20 weeks of gestation in a woman with a previously normal blood pressure 8. Women with \>1+ of protein in urine (regardless of blood pressure) 9. Women with gestational, type 1 or type 2 diabetes. 10. Women with glycosuria on dipstick 11. Women known to be allergic to any components of the vaccine, known to be allergic to aluminium or having had an allergic reaction to any previous vaccination. 12. Women with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease, cognitive disorder or current infection and significant illness 4 weeks prior to randomization. 13. Women with current or history of drug or alcohol abuse within the last two years. 14. Women who have received a vaccine within 28 days of receiving the first dose of GBS NN/NN2 or placebo or who expect to require vaccination during the course of the study. (Vaccines recommended for administration during pregnancy e.g. tetanus toxoid, pertussis and influenza are permitted. Administration of concurrent vaccines must not be within 7 days of investigational vaccine.) 15. Women who have a fever (axillary temperature \>37.9°C) on the day of dosing or have had an acute infection in the 7 days before dosing. 16. Women who have any bleeding disorders that prolong the bleeding time. 17. Women who are receiving immunosuppressive medication, including systemic steroids (inhaled and topical steroids are acceptable). 18. Women who have received blood or blood products and/or plasma derivatives or any immunoglobulin preparations in 12 weeks preceding screening. 19. Women with severe anaemia, haemoglobin \< 9g/dL (90 g/L) as per Sheffield grading system ( \> Grade 1) 20. Women who are currently breast feeding 21. Women who are part of the study personnel or a close family member of study personnel. 22. Women who in the opinion of the investigator are not suitable to participate in the study. 23. Concurrent participation in another clinical trial during which subject will be exposed to an investigational product.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Empilweni Services and Research Unit (ESRU), Rahima Moosa Mother and Child Hospital

    Johannesburg, South Africa

  • MUJHU Research Collaboration/MUJHU Care Ltd, Kawempe National Referral Hospital

    Kawempe, Uganda

  • University of the Witwatersrand, Johannesburg (Respiratory and Meningeal Pathogens Research unit)

    Johannesburg, South Africa

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