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Booster shot for Moms-to-Be could shield newborns from deadly infections

NCT ID NCT06592586

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study follows women who previously received the GBS-NN/NN2 vaccine during pregnancy to see how long their immune protection lasts. It also tests whether a booster dose given in a new pregnancy is safe and boosts immunity, aiming to protect newborns from group B strep infections like sepsis, pneumonia, and meningitis. About 338 women in Denmark and South Africa are taking part.

What this could mean

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

Active substance
GBS-NN/NN2 vaccine
What this could lead to
If successful, this could show that a booster dose of the GBS vaccine during a later pregnancy maintains protection for newborns against life-threatening group B strep infections.
What could go wrong
This is a follow-up study with a small number of participants (338) and results may not apply to all populations. The vaccine is still in Phase 2/3, so it is not yet proven to be effective or safe for widespread 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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

137 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Jun 2029

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.

Ages

18 years and older

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: * Participant living in Denmark or South Africa who has participated in Trial MVX0004 (NCT05154578) and has received at least 1 dose of the GBS-NN/NN2 vaccine. * Participant who is able to read and understand and capable of giving personal signed informed consent. * Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures. * Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX0004. * Participant who is expected to be available for the duration of the trial and who can be contacted by telephone during trial participation. Exclusion Criteria: * Any personnel involved in the conduct of the trial (and their family members), including, but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation (CRO) employees. * Participant with confirmed Group B Streptococcus (GBS) infection since participation in Trial MVX0004. * Participant with any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator's judgement, make the participant unsuitable for participation in the trial. * Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial entry, and/or are participating in other trials involving investigational drug(s) or devices at trial entry, or plan to (continue to) participate in other trials involving investigational drug(s) or devices during this trial. * Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency. Note: Human immunodeficiency virus (HIV) infection is not an exclusion criterion if HIV viral load is ≤1000 copies/mL and the participant has been on antiretroviral therapy for at least 3 months prior to screening and is clinically stable. * Participant receiving chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to trial entry. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. * Participant who received blood, blood products, plasma derivatives, or any immunoglobulin preparations in the 12 weeks prior to trial entry or is planning to receive such products during this trial. * Participant with current or history of drug or alcohol abuse, as judged by the investigator. * Participant who received any marketed or investigational GBS vaccines (other than GBS-NN/NN2 in the MVX0004 Trial) or who is planning to receive any marketed or investigational (other than GBS NN/NN2) GBS vaccines during this trial.

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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

  • Aarhus Universitetshospital

    Aarhus N, Central Jutland, 8200, Denmark

  • Hvidovre Hospital - Department Of Obstetrics And Gynaecology

    Copenhagen, Capital Region, 2650, Denmark

  • Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)

    Ga-Rankuwa, Gauteng, 0204, South Africa

  • Setshaba Research Centre

    Pretoria, Guateng Province, 0152, South Africa

  • Sygehus Lillebælt - Kolding Sygehus

    Kolding, Region Syddanmark, 6000, Denmark

  • Wits Reproductive Health and HIV Institute (Wits RHI)

    Johannesburg, Guateng Province, 2001, South Africa

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Other studies related to the condition(s) this trial covers.