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Could a vaccine given during pregnancy shield infants from a deadly virus?

NCT ID NCT06325657

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests an RSV vaccine in pregnant women living with HIV. The goal is to see if the vaccine is safe and helps mothers pass protective antibodies to their babies, potentially preventing severe RSV lung infections in infants. The trial involves about 681 pregnant participants and follows both mothers and their babies for up to 6 months 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
RSVpreF vaccine
What this could lead to
If successful, this vaccine could help protect infants born to mothers with HIV from severe RSV infections, potentially reducing hospitalizations and deaths.
What could go wrong
This is a phase 3 trial, but results may not confirm full protection or safety for all. The vaccine may cause side effects or not generate enough immunity in this specific population.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

681 people

The number who actually took part.

Started

Mar 2024

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

0 to 49 years

Sex

Anyone

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.

Key Inclusion Criteria - Maternal Participants * Women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated singleton pregnancy who are at no known increased risk for complications. * Confirmed stable HIV disease. * Current and stable use of antiretroviral therapy(ART) for at least 90 days prior to enrolment. * Had a fetal anomaly ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed. * Intention to deliver at a hospital or birthing facility where study procedures can be obtained. * Participant is willing to give informed consent for the participant's infant to participate in the study. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol. Key Inclusion Criteria - Infant Participants * Evidence of a signed and dated ICD, signed by the parent(s)/legal guardian(s). * Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures Key Exclusion Criteria - Maternal Participants * Prepregnancy body mass index (BMI) of \>40 kg/m2 . If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used. * Participant with opportunistic infections or malignancy. * History of active chronic viral hepatitis with biochemical evidence of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values \>5 times the upper limit of normal within 6 months before enrollment. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine. * Current pregnancy resulting from in vitro fertilization. Participants known to have used clomiphene citrate and/or letrozole with or without intrauterine insemination (IUI) are permitted. * Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not l limited to the following: * Preeclampsia, eclampsia, or uncontrolled gestational hypertension. * Placental abnormality. * Polyhydramnios or oligohydramnios. * Significant bleeding or blood clotting disorder. * Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent. * Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth. * Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the study, including but not limited to the following: * Prior preterm delivery at ≤34 weeks' gestation * Prior stillbirth or neonatal death * Previous infant with a known genetic disorder or significant congenital anomaly * Non-HIV-associated congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications. * Antituberculosis treatment use currently or at any time during this current pregnancy. Key Exclusion Criteria - Infant Participants • Infant who is a direct descendant (eg, child or grandchild) of the investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.

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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

  • Botho Ke Bontle Health Services

    Pretoria, Gauteng, 0184, South Africa

  • FAMCRU - Worcester

    Worcester, Western Cape, 6850, South Africa

  • Gole Biomed Research Centre

    Polokwane, Limpopo, 0699, South Africa

  • Gugulethu Green Clinic

    Cape Town, Western Cape, 7750, South Africa

  • Josha Research

    Bloemfontein, Free State, 9301, South Africa

  • MRC Unit on Child And Adolescent Health

    Cape Town, Western Cape, 7700, South Africa

  • Qhakaza Mbokodo Research Clinic

    Ladysmith, KwaZulu-Natal, 3370, South Africa

  • REIMED Reiger Park

    Boksburg, Gauteng, 1459, South Africa

  • Setshaba Research Centre

    Pretoria, Gauteng, 0152, South Africa

  • Synergy Biomed Research Institute

    East London, Eastern Cape, 5241, South Africa

  • University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

    Johannesburg, Gauteng, 2013, South Africa

  • Wits RHI

    Johannesburg, Gauteng, 2001, South Africa

  • Wits VIDA Nkanyezi Research Unit

    Johannesburg, Gauteng, 2093, South Africa

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1500, South Africa

More trials for these conditions

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