Could a vaccine given during pregnancy shield infants from a deadly virus?
NCT ID NCT06325657
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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681 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Jun 2025
- Lead sponsor
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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
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0 to 49 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Botho Ke Bontle Health Services
Pretoria, Gauteng, 0184, South Africa
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FAMCRU - Worcester
Worcester, Western Cape, 6850, South Africa
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Gole Biomed Research Centre
Polokwane, Limpopo, 0699, South Africa
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Gugulethu Green Clinic
Cape Town, Western Cape, 7750, South Africa
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Josha Research
Bloemfontein, Free State, 9301, South Africa
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MRC Unit on Child And Adolescent Health
Cape Town, Western Cape, 7700, South Africa
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Qhakaza Mbokodo Research Clinic
Ladysmith, KwaZulu-Natal, 3370, South Africa
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REIMED Reiger Park
Boksburg, Gauteng, 1459, South Africa
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Setshaba Research Centre
Pretoria, Gauteng, 0152, South Africa
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Synergy Biomed Research Institute
East London, Eastern Cape, 5241, South Africa
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University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
Johannesburg, Gauteng, 2013, South Africa
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Wits RHI
Johannesburg, Gauteng, 2001, South Africa
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Wits VIDA Nkanyezi Research Unit
Johannesburg, Gauteng, 2093, South Africa
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Worthwhile Clinical Trials
Benoni, Gauteng, 1500, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Four weeks vs twelve weeks: can a shorter TB prevention course work?
- Can a phone app keep young people with HIV engaged in care?
- Massive Real-World database aims to map how chronic diseases interact
- How do HIV drugs behave when kidneys fail? study measures blood levels
- Can HIV-Positive mothers breastfeed without passing the virus to their babies?