Could a shot for moms shield babies from deadly RSV?
NCT ID NCT06955728
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This large study tests an RSV vaccine given to pregnant women to see if it safely protects their babies from severe RSV infection in the first months of life. About 13,000 pregnant women in Africa will receive either the vaccine or a placebo. The study also closely monitors whether the vaccine increases the risk of preterm birth, which was seen in earlier trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RSV vaccine (RSVpreF, brand name ABRYSVO)
- What this could lead to
- If successful, this could confirm that vaccinating pregnant women safely protects infants from severe RSV, reducing hospitalizations and deaths in low- and middle-income countries.
- What could go wrong
- Previous studies showed a slightly higher rate of preterm births in vaccinated women, though babies were born only a few weeks early and survived. This trial is needed to clarify that risk.
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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About 13,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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14 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
Inclusion Criteria: * Pregnant women considered to be legally competent, as per country legislation, to consent for trial participation for herself and her newborn * At a gestational age in keeping with in-country approval of the vaccine administration, and not in active labour. Gestational age will be based on GAIA LOC 1 to 2B criteria * Mother is able to understand and comply with planned trial procedures * Mother is attending ante-natal clinic * Mother has documented test for HIV and syphilis during the current pregnancy, * Provides written informed consent prior to initiation of trial. If the maternal participant is illiterate, a witnessed thumb-printed informed consent is acceptable * Intention to deliver at a hospital or birthing facility where trial procedures can be obtained (for immunogenicity cohort) * Expected to be available for the duration of the trial and can be contacted by telephone or by physical visit during trial participation * Participant is willing to give informed consent for her infant to participate in the trial Exclusion Criteria: * Body mass index of \>40 kg/m2 at the time of the first obstetric visit during the current pregnancy * Bleeding diathesis or condition (past or present) associated with prolonged bleeding that would, in the opinion of the investigator, contra-indicate intramuscular injection * History of severe adverse reaction associated with a vaccine * Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the trial, including but not limited to the following: 1. More than two fetuses (i.e. twins will be allowed) 2. Preeclampsia, eclampsia, or uncontrolled gestational hypertension 3. Known placental abnormality. 4. Known polyhydramnios or oligohydramnios 5. Known endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism, or uncontrolled diabetes mellitus at the time of consent. 6. Any signs of premature labour with the current pregnancy or having ongoing intervention (medical/ surgical) in the current pregnancy to prevent preterm birth. * At least THREE 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 trial, including but not limited to the following: 1. Prior preterm delivery between 18 to ≤34 weeks gestation, or birth weight \<2200 grams; (may be based on maternal history of prior preterm delivery where these details are not otherwise documented) 2. Prior stillbirth or neonatal death within 7 days of birth. 3. Previous infant with a known genetic disorder or major congenital anomaly * Mother who is positive for syphilis and untreated at time of enrolment * Mother living with HIV/AIDS considered to have WHO Clinical Stage 3 or 4 AIDS, or considered to be clinically unstable * Major illness of the maternal participant or conditions of the foetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal participant's participation in, and completion of, the trial * Known or history of congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrolment * Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour or laboratory abnormality that may increase the risk associated with trial participation and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial * Participation in other studies involving investigational drug(s) within 28 days prior to consent and/or during trial participation. * Use of systemic corticosteroids for \>14 days within 28 days prior to trial enrolment. Prednisone use of \<20 mg/day for ≤14 days is permitted. Inhaled/nebulized, intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted * Current alcohol abuse or illicit drug use * Receipt of blood or plasma products or immunoglobulin (Ig) in past 60 days or planned receipt through delivery, with exception of Rho(D) immune globulin (eg, RhoGAM), which can be given at any time * Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during trial participation
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Dodowa Health Research Centre
NOT_YET_RECRUITINGDodowa, Greater Accra Region, Ghana
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Enhancing Care Foundation
RECRUITINGDurban, KwaZulu-Natal, 4052, South Africa
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Kenya Medical Research Institute Centre for Global Health Research
RECRUITINGKisumu, Nyanza, 40100, Kenya
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Kenya Medical Research Institute Wellcome Trust
NOT_YET_RECRUITINGKilifi, Kilifi County, 230-80108, Kenya
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Kintampo Health Research Centre
NOT_YET_RECRUITINGKintampo, Bono East, Ghana
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MRC Unit The Gambia at London School of Hygiene & Tropical Medicine
RECRUITINGBasse Santa Su, Upper River Division, The Gambia
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MRC Unit on Child and Adolescent Health
RECRUITINGRondebosch, Western Cape, 7700, South Africa
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Setshaba Research Centre
RECRUITINGSoshanguve, Gauteng, 0152, South Africa
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VIDA Nkanyezi Research Unit
RECRUITINGJohannesburg, Gauteng, 2093, South Africa
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Wits RHI Shandukani CRS
RECRUITINGHillbrow, Gauteng, 2001, South Africa
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Wits Vaccines & Infectious Diseases Analytics (VIDA) Research unit
RECRUITINGSoweto, Gauteng, 1864, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple breath test catch flu in High-HIV regions?
- New study tracks immune clues in seniors with flu, RSV, and COVID-19
- RSV drug trial for kids under 5 halted early – only 4 children enrolled
- RSV study seeks immune clues in older adults
- France launches massive virus surveillance in GP clinics
- New study aims to predict severe bronchiolitis in infants