Could a shot for moms shield babies from deadly RSV?

NCT ID NCT06955728

Recruiting now ⭐️ VACCINE ⭐️ Sponsor: University of Witwatersrand, South Africa Source: ClinicalTrials.gov ↗

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.

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Conditions

The condition(s) this trial relates to.

Obstetric Labor, Premature respiratory syncytial virus infectious disease respiratory syncytial virus bronchiolitis prevention target

As listed by the trial registrant

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

PRETERM LABOUR RSV IMMUNISATION RSV INFECTIONS

Contacts and locations

Locations

Dodowa Health Research Centre
NOT_YET_RECRUITING

Dodowa, Greater Accra Region, Ghana
Enhancing Care Foundation
RECRUITING

Durban, KwaZulu-Natal, 4052, South Africa
Kenya Medical Research Institute Centre for Global Health Research
RECRUITING

Kisumu, Nyanza, 40100, Kenya
Kenya Medical Research Institute Wellcome Trust
NOT_YET_RECRUITING

Kilifi, Kilifi County, 230-80108, Kenya
Kintampo Health Research Centre
NOT_YET_RECRUITING

Kintampo, Bono East, Ghana
MRC Unit The Gambia at London School of Hygiene & Tropical Medicine
RECRUITING

Basse Santa Su, Upper River Division, The Gambia
MRC Unit on Child and Adolescent Health
RECRUITING

Rondebosch, Western Cape, 7700, South Africa
Setshaba Research Centre
RECRUITING

Soshanguve, Gauteng, 0152, South Africa
VIDA Nkanyezi Research Unit
RECRUITING

Johannesburg, Gauteng, 2093, South Africa
Wits RHI Shandukani CRS
RECRUITING

Hillbrow, Gauteng, 2001, South Africa
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research unit
RECRUITING

Soweto, Gauteng, 1864, South Africa

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