Actively Recruiting
A Phase-IIIb Randomized, Placebo-Controlled Trial on Safety of RSVA/B-preF Vaccine in Pregnant Women and Protection Against Severe RSV Lower Respiratory Tract Infection in Infants
Led by University of Witwatersrand, South Africa · Updated on 2026-05-18
13000
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Witwatersrand, South Africa
Lead Sponsor
W
World Health Organization
Collaborating Sponsor
AI-Summary
What this Trial Is About
Respiratory syncytial virus (RSV) is a common virus affecting children, especially young babies, premature infants, and those with heart or lung problems. It is a leading cause of hospitalization for children under 5 years old globally, with many severe cases and deaths occurring in low- and middle-income countries. This research evaluates the safety of an RSV vaccine called ABRYSVO given to pregnant women and how well it protects their infants from severe RSV infections during the first six months of life, particularly in African and lower-middle income countries where data is limited. Pregnant women will receive either the ABRYSVO vaccine or a placebo in a randomized, double-blind trial. The vaccine contains stabilized RSV prefusion F antigens from virus subgroups A and B. The study will enroll pregnant women at the approved gestational age for vaccination, with participants randomly assigned to receive either the vaccine or placebo in equal numbers. The trial will monitor the safety of the vaccine in mothers and infants and measure how well the vaccine prevents severe RSV lower respiratory tract infections in babies up to 180 days old. Participants will attend antenatal clinics and provide informed consent for themselves and their infants. Researchers will follow the women through pregnancy and delivery, recording any preterm births and birth weights. Infants will be monitored for RSV infections confirmed by laboratory tests, and hospitalizations due to RSV will be tracked up to six months of age. Safety assessments include monitoring adverse events in mothers and babies, with follow-up visits and telephone contacts to ensure comprehensive data collection throughout the trial period.
CONDITIONS
Brief Title
A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women legally competent to consent for themselves and their newborn
- At approved gestational age for vaccine administration, not in active labour
- Able to understand and follow trial procedures
- Attending antenatal clinic
- Documented HIV and syphilis test during current pregnancy
- Provide written informed consent (witnessed thumbprint if illiterate)
- Intend to deliver at a hospital or birthing facility with trial access
- Expected to be available and reachable during trial
- Willing to consent for infant participation
You will not qualify if you...
- Body mass index over 40 kg/m2 at first obstetric visit
- Bleeding disorders contra-indicating intramuscular injection
- History of severe vaccine-related adverse reactions
- Current pregnancy complications increasing risk, such as more than two fetuses, preeclampsia, placental abnormalities, polyhydramnios or oligohydramnios, untreated thyroid disorders, uncontrolled diabetes, or signs of premature labour
- At least three prior pregnancy complications increasing risk, including prior preterm delivery, stillbirth, neonatal death, or infant with genetic disorder
- Untreated syphilis at enrolment
- Clinically unstable HIV/AIDS stage 3 or 4
- Major maternal or fetal illness increasing trial risk
- Known or history of immunodeficiency or rheumatologic disorders requiring immunosuppressants
- Other acute or chronic medical or psychiatric conditions increasing trial risk
- Participation in other investigational drug studies within 28 days
- Systemic corticosteroids use over 14 days within 28 days prior, except low-dose prednisone
- Current alcohol abuse or illicit drug use
- Recent receipt or planned receipt of blood products or immunoglobulin except Rho(D) immune globulin
- Prior or planned RSV vaccination during trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From vaccination during pregnancy until delivery
Participants receive either the RSV vaccine or a placebo to evaluate safety in pregnant women and protection against RSV in infants.
1 vaccination visit during pregnancy
Duration - Up to 6 months (180 days) after infant birth
Participants and their infants are monitored to evaluate vaccine efficacy against RSV-associated severe lower respiratory tract infections and safety outcomes through 180 days after birth.
Multiple follow-up visits up to 180 days postpartum
Trial Site Locations
Total: 11 locations
1
Kintampo Health Research Centre
Kintampo, Bono East, Ghana
Not Yet Recruiting
2
Dodowa Health Research Centre
Dodowa, Greater Accra Region, Ghana
Not Yet Recruiting
3
Kenya Medical Research Institute Wellcome Trust
Kilifi, Kilifi County, Kenya, 230-80108
Not Yet Recruiting
4
Kenya Medical Research Institute Centre for Global Health Research
Kisumu, Nyanza, Kenya, 40100
Actively Recruiting
5
Wits RHI Shandukani CRS
Hillbrow, Gauteng, South Africa, 2001
Actively Recruiting
6
VIDA Nkanyezi Research Unit
Johannesburg, Gauteng, South Africa, 2093
Actively Recruiting
7
Setshaba Research Centre
Soshanguve, Gauteng, South Africa, 0152
Actively Recruiting
8
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research unit
Soweto, Gauteng, South Africa, 1864
Actively Recruiting
9
Enhancing Care Foundation
Durban, KwaZulu-Natal, South Africa, 4052
Actively Recruiting
10
MRC Unit on Child and Adolescent Health
Rondebosch, Western Cape, South Africa, 7700
Actively Recruiting
11
MRC Unit The Gambia at London School of Hygiene & Tropical Medicine
Basse Santa Su, Upper River Division, The Gambia
Actively Recruiting
Research Team
L
Lisa Nunes
A
Anthonet Koen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here