What is ABRYSVO studying for RSV infections?

ABRYSVO is being studied to see if giving the vaccine to pregnant women can safely protect their babies from severe RSV infections during the first six months of life. The research aims to understand the vaccine's safety and effectiveness, especially in African countries where severe RSV disease is common. The University of Witwatersrand in South Africa is leading this trial.

Who may be eligible for this RSV vaccine clinical trial?

Women aged 14 to 55 years who are pregnant and attending antenatal clinics may be eligible. They must be able to consent for themselves and their infants and have no serious pregnancy complications or conditions that increase risk. Only women without certain infections or immune disorders are included. Please review eligibility criteria for more details.

Is there any cost to participate in this RSV vaccine clinical trial?

Study-related care, including the vaccine or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect that all necessary medical care related to the trial will be free.

Actively Recruiting

Phase 3

Age: 14Years - 55Years

FEMALE

Healthy Volunteers

ID06955728

Safety and Effectiveness of the ABRYSVO RSV Vaccine in Pregnant Women and Protection for Their Infants from Severe RSV Infection

Led by University of Witwatersrand, South Africa · Updated on 2026-05-18

13000

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 14Years - 55Years

FEMALE

Healthy Volunteers

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

Research Team

Lisa Nunes

Anthonet Koen

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