NCT06325657

A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PREGNANT PARTICIPANTS LIVING WITH HIV AND THEIR INFANTS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 648 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother. The study will look at the safety, tolerability, and immune activity in mothers and their infants. This study is seeking pregnant women who are: * Less than or equal to 49 years old and have HIV (Human immunodeficiency virus - * Receiving standard medical care during the pregnancy * Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection). * Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days. * agree to be present for all study visits, procedures, and blood draws. Participants will either receive: * RSVpreF vaccine * A placebo. A placebo does not have any medicine it but looks just like the study vaccine. Pregnant participants will be involved in the study from: * consent during their current pregnancy, and * for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
BIOLOGICAL	RSVpreF vaccine	RSVpreF vaccine
BIOLOGICAL	Placebp	Placebo

Timeline

• Start date: 2024-03-12
• Primary completion: 2025-06-11
• Completion: 2025-06-11
• First posted: 2024-03-22
• Last updated: 2025-07-14

Locations

14 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study