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

Respiratory Syncytial Virus Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06325657
Study type Interventional
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Status Recruiting
Phase Phase 3
Start date March 12, 2024
Completion date October 10, 2026
View Details
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