Vaccination for RSV prevention in mothers and infants
A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVO (TM)), Infant Nirsevimab (BEYFORTUS (TM)) Immunization, or Both Products During the First Year of Life
This study is testing if giving a vaccine to pregnant women and a special antibody to infants can help protect babies from getting sick with RSV.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Drugs / interventions | palivizumab, nirsevimab |
| Locations | 8 sites (Atlanta, Georgia and 7 other locations) |
| Trial ID | NCT06551506 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the immunology and safety of two FDA-approved products for preventing Respiratory Syncytial Virus (RSV) infection: an active vaccine (ABRYSVO) administered to pregnant women and a monoclonal antibody (BEYFORTUS) given to infants. The study aims to compare the antibody responses generated by each product and assess the potential benefits of administering both to infants. Participants will include healthy pregnant women who meet specific eligibility criteria and intend to deliver at participating hospitals. The trial will provide insights into the effectiveness of these interventions in preventing RSV-related lower respiratory tract infections in infants.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy pregnant women aged 18-45 who are at no known increased risk for complications.
Not a fit: Patients who are not pregnant or those with high-risk pregnancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of RSV infections and related complications in infants.
How similar studies have performed: Other studies have shown success with similar approaches in RSV prevention, making this a promising area of investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-45 years of age at time of enrollment with an uncomplicated singleton pregnancy who are at no known increased risk for complications per clinical judgement of the investigator 2. Understands and agrees to comply with all study procedures 3. Willing and able to provide consent for study participation for themselves and their infant prior to initiation of any study procedures 4. In good health, as determined by the medical history and clinical judgment of the investigator Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. 5. Intention to deliver at a hospital or birthing facility where study procedures can be performed 6. Eligible to receive either product per the FDA package inserts. (Maternal RSVpreF from 32 0/7 to 36 6/7 weeks gestational age (GA) from September 1 to March 31) Exclusion Criteria: 1. Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study 2. Any condition which, in the opinion of the investigators, may pose a health risk for the participant or interfere with the evaluation of study objectives 3. Maternal bleeding diathesis, or any condition which may contraindicate intramuscular injection 4. Maternal known or suspected congenital or acquired disease that impairs the immune system, including functional asplenia or immunosuppression due to underlying illness or treatment 5. Maternal receipt of immunosuppressive drugs or biologic agents within 30 days prior to enrollment (This includes oral or parenteral corticosteroids. The use of inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eye, ears) steroids are permitted. This does not include RhoGAM) 6. Maternal conditions known to impair transplacental transfer of maternal antibodies (e.g., placental pathology, hypergammaglobulinemia, HIV) 7. Maternal history of GBS or other potentially immune-mediated medical condition (PIMMC) 8. Maternal history of severe adverse reaction or anaphylaxis to ABRYSVO or its components 9. Maternal history of preterm birth (\<34 weeks GA) 10. Current pregnancy complicated by uncontrolled hypertension, pre-eclampsia, or eclampsia 11. Previous receipt of ABRYSVO or other approved or investigational RSV vaccine
Where this trial is running
Atlanta, Georgia and 7 other locations
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- University of Maryland, School of Medicine, Center for Vaccine Development and Global Health — Baltimore, Maryland, United States (Recruiting)
- New York University School of Medicine - Langone Medical Center - Vaccine Center — New York, New York, United States (Recruiting)
- University of Rochester Medical Center - Vaccine Research Unit — Rochester, New York, United States (Not_yet_recruiting)
- Cincinnati Children's Hospital Medical Center Vaccine Research Center — Cincinnati, Ohio, United States (Recruiting)
- University of Pittsburgh - Medicine - Infectious Diseases — Pittsburgh, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Christina Rostad
- Email: christina.rostad@emory.edu
- Phone: 14047122472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.