A Prospective Randomized Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVOTM) Infant Nirsevimab (BEYFORTUSTM) Immunization or Both Products During the First Year of Life
Brief description of study
At the NYU Langone Vaccine Center, we are conducting an NIH sponsored clinical trial on two FDA-approved products that protect against RSV (Respiratory Syncytial Virus): the Maternal RSV Vaccine (ABRYSVOTM) and the Infant RSV Immunization (BEYFORTUSTM).
RSV infection can be fatal to infants. Thus, protection against this virus is strongly recommended by the CDC. The standard single protection approach is either the Maternal RSV Vaccine (ABRYSVOTM) during pregnancy or the Infant RSV Immunization (BEYFORTUSTM) after birth.
Given the danger of RSV, researchers are conducting this clinical trial to compare the safety and effectiveness of a new double protection approach versus the standard single protection approach using these FDA-approved products. The new double protection approach includes both the Maternal RSV Vaccine (ABRYSVOTM) during pregnancy and the Infant RSV Immunization (BEYFORTUSTM).
If you are eligible and agree to participate, you will be randomly assigned to 1 of 4 study groups:
New Approach: Double protection
- Group 1
- Mother gets the RSV vaccine (ABRYSVOTM) at 32 to 36 weeks of pregnancy
- Infant gets the RSV immunization (BEYFORTUSTM) at birth
- Group 2
- Mother gets the RSV vaccine (ABRYSVOTM) at 32-36 weeks of pregnancy
- Infant gets the RSV immunization (BEYFORTUSTM) at 3 months old
- Group 3
- Mother gets the RSV vaccine (ABRYSVOTM) at 32 to 36 weeks of pregnancy
- Group 4
- Infant gets the RSV immunization (BEYFORTUSTM) at birth
You will be compensated $140 for completing each in-person visit. This includes a study visit at the time of delivery. Additionally, you will be compensated $30 for telephone visits and $15 for completing all electronic diary entries.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.