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
Standard Approach: Single protection
  • 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
If you are interested in participating, you will be asked to provide informed consent for yourself and your infant to be part of this study. In this study, you will be asked to complete 6 to 7 in-person visits and 2 phone visits. Your infant will have 5 in-person study visits, which will coincide with your study visits. Participation in this study would begin between 20 to 32 weeks of pregnancy and last until 12 months after your delivery.

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.




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