PROMISE study researches immunology and safety of maternal RSV vaccination

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DMID 24-0003: 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 (PROMISE)

Although maternal vaccination with RSVpreF and passive immunization of infants with nirsevimab have both been approved for the prevention of RSV LRTI in all infants, the two products have not been evaluated in a single study. Furthermore, the sequential administration of both products may be indicated for some infants, but the safety and immunologic results of this approach have not been evaluated. An understanding of the safety and serology of the administration of both products versus either product alone could help guide clinical decision-making for pregnant women and their infants.

“We are excited to report that this trial, being performed at eight sites, is a study of two products that can reduce the risk of Respiratory Syncytial Virus in infants, which has launched. We, the protocol chairs, are so thankful to all the many people who have gotten us to this milestone and who are working so hard on this important study," shares protocol co-chair, Jim Campbell, MD, MS.

"RSV is the leading cause of hospitalization in U.S. infants, in whom it can cause severe bronchiolitis and pneumonia. The DMID 24-0003 study will evaluate the safety and immunology of maternal RSV vaccine, infant nirsevimab immunization, or sequential administration of both products for infants. It will provide information about the magnitude and durability of RSV antibodies in mothers and infants, breast milk antibodies, and intercurrent RSV infections. We are grateful for the opportunity to conduct this study, and we hope the results can help inform decision-making for pregnant individuals and their infants," shares protocol co-chair, Christina Rostad, MD.

About the Study:

PROMISE is a Phase IV parallel trial enrolling approximately 200 healthy mother-infant pairs at eight sites. Pregnant individuals will be randomized 1:1:1:1 at the time of enrollment (during pregnancy) into the following groups: Group 1A: maternal RSVpreF vaccine/no infant nirsevimab; Group 1B: maternal RSVpreF vaccine/infant nirsevimab at birth; Group 1C: maternal RSVpreF vaccine/infant nirsevimab at 3 months; or Group 2: no maternal RSVpreF vaccine/infant nirsevimab at birth. Participants will be in the study for up to approximately 14 months; Group 1 maternal participants will be vaccinated at 32 weeks, 0 days to 36 weeks, 6 days GA and all maternal participants (Group 1 and Group 2) will be followed for 12 months post birth-visit. Infant participants will be followed through the 12 months of life. The study is actively enrolling through January 2025.

IDCRC Sites:

  • Baylor College of Medicine VTEU
  • Cincinnati Children’s Hospital and Medical Center (CCHMC) VTEU
  • Emory University VTEU
  • New York University VTEU
  • University of Rochester VTEU
  • Vanderbilt University VTEU
  • University of Pittsburgh sub site to Vanderbilt University VTEU
  • University of Maryland VTEU

ClinicalTrials.gov identifier: NCT06551506