IMPAACT 2021: Randomized Phase IB Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV delta NS2/delta 1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

Study Status Study Restriction

In Development

United States

What is IMPAACT 2021?

IMPAACT 2021 is a double-blind, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of recombinant live-attenuated respiratory syncytial virus vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or placebo in infants confirmed to be RSV-seronegative within 42 days prior to inoculation. Approximately 450 healthy RSV-seronegative infants ≥6 months (180 days) to <25 months (750 days) of age will be enrolled. Eligible infants will receive a single dose of RSV ΔNS2/Δ1313/I1314L vaccine or RSV 276 vaccine or placebo intranasally at entry. Participants will be enrolled in the protocol outside of RSV season and will remain on study until they complete the post-RSV season visit between April 1st and April 30th in the calendar year following their enrollment.

Study Trainings

Please contact the Clinical Trials Specialists for access to training materials (see contact list below).

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Co-Chair: Coleen Cunningham

Study Co-Chair: Ruth Karron

Study Vice-Chair: Elizabeth (Betsy) McFarland

Study Vice-Chair: Amelia Thompson

DAIDS Medical Officer: Patrick Jean-Philippe

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Jennifer Libous

Clinical Trials Specialist: Charlotte Perlowski

Data Manager: Kayla Denson

Data Manager: Benjamin Johnston

Field Representative: Emily Barr

Investigator: Ursula Buchholz

Investigator: Peter Collins

Laboratory Data Manager (LDM): Frederic Bone

Laboratory Specialist: Dale Dayton

Laboratory Specialist: Nicole Tobin

Laboratory Technologist: Paul Harding

Laboratory Technologist: Jason Rippe

Protocol Pharmacist: Kelly Parsons

Protocol Pharmacist: Lynette Purdue

Statistician: Jane Lindsey

Statistician: Petronella Muresan

Westat Representative: Scott Watson

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.