IMPAACT 2018: Randomized Phase I Study of the Infectivity, 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

Open to Accrual

United States

What is IMPAACT 2018?

IMPAACT 2018 is a double-blind, randomized, placebo-controlled trial that will evaluate the infectivity, safety, and immunogenicity of two recombinant live-attenuated respiratory syncytial virus vaccines (RSV ΔNS2/Δ1313/I1314L and RSV 276) in infants confirmed to be RSV-seronegative within 42 days prior to inoculation. Approximately 80 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 or RSV 276 vaccine or placebo intranasally at entry. Participants will be enrolled in the protocol between April 1st and October 14th (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 enrollment.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country

3801

Texas Childrens Hosp. CRS

Houston

United States of America

4001

Chicago Children's CRS

Chicago

United States of America

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5030

Emory University School of Medicine NICHD CRS

Atlanta

United States of America

5040

SUNY Stony Brook

Stony Brook

United States of America

5048

University of Southern California LA

Los Angeles

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5112

UCLA - David Geffen School of Medicine

Los Angeles

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

31779

Johns Hopkins University Center for Immunization Research

Baltimore

United States of America

Study contacts:

Study Chair: Coleen Cunningham

Study Vice-Chair: Matthew Kelly

Study Vice-Chair: Elizabeth (Betsy) McFarland

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: Linda Marillo

Field Representative: Emily Barr

Investigator: Ursula Buchholz

Investigator: Peter Collins

Investigator: Amanda (Mandy) Dempsey

Investigator: Elizabeth Schappell

Laboratory Data Manager (LDM): Andee Fox

Laboratory Specialist: Dale Dayton

Laboratory Technologist: Paul Harding

Protocol Pharmacist: Lynette Purdue

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.