IMPAACT 2021: Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 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, RSV 6120 ΔNS2/1030s, RSV 276 or placebo in children confirmed to be RSV-seronegative within 42 days prior to study product administration. Approximately 160 healthy RSV-seronegative children ≥6 months (180 days) to <25 months (750 days) of age will be enrolled. Eligible children will receive a single dose of RSV ΔNS2/Δ1313/I1314L vaccine, RSV 6120 ΔNS2/1030s vaccine, RSV 276 vaccine or placebo intranasally at entry. Participants will be enrolled in the study 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 Documents

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

30344

Saint Louis University Center for Vaccine Development

Saint Louis

United States

32014

Duke Vaccine and Trials Unit

Durham

United States

32015

Sealy Institute for Vaccine Sciences Clinical Trials Program at University of Texas Medical Branch

Galveston

United States

32016

University of Maryland School of Medicine Center for Vaccine Development

Baltimore

United States

32017

The Children's Mercy Hospital Kansas City

Kansas City

United States

32018

Gamble Center for Clinical Studies at Cincinnati Children’s Hospital Medical Center

Cincinnati

United States

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

31779

Johns Hopkins University Center for Immunization Research

Baltimore

United States of America

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

Community Program Manager: Marcus Bolton

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: Mark Giganti

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.