IMPAACT 2012: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID cp ΔM2-2, Lot RSV#009B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

Study Status Study Restriction

Closed to Follow Up

United States

What is IMPAACT 2012?

IMPAACT 2012 is a double-blind, randomized, placebo-controlled trial that will evaluate the infectivity, safety, and immunogenicity of Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID cp ΔM2-2, Lot RSV#009B in infants and children confirmed to be RSV-seronegative within 42 days prior to inoculation. Approximately 33 healthy RSV-seronegative infants and children ≥6 months (180 days) to <25 months (750 days) of age will be enrolled. Eligible infants and children will receive a single dose of RSV LID cp ΔM2-2 vaccine or placebo intranasally at entry. Children 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

4001

Chicago Children's CRS

Chicago

United States of America

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

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 Co-Chair: Ruth Karron

DAIDS Medical Officer: Patrick Jean-Philippe

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Jennifer Libous

Clinical Trials Specialist: Charlotte Perlowski

Data Manager: Benjamin Johnston

Data Manager: Linda Marillo

Field Representative: Emily Barr

Investigator: Ursula Buchholz

Investigator: Peter Collins

Investigator: Elizabeth (Betsy) McFarland

Investigator: Elizabeth Schappell

Laboratory Data Manager (LDM): Oswald Dadson

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.