IMPAACT 2000 (DAIDS ID 12016): A Phase I Study of the Safety and Immunogenicity of Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID ΔM2-2 in RSV-Seronegative Infants and Children

Study Status Study Restriction

Closed to Follow Up

United States

What is IMPAACT 2000?

IMPAACT 2000 is a double-blind, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID ΔM2-2 in infants and children confirmed to be RSV-seronegative within 42 days prior to inoculation.  Approximately 51 healthy RSV-seronegative infants and children ≥6 months (180 days) to <25 months (750 days) of age will be enrolled to yield 45 subjects with evaluable results.  Eligible infants and children will receive a single dose of RSV LID 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:

Study Trainings

CRF Training

Sites where the study is implemented:

CRS ID Site Name City Country

5117

Hospital Nossa Senhora da Conceicao CRS

Porto Alegre

Brazil

4001

Chicago Children's CRS

Chicago

United States of America

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

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

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: Elizabeth (Betsy) McFarland

Study Co-Chair: Ruth Karron

DAIDS Medical Officer: Devasena Gnanashanmugam

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Charlotte Perlowski

DAIDS Protocol Pharmacist: Ana Martinez

Data Manager: Linda Marillo

Field Representative: Emily Barr

Investigator: Ursula Buchholz

Investigator: Peter Collins

Investigator: Coleen Cunningham

Investigator: Elizabeth Schappell

Laboratory Data Manager (LDM): Heather Sprenger

Laboratory Specialist: Carolyn Yanavich

Laboratory Technologist: Paul Harding

Medical Monitor: Marc Teitelbaum

Protocol Pharmacist: Vivian Rexroad

Statistician: Petronella Muresan

 

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.