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


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


Chicago Children's CRS


United States of America


UCSD Mother-Child-Adolescent HIV Program

San Diego

United States of America


University of Southern California LA

Los Angeles

United States of America


University of Colorado Denver NICHD CRS


United States of America


Rush University Cook County Hospital Chicago NICHD CRS


United States of America




United States of America


Johns Hopkins University Center for Immunization Research


United States of America

Study contacts:

Study Chair: Elizabeth (Betsy) McFarland

Study Co-Chair: Ruth Karron

DAIDS Medical Officer: Patrick Jean-Philippe

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.