P1114 (DAIDS ID 11948): A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

Study Status Study Restriction

Closed to Follow Up

United States

What is P1114?

P1114 is a double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of the vaccine in seronegative infants and children. This protocol is a companion study to CIR 285, a study being conducted by the Center for Immunization Research (CIR, Johns Hopkins, Baltimore), and the Laboratory of Infectious Diseases (NIAID, Bethesda). The protocols have identical primary and secondary objectives; immunization schedules; evaluation assays and schedules; and safety monitoring and reporting. The protocols will vary slightly in site-selection requirements, eligibility requirements and site monitoring. These are all operational issues modified to account for the IMPAACT sites’ operations and infrastructure.

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

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

5093

Miller Children's Hospital Long Beach CA

Long Beach

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: 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: Alexandria DiPerna

Field Representative: Michele Kelly

Investigator: Ursula Buchholz

Investigator: Peter Collins

Investigator: Elizabeth (Betsy) McFarland

Investigator: Elizabeth Schappell

Laboratory Data Manager (LDM): Heather Sprenger

Laboratory Technologist: Linda Lambrecht

Medical Monitor: Marc Teitelbaum

Proposal Statistician: Petronella Muresan

Protocol Pharmacist: Vivian Rexroad

 

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.