Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byRuth A. Karron, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants and children 6 to 24 months of age. This study is a companion study to IMPAACT 2018.

Research Team

Ruth A. Karron, MD

Principal Investigator

Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)

Eligibility Criteria

Inclusion Criteria

Greater than or equal to 6 months (defined as greater than or equal to 180 days) of age at the time of screening and less than 25 months (defined as less than 750 days) of age at the time of enrollment

In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease.

Parent/guardian is willing and able to provide written informed consent as described in the protocol.

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