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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

Phase 1
Waitlist Available
Led By Ruth A. Karron, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through month 13

Summary

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.

Eligible Conditions
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through month 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through month 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of virus shedding in nasal washes
Frequency of RSV neutralizing antibody responses
Frequency of a greater than or equal to 4-fold rise in RSV serum neutralizing antibody titer
+7 more
Secondary study objectives
Frequency of B cell response to vaccine
Frequency of antibody responses in the vaccine and placebo recipients who experience natural infection with wt RSV during the subsequent RSV season
Frequency of mucosal antibody responses to vaccine
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: RSV ΔNS2/Δ1313/I1314L vaccineExperimental Treatment1 Intervention
Participants will receive a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
Group II: RSV 276 vaccineExperimental Treatment1 Intervention
Participants will receive a single dose of the RSV 276 vaccine at study entry (Day 0).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo at study entry (Day 0).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSV ΔNS2/Δ1313/I1314L
2017
Completed Phase 1
~70
RSV 276
2017
Completed Phase 1
~70

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,327 Previous Clinical Trials
5,365,909 Total Patients Enrolled
Ruth A. Karron, MDPrincipal InvestigatorCenter for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)
19 Previous Clinical Trials
858 Total Patients Enrolled
~10 spots leftby Dec 2025
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