RSV Vaccine for Respiratory Syncytial Virus

Recruiting in Palo Alto (17 mi)

+1 other location

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?

This trial tests a new RSV vaccine given as nose drops to help protect against lung infections caused by the RSV virus. It involves healthy children and infants, including those who have and have not had an RSV infection before. The vaccine works by teaching the body to recognize and fight the virus.

Research Team

Ruth A. Karron, MD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

This trial is for healthy infants and children aged 12 to 59 months. It includes those who have had RSV before (seropositive) and those who haven't (seronegative), as well as younger infants not screened for RSV. Participants must be in good health, available for the study duration, and have parental consent.

Inclusion Criteria

Seropositive for RSV as defined by serum RSV neutralizing antibody titer equal to or greater than 1:40

Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health

Seronegative for RSV antibody, defined as a serum RSV neutralizing antibody titer less than 1:40 as determined not more than 42 days prior to inoculation

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Exclusion Criteria

Known hypersensitivity to any vaccine component

Previous serious vaccine-associated AE or anaphylactic reaction

Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization

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Treatment Details

Interventions

RSV ΔNS2 Δ1313 I1314L Vaccine (Virus Therapy)

Trial OverviewThe trial tests a new vaccine called RSV ΔNS2 Δ1313 I1314L against a placebo to see if it's safe and how well it triggers an immune response in kids with different histories of RSV infection.

Participant Groups

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 4: RSV vaccineExperimental Treatment1 Intervention

Healthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Group II: Group 3: RSV vaccineExperimental Treatment1 Intervention

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Group III: Group 2: RSV vaccineExperimental Treatment1 Intervention

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Group IV: Group 1: RSV vaccineExperimental Treatment1 Intervention

Healthy RSV-seropositive children ages 12 to 59 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Group V: Group 4: PlaceboPlacebo Group1 Intervention

Healthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the placebo administered as nose drops at study entry.

Group VI: Group 2: PlaceboPlacebo Group1 Intervention

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry.

Group VII: Group 3: PlaceboPlacebo Group1 Intervention

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry.

Group VIII: Group 1: PlaceboPlacebo Group1 Intervention

Healthy RSV-seropositive children ages 12 to 59 months will receive one dose of the placebo administered as nose drops at study entry.