RSV Vaccines for Respiratory Syncytial Virus

Recruiting in Palo Alto (17 mi)

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 is testing two types of weakened RSV vaccines in children to see if these vaccines can safely help their bodies learn to fight off the virus.

Research Team

Ruth A. Karron, MD

Principal Investigator

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

Eligibility Criteria

This trial is for children aged 6 to 59 months who have either been previously exposed to RSV (seropositive) or not (seronegative). Participants must be in good health, with normal growth and up-to-date vaccinations. They cannot join if they were born very prematurely, have a history of severe vaccine reactions, chronic diseases, immune system problems, or recent use of certain medications.

Inclusion Criteria

My growth is normal for my age, with height and weight above the 3rd percentile.

Expected to be available for the duration of the study

Pre-inoculation serum sample for RSV-neutralizing antibody specimen is obtained no more than 56 days prior to inoculation

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Exclusion Criteria

I am receiving treatment for a heart condition.

I have had wheezing or used a bronchodilator in the last year.

Previous anaphylactic reaction

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Treatment Details

Interventions

Placebo (Other)
RSV 6120/F1/G2/∆NS1 (Virus Therapy)
RSV 6120/∆NS1 (Virus Therapy)

Trial OverviewThe study tests two live-attenuated RSV vaccines: RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1 against a placebo. It aims to assess how well these vaccines create an immune response in young children and monitor their safety.

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 2: RSV 6120/∆NS1 VaccineExperimental Treatment1 Intervention

Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS1 vaccine at Day 0.

Group II: Group 2: RSV 6120/F1/G2/∆NS1Experimental Treatment1 Intervention

Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.

Group III: Group 1: RSV 6120/∆NS1 VaccineExperimental Treatment1 Intervention

Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.

Group IV: Group 1: RSV 6120/F1/G2/∆NS1 VaccineExperimental Treatment1 Intervention

Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.

Group V: Group 2: PlaceboPlacebo Group1 Intervention

Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of placebo at Day 0.

Group VI: Group 1: PlaceboPlacebo Group1 Intervention

Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.