RSV Vaccines for Respiratory Syncytial Virus

Age: < 18

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Antibacterials, Antivirals, Antifungals, others

Disqualifiers: Chronic disease, Immune impairment, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1 vaccine or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days for Group 1 and 6 to 13 months for Group 2

Multiple visits (in-person and virtual)

Post-RSV Season Follow-up

Participants in Group 2 are monitored for natural RSV infection and antibody responses

6 to 13 months

Treatment Details

Interventions

• Placebo
• RSV 6120/F1/G2/∆NS1
• RSV 6120/∆NS1

Trial Overview The 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

Group I: Group 2: RSV 6120/∆NS1 Vaccine Experimental Treatment 1 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/∆NS1 Experimental Treatment 1 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 Vaccine Experimental Treatment 1 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 Vaccine Experimental Treatment 1 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: Placebo Placebo Group 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+