RSV Challenge Strain for Healthy Adults

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Steroids, Immunosuppressants, Inhalers, others

Disqualifiers: Asthma, Pregnancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.

Research Team

Kawsar Talaat, MD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

Healthy adults aged 18-50 can join this trial. They must be in good health, pass a test showing they understand RSV and the study, and stay at the hospital for the trial period. Participants need to use reliable birth control or be sterile.

Inclusion Criteria

General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator

Available for the duration of the trial

Willingness to refrain from receiving licensed or investigational vaccines or other investigational products from the day of enrollment until Study Day 56

Exclusion Criteria

I have received all required vaccines within the specified timeframes.

Receipt of any investigational vaccine or drug within specific timeframes

I have had my spleen removed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Challenge

Participants are admitted to the inpatient isolation unit and receive a single dose of 10^5 PFUs of rRSV A/Maryland/001/11 intranasally on Day 0

8 days

Inpatient stay

Outpatient Follow-up

Participants attend outpatient visits for monitoring, including physical examinations, blood collection, and nasal washes

56 days

Visits on Days 10, 28, and 56

Long-term Follow-up

Follow-up phone contact at 6 months to assess for any new chronic conditions or serious health events/hospitalizations

Treatment Details

Interventions

• rRSV A/Maryland/001/11

Trial Overview The trial is testing rRSV A/Maryland/001/11, a lab-made version of Respiratory Syncytial Virus (RSV). It's given through the nose to see how safe it is, if it causes an immune response, and how well it grows inside the body.

Participant Groups

Group I: Cohort 2: rRSV A/Maryland/001/11 Experimental Treatment 1 Intervention

Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0).

Group II: Cohort 1: rRSV A/Maryland/001/11 Experimental Treatment 1 Intervention

Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (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+