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Virus Therapy

RSV Challenge Strain for Healthy Adults

Phase 1
Recruiting
Led By Kawsar Talaat, 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
Non-pregnant adults between 18 years and 50 years of age, inclusive
Willingness to refrain from blood and plasma donation for 1 year after study enrollment
Must not have
History of surgical splenectomy
Presence of any febrile illness or symptoms suggestive of a respiratory infection within 2 weeks prior to inoculation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through day 56
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new virus in healthy adults to see if it is safe and how the body responds to it.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects are not detailed but may include typical responses to viral infections such as nasal congestion, coughing, sore throat, headache or fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old and not pregnant.
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I agree not to donate blood or plasma for a year after joining the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had my spleen removed.
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I have not had a fever or signs of a respiratory infection in the last 2 weeks.
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I have had significant issues or surgery on my nose or sinuses.
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I have had Bell's palsy in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in serum neutralizing antibody titer to RSV
Frequency of adverse events (AEs)
Frequency of challenge virus-related solicited signs and symptoms
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: rRSV A/Maryland/001/11Experimental Treatment1 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/001/11Experimental Treatment1 Intervention
Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0).

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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
3,322 Previous Clinical Trials
5,364,698 Total Patients Enrolled
Kawsar Talaat, MDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
11 Previous Clinical Trials
714 Total Patients Enrolled
~6 spots leftby Nov 2025
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