Phase 2
N=46
Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02796001 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Virus Infection — 8; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- human rhinovirus (Biological); no intervention (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Virus Infection |
8; 18 | — |
Summary
The primary objective of this study is to assess the relationship between rhinovirus specific T-cell immunity and the human host response to primary rhinovirus challenge and subsequent secondary challenge with either homologous or heterologous rhinovirus serotypes.
Eligibility Criteria
Inclusion Criteria
- Subject must be 18-40 years of age
- Subject must read and sign a copy of the approved Consent Form
- Subject must have a serum neutralizing antibody titer of ≤1:2 to rhinovirus type 39 and rhinovirus type 16
- Female subjects must be using an effective birth control method.
- Total IgE <150 IU/ml.
Exclusion Criteria
- Any clinically significant abnormalities of the upper respiratory tract
- Any clinically significant acute or chronic respiratory illness
- Any clinically significant bleeding tendency by history
- Hypertension that requires treatment with antihypertensive medications
- History of angina or other clinically significant cardiac disease
- Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study
- Any medical condition that in the opinion of the Investigator is cause for exclusion from the study
- Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the 1 month prior to the study
- Regular use of tobacco in the last 6 months (ie. more than 2 days out of 7) or inability to refrain from smoking during the study
- Inability to refrain from the use of common cold therapies in the 5 days after each rhinovirus challenge.
- Participation in any other clinical drug trial in the month prior to the study
- Female subjects with a positive urine pregnancy screen.
Data sourced from ClinicalTrials.gov (NCT02796001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.