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Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

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ClinicalTrials.gov Identifier: NCT02796001
Recruitment Status : Enrolling by invitation
First Posted : June 10, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ronald Turner, MD, University of Virginia

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: human rhinovirus Phase 1 Phase 2

Detailed Description:
The primary objective of this study is to assess the relationship between RV-specific T-cell immunity and the human host response to primary RV challenge and subsequent secondary challenge with either homologous or heterologous RV serotypes. The overall hypothesis that will be addressed by the mechanistic studies in this proposal is that T helper (Th) and T follicular helper (Tfh) cells directed against conserved RV epitopes expand upon RV exposure and some of these cells persist as stable cross-reactive memory populations capable of displaying lineage-specific protective functions upon re-infection with related or unrelated strains of RV. The human specimens collected in this study will be analyzed with a variety of state-of-the-art techniques to provide an in depth description of T-cell responses to RV infection, and the correlation of these responses with viral infection, antibody responses, and illness. Beyond this objective, by using a systems biology approach, we aim to gain new insight into the role of diverse cell types involved in adaptive immunity to RV. .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Active Comparator: RV16
volunteers re-challenged with RV16
Biological: human rhinovirus
human rhinovirus

Active Comparator: RV39
volunteers re-challenged with RV39
Biological: human rhinovirus
human rhinovirus




Primary Outcome Measures :
  1. virus shedding [ Time Frame: 15 weeks ]
    The primary clinical outcome will be the correlation between the number of pre-existing RV-16 specific T-cells (15 wks.) and infection following re-challenge with RV-39 as assessed by virus shedding in nasal lavage.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject must be 18-40 years of age
  2. Subject must read and sign a copy of the approved Consent Form
  3. Subject must have a serum neutralizing antibody titer of ≤1:2 to rhinovirus type 39 and rhinovirus type 16
  4. Female subjects must be using an effective birth control method.
  5. Total IgE <150 IU/ml.

Exclusion Criteria:

  1. Any clinically significant abnormalities of the upper respiratory tract
  2. Any clinically significant acute or chronic respiratory illness
  3. Any clinically significant bleeding tendency by history
  4. Hypertension that requires treatment with antihypertensive medications
  5. History of angina or other clinically significant cardiac disease
  6. Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study
  7. Any medical condition that in the opinion of the Investigator is cause for exclusion from the study
  8. Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the 1 month prior to the study
  9. 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
  10. Inability to refrain from the use of common cold therapies in the 5 days after each rhinovirus challenge.
  11. Participation in any other clinical drug trial in the month prior to the study
  12. Female subjects with a positive urine pregnancy screen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796001


Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Ronald Turner, MD
Investigators
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Principal Investigator: Ronald Turner, MD Univ of Virginia

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Responsible Party: Ronald Turner, MD, Professor of Pediatrics, University of Virginia
ClinicalTrials.gov Identifier: NCT02796001     History of Changes
Other Study ID Numbers: 16-0055
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection