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Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

Primary Purpose

Healthy Volunteers

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

human rhinovirus

no intervention

About this trial

This is an interventional basic science trial for Healthy Volunteers

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Arm Label

RV16 infected volunteers re-challenged with RV16

RV infected volunteers re-challenged with RV39

RV infected not rechallenged

Arm Description

volunteers re-challenged with RV16

volunteers re-challenged with RV39

Volunteers who were infected with RV16 and eligible for re-challenge but who were not re-challenged due to voluntary withdrawal (3) or removal for exclusion criteria

Outcomes

Primary Outcome Measures

Virus Infection

Number infected after re-challenge with RV16 compared to RV39 as determined by virus isolation in cell culture or viral serology

Secondary Outcome Measures

Full Information

NCT ID

NCT02796001

First Posted

June 7, 2016

Last Updated

June 2, 2022

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT02796001

Brief Title

Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

Official Title

Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

September 25, 2017 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Volunteers who were infected with RV16 by experimental challenge were eligible for participation by re-challenge with either RV16 or RV39 to assess the host response to homologous or heterologous rechallenge.

Masking

Participant

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RV16 infected volunteers re-challenged with RV16

Arm Type

Active Comparator

Arm Description

volunteers re-challenged with RV16

Arm Title

RV infected volunteers re-challenged with RV39

Arm Type

Active Comparator

Arm Description

volunteers re-challenged with RV39

Arm Title

RV infected not rechallenged

Arm Type

Other

Arm Description

Volunteers who were infected with RV16 and eligible for re-challenge but who were not re-challenged due to voluntary withdrawal (3) or removal for exclusion criteria

Intervention Type

Biological

Intervention Name(s)

human rhinovirus

Intervention Description

human rhinovirus

Intervention Type

Other

Intervention Name(s)

no intervention

Intervention Description

4 volunteers were not re-challenged and did not participate in the second challenge

Primary Outcome Measure Information:

Title

Virus Infection

Description

Number infected after re-challenge with RV16 compared to RV39 as determined by virus isolation in cell culture or viral serology

Time Frame

Volunteers were cultured daily for detection of virus shedding for 5 days after the virus re-challenge and serum was collected for viral serology 4 weeks after virus re-challenge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Turner, MD

Organizational Affiliation

Univ of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34350827

Citation

Barone SM, Paul AG, Muehling LM, Lannigan JA, Kwok WW, Turner RB, Woodfolk JA, Irish JM. Unsupervised machine learning reveals key immune cell subsets in COVID-19, rhinovirus infection, and cancer therapy. Elife. 2021 Aug 5;10:e64653. doi: 10.7554/eLife.64653.

Results Reference

derived

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Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

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