Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

NCT02796001 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 16-0055
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Virus Infection

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

  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

Study Arms (3)

RV16 infected volunteers re-challenged with RV16

ACTIVE COMPARATOR

volunteers re-challenged with RV16

Biological: human rhinovirus

RV infected volunteers re-challenged with RV39

ACTIVE COMPARATOR

volunteers re-challenged with RV39

Biological: human rhinovirus

RV infected not rechallenged

OTHER

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

Other: no intervention

Interventions

human rhinovirus BIOLOGICAL

human rhinovirus

RV infected volunteers re-challenged with RV39; RV16 infected volunteers re-challenged with RV16

no intervention OTHER

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

RV infected not rechallenged

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 34350827 DERIVED

MeSH Terms

Interventions

viral protein 1, rhinovirus

Results Point of Contact

• Title: Ronald Turner, MD
• Organization: University of Virginia School of Medicine

rbt2n@virginia.edu

4349819964

Study Officials

• Ronald Turner, MD

  Univ of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 10, 2016
• Study Start: September 25, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 6, 2022
• Results First Posted: June 6, 2022

Record last verified: 2022-06

Locations

US (1)