Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

Healthy Volunteers Clinical Trial

Official title:

Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796001
• Other study ID #: 16-0055
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 25, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: June 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Infections

Intervention

Biological:
• human rhinovirus
human rhinovirus

Other:
• no intervention
4 volunteers were not re-challenged and did not participate in the second challenge

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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