NCT02796001

Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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. .

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	human rhinovirus	human rhinovirus
OTHER	no intervention	4 volunteers were not re-challenged and did not participate in the second challenge

Timeline

• Start date: 2017-09-25
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2016-06-10
• Last updated: 2022-06-06
• Results posted: 2022-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study