NCT03624790

Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers

Phase I, Open Label, Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.

Detailed description

This study will evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults. Participants will be admitted to the inpatient isolation unit and will receive a single dose of 10\^5 plaque forming units (PFUs) of rRSV A/Maryland/001/11, delivered intranasally on Day 0. Participants will be enrolled outside of the RSV season between April 1 and October 31. Participants will remain in the inpatient isolation unit for a minimum of 8 days after the challenge and will be discharged after two RSV reverse transcription polymerase chain reaction (RT-PCR) results lower than 3 Log10 genome equivalents per mL of nasal wash. Upon discharge from the inpatient unit, participants will attend outpatient visits on Days 10 (if previously discharged), 28, and 56. These study visits may include physical examinations, blood collection, and nasal washes. At 6 months, there will be a follow-up phone contact to assess for any new chronic conditions or serious health events/hospitalizations. Volunteers in Cohort 1 received a dose of 10\^5 PFU, consistent with similar RSV challenge studies done previously. Cohort 2 will be conducted as an extension of Cohort 1 to extend the safety and infectivity evaluation, and will also receive a single dose of 10\^5 PFU rRSV A/Maryland/001/11 challenge.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	rRSV A/Maryland/001/11	10\^5 PFU; delivered intranasally

Timeline

• Start date: 2018-07-31
• Primary completion: 2024-10-24
• Completion: 2024-10-24
• First posted: 2018-08-10
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study