NCT04978454View on ClinicalTrials.gov

Influenza Challenge Study to Determine the Optimal Infection Dose and Safety of a Recombinant H3N2 (A/Texas/71/2017 (H3N2, Clade 3C3a) Influenza Strain

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 19, 2021

Primary Completion Date

September 22, 2022

Study Completion Date

September 22, 2022

Conditions
Influenza
Interventions
BIOLOGICAL

Influenza RG-A/Texas/71/2017 (H3N2) Challenge

RG-A/Texas/71/2017 (H3N2) is an infectious influenza virus and requires handling at BioSafety Level 2. The challenge virus will be administered intranasally in a volume of approximately 0.5 mL per nostril. Intranasal challenge will be carried out using the Intranasal Mucosal Atomization ( MAD Nasa(TM)) Device attached to a 1 mL syringe.

OTHER

Placebo

Sucrose phosphate glutamate (SPG) inoculum

Trial Locations (2)

27710

Duke University Trent Drive, Durham

21201-4606

University of Maryland, School of Medicine, Center for Vaccine Development and Global Health, Baltimore

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT04978454 - Influenza Challenge Study to Determine the Optimal Infection Dose and Safety of a Recombinant H3N2 (A/Texas/71/2017 (H3N2, Clade 3C3a) Influenza Strain | Biotech Hunter | Biotech Hunter