pH1N1 Blinded Challenge Study

PHASE1RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

October 14, 2025

Study Completion Date

December 6, 2025

Conditions
Influenza
Interventions
BIOLOGICAL

A/Arkansas/08/2020 (pH1N1)

GMP-grade, cell-based influenza A (pH1N1) virus (Lot #24-005), derived via reverse genetics for use in controlled human infection studies.

OTHER

Sham/Diluent (1X SPG+Arg+Gel)

Sterile diluent containing 1X Sucrose Phosphate Glutamate (SPG), 1% arginine, and 1% hydrolyzed gelatin, used as a sham comparator in the human challenge trial.

Trial Locations (2)

27710

RECRUITING

Duke Vaccine and Trials Unit, Durham

21201-1509

RECRUITING

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

NCT07110532 - pH1N1 Blinded Challenge Study | Biotech Hunter | Biotech Hunter