pH1N1 Blinded Challenge Study

Sex: All

Ages: 18 Years – 55 Years

Healthy volunteers: Yes

Phase: PHASE1

Enrollment: 90

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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

Summary

This protocol describes a clinical trial to develop and validate a Controlled Human Infection Model (CHIM) for influenza A/Arkansas/08/2020 (pH1N1). The study is designed to determine the optimal infectious dose of the pH1N1 challenge strain for use in future clinical trials evaluating influenza countermeasures. The study will enroll and challenge adult volunteers with the pH1N1 influenza virus challenge or sham inoculations. Given the adaptive design of this trial, the potential number of participants can vary. Depending on the pathway recommended by the PSRT and followed in the Trial Schema, the study population can range from around 30 to 99. The anticipated final sample size will be approximately 90 receiving pH1N1 challenge product plus and 6 persons receiving a sham inoculation. Participants will be pre-screened for health and for serological HAI antibody titers of \

Eligibility Criteria

Inclusion Criteria: 1. Provides signed and dated informed consent form prior to the initiation of any trial procedures. 2. Able to understand and agrees to comply with all planned trial procedures and to be available for all study visits. 3. Age \>/= 18 and \

Source: ClinicalTrials.gov (NCT07110532). StuddyBuddy aggregates publicly available trial information.