pH1N1 Blinded Challenge Study

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07110532
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • A/Arkansas/08/2020 (pH1N1) — BIOLOGICAL
    GMP-grade, cell-based influenza A (pH1N1) virus (Lot #24-005), derived via reverse genetics for use in controlled human infection studies.
  • Sham/Diluent (1X SPG+Arg+Gel) — OTHER
    Sterile diluent containing 1X Sucrose Phosphate Glutamate (SPG), 1% arginine, and 1% hydrolyzed gelatin, used as a sham comparator in the human challenge trial.

Study Details

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 \</1:40 against the challenge strain. Eligible participants will be enrolled sequentially into challenge cohorts and will be randomly assigned to receive a single dose of either sham inoculation or the interventional study product at a dose between 10\^6 to 10\^7 TCID50 (or 10\^5 TCID50 if needed). Dose titration will be conducted under an adaptive escalation schedule whereby dosing will start at 10\^6 TCID50 and escalate to the next dose if a pre-determined symptomatic influenza attack rate and clinical symptom score thresholds are not met and if the dose is determined to be safe with no pre-defined halting criteria being met. The primary objectives of this study are to determine the optimal infectious dose of a pH1N1 viral challenge to cause laboratory-confirmed clinical influenza and to assess the safety profile of pH1N1 viral challenge.

Key Dates

Start date
Sep 10, 2025
Status verified
Apr 2026
Primary completion
Jun 23, 2026
Completion
Aug 18, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1A
    Subjects will randomly be administered a single intranasal virus (RG) -A/Arkansas/08/2020 (pH1N1) at a dose of 10\^6 TCID50. One of the subjects will receive a sham dose of 0 TCID50. If the Protocol Safety Review Team (PSRT) agrees that the dose is safe then Cohort 1B and Cohort 2A will begin. If proven unsafe the dose will be de-escalated to Cohort XA. N=30
  • Experimental: Cohort 1B
    Subjects will randomly be administered a single intranasal virus (RG) -A/Arkansas/08/2020 (pH1N1) at a dose of 10\^6 TCID50. One of the subjects will receive a sham dose of 0 TCID50. If the PSRT agrees that the dose is safe then Cohort 1C and Cohort 2A will begin. If proven unsafe the dose will be de-escalated to Cohort XA. N=30
  • Experimental: Cohort 1C
    Subjects will randomly be administered a single intranasal virus (RG) -A/Arkansas/08/2020 (pH1N1) at a dose of 10\^6 TCID50. One of the subjects will receive a sham dose of 0 TCID50. If the PSRT agrees that the dose is safe then Cohort 2A will begin. If proven unsafe the dose will be de-escalated to Cohort XA. N=30
  • Experimental: Cohort 2A
    Subjects will randomly be administered a single intranasal virus (RG) -A/Arkansas/08/2020 (pH1N1) at a dose of 10\^7 TCID50. One of the subjects will receive a sham dose of 0 TCID50. If the PSRT agrees that the dose is safe then Cohort 2B will begin. N=30
  • Experimental: Cohort 2B
    Subjects will randomly be administered a single intranasal virus, (RG) -A/Arkansas/08/2020 (pH1N1), at a dose of 10\^7 TCID50. One of the subjects will receive a sham dose of 0 TCID50. If the PSRT agrees that the dose is safe then Cohort 2C will begin. N=30
  • Experimental: Cohort 2C
    Subjects will randomly be administered a single intranasal virus, (RG) -A/Arkansas/08/2020 (pH1N1), at a dose of 10\^7 TCID50. One of the subjects will receive a sham dose of 0 TCID50. N=30
  • Experimental: Cohort 3A
    Subjects will randomly be administered two inoculations of intranasal virus, (RG) -A/Arkansas/08/2020 (pH1N1), at a dose of 10\^5 TCID50 administered 2-5 hours apart. If the PSRT agrees that the dose is safe, then Cohort 3B will begin. N=30
  • Experimental: Cohort 3B
    Subjects will randomly be administered two inoculations of intranasal virus, (RG) -A/Arkansas/08/2020 (pH1N1), at a dose of 10\^7 TCID50 administered 2-5 hours apart. If the PSRT agrees that the dose is safe, then Cohort 4 will begin. N=30
  • Experimental: Cohort 4
    Subjects will randomly be administered two inoculations of intranasal virus, (RG) -A/Arkansas/08/2020 (pH1N1), at a dose of 10\^6 TCID50 administered 2-5 hours apart. N=30
  • Experimental: Cohort XA
    Subjects will randomly be administered a single intranasal virus, (RG) -A/Arkansas/08/2020 (pH1N1), at a dose of 10\^5 TCID50. One of the subjects will receive a sham dose of 0 TCID50. De-escalation will occur after PSRT review of Cohort 1A, Cohort 1B, and Cohort 1C. If the PSRT agrees that the dose is safe then Cohort XB will begin. N=30
  • Experimental: Cohort XB
    Subjects will randomly be administered a single intranasal virus, (RG) -A/Arkansas/08/2020 (pH1N1), at a dose of 10\^5 TCID50. One of the subjects will receive a sham dose of 0 TCID50. If the PSRT agrees that the dose is safe then Cohort XC will begin. N=30
  • Experimental: Cohort XC
    Subjects will randomly be administered a single intranasal virus, (RG) -A/Arkansas/08/2020 (pH1N1), at a dose of 10\^5 TCID50. One of the subjects will receive a sham dose of 0 TCID50. N=30

Primary Outcome Measure

Number and percentage of participants reporting a related SAE at any time from the time of the first challenge inoculation. [ Time Frame: Through Day 57 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Maryland, School of Medicine, Center for Vaccine Development and Global HealthBaltimoreMaryland21201-1509-
Duke Vaccine and Trials UnitDurhamNorth Carolina27710-

Find similar trials in Baltimore, MD

By research site
University of Maryland, School of Medicine, Center for Vaccine Development and Global Health· Baltimore, MDDuke Vaccine and Trials Unit· Durham, NC

Related Studies