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NCT07110532 · ClinicalTrials.gov registry record · Phase 1
pH1N1 Blinded Challenge Study
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
- 2
- Study locations
NCT07110532: Recruiting Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07110532 is a Phase 1 study of Influenza that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07110532, a Phase 1 study of Influenza, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
- 2
- Study locations
Study 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 120. However, it is anticipated that the final sample size will be around 60 participants receiving pH1N1 challenge product plus approximately 4 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.
Conditions Studied
Interventions
- BIOLOGICAL A/Arkansas/08/2020 (pH1N1)
- OTHER Sham/Diluent (1X SPG+Arg+Gel)
Study Locations (2)
Maryland
- University of Maryland, School of Medicine, Center for Vaccine Development and Global Health - Baltimore
North Carolina
- Duke Vaccine and Trials Unit - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-09-10 |
| Est. Completion | 2026-08-18 |
| Phase | Phase 1 |
What NCT07110532 shows while recruiting
NCT07110532 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which A/Arkansas/08/2020 (pH1N1) is the first listed.
NCT07110532 reports a single indexed study location in Maryland, North Carolina.
Frequently Asked Questions
What is clinical trial NCT07110532 about?
NCT07110532 is a clinical study titled "pH1N1 Blinded Challenge Study". 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 cou...
What is the current status of trial NCT07110532?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2025-09-10. Estimated completion is 2026-08-18.
What conditions does trial NCT07110532 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT07110532?
The interventions under investigation include: A/Arkansas/08/2020 (pH1N1) (BIOLOGICAL), Sham/Diluent (1X SPG+Arg+Gel) (OTHER).
Who is sponsoring clinical trial NCT07110532?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07110532 being conducted?
This trial has 2 study locations across Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07110532's enrollment target sits among peer trials
180 85th of 156 higher than 72 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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