Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07110532
The ClinicalTrials.gov registry entry for NCT07110532 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
-
A/Texas Flu Challenge
RECRUITING · Phase 1
-
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
RECRUITING · Phase 1
-
Influenza Human Challenge Model
RECRUITING · Phase 1
-
A Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults
ACTIVE NOT RECRUITING · Phase 1
-
Pilot Influenza Challenge Study
ACTIVE NOT RECRUITING · Phase 1
-
A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older
ACTIVE NOT RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.