Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01646138 · ClinicalTrials.gov registry record · Phase 1
Influenza A 2009 H1N1 Challenge Study in Healthy Adults
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT01646138: Completed Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01646138 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 49 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01646138, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- A challenge study exposes a person to a disease and allows researchers to study the disease through the body's healing process. An influenza challenge study that looks at different amounts of the flu virus can provide more information on the smallest amount needed to cause an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy volunteers to see how the body responds to the virus. Objectives: * To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate flu infection in a healthy adult. * To study how the body s immune system responds to the virus. Eligibility: * Healthy volunteers at least 18 years of age. * Participants must be willing to remain in isolation for a minimum of 9 days. Design: * Participants will be admitted to a hospital inpatient isolation unit. They will be screened with a physical exam and medical history. They will also have heart and lung function tests. Blood, urine, and nasal swab/wash samples will be collected. * Participants will receive a single nasal spray of the flu virus. They will stay on the inpatient unit for at least 9 days. * Participants will be monitored for the length of their stay. They will have frequent blood tests and other procedures as needed. * Participants will be allowed to go home once they have had two negative tests for the virus. The tests will be given on two consecutive days....
Primary Outcome
Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.
Conditions Studied
Interventions
- BIOLOGICAL Ca/04/2009/H1N1 Vero Grown Challenge Virus
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01646138 record still lists
NCT01646138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 36,804-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 1 intervention - of which Ca/04/2009/H1N1 Vero Grown Challenge Virus is the first listed.
NCT01646138 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01646138 about?
NCT01646138 is a clinical study titled "Influenza A 2009 H1N1 Challenge Study in Healthy Adults". Background: \- A challenge study exposes a person to a disease and allows researchers to study the disease through the body's healing process. An influenza challenge study that looks at different amounts of the flu virus can provide more information on the smallest amount needed to cause an infecti...
What is the current status of trial NCT01646138?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-02. Estimated completion is 2013-12.
What conditions does trial NCT01646138 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01646138?
The interventions under investigation include: Ca/04/2009/H1N1 Vero Grown Challenge Virus (BIOLOGICAL).
Who is sponsoring clinical trial NCT01646138?
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 NCT01646138 being conducted?
This trial has 1 study location across Maryland. 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 NCT01646138's enrollment target sits among peer trials
49 133rd of 156 higher than 24 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
-
pH1N1 Blinded Challenge Study
RECRUITING · Phase 1
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02704858 · 49 participants · Phase 1
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
- NCT03516708 · 49 participants · Phase 1
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
- NCT03692429 · 49 participants · Phase 1
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
- NCT04329494 · 49 participants · Phase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia