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NCT01443936 · ClinicalTrials.gov registry record · Phase 1
Experimental AD4-H5-VTN Vaccine in Healthy Volunteers
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
NCT01443936: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01443936 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01443936, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
Study Summary
This is a Phase 1 randomized, single center, dose-escalation study designed to evaluate the safety and immunogenicity of live, replication competent recombinant Adenovirus type 4-H5N1Influenza Vietnam 1194 Hemagglutinin (HA) (Ad4-H5-Vtn). Determining the optimal route and dose for this recombinant platform will greatly accelerate investigations of this vector as an influenza vaccine and an HIV vaccine platform. Intranasal and tonsillar administration of the vaccine will be separately assessed. The oral enteric-coated capsule will also be assessed in 10 outpatients using similar blood sampling for comparison. The Ad4-H5-Vtn orally administered as enteric-coated capsules has already been evaluated in an ascending dose Phase 1 study, in dosages as high as 10(11) viral particles (vp). The primary goal of this study is to evaluate safety of ascending dosages of the Ad4-H5-Vtn vaccine following intranasal and tonsillar administration. A dosage or dosages will be selected to further evaluate the humoral, cellular, and mucosal immune responses against both the vector and the inserted gene. The Ad4-H5-Vtn will be initiated at 10(3) vp. Once safety is established at the initial dose, a second round of testing will begin at the next ten-fold higher dose. The Ad4-H5-Vtn vaccine will be assessed in three participants at each dosage level. The maximum viral dose administered by the tonsillar route will be 10(8) vp. In addition to clinical and laboratory monitoring of safety, the principal assessments will be shedding of the Ad4-H5-Vtn virus in rectal, cervicovaginal, throat, and nasal swabs, and assessment of the antibody (mucosal and systemic) response to the HA and to the Ad4 virus. When safety has been confirmed in all three participants at a given dosage level, the next higher dose group is enrolled. If one grade 3 or greater toxicity (or pre-specified Grade 2 toxicity, see Section 3.4) attributable to the vaccine is observed, the group will be expanded at that dose. If a
Interventions
- BIOLOGICAL Ad4-H5-VTN vaccination-tonsillar route
- BIOLOGICAL Ad4-H5-vaccination-oral route
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2011-09-14 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 1 |
What the finished NCT01443936 record still lists
NCT01443936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 2 interventions - of which Ad4-H5-VTN vaccination-tonsillar route is the first listed.
NCT01443936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01443936 about?
NCT01443936 is a clinical study titled "Experimental AD4-H5-VTN Vaccine in Healthy Volunteers". This is a Phase 1 randomized, single center, dose-escalation study designed to evaluate the safety and immunogenicity of live, replication competent recombinant Adenovirus type 4-H5N1Influenza Vietnam 1194 Hemagglutinin (HA) (Ad4-H5-Vtn). Determining the optimal route and dose for this recombinant p...
What is the current status of trial NCT01443936?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2011-09-14. Estimated completion is 2019-04-24.
What interventions are being tested in trial NCT01443936?
The interventions under investigation include: Ad4-H5-VTN vaccination-tonsillar route (BIOLOGICAL), Ad4-H5-vaccination-oral route (BIOLOGICAL).
Who is sponsoring clinical trial NCT01443936?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01443936's enrollment target sits among peer trials
96 600th of 2000 higher than 1,391 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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