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NCT04009824 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT04009824: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04009824 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04009824, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.
Primary Outcome
A treatment emergent adverse event is any untoward medical occurrence in a human subject that manifest after administration of the study treatment, whether or not considered related to the treatment. AE severity was graded using FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September 2007 or the following grading scale: Grade 1 (Mild) Events causing no or minimal interference with daily activity and not requiring medical i
Interventions
- BIOLOGICAL AGS-v PLUS Vaccine
- BIOLOGICAL Montanide ISA-51 Adjuvant
- BIOLOGICAL Alhydrogel® Adjuvant
- BIOLOGICAL Saline Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2021-02-23 |
| Phase | Phase 1 |
What the finished NCT04009824 record still lists
NCT04009824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 4 interventions - of which AGS-v PLUS Vaccine is the first listed.
NCT04009824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04009824 about?
NCT04009824 is a clinical study titled "Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine". The purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.
What is the current status of trial NCT04009824?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2019-07-08. Estimated completion is 2021-02-23.
What interventions are being tested in trial NCT04009824?
The interventions under investigation include: AGS-v PLUS Vaccine (BIOLOGICAL), Montanide ISA-51 Adjuvant (BIOLOGICAL), Alhydrogel® Adjuvant (BIOLOGICAL), Saline Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT04009824?
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 NCT04009824's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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