Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03055000 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT03055000: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03055000 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03055000, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
Background: Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person. Objective: To see if the AGS-v vaccine is safe in humans and how it affects the immune system. Eligibility: Healthy adults ages 18-50 Design: Participants will be screened another study. Participants will be randomly assigned to get either the vaccine with a booster vaccine, the vaccine without the booster, or a placebo. These are given through a needle in the upper arm. Participants will have visits that include medical history, physical exam, and blood and urine tests: Baseline: They will get the vaccine and be monitored for 2 hours. Follow-up visits 1 and 2 weeks after baseline. Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours. Follow-up visits 1 and 2 weeks after booster visit. Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the feeding. Phone follow-up a few days after the mosquito feeding. After the feeding visit, 5 follow-up visits about every 2 months Participants will keep a symptom diary for 7 days after each vaccine. They will record their temperature. They will measure any redness around the injection site. They will document and if possible photograph any mosquito bites they get.
Primary Outcome
Grade 3 or higher adverse events identified within 1 year after 2 vaccinations 21 days apart.
Interventions
- OTHER Placebo
- BIOLOGICAL AGS-v
- BIOLOGICAL AGS-v + adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-02-15 |
| Est. Completion | 2018-12-28 |
| Phase | Phase 1 |
What the finished NCT03055000 record still lists
NCT03055000 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03055000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03055000 about?
NCT03055000 is a clinical study titled "Safety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine". Background: Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person. Objective: To s...
What is the current status of trial NCT03055000?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2017-02-15. Estimated completion is 2018-12-28.
What interventions are being tested in trial NCT03055000?
The interventions under investigation include: Placebo (OTHER), AGS-v (BIOLOGICAL), AGS-v + adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT03055000?
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 NCT03055000's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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
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
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI