drugset / Trial / NCT06669208
Trial of an Inactivated Chikungunya Virus Vaccine
Phase 1
Completed
48 enrolled
Najit Technologies, Inc.
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedSequentialTriple-blindPrevention
Summary
This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial, evaluating dosages of 2.5 mcg and 8 mcg of HydroVax-005 CHIKV vaccine given intramuscularly on Day 1 and Day 29 in up to 48 healthy adults healthy adults ≥ 18 and \< 50 years of age. The primary objective is to assess the safety and reactogenicity of the HydroVax-005 CHIKV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 2.5 mcg or a dose of 8 mcg.
Timeline
- Start
- 2024-11-04
- Primary completion
- 2026-02-06
- Completion
- 2026-02-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HydroVax-005 CHIKV | Vaccine | 2.5 ug | Intramuscular |
| Subject | HydroVax-005 CHIKV | Vaccine | 8 ug | Intramuscular |