NCT06669208

Trial of an Inactivated Chikungunya Virus Vaccine

A Double Blind, Randomized, Placebo-Controlled, Phase 1 Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Inactivated Chikungunya Virus Vaccine, HydroVax-005 CHIKV, in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Najit Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 (the day of first vaccination is defined as Day 1) and Day 29 in healthy adults ≥ 18 and \< 50 years of age. The study will consist of two dosing groups of HydroVax-005 CHIKV vaccine to be enrolled sequentially. Each dose group will consist of 20 individuals who receive HydroVax-002 YFV, as well as 8 total subjects who receive placebo. Each dose-group will include a sentinel subgroup consisting of 5 vaccine and 1 placebo recipient. In each of the two (2.5 mcg and 8 mcg) dose phases, enrollment is halted after the dose 1 vaccination of the sentinel subgroup. Following assessment of safety and reactogenicity data of Group 1 by the Internal Safety Review Committee (ISRC), the vaccine dose will be increased to 8 mcg for Group 2.

Conditions

• Chikungunya Fever
• Chikungunya Virus
• Chikungunya

Interventions

Type	Name	Description
BIOLOGICAL	HydroVax-005 CHIKV	HydroVax-005 CHIKV vaccine
OTHER	Placebo	NaCl 0.9%, Normal Saline

Timeline

• Start date: 2024-11-04
• Primary completion: 2026-02-06
• Completion: 2026-02-06
• First posted: 2024-11-01
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study