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Trial of an Inactivated Chikungunya Virus Vaccine

NCT06669208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Chikungunya Fever
  • Chikungunya Virus
  • Chikungunya

Interventions

BIOLOGICAL

HydroVax-005 CHIKV

HydroVax-005 CHIKV vaccine

OTHER

Placebo

NaCl 0.9%, Normal Saline

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Najit Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2026-02-06
Completion
2026-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06669208 on ClinicalTrials.gov