A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
Part of paid clinical trials in Fountain Valley, California.
- Sponsor
- Bavarian Nordic
- Study ID
- NCT07003984
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Chikungunya Virus
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 11 Years
- Healthy Volunteers
- Accepted
Interventions
- CHIKV VLP vaccine — BIOLOGICALCHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
- Placebo — BIOLOGICALPlacebo is comprised of formulation buffer
Study Details
The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to \<12 years of age.
Key Dates
- Start date
- Jun 5, 2025
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 720 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Arm 1Cohort 1 Active Group
- Placebo Comparator: Arm 2Cohort 1 Placebo Group
- Experimental: Arm 3Cohort 2 Active Group
- Placebo Comparator: Arm 4Cohort 2 Placebo Group
Primary Outcome Measure
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs [ Time Frame: From vaccination through the end of the trial, planned to be Day 732 for study completers. ]
Central Contacts
- Priya Uppin844-422-8274
- Faye Cross
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ARK Clinical Research, LLC | Fountain Valley | California | 92708 | Justin Yanuck (PRINCIPAL_INVESTIGATOR) |
| Emerson Clinical Research Institute- DC | Washington D.C. | District of Columbia | 20009 | Julie Pineda, MD (PRINCIPAL_INVESTIGATOR) |
| Acevedo Clinical Research | Miami | Florida | 33142 | Giselle Deiros, MD (PRINCIPAL_INVESTIGATOR) |
| Hope Research Network | Miami | Florida | 33166 | Mario Reyes, MD (PRINCIPAL_INVESTIGATOR) |
| Velocity Clinical Research-Omaha | Omaha | Nebraska | 68134 | Frederick Raiser, DO (PRINCIPAL_INVESTIGATOR) |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Robert Frenck, MD (PRINCIPAL_INVESTIGATOR) |
| KidCare Pediatrics | Beaumont | Texas | 77706 | Robert Codey Bell, MD (PRINCIPAL_INVESTIGATOR) |
| Velocity Clinical Research - Salt Lake City | West Jordan | Utah | 84088 | Barbara Rizzardi, MD (PRINCIPAL_INVESTIGATOR) |