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NCT06007183 · ClinicalTrials.gov registry record · Phase 3
Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination
A Phase 3 study of Chikungunya Virus Infection, sponsored by Bavarian Nordic.
- Active
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
- 20
- Study locations
NCT06007183: Active Phase 3 study of Chikungunya Virus Infection, sponsored by Bavarian Nordic.
NCT06007183 is a Phase 3 study of Chikungunya Virus Infection that is active but no longer recruiting, run by Bavarian Nordic. The registered enrollment target is 800 participants, above the 258-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (210% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06007183, a Phase 3 study of Chikungunya Virus Infection, is active but no longer recruiting, sponsored by Bavarian Nordic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of CHIKV VLP vaccine in adult and adolescent participants and to evaluate CHIKV VLP booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial CHIKV VLP vaccination.
Primary Outcome
For all groups using the immunogenicity evaluable population (IEP) the proportion of participants maintaining a preboost anti-CHIKV SNA titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years post-initial vaccination in one of the feeder studies; only prebooster data will be summarized.
Conditions Studied
Interventions
- BIOLOGICAL CHIKV VLP vaccine booster
- BIOLOGICAL Placebo booster
Study Locations (20)
Florida
- Optimal Research, LLC - Melbourne
- Suncoast Research Associates, LLC - Miami
Illinois
- Synexus Clinical Research US, Inc. - Chicago
- Optimal Research, LLC - Peoria
Kansas
- Alliance for Multispecialty Research, LLC - Newton
- Alliance for Multispecialty Research, LLC - Wichita
Nevada
- Wr-Crcn, Llc - Las Vegas
- Alliance for Multispecialty Research, LLC - Las Vegas
Texas
- Velocity Clinical Research, Austin - Cedar Park
- DM Clinical Research - Houston
Alabama
- Alliance for Multispecialty Research, LLC - Mobile
Arizona
- Alliance for Multispecialty Research, LLC - Tempe
Kentucky
- Alliance for Multispecialty Research, LLC - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2023-08-30 |
| Est. Completion | 2028-08 |
| Phase | Phase 3 |
What the registry record for NCT06007183 still lists
NCT06007183 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 258-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (210% higher).
The record links to 1 condition, with Chikungunya Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which CHIKV VLP vaccine booster is the first listed.
NCT06007183 names 20 study sites across 15 states, led by Florida, Illinois, Kansas.
Frequently Asked Questions
What is clinical trial NCT06007183 about?
NCT06007183 is a clinical study titled "Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination". The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of CHIKV VLP vaccine in adult and adolescent participants and to evaluate CHIKV VLP booster vaccine induced serum neutralizing antibody (SNA) re...
What is the current status of trial NCT06007183?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2023-08-30. Estimated completion is 2028-08.
What conditions does trial NCT06007183 study?
This clinical trial studies the following conditions: Chikungunya Virus Infection.
What interventions are being tested in trial NCT06007183?
The interventions under investigation include: CHIKV VLP vaccine booster (BIOLOGICAL), Placebo booster (BIOLOGICAL).
Who is sponsoring clinical trial NCT06007183?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06007183 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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