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Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination
NCT06007183 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06007183
The ClinicalTrials.gov registry entry for NCT06007183 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bavarian Nordic, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06007183 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Illinois, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06007183?
The interventions under investigation include: CHIKV VLP vaccine booster (BIOLOGICAL), Placebo booster (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06007183?
This trial is sponsored by Bavarian Nordic, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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