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COMPLETED Phase 2

Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults

NCT03483961 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults. Primary Objective: To assess the immune response to the vaccine Secondary Objectives: To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine Safety Objective: To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL CHIKV VLP/unadjuvanted
  • BIOLOGICAL CHIKV VLP/adjuvanted

Study Locations (3)

Kansas

  • Johnson County Clin-Trials — Lenexa

Missouri

  • The Center for Pharmaceutical Research — Kansas City

Utah

  • Advanced Clinical Research — West Jordan

Trial Details

FieldValue
Enrollment Target 445 participants
Start Date 2018-04-18
Est. Completion 2020-09-21
Phase Phase 2

Sponsor

Bavarian Nordic

16 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03483961

The ClinicalTrials.gov registry entry for NCT03483961 describes a study currently listed as completed. It is categorized as Phase 2, 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 445 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 3 interventions — of which Placebo 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: NCT03483961 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Kansas, Missouri, Utah. 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 NCT03483961 about?

NCT03483961 is a clinical study titled "Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults". The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults. Primary Objective: To assess the immune response to the vaccine Secondary Objectives: To assess the kinetics of the...

What is the current status of trial NCT03483961?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 445 participants. The study started on 2018-04-18. Estimated completion is 2020-09-21.

What conditions does trial NCT03483961 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 NCT03483961?

The interventions under investigation include: Placebo (BIOLOGICAL), CHIKV VLP/unadjuvanted (BIOLOGICAL), CHIKV VLP/adjuvanted (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03483961?

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 NCT03483961 being conducted?

This trial has 3 study locations across Kansas, Missouri, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial