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NCT03483961 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Chikungunya Virus Infection, sponsored by Bavarian Nordic.

Completed
Registry status
Phase 2
Development phase
445
Enrollment target
3
Study locations

NCT03483961 is a Phase 2 study of Chikungunya Virus Infection that has completed, run by Bavarian Nordic. The registered enrollment target is 445 participants, above the 346-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (29% higher). The trial reports 3 study locations across 3 states.

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The verdict

NCT03483961, a Phase 2 study of Chikungunya Virus Infection, has completed, sponsored by Bavarian Nordic.

COMPLETED
Registry status
Phase 2
Development phase
445 participants
Enrollment target
3
Study locations

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

41 total trials

What the Registry Record Tells You About NCT03483961

The ClinicalTrials.gov registry entry for NCT03483961 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 445 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 346-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (29% higher). The listed sponsor is Bavarian Nordic, which has 41 total studies on file at ClinicalTrials.gov.

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.

NCT03483961 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Kansas, Missouri, Utah.

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.

What interventions are being tested in trial NCT03483961?

The interventions under investigation include: Placebo (BIOLOGICAL), CHIKV VLP/unadjuvanted (BIOLOGICAL), CHIKV VLP/adjuvanted (BIOLOGICAL).

Who is sponsoring clinical trial NCT03483961?

This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.

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.

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

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