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Virus Therapy

CHIKV VLP/adjuvant for Chikungunya (CHIKV VLP Trial)

Phase 3
Waitlist Available
Research Sponsored by Bavarian Nordic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 183 days
Awards & highlights

CHIKV VLP Trial Summary

This trial is testing a new vaccine to see if it is safe and effective.

Eligible Conditions
  • Chikungunya

CHIKV VLP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~183 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 183 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-CHIKV SNA GMT ratios between pairs of PXVX0317 lots at Day 22
Anti-CHIKV SNA geometric mean titers (GMT) at Day 22
Anti-CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 22
+5 more
Secondary outcome measures
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183
Anti-CHIKV SNA seroresponse rates at Days 15, 183, and 8
Geometric Mean Fold Increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Days 8, 15, 22, and 183
+1 more

CHIKV VLP Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3Experimental Treatment1 Intervention
Group 3 - PXVX0317 lot C (Lot 106)
Group II: Group 2Experimental Treatment1 Intervention
Group 2 - PXVX0317 lot B (Lot 105)
Group III: Group 1Experimental Treatment1 Intervention
Group 1 - PXVX0317 lot A (Lot 104)
Group IV: Group 4Placebo Group1 Intervention
Group 4 - Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CHIKV VLP/adjuvant
2022
Completed Phase 3
~3680

Find a Location

Who is running the clinical trial?

Bavarian NordicLead Sponsor
61 Previous Clinical Trials
46,670 Total Patients Enrolled
1 Trials studying Chikungunya
60 Patients Enrolled for Chikungunya
Emergent BioSolutionsIndustry Sponsor
61 Previous Clinical Trials
934,186 Total Patients Enrolled
1 Trials studying Chikungunya
60 Patients Enrolled for Chikungunya
Patrick Ajiboye, MDStudy DirectorBavarian Nordic
2 Previous Clinical Trials
827 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being actively recruited for this research project?

"Unfortunately, this particular study is no longer recruiting patients as of October 12th, 2022. This is according to the clinicaltrials.gov listing, which was first posted on September 29th, 2021. There are, however, 8 other trials recruiting patients as we speak."

Answered by AI

Could you tell me how many different places are managing this experiment?

"At the moment, this medical trial has 49 patients. Potential participants can be found at the Lynn Institute of the Rockies in Colorado Springs, Optimal Research, LLC in Melbourne, Palm Beach Research Center in West Palm Beach, and other locations."

Answered by AI

What are the treatment goals of this clinical trial?

"The primary objective of this clinical trial is to measure the incidence of solicited Adverse Events (AE) over a period of 29 days. Secondary objectives include CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183, Geometric Mean Fold Increase (GMFI) in CHIKV SNA titers from Day 1 to Days 8, 15, 22, and 183, and Number and percentage of subjects with CHIKV SNA titers at or above selected thresholds at Days 8, 15, 22, and 183."

Answered by AI

Are there any restrictions on who can sign up for this research project?

"This clinical trial is seeking 3258 individuals who have contracted chikungunya fever and are aged between 12 and 64. The eligible patient population for this study is defined as follows: Male or female, 12 to <65 years of age., Women who are either: (i) Not of childbearing potential (CBP): pre-menarche, surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or post-menopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other path"

Answered by AI

Is this study open to patients who are 18 years and older?

"The age demographic that this trial is looking to enroll are people who have not yet hit retirement age and are above 12 years old."

Answered by AI

Does the FDA approve of CHIKV VLP/adjuvant therapy?

"The safety of CHIKV VLP/adjuvant is estimated to be a 3. This is based on the fact that this is a Phase 3 trial, which means that there is both evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Kentucky
How old are they?
18 - 65
What site did they apply to?
Alliance for Multispecialty Research, LLC
Trial Management Associates, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~931 spots leftby Apr 2025