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Virus Therapy

CHIKV VLP/adjuvant for Chikungunya

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 older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 182 days post vaccination

Awards & highlights

Study Summary

This trial will test how safe and effective a new shingles vaccine is for adults aged 65 and over.

Eligible Conditions

Chikungunya

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 182 days post vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~182 days post vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and 182 days post vaccination 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 GMTs at Day 22

Anti-CHIKV SNA seroresponse rates at Day 22 in baseline seronegative participants

Incidence of Adverse Events of Special Interest (AESI)

+4 more

Secondary outcome measures

Anti-CHIKV SNA GMTs at Days 15 and 183

Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)

Anti-CHIKV SNA seroresponse rates at Days 15 and 183

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 - PXVX0317Experimental Treatment1 Intervention

Group II: Group 2 - PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CHIKV VLP/adjuvant

2022

Completed Phase 3

~3680

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emergent BioSolutionsIndustry Sponsor

61 Previous Clinical Trials

937,031 Total Patients Enrolled

1 Trials studying Chikungunya

60 Patients Enrolled for Chikungunya

Bavarian NordicLead Sponsor

61 Previous Clinical Trials

49,515 Total Patients Enrolled

1 Trials studying Chikungunya

60 Patients Enrolled for Chikungunya

Catalyst Clinical Research, LLCUNKNOWN

Frequently Asked Questions

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

In how many different physical sites is this trial being run today?

"There are 10 available sites for this study, they are: Coastal Carolina Research Center in North Charleston, Suncoast Research Associates, LLC in Miami, DM Clinical Research CyFair in Houston, and 7 other locations."

Answered by AI

Are there any risks associated with CHIKV VLP/adjuvant for patients?

"CHIKV VLP/adjuvant received a safety score of 3 because this is a Phase 3 trial. This indicates that while there is still some data missing, what data is available supports both efficacy and safety."

Answered by AI

Are any volunteers needed for this test right now?

"That is correct, according to the information available on clinicaltrials.gov. The trial in question was first posted on May 12th, 2022 and was last updated on August 15th, 2022. The study is looking for 400 participants across 10 different sites."

Answered by AI

Could you explain the main goals of this clinical trial?

"According to the sponsor of this clinical trial, Emergent BioSolutions, the primary outcome will be measured over a 22 day time frame. This outcome is defined as the number of subjects with anti-CHIKV SNA titers (i.e. the response to the virus) of at least 4-fold over the baseline at days 15, 22, and 183 for both the PXVX0317 and placebo groups. Additionally, the study will be evaluating secondary outcomes including the Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI) from day 1 to day 15, day 22, and"

Answered by AI

Recent research and studies

The Lancet Infectious DiseasesJournal

Safety and Immunogenicity of PXVX0317, an Aluminium Hydroxide-adjuvanted Chikungunya Virus-like Particle Vaccine: A Randomised, Double-blind, Parallel-group, Phase 2 Trial

Bennett, Sean R, James M McCarty, Roshan Ramanathan, Jason Mendy, Jason S Richardson, Jonathan Smith, Jeff Alexander, et al.. 2022. “Safety and Immunogenicity of PXVX0317, an Aluminium Hydroxide-adjuvanted Chikungunya Virus-like Particle Vaccine: A Randomised, Double-blind, Parallel-group, Phase 2 Trial”. The Lancet Infectious Diseases. Elsevier BV. doi:10.1016/s1473-3099(22)00226-2.

The Lancet Infectious DiseasesJournal

Safety and Immunogenicity of PXVX0317, an Aluminium Hydroxide-adjuvanted Chikungunya Virus-like Particle Vaccine: A Randomised, Double-blind, Parallel-group, Phase 2 Trial

clinicaltrials.govStudy

Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years

2022. "Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05349617.