← Back to Search

PXVX0317 Booster for Chikungunya

Phase 3
Recruiting
Research Sponsored by Bavarian Nordic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post-initial vaccination in feeder study ebsi-cv-317-004 until booster
Awards & highlights

Study Summary

This trial studies the safety & long-term effectiveness of a vaccine, & how it works after 3-5 years.

Who is the study for?
Adults and adolescents aged 12 to under 65 who previously received the PXVX0317 vaccine in an earlier study, are generally healthy, and have complied with previous study protocols. Women of childbearing potential must use effective contraception from a month before until six months after receiving the booster.Check my eligibility
What is being tested?
This phase 3 trial is testing the long-term safety and immune response to a booster dose of PXVX0317 vaccine for Chikungunya fever. Participants will be randomly assigned to receive either the booster or a placebo, in a double-blind setup where neither they nor the researchers know which one they're getting.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical vaccine-related side effects may include soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea. Serious allergic reactions are rare but possible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post-initial vaccination in feeder study ebsi-cv-317-004 until booster
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post-initial vaccination in feeder study ebsi-cv-317-004 until booster for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants maintaining an anti-CHIKV SNA titer ≥100 at yearly intervals up to 5 years post-initial vaccination
Proportion of vaccine boosted participants with composite booster response at 21 days after booster vaccination
Secondary outcome measures
Anti-CHIKV SNA GMTs at 21 days postboost
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI) Prebooster to Postbooster
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at yearly intervals
+1 more
Other outcome measures
Proportion of participants with Serious Adverse Events (SAEs)
Proportion of vaccine boosted participants with local or systemic solicited adverse events (AEs) within 7 days after booster vaccination
Proportion of vaccine or placebo boosted participants with Medically Attended Adverse Event (MAAE)
+2 more

Trial Design

7Treatment groups
Active Control
Placebo Group
Group I: Group 3aActive Control1 Intervention
PXVX0317 vaccine booster, 5 years post initial vaccination
Group II: Group 1aActive Control1 Intervention
PXVX0317 vaccine booster, 3 years post initial vaccination
Group III: Group 2aActive Control1 Intervention
PXVX0317 vaccine booster, 4 years post initial vaccination
Group IV: Group 4Active Control1 Intervention
Unrandomized or unboosted participants, for any reason
Group V: Group 3bPlacebo Group1 Intervention
Placebo booster, 5 years post initial vaccination
Group VI: Group 1bPlacebo Group1 Intervention
Placebo booster, 3 years post initial vaccination
Group VII: Group 2bPlacebo Group1 Intervention
Placebo booster, 4 years post initial vaccination

Find a Location

Who is running the clinical trial?

Bavarian NordicLead Sponsor
61 Previous Clinical Trials
49,128 Total Patients Enrolled
1 Trials studying Chikungunya
60 Patients Enrolled for Chikungunya
Patrick Ajiboye, MDStudy DirectorBavarian Nordic
2 Previous Clinical Trials
3,285 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 individuals aged thirty or older eligible to enroll in this clinical experiment?

"As per the specified requirements for participation, individuals aged between 12 and 67 are eligible to join this clinical trial."

Answered by AI

Who is eligible to be involved in this experiment?

"Those hoping to join this clinical trial must have chikungunya and be between 12 to 67 years old. 800 participants are being looked for in total."

Answered by AI

Are there still openings for participants in this study?

"Clinicaltrials.gov confirms that the recruitment process for this study is ongoing, with its initial posting on August 30th 2023 and an update made at the end of September."

Answered by AI

Has Group 1a obtained authorization from the FDA?

"Our team at Power judged Group 1a's safety to be a 3, based on the data from the Phase 3 trial. This indicates that not only is there some evidence for its efficacy but also multiple rounds of proof validating its security."

Answered by AI

How many people have participated in this trial thus far?

"This clinical trial, sponsored by Bavarian Nordic, requires 800 qualified participants enrolled across multiple sites. These locations include the Rochester Clinical Research LLC in New york and M3 Wake Research Incorporated of North carolina."

Answered by AI

How many locations in the state are offering this medical research?

"Currently, 6 clinical trial sites are supporting this research. They are present in Rochester, Raleigh and Norman as well as 3 other cities. To reduce the burden of travel, it is advisable to select a site close to your current location if you choose to participate."

Answered by AI

Who else is applying?

What site did they apply to?
Velocity Clinical Research, Salt Lake City
Optimal Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination
2023. "Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007183.
All > Chikungunya > Paid Studies Las Vegas
~533 spots leftby Apr 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top