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CHIKV VLP/adjuvant for Chikungunya (CHIKV VLP Trial)
CHIKV VLP Trial Summary
This trial is testing a new vaccine to see if it is safe and effective.
- Chikungunya
CHIKV VLP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CHIKV VLP Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
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."
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."
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."
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"
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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