- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05072080
A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317
December 7, 2023 updated by: Bavarian Nordic
A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents
The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 in healthy adult and adolescent subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Coprimary Objectives:
- To evaluate the safety of PXVX0317 in healthy adult and adolescent participants 12 to <65 years of age.
- To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate.
- To demonstrate the consistency of the anti-CHIKV SNA response across three lots of PXVX0317 at Day 22.
Secondary Objectives:
- To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15, Day 183, and Day 8 as measured by GMT and seroresponse rate.
- To compare the GMT fold increase in anti-CHIKV SNA response and number and percentage of participants with an anti-CHIKV SNA titer >=15 and 4-fold rise over baseline, both at Day 8, 15, 22, and 183.
Study Type
Interventional
Enrollment (Actual)
3258
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35802
- Optimal Research, LLC
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Mobile, Alabama, United States, 36608
- Alliance for Multispecialty Research - Mobile
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Arizona
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Tempe, Arizona, United States, 85281
- Alliance For multispecialty Research, LLC
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California
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Banning, California, United States, 92220
- Velocity Clinical Research, Banning
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San Diego, California, United States, 92108
- Optimal Research, LLC
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Colorado
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Colorado Springs, Colorado, United States, 80918
- Lynn Institute Of The Rockies
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Florida
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Jacksonville, Florida, United States, 32216
- Jacksonville Center for Clinical Research
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Lake Mary, Florida, United States, 32746
- Accel Research Sites-DeLand Clinical Research Unit
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Melbourne, Florida, United States, 32934
- Optimal Research, LLC
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Miami, Florida, United States, 33173
- Suncoast Research Associates, LLC
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Pinellas Park, Florida, United States, 33781
- Synexus Clinical Research US, Inc.
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West Palm Beach, Florida, United States, 33409
- Palm Beach Research Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School of Medicine
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Idaho
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Meridian, Idaho, United States, 83642
- Velocity Clinical Research, Boise
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Illinois
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Chicago, Illinois, United States, 60602
- Synexus Clinical Research US, Inc.
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Peoria, Illinois, United States, 61614
- Optimal Research LLC
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Kansas
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Lenexa, Kansas, United States, 66219
- Johnson County ClinTrials
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Newton, Kansas, United States, 67114
- Alliance For multispecialty Research, LLC
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Wichita, Kansas, United States, 67207
- Alliance for Multispecialty Research - Wichita East
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Kentucky
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Lexington, Kentucky, United States, 40509
- Alliance For multispecialty Research, LLC
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Louisiana
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New Orleans, Louisiana, United States, 70119
- Alliance For multispecialty Research, LLC
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Maryland
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Rockville, Maryland, United States, 20850
- Optimal Research, LLC
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Missouri
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Kansas City, Missouri, United States, 64114
- Alliance for Multispecialty Research - Kansas City
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Saint Louis, Missouri, United States, 63104
- Saint Louis University
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Saint Louis, Missouri, United States, 63141
- Synexus Clinical Research US, Inc.
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Nevada
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Las Vegas, Nevada, United States, 89106
- Wr-Crcn, Llc
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Las Vegas, Nevada, United States, 89119
- Alliance for Multispecialty Research, LLC.
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New York
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Rochester, New York, United States, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Raleigh, North Carolina, United States, 27612
- M3 Wake Research, Inc
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Wilmington, North Carolina, United States, 28403
- Trial Management Associates, LLC
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center
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Cleveland, Ohio, United States, 44122
- Velocity Clinical Rsearch, Inc.
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Columbus, Ohio, United States, 43213
- Aventiv Research Inc.
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Oklahoma
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Norman, Oklahoma, United States, 73072
- Lynn Institute of Norman
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Oklahoma City, Oklahoma, United States, 73112
- Lynn Health Science Institute
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Oregon
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Medford, Oregon, United States, 97504
- Velocity Clinical Research, Medford
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Rhode Island
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East Greenwich, Rhode Island, United States, 02818
- Velocity Clinical Research-Providence
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South Carolina
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Anderson, South Carolina, United States, 29621
- Synexus Clinical Research US, Inc.
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North Charleston, South Carolina, United States, 29405
- Coastal Carolina Research Center
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Tennessee
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Knoxville, Tennessee, United States, 37920
- Alliance For multispecialty Research, LLC
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Texas
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Cedar Park, Texas, United States, 78613
- Velocity Clinical Research, Austin
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Houston, Texas, United States, 77081
- Texas Center for Drug Development, Inc.
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Plano, Texas, United States, 75093
- Research Your Health
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San Antonio, Texas, United States, 78249
- BFHC Research
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Tomball, Texas, United States, 77375
- DM Clinical Research
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Utah
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West Jordan, Utah, United States, 84088
- Advanced Clinical Research
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Virginia
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Norfolk, Virginia, United States, 23502
- Alliance For multispecialty Research, LLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 64 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable).
- Males or females, 12 to <65 years of age.
- Generally healthy, in the opinion of the investigator, based on medical history, physical examination, and screening laboratory assessments.
- 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 postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment) or (ii) Meeting all the below criteria: Negative serum pregnancy test at screening visit, Negative urine pregnancy test immediately prior to dosing at Day 1, Using an acceptable method of contraception (if women of CBP) for the duration of participation, such as hormonal contraceptives (eg, implants, pills, patches) initiated ≥30 days prior to dosing, intrauterine device (IUD) inserted ≥30 days prior to dosing, double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap), Abstinence is acceptable only for adolescents (12 to <18 years old) who are not sexually active.
Exclusion Criteria:
- Currently pregnant, breastfeeding, or planning to become pregnant during the study.
- Body Mass Index (BMI) ≥35 kg/m2.
- Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).
- History of severe allergic reaction or anaphylaxis to any component of the vaccine.
- History of any known congenital or acquired immunodeficiency that could impact response to vaccination (eg, leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis).
- Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to screening through Day 22. Note: For systemic corticosteroids, use at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within three months of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, ocular, or intraocular steroids is allowed.
- Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22.
- Acute disease within the last 14 days (participants with an acute mild febrile illness can be considered for a deferral of vaccination two weeks after the illness has resolved and treatment has been completed).
- Clinically significant cardiac, pulmonary, rheumatologic, or other chronic disease, in the opinion of the investigator. This may include chronic illness requiring hospitalization in the last 30 days prior to screening.
- Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation.
- Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22.
- Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
- Prior receipt of an investigational CHIKV vaccine/product.
- Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Group 4
Group 4 - Placebo
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Placebo is comprised of formulation buffer
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Experimental: Group 1
Group 1 - PXVX0317 lot A (Lot 104)
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PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
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Experimental: Group 2
Group 2 - PXVX0317 lot B (Lot 105)
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PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
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Experimental: Group 3
Group 3 - PXVX0317 lot C (Lot 106)
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PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of solicited Adverse Events (AE)
Time Frame: 8 days
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Incidence of solicited AEs through Day 8 for PXVX0317 and placebo for all age strata combined (safety population).
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8 days
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Incidence of unsolicited AEs
Time Frame: 29 days
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Incidence of unsolicited AEs through Day 29 for PXVX0317 and placebo for all age strata combined (safety population).
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29 days
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Incidence of Adverse Events of Special Interest (AESI)
Time Frame: 183 days
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Incidence of AESIs, through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
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183 days
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Incidence of Medically Attended Adverse Event (MAAE)
Time Frame: 183 days
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Incidence of MAAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
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183 days
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Incidence of Serious Adverse Event (SAE)
Time Frame: 183 days
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Incidence of SAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
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183 days
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Anti-CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 22
Time Frame: 22 days
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Anti-CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% confidence interval (CI) at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.
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22 days
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Anti-CHIKV SNA geometric mean titers (GMT) at Day 22
Time Frame: 22 days
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Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 and placebo for the IEP, all age strata combined.
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22 days
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Anti-CHIKV SNA GMT ratios between pairs of PXVX0317 lots at Day 22
Time Frame: 22 days
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Anti-CHIKV SNA GMT ratios and associated 95% CIs between all three pairs of PXVX0317 lots (A:B, A:C, B:C) in adults 18 to <46 years of age in the IEP at Day 22.
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22 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-CHIKV SNA seroresponse rates at Days 15, 183, and 8
Time Frame: 183 days
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Anti-CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% CIs at Day 15, Day 183, and Day 8, in that order, for the IEP, all age strata combined.
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183 days
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Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183
Time Frame: 183 days
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Anti-CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 and placebo for the IEP, all age strata combined.
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183 days
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Geometric Mean Fold Increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Days 8, 15, 22, and 183
Time Frame: 183 days
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Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
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183 days
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Number and percentage of participants with anti-CHIKV SNA titer >15 and 4-fold rise over baseline at Days 8, 15, 22, and 183
Time Frame: 183 days
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Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
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183 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Patrick Ajiboye, MD, Bavarian Nordic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2021
Primary Completion (Actual)
April 3, 2023
Study Completion (Actual)
April 3, 2023
Study Registration Dates
First Submitted
September 28, 2021
First Submitted That Met QC Criteria
September 28, 2021
First Posted (Actual)
October 8, 2021
Study Record Updates
Last Update Posted (Actual)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBSI-CV-317-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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