Chikungunya VirusPhase 3NCT05072080
A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine)
A Phase 3 study testing CHIKV VLP/adjuvant in people with Chikungunya Virus, run by Bavarian Nordic at 47 sites in United States.
Trial summary
The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent subjects. Read more about this study
- Who is it for?
- Ages 12 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Virus
- What is being tested?
- CHIKV VLP/adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,258 participants
- Where
- 47 sitesUnited States
- Study dates
- 29 Sep 2021to 3 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Synexus Clinical Research US, Inc.
Anderson, South Carolina, 29621
Emory University School of Medicine
Atlanta, Georgia, 30322
Velocity Clinical Research, Banning
Banning, California, 92220
Velocity Clinical Research, Austin
Cedar Park, Texas, 78613
Synexus Clinical Research US, Inc.
Chicago, Illinois, 60602
Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center
Cincinnati, Ohio, 45229
Velocity Clinical Rsearch, Inc.
Cleveland, Ohio, 44122
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80918
Aventiv Research Inc.
Columbus, Ohio, 43213
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Optimal Research, LLC
Huntsville, Alabama, 35802
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, 64114
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
Accel Research Sites-DeLand Clinical Research Unit
Lake Mary, Florida, 32746
Wr-Crcn, Llc
Las Vegas, Nevada, 89106
Alliance for Multispecialty Research, LLC.
Las Vegas, Nevada, 89119
Johnson County ClinTrials
Lenexa, Kansas, 66219
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509
Velocity Clinical Research, Medford
Medford, Oregon, 97504
Optimal Research, LLC
Melbourne, Florida, 32934
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
Suncoast Research Associates, LLC
Miami, Florida, 33173
Alliance for Multispecialty Research - Mobile
Mobile, Alabama, 36608
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502
Lynn Institute of Norman
Norman, Oklahoma, 73072
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Optimal Research LLC
Peoria, Illinois, 61614
Synexus Clinical Research US, Inc.
Pinellas Park, Florida, 33781
Research Your Health
Plano, Texas, 75093
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Optimal Research, LLC
Rockville, Maryland, 20850
BFHC Research
San Antonio, Texas, 78249
Optimal Research, LLC
San Diego, California, 92108
Saint Louis University
St Louis, Missouri, 63104
Synexus Clinical Research US, Inc.
St Louis, Missouri, 63141
Alliance for Multispecialty Research, LLC
Tempe, Arizona, 85281
DM Clinical Research
Tomball, Texas, 77375
Advanced Clinical Research
West Jordan, Utah, 84088
Palm Beach Research Center
West Palm Beach, Florida, 33409
Alliance for Multispecialty Research - Wichita East
Wichita, Kansas, 67207
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
About this study
Official title: 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 (CHIKV VLP vaccine) in healthy adult and adolescent subjects.
Read the detailed description
Coprimary Objectives:
- To evaluate the safety of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent participants 12 to <65 years of age.
- To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo).
- To demonstrate the consistency of the anti-CHIKV SNA response across three consecutively manufactured lots of PXVX0317 (CHIKV VLP vaccine) at Day 22 as measured by GMT.
Secondary Objectives:
- To compare the anti-CHIKV SNA response to PXVX0317 (CHIKV VLP vaccine) 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.
- Conditions
- Chikungunya Virus
- Being tested
- CHIKV VLP/adjuvant, Placebo
- Keywords
- Chikungunya, VLP, PXVX0317, vaccine, immunogenicity, CHIKV
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHIKV VLP/adjuvantBiological
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
PlaceboBiological
Placebo is comprised of formulation buffer
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 - PXVX0317 lot A (Lot 104) Receives: Biological: CHIKV VLP/adjuvant |
| Group 2 | Experimental | Group 2 - PXVX0317 lot B (Lot 105) Receives: Biological: CHIKV VLP/adjuvant |
| Group 3 | Experimental | Group 3 - PXVX0317 lot C (Lot 106) Receives: Biological: CHIKV VLP/adjuvant |
| Group 4 | Placebo comparator | Group 4 - Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Solicited Adverse Events (AE)
Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 7 days post-vaccination
Incidence of Unsolicited AEs
Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 28 days post-vaccination
Incidence of Adverse Events of Special Interest (AESI)
Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 182 days post-vaccination
Incidence of Medically Attended Adverse Event (MAAE)
Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 182 days post-vaccination
Incidence of Serious Adverse Event (SAE)
Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 182 days post-vaccination
Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22
Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) 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.
Measured: 21 days post-vaccination
Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22 (Data Reported Per Arm)
Anti-CHIKV SNA seroresponse rates and associated 95% confidence interval for PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.
Measured: 21 days post-vaccination
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Measured: 21 days post-vaccination
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (Data Reported Per Arm - All Age Strata)
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Measured: 21 days post-vaccination
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (for Lot Comparison)
Anti-CHIKV SNA GMTs and associated 95% CIs between all three pairs of PXVX0317 (CHIKV VLP vaccine) lots (104:105, 104:106, 105:106) in adults 18 to <46 years of age in the IEP at Day 22. Placebo group 4 is not relevant for this lot-to-lot consistency analysis.
Reported GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.
Measured: 21 days post-vaccination
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (Data Reported Per Arm - Adults 18 to <46)
Anti-CHIKV SNA GMTs and associated 95% CIs for PXVX0317 (CHIKV VLP vaccine) and placebo in adults 18 to <46 years of age in the IEP at Day 22.
Measured: 21 days post-vaccination
Secondary outcomes (8)
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8
Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) 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.
Number analyzed is number of participants with a sample result available at the indicated visit.
Measured: Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8 (Data Reported Per Arm)
Anti-CHIKV SNA seroresponse rates and associated 95% CIs for PXVX0317 (CHIKV VLP vaccine) and placebo at Day 15, Day 183, and Day 8, in that order, for the IEP, all age strata combined.
Number analyzed is number of participants with a sample result available at the indicated visit.
Measured: Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183
Anti-CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Number analyzed is number of participants with a sample result available at the indicated visit.
Measured: Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 (Data Reported Per Arm)
Anti-CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Number analyzed is number of participants with a sample result available at the indicated visit
Measured: Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183
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.
Fold rise in geometric mean titer is the ratio of the post-baseline value to the baseline value (e.g. number of 2 represents a post-baseline doubling of geometric mean titer).
Number analyzed is number of participants with a sample result available at both Day 1 and the indicated visit.
Measured: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183 (Data Reported Per Arm)
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.
Fold rise in geometric mean titer is the ratio of the post-baseline value to the baseline value (e.g. number of 2 represents a post-baseline doubling of geometric mean titer).
Number analyzed is number of participants with a sample result available at both Day 1 and the indicated visit.
Measured: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
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.
Number analyzed is number of participants with a sample result available at the indicated visit.
Measured: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
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.
Number analyzed is number of participants with a sample result available at the indicated visit.
Measured: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start29 Sep 2021
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chikungunya VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 2:2:2:1 ratio within each age stratum (12 to \<18, 18 to \<46, and 46 to \<65). This study will be conducted in the US, using up to 50 sites.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent BioSolutions
- Responsible party
- Sponsor
- Investigators
- Patrick Ajiboye, MD, Study director, Bavarian Nordic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072080
- Sponsor's protocol ID
- EBSI-CV-317-004
- Status last verified
- Aug 2024
- First submitted
- 28 Sep 2021
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richardson JS, Anderson DM, Mendy J, Tindale LC, Muhammad S, Loreth T, Tredo SR, Warfield KL, Ramanathan R, Caso JT, Jenkins VA, Ajiboye P, Bedell L; EBSI-CV-317-004 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1343-1352. doi: 10.1016/S0140-6736(25)00345-9. Epub 2025 Mar 27.
PubMed 40158526Miao Q, Nguyen W, Zhu J, Liu G, van Oers MM, Tang B, Yan K, Larcher T, Suhrbier A, Pijlman GP. A getah virus-like-particle vaccine provides complete protection from viremia and arthritis in wild-type mice. Vaccine. 2024 Nov 14;42(25):126136. doi: 10.1016/j.vaccine.2024.07.037. Epub 2024 Jul 14.
PubMed 39004524Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.
PubMed 35709798
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents
- ClinicalTrials.gov ID
- NCT05072080
- Acronym / sponsor ID
- EBSI-CV-317-004
- Conditions
- Chikungunya Virus
- Keywords
- Chikungunya, VLP, PXVX0317, vaccine, immunogenicity, CHIKV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,258 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- Emergent BioSolutions
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Posted 30 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent subjects.
Detailed description
Coprimary Objectives:
- To evaluate the safety of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent participants 12 to <65 years of age.
- To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo).
- To demonstrate the consistency of the anti-CHIKV SNA response across three consecutively manufactured lots of PXVX0317 (CHIKV VLP vaccine) at Day 22 as measured by GMT.
Secondary Objectives:
- To compare the anti-CHIKV SNA response to PXVX0317 (CHIKV VLP vaccine) 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Participants will be randomized in a 2:2:2:1 ratio within each age stratum (12 to <18, 18 to <46, and 46 to <65). This study will be conducted in the US, using up to 50 sites.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: CHIKV VLP/adjuvantGroup 1 - PXVX0317 lot A (Lot 104) |
| Group 2 | Experimental | Biological: CHIKV VLP/adjuvantGroup 2 - PXVX0317 lot B (Lot 105) |
| Group 3 | Experimental | Biological: CHIKV VLP/adjuvantGroup 3 - PXVX0317 lot C (Lot 106) |
| Group 4 | Placebo comparator | Biological: PlaceboGroup 4 - Placebo |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHIKV VLP/adjuvantCHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2% | Biological | Group 1, Group 2, Group 3 |
| PlaceboPlacebo is comprised of formulation buffer | Biological | Group 4 |
Primary outcome
Incidence of Solicited Adverse Events (AE)
Time frame: 7 days post-vaccination
Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of Unsolicited AEs
Time frame: 28 days post-vaccination
Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of Adverse Events of Special Interest (AESI)
Time frame: 182 days post-vaccination
Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of Medically Attended Adverse Event (MAAE)
Time frame: 182 days post-vaccination
Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of Serious Adverse Event (SAE)
Time frame: 182 days post-vaccination
Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22
Time frame: 21 days post-vaccination
Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) 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.
Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22 (Data Reported Per Arm)
Time frame: 21 days post-vaccination
Anti-CHIKV SNA seroresponse rates and associated 95% confidence interval for PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22
Time frame: 21 days post-vaccination
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (Data Reported Per Arm - All Age Strata)
Time frame: 21 days post-vaccination
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (for Lot Comparison)
Time frame: 21 days post-vaccination
Anti-CHIKV SNA GMTs and associated 95% CIs between all three pairs of PXVX0317 (CHIKV VLP vaccine) lots (104:105, 104:106, 105:106) in adults 18 to <46 years of age in the IEP at Day 22. Placebo group 4 is not relevant for this lot-to-lot consistency analysis. Reported GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (Data Reported Per Arm - Adults 18 to <46)
Time frame: 21 days post-vaccination
Anti-CHIKV SNA GMTs and associated 95% CIs for PXVX0317 (CHIKV VLP vaccine) and placebo in adults 18 to <46 years of age in the IEP at Day 22.
8 secondary outcomes
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8
Time frame: Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8 (Data Reported Per Arm)
Time frame: Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183
Time frame: Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 (Data Reported Per Arm)
Time frame: Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183
Time frame: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183 (Data Reported Per Arm)
Time frame: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)
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: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
Time frame: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40158526Richardson JS, Anderson DM, Mendy J, Tindale LC, Muhammad S, Loreth T, Tredo SR, Warfield KL, Ramanathan R, Caso JT, Jenkins VA, Ajiboye P, Bedell L; EBSI-CV-317-004 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1343-1352. doi: 10.1016/S0140-6736(25)00345-9. Epub 2025 Mar 27.
- Derived from this study: PubMed 39004524Miao Q, Nguyen W, Zhu J, Liu G, van Oers MM, Tang B, Yan K, Larcher T, Suhrbier A, Pijlman GP. A getah virus-like-particle vaccine provides complete protection from viremia and arthritis in wild-type mice. Vaccine. 2024 Nov 14;42(25):126136. doi: 10.1016/j.vaccine.2024.07.037. Epub 2024 Jul 14.
- Derived from this study: PubMed 35709798Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Ajiboye, MD study director
Bavarian Nordic
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHIKV VLP/adjuvant in people with Chikungunya Virus, run by Bavarian Nordic at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Solicited Adverse Events (AE) (time frame: 7 days post-vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072080, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.