Chikungunya VirusPhase 3NCT07003984
A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
A Phase 3 study testing CHIKV VLP vaccine in people with Chikungunya Virus, run by Bavarian Nordic at 15 sites in 3 countries.
Trial summary
The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to <12 years of age. Read more about this study
- Who is it for?
- Ages 1 year to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Virus
- What is being tested?
- CHIKV VLP vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 5 Jun 2025to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 1 year to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males or females between 1 and <12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active/open cohorts. Please see Section 6.1 for details
- Body weight ≥6.5 kg.
- In general good health, in the opinion of the investigator, based on medical history and physical examination.
- Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.
- Able and willing to complete all scheduled visits and comply with all study procedures.
Who cannot join
- Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; these instances should be discussed with the sponsor's medical monitor and written agreement obtained prior to enrollment.
- Current acute illness, with or without fever.
- Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT.
- History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
- History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
- Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 180 days prior to screening through Day 22. Note: Systemic corticosteroid use at a dose or equivalent dose of 20 mg or greater (≥0.5 mg/kg for children <40 kg) of prednisone for 14 consecutive days or more within 90 days of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed.
Show all 18Show fewer
- Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.
- Any administration or planned administration of:
- A licensed live attenuated vaccine within 28 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
- Other licensed (not live) vaccine within 14 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
- Another licensed or investigational CHIKV vaccine.
- Known infection with human immunodeficiency virus, hepatitis C virus (HCV), or hepatitis B virus. Note: Positive anti-HCV antibodies and negative HCV polymerase chain reaction would NOT be exclusionary. Polymerase chain reaction testing will not be performed as part of this protocol.
- Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator.
- Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.
- Onset of menarche prior to study vaccination.
- Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study.
- Identified as an immediate family member of the investigator or employee with direct involvement in the study. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study.
- Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant's participation or conduct of the study.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States8 sites
KidCare Pediatrics
Beaumont, Texas, 77706
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
ARK Clinical Research, LLC
Fountain Valley, California, 92708
Acevedo Clinical Research
Miami, Florida, 33142
Hope Research Network
Miami, Florida, 33166
Velocity Clinical Research-Omaha
Omaha, Nebraska, 68134
Emerson Clinical Research Institute- DC
Washington D.C., District of Columbia, 20009
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, 84088
Philippines6 sites
CARE CT Group Inc.
Dasmariñas, Cavite, 4114
HIMC Research and Development on Medical Sciences
Imus, Cavite, 4103
University of Perpetual Help DALTA Medical Center, Biomedical Research Institute
Las Piñas, National Capital Region, 1740
University of the Philippines-Philippine General Hospital
Manila, Cavite, 100
Institute of Child Health and Human Development, University of the Philippines
Manila, National Capital Region, 1000
Silang Specialist Medical Center
Silang, Cavite, 4118
About this study
Official title: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to <12 Years of Age
The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to <12 years of age.
- Conditions
- Chikungunya Virus
- Being tested
- CHIKV VLP vaccine, Placebo
- Keywords
- Chikungunya, PXVX0317, CHIKV VLP, vaccine, immunogenicity, VIMKUNYA, children
- 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 vaccineBiological
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
PlaceboBiological
Placebo is comprised of formulation buffer
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Cohort 1 Active Group Receives: Biological: CHIKV VLP vaccine |
| Arm 2 | Placebo comparator | Cohort 1 Placebo Group Receives: Biological: Placebo |
| Arm 3 | Experimental | Cohort 2 Active Group Receives: Biological: CHIKV VLP vaccine |
| Arm 4 | Placebo comparator | Cohort 2 Placebo Group Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs
Incidence of adverse events of special interest (AESIs; defined as new onset or worsening arthralgia that is medically attended), medically attended adverse events (MAAEs), and serious adverse events (SAEs) through end of the trial.
Measured: From vaccination through the end of the trial, planned to be Day 732 for study completers.
Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to <12 years of age in the immunogenicity evaluable population.
Measured: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Safety Endpoint 2: Incidence of unsolicited AEs through Day 29
Incidence of unsolicited adverse events (AEs) through Day 29.
Measured: From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.
Secondary outcomes (11)
Key Secondary Immunogenicity Endpoint 2: Day 22 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to <12 years of age in the immunogenicity evaluable population.
Measured: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Day 15 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to <12 years of age in the immunogenicity evaluable population.
Measured: Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.
Safety Endpoint 1: Incidence of solicited adverse events through Day 8
Incidence of solicited adverse events through Day 8.
Measured: From vaccination on study Day 1 through Day 8, 7 days after vaccination with CHIKV VLP vaccine or placebo.
Key Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in seronegative children
Day 15 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to <12 years of age in the immunogenicity evaluable population.
Measured: Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.
Secondary Immunogenicity Endpoint 2: Day 183 and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Day 183 and Day 366 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to <12 years of age in the immunogenicity evaluable population.
Measured: Study Day 183 and Day 366, 182 and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.
Secondary Immunogenicity Endpoint 3: Day 15, Day 22, Day 183, and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Day 15, Day 22, Day 183, and Day 366 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to <12 years of age in the immunogenicity evaluable population, stratified by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Measured: Day 15, Day 22, Day 183, and Day 366, 14, 21, 182, and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.
Secondary Immunogenicity Endpoint 4: GMTs of anti-CHIKV SNA at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only
Geometric mean titers (GMTs) of anti-CHIKV serum neutralizing antibodies (SNA) at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only, in children 1 to <12 years of age in the immunogenicity evaluable population by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Measured: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 5a: GMFIs from Day 1 to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only
Geometric mean fold increases (GMFIs) from Day 1 (prevaccination) to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only in children 1 to <12 years of age in the IEP and by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Measured: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 5b: Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only
Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only in children 1 to <12 years of age in the IEP and by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Measured: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 6: Anti-CHIKV SNA seroresponse rates at Day 732 in the CHIKV VLP vaccine group only
For the CHIKV VLP vaccine group only, anti-CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 732 in both baseline seronegative and seropositive children 1 to <12 years of age and by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Measured: Study Day 732, 731 days after vaccination with CHIKV VLP vaccine.
Secondary Immunogenicity Endpoint 7: Day 22 anti-CHIKV SNA seroresponse rate between seronegative children in the IEP versus adolescents and adults study EBSI-CV-317-004
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate between baseline seronegative children 1 to <12 years of age in the immunogenicity evaluable population (IEP) versus adolescents and adults from 12 to <65 years of age in study EBSI-CV-317-004.
Measured: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start5 Jun 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 stratified by site and age subgroup, 6 to \<12 years of age (Cohort 1) and 1 to \<6 years of age (Cohort 2), and randomized in a 4:1 ratio to receive either a single intramuscular (IM) dose of 40 µg CHIKV VLP vaccine or placebo at Day 1. Using the same strata, participants will be randomized in a 1:1 ratio to attend Visit 2 at either Day 15 or Day 22.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003984
- Sponsor's protocol ID
- EBSI-CV-317-006
- Status last verified
- Sep 2026
- First submitted
- 27 May 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett 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 35709798McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, Tredo SR, Warfield KL, Richardson JS. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. Vaccine. 2023 Oct 6;41(42):6146-6149. doi: 10.1016/j.vaccine.2023.08.086. Epub 2023 Sep 9.
PubMed 37690874Richardson 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 40158526
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to <12 Years of Age
- ClinicalTrials.gov ID
- NCT07003984
- Acronym / sponsor ID
- EBSI-CV-317-006
- Conditions
- Chikungunya Virus
- Keywords
- Chikungunya, PXVX0317, CHIKV VLP, vaccine, immunogenicity, VIMKUNYA, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
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 CHIKV VLP Vaccine in children 1 to <12 years of age.
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 stratified by site and age subgroup, 6 to <12 years of age (Cohort 1) and 1 to <6 years of age (Cohort 2), and randomized in a 4:1 ratio to receive either a single intramuscular (IM) dose of 40 µg CHIKV VLP vaccine or placebo at Day 1. Using the same strata, participants will be randomized in a 1:1 ratio to attend Visit 2 at either Day 15 or Day 22.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: CHIKV VLP vaccineCohort 1 Active Group |
| Arm 2 | Placebo comparator | Biological: PlaceboCohort 1 Placebo Group |
| Arm 3 | Experimental | Biological: CHIKV VLP vaccineCohort 2 Active Group |
| Arm 4 | Placebo comparator | Biological: PlaceboCohort 2 Placebo Group |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females between 1 and <12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active/open cohorts. Please see Section 6.1 for details
- Body weight ≥6.5 kg.
- In general good health, in the opinion of the investigator, based on medical history and physical examination.
- Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.
- Able and willing to complete all scheduled visits and comply with all study procedures.
Key exclusion criteria (18 listed)
- Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; these instances should be discussed with the sponsor's medical monitor and written agreement obtained prior to enrollment.
- Current acute illness, with or without fever.
- Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT.
- History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
- History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
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 vaccineCHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2% | Biological | Arm 1, Arm 3 |
| PlaceboPlacebo is comprised of formulation buffer | Biological | Arm 2, Arm 4 |
Primary outcome
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs
Time frame: From vaccination through the end of the trial, planned to be Day 732 for study completers.
Incidence of adverse events of special interest (AESIs; defined as new onset or worsening arthralgia that is medically attended), medically attended adverse events (MAAEs), and serious adverse events (SAEs) through end of the trial.
Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children
Time frame: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to <12 years of age in the immunogenicity evaluable population.
Safety Endpoint 2: Incidence of unsolicited AEs through Day 29
Time frame: From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.
Incidence of unsolicited adverse events (AEs) through Day 29.
11 secondary outcomes
Key Secondary Immunogenicity Endpoint 2: Day 22 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Time frame: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Time frame: Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.
Safety Endpoint 1: Incidence of solicited adverse events through Day 8
Time frame: From vaccination on study Day 1 through Day 8, 7 days after vaccination with CHIKV VLP vaccine or placebo.
Key Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in seronegative children
Time frame: Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.
Secondary Immunogenicity Endpoint 2: Day 183 and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Time frame: Study Day 183 and Day 366, 182 and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.
Secondary Immunogenicity Endpoint 3: Day 15, Day 22, Day 183, and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Time frame: Day 15, Day 22, Day 183, and Day 366, 14, 21, 182, and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.
Secondary Immunogenicity Endpoint 4: GMTs of anti-CHIKV SNA at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only
Time frame: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 5a: GMFIs from Day 1 to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only
Time frame: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 5b: Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only
Time frame: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 6: Anti-CHIKV SNA seroresponse rates at Day 732 in the CHIKV VLP vaccine group only
Time frame: Study Day 732, 731 days after vaccination with CHIKV VLP vaccine.
Secondary Immunogenicity Endpoint 7: Day 22 anti-CHIKV SNA seroresponse rate between seronegative children in the IEP versus adolescents and adults study EBSI-CV-317-004
Time frame: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: 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.
- Background: PubMed 37690874McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, Tredo SR, Warfield KL, Richardson JS. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. Vaccine. 2023 Oct 6;41(42):6146-6149. doi: 10.1016/j.vaccine.2023.08.086. Epub 2023 Sep 9.
- Background: 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHIKV VLP vaccine in people with Chikungunya Virus, run by Bavarian Nordic at 15 sites in 3 countries.
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 5 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Philippines, Puerto Rico. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs (time frame: From vaccination through the end of the trial, planned to be Day 732 for study completers.). The study lists 3 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 NCT07003984, 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 Sep 2026.