A Phase 3 interventional study of CHIKV VLP vaccine and Placebo in Chikungunya Virus, sponsored by Bavarian Nordic. Recruiting at 3 sites in 2 countries. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Bavarian Nordic · Phase 3, Interventional, and Prevention
Study EBSI-CV-317-007 is a field study to evaluate the efficacy, immunogenicity, and safety of CHIKV VLP vaccine. The study was designed using infectious disease models and advanced analytics to guide region and clinical site prioritization, define the timing of study activities, and optimize the study parameters to local epidemiological conditions for CHIKV disease to overcome the challenges of assessing efficacy for CHIKV VLP vaccine.
88 studies on the registry are indexed under Chikungunya Fever; 21 are open to participants now.
This study's planned enrollment of 6,144 is above the median of 263 across 57 interventional studies indexed under Chikungunya Fever.
Browse Chikungunya Fever studies →Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women who are either:
Meeting all the below criteria:
Note: Contraception requirements do not apply for participants in exclusively same-sex relationships and these participants should have no plans to become pregnant by any other means for at least 8 weeks after investigational product administration.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CHIKV VLP/adjuvant
Biological: CHIKV VLP vaccine
Placebo
Biological: Placebo
CHIKV VLP vaccine is comprised of 40 µg CHIKV VLP adsorbed on aluminum hydroxide (corresponding to approximately 300 µg of aluminum and stabilized with formulation buffer). CHIKV VLP vaccine is supplied as a single dose of 0.8 mL in a single use pre-filled syringe administered via IM injection in the deltoid muscle.
Placebo is comprised of formulation buffer supplied as a single dose of 0.8 mL in a single use pre-filled syringe administered via IM injection in the deltoid muscle.
Incidence of laboratory-confirmed acute CHIKV disease
Laboratory-confirmed acute CHIKV disease is defined by the presence of fever, one or more of arthralgia, myalgia or rash, and reverse transcription-quantitative polymerase chain reaction (RT-qPCR) confirmation of CHIKV ribonucleic acid.
Time frame: From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination
Incidence of laboratory-confirmed chronic CHIKV disease
Laboratory-confirmed chronic CHIKV disease is defined as the persistence of at least one of the articular manifestations (continuous or recurrent pain, rigidity, edema) for \>12 weeks after the onset of laboratory confirmed acute CHIKV disease.
Time frame: 98 days postvaccination through end of study follow-up, up to 1095 days postvaccination
Incidence of laboratory-confirmed severe CHIKV disease.
Laboratory-confirmed severe CHIKV disease is defined as a laboratory confirmed acute CHIKV disease presenting with dysfunction of at least one organ or system that threatens life and requires hospitalization.
Time frame: 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination
Number of participants with Solicited or Local Adverse Events
In the Safety Subset, the number and percentage of participants with local and systemic reactogenicity events through 7 days postvaccination.
Time frame: Within 7 days postvaccination
Number of participants with Unsolicited Adverse Events
In the Safety Subset, the number and percentage of participants with unsolicited adverse events through 28 days postvaccination.
Time frame: Within 28 days postvaccination
Number of Participants with Serious Adverse Events
For all study participants who receive investigational product, number and percentage of participants with Serious Adverse Events (SAEs). Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.
Time frame: Through end of study follow-up, up to 1095 days postvaccination
Number of Participants with Adverse Events of Special Interest
Adverse events of special interest are defined as the occurrence of new onset or worsening arthralgia that is medically attended and are not associated with a febrile disease case. For all study participants who receive investigational product, number and percentage of participants with AESI for the duration of the study. Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.
Time frame: Through end of study follow-up, up to 1095 days postvaccination
Number of Participants with Medically Attended Adverse Events
Medically attended adverse events (MAAEs) are defined as adverse events requiring a visit to the hospital, emergency room, urgent care clinic, or other visits to or from medical personnel that are not part of routine scheduled study visits. For study participants in the Safety Subset, the number and percentage of participants with MAAEs for the duration of the study. Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.
Time frame: Through end of study follow-up, up to 1095 days postvaccination
Anti-CHIKV Serum Neutralizing antibody titers
Geometric Mean Titers (GMTs) of anti-CHIKV serum neutralizing antibodies based on a validated luciferase based anti-CHIKV neutralization assay.
Time frame: 3 weeks postvaccination
Anti-CHIKV Serum Neutralizing Antibody seroresponse rate
Seroresponse is defined as the presence of anti-CHIKV serum neutralizing antibody (SNA) titer meeting or exceeding 100. Seroresponse rate is defined as the percentage of participants with an Anti-CHIKV SNA titer meeting or exceeding a titer of 100 based on a validated luciferase based anti-CHIKV neutralization assay.
Time frame: 3 weeks postvaccination
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for May 2030, 48 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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