[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chikungunya-virus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chikungunya-virus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100628904","phase-3-an-efficacy-safety-and-immunogenicity-study-of-chikv-vlp-vaccine-for-the-prevention-of-chikungunya-disease-in-adolescents-and-adults-100628904",false,"NCT07467707","An Efficacy, Safety, and Immunogenicity Study of CHIKV VLP Vaccine for the Prevention of Chikungunya Disease in Adolescents and Adults","A Phase 3b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Adjuvanted Chikungunya Virus Virus-like Particle (CHIKV VLP) Vaccine for the Prevention of Chikungunya Disease in Adolescents (12 to \u003C18 Years) and Adults (≥18 Years)","Inclusion Criteria:\n\n1. Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). Must verbalize understanding of the reason for and the procedures needed for the study and be willing to stay in the study for its entire duration.\n2. Male or nonpregnant female 12 years of age and older.\n3. In stable health per the investigator, and no hospital admission or major surgical procedure in the last 30 days before investigational product administration.\n4. Women who are either:\n\n   1. Not of CBP: premenarchal, surgically sterile (at least 6 weeks post bilateral tubal ligation, bilateral salpingectomy, 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\n   2. Meeting all the below criteria:\n\n      * Negative urine pregnancy test at screening visit\n      * Negative urine pregnancy test immediately prior to dosing\n      * Using an acceptable form of contraception per local standards and agree to use this for at least 8 weeks after investigational product administration\n\nNote: 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.\n\nExclusion Criteria:\n\n1. Currently pregnant or breastfeeding.\n2. Participation or planned participation in an investigational clinical study within 30 days of Day 1 (investigational product administration) and for the duration of the study. Note: Participation in an observational trial\u002Fstudy or follow-up phase of a trial\u002Fstudy may be eligible; however, participation in any other study should be discussed with the MM prior to enrollment.\n3. History of severe allergic reaction or anaphylaxis to any component of the investigational product.\n4. Prior receipt of any CHIKV vaccine (or therapeutic) or participation in a prior interventional CHIKV trial\u002Fstudy.\n5. Prior documented, laboratory confirmed CHIKV disease.\n6. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to investigational product administration (eg, leukemia, lymphoma, malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Notes: i) history of basal cell and squamous cell carcinoma of the skin or carcinoma in situ of the cervix considered cured is not exclusionary; ii) history of malignancy considered cured from over 5 years from the date of screening with minimal risk of reoccurrence or relapse is not exclusionary; iii) documented controlled HIV infection (most recent tests show undetectable viral load and a CD4 cell count over 350 at the time of investigational product administration) is not exclusionary.\n7. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications including hyperimmune products, monoclonal antibody therapies, systemic corticosteroids, and\u002For therapy with alkylating agents, antimetabolites, or radiation from 6 months prior to screening through Day 22 visit (21 days \\[-3\u002F+5\\] after investigational product administration). Note: i) for systemic corticosteroid uses at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within 90 days of screening through Day 22 visit is exclusionary, and ii) use of inhaled, intranasal, topical, or ocular steroids is not exclusionary.\n8. Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22 visit.\n9. Unstable medical condition in the last 30 days prior to Day 1.\n10. Acute illness with or without fever (oral temperatures ≥38.0 ºC \\[100.4 °F\\]) within 14 days prior to investigational product administration.\n11. Medical or social condition (eg, substance abuse) that could have an impact on the participant's ability to be compliant with study procedures\u002Fvisits, as determined by the investigator.\n12. Plans to travel outside the study area or move away for more than 3 consecutive months and will not be available for follow up at the site.\n13. Identified as an investigator or employee of an investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse) of the investigator or employee with direct involvement in the proposed study, or identified as an employee of Bavarian Nordic, their families, contractors, agents, business partners, or anyone with a financial interest in the outcome of the study.\n14. Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.",true,"ALL","12 Years",{"count":20,"type":21},6144,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.",[27],"Chikungunya Virus",[29,30,31,32,33,34,35,36,37,38],"Chikungunya","PXVX0317","CHIKV VLP","vaccine","immunogenicity","efficacy","safety","VIMKUNYA","adolescents","adults","RECRUITING","2026-06-25",{"date":42,"type":43},"2026-06-29","ACTUAL",{"date":45,"type":43},"2026-05-26",{"date":47,"type":21},"2030-05",{"name":49,"class":50},"Bavarian Nordic","INDUSTRY",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100623268","early-phase-1-a-phase-i-study-of-pepgnp-chikv-in-healthy-volunteers-100623268","NCT07394426","A Phase I Study of PepGNP-ChikV in Healthy Volunteers","A Phase I, Dose-escalation, Randomized, Single-blind, Placebo-controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of PepGNP-ChikV, a Synthetic Nanoparticle-based T Cell Next-generational Vaccine Against Chikungunya in Healthy Adults","Inclusion Criteria:\n\n1. Healthy individuals aged ≥18 years to ≤60 years of age, inclusive at time of consent, who are not receiving any excluded concomitant medications as detailed in protocol\n2. Informed consent form signed.\n3. Determined to be eligible by the Investigator based on medical history, physical examination, and screening laboratory testing.\n4. Women of childbearing potential\\* are willing to use effective birth control method(s)\\*\\* for a minimum of 14 days prior to dosing through 90 days after last study vaccination.\n5. Male participants with a partner of childbearing potential must agree to use a highly effective method of contraception (e.g. sterilization or male condom) and refrain from sperm donation during the study and for at least 6 months after the last dose of study drug.\n\n   * An individual who has experienced menarche and who is neither permanently surgically sterile (permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) nor post-menopausal. In line with the guidance provided by the Clinical Trial Facilitation Group (CTFG), a post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\n     * Females of childbearing potential and males must be willing to use a highly effective (acceptable effective contraceptive measures are only acceptable for IMPs with unlikely human teratogenicity \u002F fetotoxicity in early pregnancy) method of contraception (hormonal or abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:\n\n       • combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n       o oral\n\n       o intravaginal\n\n       o transdermal\n\n       • progestogen-only hormonal contraception associated with inhibition of ovulation\n\n       o oral\n\n       o injectable\n\n       o implantable\n\n       • intrauterine device\n       * intrauterine hormone-releasing system\n       * bilateral tubal occlusion\n       * vasectomised partner\n       * sexual abstinence, (refraining from heterosexual intercourse during the entire period of risk associated with the study treatments (up to Day 407), if this is the preferred and usual lifestyle of the participant).\n\nExclusion Criteria:\n\n1. Self-reported or documented history of laboratory-confirmed chikungunya or other mosquito-borne (arthropod) disease, such as Zika or dengue within 90 days prior to consent.\n2. Travel in the previous 90 days to areas where exposure to flaviviruses such as Zika, dengue, West Nile Fever are common, as well as areas increasing in cases of chikungunya (refer to the following website: Chikungunya virus disease worldwide overview).\n3. Self-reported or documented receipt of any chikungunya (alphavirus) or flavivirus vaccine (investigational or licensed) within 90 days prior to consent.\n4. Receipt of any licensed vaccine, including COVID-19 vaccine, within the 28 days prior to consent or planned receipt within 90 days following last study vaccination (if unplanned circumstances subsequent to enrolment necessitate the receipt of a licensed vaccine e.g. tetanus and rabies, in unavoidable clinical settings, these should be documented in the source documents by the Investigator and not considered a protocol deviation. However, if the licensed vaccine is not urgently required, it should be delayed until at least 90 days following last study vaccination).\n5. Known systemic hypersensitivity to any of the vaccine components (e.g. gold), or history of a life-threatening reaction to vaccines, or to a vaccine containing any of the same substances.\n6. Acute illness according to Investigator judgment especially if febrile (≥38.0°C).\n7. Screening laboratory testing, including vital signs, ECG, urinalysis and blood laboratory tests, must be within the normal reference ranges; if an isolated abnormality is reported, but is assessed by the Investigator as not clinically relevant the participant may be enrolled and the Investigator's judgement documented in the participant's source data. However, the following laboratory values must be within normal ranges: AST, ALT, bilirubin, all measures of renal function, neutrophil count and platelet count. If the Investigator suspects it to be an erroneous result, it can be repeated; the new result should be used for eligibility determination by the Investigator after documenting any clinical significance to any persistently abnormal result.\n8. A positive SARS-CoV-2 polymerase chain reaction (PCR) or a positive rapid SARS-CoV-2 antigen test at Screening.\n9. Women who are pregnant, or lactating,\n10. Calculated body mass index (BMI) \\> 32.0 kg\u002Fm2.\n11. Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure within 90 days or five half-lives, whichever is longer, prior to consent or planned participation in such a study during the period of this clinical study.\n12. Receipt of immunoglobulins, blood or blood-derived products within 90 days prior to consent or planned receipt during the period of this chikungunya vaccine study.\n13. Known or suspected congenital or acquired immunodeficiency or autoimmune disease; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, within 90 days prior to consent; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within 90 days prior to consent).\n14. Self-reported or documented Hepatitis surface antigen (HBsAg) positivity or antibody against human immunodeficiency virus (HIV), Hepatitis B core, or Hepatitis C. If the viral screening sample at the screening visit provides a positive result, the participant will be excluded.\n15. Thrombocytopenia (platelet count \\\u003C150,000\u002FmL) or any coagulation disorder considered clinically significant by the Investigator.\n16. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or study completion.\n17. Current alcohol abuse or drug addiction (reported or suspected).\n18. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. (i.e. in the employment of the clinical study site).","18 Years","60 Years",{"count":61,"type":21},40,[63],"EARLY_PHASE1","This is a Phase I, randomized, single-blind, placebo-controlled, study of four separate dose cohorts, with a 42-day interval between each vaccine dose, of a novel Chikungunya Peptide Immunotherapy Vaccine in Healthy Adults (18-60 years of age).\n\nAll participants will undergo a screening visit scheduled for a maximum of 28 days before the enrolment in the clinical study and will provide a blood sample for clinical laboratory tests (complete blood count (CBC)\\*, platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine and activated partial thromboplastin time (aPTT), human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)), and a urine sample for tests for Urinary protein, Urinary blood, Urinary glucose and human chorionic gonadotropin β-subunit (βhCG) urine test (only the female participants)) in order to confirm their eligibility for participation in the study.\n\nA total of 40 participants are planned to be enrolled. A randomization system will be used to assign treatment group and participant number at the clinical site.\n\nParticipants will receive 2 injections, 42 days apart. A final visit will take place at Day 407 (i.e. 365 days after last vaccination).\n\nParticipants will be kept under observation for a minimum of one hour after each vaccination to ensure their safety. Reactogenicity data will be collected in all participants after each vaccine injection: solicited injection site reactions will be collected for Days 0-10 and Days 42-52 and solicited systemic reactions will be collected for Days 0-21 and Days 42-63. Unsolicited events will be collected for Days 0-52. Serious adverse events (SAEs) will be reported throughout the study (from inclusion until 12 months after last vaccination). Serious and non-serious medically attended adverse events (MAAEs) and adverse events of special interest (AESIs) will be collected throughout the study (from inclusion until 12 months after last vaccination).",[29,66,67,68,27],"Chikungunya Fever","Chikungunya Virus Infection","Chikungunya Virus Infections",[70],"Infectious disease, chikungunya, T cell priming vaccine, first in human, healthy volunteer","NOT_YET_RECRUITING","2026-04-23",{"date":74,"type":43},"2026-04-29",{"date":76,"type":21},"2026-08-03",{"date":78,"type":21},"2028-05-01",{"name":80,"class":50},"Gylden Pharma Ltd",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":16,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100593249","phase-3-a-safety-and-immunogenicity-study-of-chikv-vlp-vaccine-in-children-100593249","NCT07003984","A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.","A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to \u003C12 Years of Age","Inclusion Criteria:\n\n1. Males or females between 1 and \\\u003C12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active\u002Fopen cohorts. Please see Section 6.1 for details\n2. Body weight ≥6.5 kg.\n3. In general good health, in the opinion of the investigator, based on medical history and physical examination.\n4. 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)\u002FIndependent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.\n5. Able and willing to complete all scheduled visits and comply with all study procedures.\n\nExclusion Criteria:\n\n1. 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.\n2. Current acute illness, with or without fever.\n3. 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.\n4. History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.\n5. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.\n6. 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\u002Fkg for children \\\u003C40 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.\n7. Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.\n8. Any administration or planned administration of:\n\n   * 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.\n   * 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.\n   * Another licensed or investigational CHIKV vaccine.\n9. 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.\n10. Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator.\n11. Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.\n12. Onset of menarche prior to study vaccination.\n13. Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study.\n14. 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.\n15. 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.","1 Year","11 Years",{"count":91,"type":21},720,[24],"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 \\\u003C12 years of age.",[27],[29,30,31,32,33,36,96],"children","2026-03-20",{"date":99,"type":43},"2026-03-24",{"date":101,"type":43},"2025-06-05",{"date":103,"type":21},"2028-12",{"name":49,"class":50},15]