A Phase 2/3 interventional study of BBV87 Chikungunya vaccine and Placebo in Active Immunisation for Chikungunya Virus Infection, sponsored by Bharat Biotech International Limited. Recruiting at 10 sites in India. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Bharat Biotech International Limited · Phase 2/3, Interventional, and Prevention
A Seamless Phase II/III, Observer-blind, Multi-centre, Randomized Clinical Trial to Evaluate Immunogenicity and Safety of BBV87, an Inactivated Chikungunya Virus Vaccine in Healthy Subjects 12-65 Years of Age
The current study is designed to evaluate the safety, immunogenicity, and lot-to-lot consistency of the BBV87 40 μg vaccine in healthy subjects.This Phase III study is a randomized, observer blind, placebo-controlled, multi-centre, lot-to-lot consistency study with a two-dose schedule. Approximately, 1000 healthy subjects 12 to 65 years of age will be randomized irrespective of CHIKV serological status at Visit 1. Nine hundred subjects will be randomized equally among three lots of BBV87 40 μg. (Lot A, Lot B,and Lot C) while 100 subjects will be administered a placebo. Thus, approximately 1000 subjects will be randomized in allocation ratio 3:3:3:1 (BBV87 40 μg. Lot A: BBV87 40 μg. Lot B: BBV87 40 μg. Lot C: Placebo). Subjects will receive 40 μg dose strength of BBV87, based on the dose approved by the DSMB and CDSCO in the Phase II study. After Day 56, the DSMB will review the safety data during the study to safeguard the interests of trial subjects and assess the vaccine's safety.
Inclusion Criteria: 1. Healthy male and female subjects aged between 12 to 65 years (both inclusive).
2. Subject or Subject's Parent should be willing to give voluntary written informed consent and/or assent prior to inclusion in the study.
3. Must be able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
4. Willing to consent to the storage and future use of biological samples for CHIKV related research.
5. Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child-bearing potential should be willing to follow effective birth control* methods for at least 3 months after the last dose of vaccine.
-
Exclusion Criteria: 1. History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Visit 1.
2. Subject a known case of diabetes mellitus (Type 1 and 2). 3. History of degenerative neurological disease (e.g. Guillain Barre Syndrome, Multiple Sclerosis).
4. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
5. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
6. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F) within 48 hours prior to vaccination.
7. Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease). 8. Subjects who are pregnant or breastfeeding. 9. Prior major surgery or radiation therapy within 4 weeks of Visit 1. 10. Known or suspected cases of HIV and Hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Investigator.
11. Current (within 14 days before Visit 1) or anticipated concomitant immune-modifying or immunosuppressive therapy (excluding inhaled, topical skin, or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
12. Administration of blood or blood product derivatives or any immunoglobulin preparation, 90 days before Visit 1.
13. Active addictive drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints.
14. Participating in a clinical trial of any vaccine, including CHIKV, within 30 days before Visit 1 or planning to participate during the study.
15. Any other condition which in the opinion of the Investigator may affect subject's safety or participation.
BBV87 Chikungunya vaccine LOT 1- Dose 1 is administered intramuscularly in the deltoid region of the arm. Dose 2 of the study vaccine will be administered at Visit 2 (28+5 days following Dose 1).
Biological: BBV87 Chikungunya vaccine
BBV87 Chikungunya vaccine LOT 2- Dose 1 is administered intramuscularly in the deltoid region of the arm. Dose 2 of the study vaccine will be administered at Visit 2 (28+5 days following Dose 1).
Biological: BBV87 Chikungunya vaccine
BBV87 Chikungunya vaccine LOT 3- Dose 1 is administered intramuscularly in the deltoid region of the arm. Dose 2 of the study vaccine will be administered at Visit 2 (28+5 days following Dose 1).
Biological: BBV87 Chikungunya vaccine
Placebo - Dose 1 is administered intramuscularly in the deltoid region of the arm. Dose 2 will be administered at Visit 2 (28+5 days following Dose 1).
Biological: Placebo
Inactivated Chikungunya Virus Vaccine (BBV87)
Placebo or normal Saline (0.9% )
Geometric mean titres of CHIKV antibodies estimation
Geometric mean titres of CHIKV antibodies estimated by PRNT50
Time frame: 28 days following Dose 2 (Visit 3-DAY 56)
Seroconversion percentage
Percentage of subjects achieving seroconversion of CHIKV antibodies
Time frame: 28 days following Dose 2 (Visit 3-DAY 56)
Geometric mean titres of CHIKV antibodies estimation of 3 lots
Geometric mean titres of CHIKV antibodies estimated by PRNT50 of three lots of BBV87 40 μg
Time frame: 28 days following Dose 2 (Visit 3-DAY 56)
Geometric mean titres of CHIKV antibodies estimation
Geometric mean titres of CHIKV antibodies estimated by PRNT50
Time frame: 28 days following Dose 1 (Visit 2-DAY 28)
Seroconversion Percentage
Percentage of subjects achieving seroconversion of CHIKV antibodies
Time frame: 28 days following Dose 1 (Visit 2-DAY 56)
Adverse events
Occurrence, relationship and severity of local and systemic solicited AEs
Time frame: 7 days following each vaccination Dose 1 on day 0 and dose 2 on day 28
Adverse events and Serious adverse events
Occurrence, relationship and severity of unsolicited AEs and SAEs
Time frame: 28 days following Dose 2 (Visit 3-DAY 56)
Related unsolicited AEs, all SAEs and AEs arthralgia, myalgia
Occurrence, relationship and severity of related unsolicited AEs, all SAEs and AEs arthralgia, myalgia occurring
Time frame: Post Visit 3 and up to end of study i.e., 11 months (approximately 334 days)
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bharat Biotech International Limited