Testing safety and immune response of an inactivated chikungunya vaccine in people aged 12–65
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.
This trial will test whether two doses of the BBV87 inactivated chikungunya vaccine are safe and produce protective immune responses in healthy people aged 12–65.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Bharat Biotech International Limited Industry-sponsored |
| Drugs / interventions | radiation, methotrexate |
| Locations | 10 sites (Guwahati, Assam and 9 other locations) |
| Trial ID | NCT07555392 on ClinicalTrials.gov |
What this trial studies
This randomized, observer-blind, placebo-controlled Phase II/III trial will enroll about 1,000 healthy participants aged 12–65 to test the BBV87 40 μg vaccine given as two doses. Participants will be randomized in a 3:3:3:1 ratio to receive one of three manufacturing lots of BBV87 or placebo, enabling lot-to-lot consistency comparisons. Immunogenicity and safety data will be collected up to key timepoints with a Data Safety Monitoring Board review after Day 56 to monitor participant safety. The trial enrolls participants irrespective of prior chikungunya serostatus and includes routine diary and clinic visit assessments.
Who should consider this trial
Good fit: Healthy males and females aged 12–65 who can give consent (or whose parent/guardian can), follow study procedures, maintain a study diary, and agree to contraception requirements if of child-bearing potential are ideal candidates.
Not a fit: People with recent moderate or severe arthritis/arthralgia, known diabetes mellitus, degenerative neurological disease, or other exclusionary conditions (or those outside the 12–65 age range) may not benefit from participation.
Why it matters
Potential benefit: If successful, BBV87 could offer a safe vaccine option to prevent chikungunya infection and reduce disease burden in vaccinated populations.
How similar studies have performed: Previous Phase II data informed the selected 40 μg dose and other chikungunya vaccine candidates have shown immunogenicity, so this approach builds on prior, promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guwahati, Assam and 9 other locations
- All India Institute of Medical Sciences — Guwahati, Assam, India (Not_yet_recruiting)
- All India Institute of Medical Sciences — Patna, Bihar, India (Not_yet_recruiting)
- All India Institute of Medical Sciences — Raipur, Chhattisgarh, India (Not_yet_recruiting)
- Redkar Hospital and Research Centre — Mumbai, Goa, India (Recruiting)
- Pgims — Rohtak, Haryana, India (Not_yet_recruiting)
- IMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital — Bhubaneswar, Odisha, India (Recruiting)
- Jawahar Lal Nehru medical College — Ajmer, Rajasthan, India (Not_yet_recruiting)
- Sardar Patel Medical College — Bikaner, Rajasthan, India (Not_yet_recruiting)
- Guru Teg Bahadur Hospital — Delhi, The National Capital Territory (nct) of Delhi, India (Recruiting)
- AIIMS Rishikesh Department of Community Medicine — Rishikesh, Uttarakhand, India (Not_yet_recruiting)
Study contacts
- Study coordinator: Dr Badri Narayan Patnaik
- Email: badri5633@bharatbiotech.com
- Phone: 914023480567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.