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
Eligibility
Sex
ALL
Min age
12 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Geometric mean titres of CHIKV antibodies estimation — 28 days following Dose 2 (Visit 3-DAY 56) Geometric mean titres of CHIKV antibodies estimated by PRNT50
Seroconversion percentage — 28 days following Dose 2 (Visit 3-DAY 56) Percentage of subjects achieving seroconversion of CHIKV antibodies
Geometric mean titres of CHIKV antibodies estimation of 3 lots — 28 days following Dose 2 (Visit 3-DAY 56) Geometric mean titres of CHIKV antibodies estimated by PRNT50 of three lots of BBV87 40 μg
Trial sites (10)
Facility
City
Region
Status
All India Institute of Medical Sciences
Guwahati
Assam
Not Yet Recruiting
All India Institute of Medical Sciences
Patna
Bihar
Not Yet Recruiting
All India Institute of Medical Sciences
Raipur
Chhattisgarh
Not Yet Recruiting
Redkar Hospital and Research Centre
Mumbai
Goa
Recruiting
PGIMS
Rohtak
Haryana
Not Yet Recruiting
IMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital
Bhubaneswar
Odisha
Recruiting
Jawahar Lal Nehru medical College
Ajmer
Rajasthan
Not Yet Recruiting
Sardar Patel Medical College
Bikaner
Rajasthan
Not Yet Recruiting
Guru Teg Bahadur Hospital
Delhi
The National Capital Territory (nct) of Delhi
Recruiting
AIIMS Rishikesh Department of Community Medicine
Rishikesh
Uttarakhand
Not Yet Recruiting
More Bharat Biotech International Limited trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.