A Seamless Phase II/III, Observer-blind, to Evaluate Immunogenicity and Safety of Chikungunya Virus Vaccine in Healthy Subjects 12-65Years of Age. (CHIKV/II-III)

April 24, 2026 updated by: Bharat Biotech International Limited

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Assam
      • Guwahati, Assam, India, 7811101
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Contact:
    • Bihar
      • Patna, Bihar, India, 801507
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Sanjay Pandey, MBBS MD
    • Chhattisgarh
      • Raipur, Chhattisgarh, India, 492099
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Abhiruchi Galhotra, MBBS MD
    • Goa
      • Mumbai, Goa, India, 403513
        • Recruiting
        • Redkar Hospital and Research Centre
        • Contact:
        • Principal Investigator:
          • Sagar vivek redkar, MBBS MD
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Not yet recruiting
        • PGIMS
        • Contact:
        • Principal Investigator:
          • savita verma, MBBS MD
    • Odisha
      • Bhubaneswar, Odisha, India, 751003
        • Recruiting
        • IMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital
        • Contact:
        • Principal Investigator:
          • Venkata Rao Epari, MBBS MD
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Not yet recruiting
        • Jawahar Lal Nehru Medical College
        • Contact:
        • Principal Investigator:
          • Sanjiv Maheshwari, MBBS MD
      • Bikaner, Rajasthan, India, 334001
        • Not yet recruiting
        • Sardar Patel Medical College
        • Contact:
        • Principal Investigator:
          • Veer Bahadur Singh, MBBS MD
    • The National Capital Territory (nct) of Delhi
      • Delhi, The National Capital Territory (nct) of Delhi, India, 110029
        • Recruiting
        • Guru Teg Bahadur Hospital
        • Contact:
        • Principal Investigator:
          • Shiva Narang, MBBS MD
    • Uttarakhand
      • Rishikesh, Uttarakhand, India, 249203
        • Not yet recruiting
        • AIIMS Rishikesh Department of Community Medicine
        • Contact:
        • Principal Investigator:
          • Mahendra Singh, MBBS MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A- Chikungunya vaccine
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
Inactivated Chikungunya Virus Vaccine (BBV87)
Experimental: Group B-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
Inactivated Chikungunya Virus Vaccine (BBV87)
Experimental: Group C-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
Inactivated Chikungunya Virus Vaccine (BBV87)
Placebo Comparator: Group D-Placebo
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
Placebo or normal Saline (0.9% )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric mean titres of CHIKV antibodies estimation
Time Frame: 28 days following Dose 2 (Visit 3-DAY 56)
Geometric mean titres of CHIKV antibodies estimated by PRNT50
28 days following Dose 2 (Visit 3-DAY 56)
Seroconversion percentage
Time Frame: 28 days following Dose 2 (Visit 3-DAY 56)
Percentage of subjects achieving seroconversion of CHIKV antibodies
28 days following Dose 2 (Visit 3-DAY 56)
Geometric mean titres of CHIKV antibodies estimation of 3 lots
Time Frame: 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
28 days following Dose 2 (Visit 3-DAY 56)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric mean titres of CHIKV antibodies estimation
Time Frame: 28 days following Dose 1 (Visit 2-DAY 28)
Geometric mean titres of CHIKV antibodies estimated by PRNT50
28 days following Dose 1 (Visit 2-DAY 28)
Seroconversion Percentage
Time Frame: 28 days following Dose 1 (Visit 2-DAY 56)
Percentage of subjects achieving seroconversion of CHIKV antibodies
28 days following Dose 1 (Visit 2-DAY 56)
Adverse events
Time Frame: 7 days following each vaccination Dose 1 on day 0 and dose 2 on day 28
Occurrence, relationship and severity of local and systemic solicited AEs
7 days following each vaccination Dose 1 on day 0 and dose 2 on day 28
Adverse events and Serious adverse events
Time Frame: 28 days following Dose 2 (Visit 3-DAY 56)
Occurrence, relationship and severity of unsolicited AEs and SAEs
28 days following Dose 2 (Visit 3-DAY 56)
Related unsolicited AEs, all SAEs and AEs arthralgia, myalgia
Time Frame: Post Visit 3 and up to end of study i.e., 11 months (approximately 334 days)
Occurrence, relationship and severity of related unsolicited AEs, all SAEs and AEs arthralgia, myalgia occurring
Post Visit 3 and up to end of study i.e., 11 months (approximately 334 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bharat Biotech International Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBIL/CHIKV/II-III/2019 (Other Identifier: Bharat Biotech International Ltd)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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