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RecruitingNCT07555392CHIKV/II-IIIUpdated Apr 29, 2026

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

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

Phase
Phase 2/3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Active Immunisation for Chikungunya Virus Infection

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Keywords

  • chikungunya
03

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.

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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.

04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • BiologicalBBV87 Chikungunya vaccine

    Inactivated Chikungunya Virus Vaccine (BBV87)

  • BiologicalPlacebo

    Placebo or normal Saline (0.9% )

05

What researchers measure

Primary outcomes

  1. 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)

  2. Seroconversion percentage

    Percentage of subjects achieving seroconversion of CHIKV antibodies

    Time frame: 28 days following Dose 2 (Visit 3-DAY 56)

  3. 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)

Secondary outcomes

  1. 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)

  2. Seroconversion Percentage

    Percentage of subjects achieving seroconversion of CHIKV antibodies

    Time frame: 28 days following Dose 1 (Visit 2-DAY 56)

  3. 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

  4. 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)

  5. 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)

06

Study locations

3 of 10 sites recruiting
  • All India Institute of Medical Sciences
    Guwahati, Assam 7811101, India
    Not yet recruiting
  • All India Institute of Medical Sciences
    Patna, Bihar 801507, India
    Not yet recruiting
  • All India Institute of Medical Sciences
    Raipur, Chhattisgarh 492099, India
    Not yet recruiting
  • Redkar Hospital and Research Centre
    Mumbai, Goa 403513, India
    • Sagar Vivek Redkar, MBBS MD · Contact · redkardr.sagar@gmail.com · 7969792769
    • Sagar vivek redkar, MBBS MD · Principal investigator
    Recruiting
  • PGIMS
    Rohtak, Haryana 124001, India
    • SAVITA Verma, MBBS MD · Contact · verma.savi@gmail.com · 9812283746
    • savita verma, MBBS MD · Principal investigator
    Not yet recruiting
  • IMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital
    Bhubaneswar, Odisha 751003, India
    • Venkata Rao Epari, MBBS MD · Contact · evenkatarao@soa.ac.in · 966843382
    • Venkata Rao Epari, MBBS MD · Principal investigator
    Recruiting
  • Jawahar Lal Nehru medical College
    Ajmer, Rajasthan 305001, India
    • Sanjiv Maheshwari, MBBS MD · Contact · doctorsanjiv@gmail.com · 9460479888
    • Sanjiv Maheshwari, MBBS MD · Principal investigator
    Not yet recruiting
  • Sardar Patel Medical College
    Bikaner, Rajasthan 334001, India
    • Veer Bahadur Singh, MBBS MD · Contact · vbsingh2@rediffmail.com · 9414136888
    • Veer Bahadur Singh, MBBS MD · Principal investigator
    Not yet recruiting
  • Guru Teg Bahadur Hospital
    Delhi, The National Capital Territory (nct) of Delhi 110029, India
    • Shiva Narang, MBBS MD · Contact · shivanarang@gmail.com · 9899838807
    • Shiva Narang, MBBS MD · Principal investigator
    Recruiting
  • AIIMS Rishikesh Department of Community Medicine
    Rishikesh, Uttarakhand 249203, India
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07555392
Lead sponsor
Bharat Biotech International Limited
Responsible party
Sponsor
First posted
Apr 29, 2026
Start date
Apr 20, 2026
Primary completion
Sep 20, 2026 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Apr 29, 2026

Study contacts

Dr Badri Narayan Patnaik
Contact
badri5633@bharatbiotech.com
914023480567

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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