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Active Immunisation for Chikungunya Virus InfectionPhase 2/3CHIKV/II-IIINCT07555392

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 study testing BBV87 Chikungunya vaccine in people with Active Immunisation for Chikungunya Virus Infection, run by Bharat Biotech International Limited at 10 sites in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 12 to 65 years
What is being tested?
BBV87 Chikungunya vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
10 sitesIndia
Study dates
20 Apr 2026to 30 Aug 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Inclusion Criteria: 1. Healthy male and female subjects aged between 12 to 65 years (both inclusive).

  1. Subject or Subject's Parent should be willing to give voluntary written informed consent and/or assent prior to inclusion in the study.
  2. Must be able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
  3. Willing to consent to the storage and future use of biological samples for CHIKV related research.
  4. 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.

  1. Subject a known case of diabetes mellitus (Type 1 and 2). 3. History of degenerative neurological disease (e.g. Guillain Barre Syndrome, Multiple Sclerosis).
  2. 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.
  3. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
  4. 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.
  5. 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.
  6. 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).
  7. Administration of blood or blood product derivatives or any immunoglobulin preparation, 90 days before Visit 1.
  8. 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.
  9. Participating in a clinical trial of any vaccine, including CHIKV, within 30 days before Visit 1 or planning to participate during the study.
  10. Any other condition which in the opinion of the Investigator may affect subject's safety or participation.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dr Badri Narayan Patnaik contact

914023480567

badri5633@bharatbiotech.com

10 sites in 1 country

India10 sites, 10 recruiting
  • Jawahar Lal Nehru medical College

    Ajmer, Rajasthan, 305001

    Sanjiv Maheshwari, MBBS MD, 9460479888, doctorsanjiv@gmail.com

    Sanjiv Maheshwari, MBBS MD

    Not yet recruiting
  • IMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital

    Bhubaneswar, Odisha, 751003

    Venkata Rao Epari, MBBS MD, 966843382, evenkatarao@soa.ac.in

    Venkata Rao Epari, MBBS MD

    Recruiting
  • Sardar Patel Medical College

    Bikaner, Rajasthan, 334001

    Veer Bahadur Singh, MBBS MD, 9414136888, vbsingh2@rediffmail.com

    Veer Bahadur Singh, MBBS MD

    Not yet recruiting
  • Guru Teg Bahadur Hospital

    Delhi, The National Capital Territory (nct) of Delhi, 110029

    Shiva Narang, MBBS MD, 9899838807, shivanarang@gmail.com

    Shiva Narang, MBBS MD

    Recruiting
  • All India Institute of Medical Sciences

    Guwahati, Assam, 7811101

    Satyajit Mohapatra, MBBS MD, 9791161626, satyajitmp@gmail.com

    Not yet recruiting
  • Redkar Hospital and Research Centre

    Mumbai, Goa, 403513

    Sagar Vivek Redkar, MBBS MD, 7969792769, redkardr.sagar@gmail.com

    Sagar vivek redkar, MBBS MD

    Recruiting
  • All India Institute of Medical Sciences

    Patna, Bihar, 801507

    Sanjay Pandey, MBBS MD, 7783892746, drsanjaypandey72@gmail.com

    Sanjay Pandey, MBBS MD

    Not yet recruiting
  • All India Institute of Medical Sciences

    Raipur, Chhattisgarh, 492099

    Abhiruchi Galhotra, MBBS MD, 8518881711, abhiruchigalhotra@aiimsraipur.edu.in

    Abhiruchi Galhotra, MBBS MD

    Not yet recruiting
  • AIIMS Rishikesh Department of Community Medicine

    Rishikesh, Uttarakhand, 249203

    Mahendra Singh, MBBS MD, 9799624704, gehlot.mahendrasingh@gmail.com

    Mahendra Singh, MBBS MD

    Not yet recruiting
  • PGIMS

    Rohtak, Haryana, 124001

    SAVITA Verma, MBBS MD, 9812283746, verma.savi@gmail.com

    savita verma, MBBS MD

    Not yet recruiting

Other trials in India

About this study

Official title: 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

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.

Being tested
BBV87 Chikungunya vaccine, Placebo
Keywords
chikungunya
Medical subject headings
Chikungunya Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBV87 Chikungunya vaccineBiological

    Inactivated Chikungunya Virus Vaccine (BBV87)

  • PlaceboBiological

    Placebo or normal Saline (0.9% )

Study groups in NCT07555392
Study groupRoleWhat they receive
Group A- Chikungunya vaccineExperimentalBBV87 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).
Receives: Biological: BBV87 Chikungunya vaccine
Group B-Chikungunya vaccineExperimentalBBV87 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).
Receives: Biological: BBV87 Chikungunya vaccine
Group C-Chikungunya vaccineExperimentalBBV87 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).
Receives: Biological: BBV87 Chikungunya vaccine
Group D-PlaceboPlacebo comparatorPlacebo - 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).
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric mean titres of CHIKV antibodies estimation

    Geometric mean titres of CHIKV antibodies estimated by PRNT50

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

  2. Seroconversion percentage

    Percentage of subjects achieving seroconversion of CHIKV antibodies

    Measured: 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

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

Secondary outcomes (5)
  1. Geometric mean titres of CHIKV antibodies estimation

    Geometric mean titres of CHIKV antibodies estimated by PRNT50

    Measured: 28 days following Dose 1 (Visit 2-DAY 28)

  2. Seroconversion Percentage

    Percentage of subjects achieving seroconversion of CHIKV antibodies

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

  3. Adverse events

    Occurrence, relationship and severity of local and systemic solicited AEs

    Measured: 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

    Measured: 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

    Measured: Post Visit 3 and up to end of study i.e., 11 months (approximately 334 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start20 Apr 2026
  3. Primary completion20 Sep 2026 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555392
Sponsor's protocol ID
BBIL/CHIKV/II-III/2019
Other IDs
BBIL/CHIKV/II-III/2019
Acronym
CHIKV/II-III
Status last verified
Apr 2026
First submitted
17 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BBV87 Chikungunya vaccine in people with Active Immunisation for Chikungunya Virus Infection, run by Bharat Biotech International Limited at 10 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr Badri Narayan Patnaik (914023480567, badri5633@bharatbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean titres of CHIKV antibodies estimation (time frame: 28 days following Dose 2 (Visit 3-DAY 56)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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