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.
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
- Conditions the study is for
- Active Immunisation for Chikungunya Virus Infection
- What is being tested?
- BBV87 Chikungunya vaccine
- Type of treatment
- Vaccines, Injection or infusion
- 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).
- Subject or Subject's Parent should be willing to give voluntary written informed consent and/or assent prior to inclusion in the study.
- Must be able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
- Willing to consent to the storage and future use of biological samples for CHIKV related research.
- 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.
- Subject a known case of diabetes mellitus (Type 1 and 2). 3. History of degenerative neurological disease (e.g. Guillain Barre Syndrome, Multiple Sclerosis).
- 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.
- History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
- 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.
- 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.
- 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).
- Administration of blood or blood product derivatives or any immunoglobulin preparation, 90 days before Visit 1.
- 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.
- Participating in a clinical trial of any vaccine, including CHIKV, within 30 days before Visit 1 or planning to participate during the study.
- 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.
10 sites in 1 country
India10 sites, 10 recruiting
- Not yet recruiting
Jawahar Lal Nehru medical College
Ajmer, Rajasthan, 305001
Sanjiv Maheshwari, MBBS MD, 9460479888, doctorsanjiv@gmail.com
Sanjiv Maheshwari, MBBS MD
- 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
- Not yet recruiting
Sardar Patel Medical College
Bikaner, Rajasthan, 334001
Veer Bahadur Singh, MBBS MD, 9414136888, vbsingh2@rediffmail.com
Veer Bahadur Singh, MBBS MD
- 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
- Not yet recruiting
All India Institute of Medical Sciences
Guwahati, Assam, 7811101
Satyajit Mohapatra, MBBS MD, 9791161626, satyajitmp@gmail.com
- Recruiting
Redkar Hospital and Research Centre
Mumbai, Goa, 403513
Sagar Vivek Redkar, MBBS MD, 7969792769, redkardr.sagar@gmail.com
Sagar vivek redkar, MBBS MD
- Not yet 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
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 group | Role | What they receive |
|---|---|---|
| Group A- Chikungunya vaccine | Experimental | 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). Receives: Biological: BBV87 Chikungunya vaccine |
| Group B-Chikungunya vaccine | Experimental | 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). Receives: Biological: BBV87 Chikungunya vaccine |
| Group C-Chikungunya vaccine | Experimental | 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). Receives: Biological: BBV87 Chikungunya vaccine |
| Group D-Placebo | Placebo comparator | 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). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Seroconversion percentage
Percentage of subjects achieving seroconversion of CHIKV antibodies
Measured: 28 days following Dose 2 (Visit 3-DAY 56)
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)
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)
Seroconversion Percentage
Percentage of subjects achieving seroconversion of CHIKV antibodies
Measured: 28 days following Dose 1 (Visit 2-DAY 56)
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
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)
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.
- First posted29 Apr 2026
- Study start20 Apr 2026
- Primary completion20 Sep 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Immunisation for Chikungunya Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07555392
- Acronym / sponsor ID
- CHIKV/II-III / BBIL/CHIKV/II-III/2019
- Keywords
- chikungunya
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A- Chikungunya vaccine | Experimental | Biological: BBV87 Chikungunya vaccineBBV87 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). |
| Group B-Chikungunya vaccine | Experimental | Biological: BBV87 Chikungunya vaccineBBV87 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). |
| Group C-Chikungunya vaccine | Experimental | Biological: BBV87 Chikungunya vaccineBBV87 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). |
| Group D-Placebo | Placebo comparator | Biological: PlaceboPlacebo - 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). |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBV87 Chikungunya vaccineInactivated Chikungunya Virus Vaccine (BBV87) | Biological | Group A- Chikungunya vaccine, Group B-Chikungunya vaccine, Group C-Chikungunya vaccine |
| PlaceboPlacebo or normal Saline (0.9% ) | Biological | Group D-Placebo |
Primary outcome
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
Seroconversion percentage
Time frame: 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
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
5 secondary outcomes
Geometric mean titres of CHIKV antibodies estimation
Time frame: 28 days following Dose 1 (Visit 2-DAY 28)
Seroconversion Percentage
Time frame: 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
Adverse events and Serious adverse events
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
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.