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

NCT07555392 | Recruiting Phase 2 DMC

• 1 other identifier: BBIL/CHIKV/II-III/2019
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Active Immunisation for Chikungunya Virus Infection

Keywords

chikungunya

Outcome Measures

Primary Outcomes (3)

• Geometric mean titres of CHIKV antibodies estimation

  Geometric mean titres of CHIKV antibodies estimated by PRNT50

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

• Seroconversion percentage

  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

  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 Outcomes (5)

• Geometric mean titres of CHIKV antibodies estimation

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

• Seroconversion Percentage

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

• Adverse events

  7 days following each vaccination Dose 1 on day 0 and dose 2 on day 28

• Adverse events and Serious adverse events

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

• Related unsolicited AEs, all SAEs and AEs arthralgia, myalgia

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

Study Arms (4)

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).

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).

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).

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).

Biological: Placebo

Interventions

BBV87 Chikungunya vaccine BIOLOGICAL

Inactivated Chikungunya Virus Vaccine (BBV87)

Group A- Chikungunya vaccine; Group B-Chikungunya vaccine; Group C-Chikungunya vaccine

Placebo BIOLOGICAL

Placebo or normal Saline (0.9% )

Group D-Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (10)

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

RECRUITING

PGIMS

Rohtak, Haryana, 124001, India

NOT YET RECRUITING

IMS & SUM Hospital bhubaneshwar Institute of Medical Sciences & SUM Hospital

Bhubaneswar, Odisha, 751003, India

RECRUITING

Jawahar Lal Nehru medical College

Ajmer, Rajasthan, 305001, India

NOT YET RECRUITING

Sardar Patel Medical College

Bikaner, Rajasthan, 334001, India

NOT YET RECRUITING

Guru Teg Bahadur Hospital

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

RECRUITING

AIIMS Rishikesh Department of Community Medicine

Rishikesh, Uttarakhand, 249203, India

NOT YET RECRUITING

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Central Study Contacts

Dr Badri Narayan Patnaik

CONTACT

914023480567; badri5633@bharatbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The appearance of the placebo is slightly different from that of the investigational vaccine. The storage temperature of BBV87 40 μg is +2º to +8°C, and that of the placebo (normal saline) is room temperature. Therefore, this study was designed as an observer-blind study where subjects, the Investigator, the study team from the Sponsor/Designee, and the study personnel responsible for evaluating the study outcomes will be unaware of the study vaccine administered. The clinical laboratories analysing the blood samples for immunogenicity will also be blinded to the treatment assignment.The study vaccine will be dispensed by designated unblinded personnel who will not participate in any clinical study evaluations. Additionally, there will be a few unblinded Sponsor/Designee personnel, including an unblinded statistician, who will be responsible for generating an unblinded report if requested by the DSMB members, unblinded personnel responsible for incorporating the randomization sheets
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: April 17, 2026
• First Posted: April 29, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

IN (10)