| CTRI Number |
CTRI/2021/09/036179 [Registered on: 02/09/2021] Trial Registered Prospectively |
| Last Modified On: |
20/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A 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
|
Scientific Title of Study
Modification(s)
|
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
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| BBIL/CHIKVII-II/2019 Version 1.1 Dated 25 Nov 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Mohan |
| Address |
Medical Affairs Department,Genome Valley,Shameerpet-500078
Medical Affairs Department,Genome Valley,Shameerpet-500078
Hyderabad
TELANGANA
500078
India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr Krishna Mohan |
| Address |
Medical Affairs Department,Genome Valley,Shameerpet-500078
Medical Affairs Department,Genome Valley,Shameerpet-500078
Hyderabad
TELANGANA
500078
India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Krishna Mohan |
| Address |
Medical Affairs Department,Genome Valley,Shameerpet-500078
Medical Affairs Department,Genome Valley,Shameerpet-500078
Hyderabad
TELANGANA
500078
India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
|
Source of Monetary or Material Support
|
| BIRAC, Department of Biotechnology, Government of India |
|
|
Primary Sponsor
|
| Name |
Bharat Biotech International Ltd |
| Address |
Medical Affairs Department,Genome Valley,Shameerpet-500078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bharat Biotech International Ltd |
Genome Valley,Shameerpet,Hyderabad 500078 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Palkar |
Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital |
Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital
Pune Satara Road Dhankawadi Pune 411043
Pune
|
9881008717
sonali.palkar@bharatividyapeeth.edu |
| Dr Kartikeya Parmar |
BJ Medical College and Civil Hospital |
Associate professor
Dept. of Medicine
BJ Medical College & Hospital, Asarva,
Ahmedabad 380016 Gujarat
Ahmadabad
|
9924643799
drkartik@gmail.com |
| Dr Sunil Kohli |
HIMSR with CHRD-SAS, HAHC Hospital |
Hamdard Institute of Medical Sciences and Research with Centre for Health Research and Development – Society for Applied Studies, Hakeem Abdul Hameed Centenary Hospital, Guru Ravidas Marg, Hamdard Nagar New Delhi – 110062
North East
|
9873351206
drskohli.himsr@gmail.com |
| Dr Veena Kamath |
Kasturba Medical College |
Manipal Academy of Higher Education,Madhav Nagar, Near Tiger Circle, Manipal -576104, Karnataka
Udupi
|
9845304647
veenak@manipal.edu |
| Dr Anand Kawade |
KEM Hospital Research Centre |
Vadu Rural Health Program, Vadu Budruk, Taluka ,Shirur, District,Pune-412216 Maharashtra
Pune
|
9552588996
anand.kawade@kemhrcvadu.org |
| DrRajapantula Vasudev |
King George Hospital |
Maharanipeta,Vishakapatnam 530002,Andhra Pradesh
Visakhapatnam
|
9866739808
vasudev.kgh@gmail.com |
| Dr Venkata Rao |
Medicine Institute of Medical Sciences & SUM Hospital |
Department of Community Medicine,
K-8 Kalinga nagar, Ghatikia, Bhuwaneshwar-751003
Odisha
Khordha
|
9668443382
e.venkata.rao@gmail.com |
| Dr Savita Verma |
Pt. Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) |
Department of Pharmacology, UHS, Rohtak-124001,Haryana
Rohtak
|
9812283746
verma.savi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Bharati Vidyapeeth (Deemed to be University) Medical College & HospitalPune |
Approved |
| Institutional Ethics Committee KGH |
Approved |
| Institutional Ethics Committee Rohtak |
Approved |
| Institutional Ethics Committee SUM |
Approved |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
| KEM HOSPITAL RESEARCH CENTRE ETHICS COMMITTE |
Approved |
| MAHE Ethics Committee,Manipal |
Approved |
| The Institutional Ethics Committee,B.J.Medical College and Civil Hospital,Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To prevent Chikungunya Virus infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chikungunya virus vaccine |
Purified inactivated Chikungunya virus antigen vaccine.Two dose strengths of investigational vaccine, BBV87. Low dose BBV87 and high dose BBV87 is administered intramuscular route in deltoid region of the arm on day 0 and day 28. |
| Comparator Agent |
Placebo |
Sodium Chloride Injection IP/BP 0.9% (Normal Saline).
Two dose strengths administered intramuscular route in deltoid region of the arm on day 0 and day 28. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-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.
|
|
| ExclusionCriteria |
| Details |
-History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Screening visit.
-Subject a known case of diabetes mellitus (Type 1 and 2).
-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).
-Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease (e.g. Systemic Lupus Erythematosus, autoimmune thyroid disease).
-Subjects who are pregnant or breast feeding.
-Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
-Positive serologic test for HIV 1 and 2, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Investigator.
-Current (within 14 days prior to Screening visit) 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).
-Receipt of licensed vaccines within 30 days prior to first vaccination.
-Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
- 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 another clinical trial within 30 days prior to Screening visit or planning to participate during the study
-History of participation in Investigational Chikungunya virus vaccine trial.
-Any other condition which in the opinion of the Investigator may affect subject’s safety or participation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Immunogeneity
1.Immune Response following two doses:
Geometric mean titres of CHIKV antibodies estimated by PRNT50
2.Safety and Tolerability:
a.Occurrence, relationship and severity of local and systemic solicited adverse events (AE)
b. Occurrence, relationship and severity of unsolicited AEs and serious adverse events (SAE)
c.Occurrence, relationship and severity of related unsolicited AEs, all SAEs and AEs- arthralgia, myalgia
|
Immunogeneity
1.Immune Response following two doses:
Geometric mean titres of CHIKV antibodies estimated by PRNT50
2.Safety and Tolerability:
a. occurring up to 7 days following each vaccination.
b. occurring up to 28 days following Dose 2 (Visit 3)
c. occurring post Visit 3 and up to end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Immunogenicity:
1.a.Immune Response following two doses: Percentage of subjects achieving seroconversion of CHIKV antibodies.
2.Immune Response following Single Dose
a.Geometric mean titres of CHIKV antibodies estimated by PRNT50
b.Percentage of subjects achieving seroconversion of CHIKV antibodies. |
1.28 days following Dose 2 (Visit 3)
2a.28 days following Dose 1 (Visit 2)
2b.28 days following Dose 1 (Visit 2) |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
21/09/2021 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
NIL |
|
Brief Summary
|
Study Title: A Seamless Phase II/ III, Double-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 Protocol ID: BBIL/CHIKV/II-III/2019 Clinical Development Phase: Phase II/III Study Indication: Active immunization for prevention of Chikungunya virus (CHIKV) infection Number of Study Sites: The study will be conducted at approximately 8 sites across India Name of the Investigational Vaccine: Inactivated Chikungunya Virus Vaccine (BBV87) Name of Control Vaccine: Phase II and Phase III: Placebo Phase II
Study Design: The current study is designed as a seamless Phase II/III study in healthy subjects, with Phase II being an age de-escalation, dose finding study followed by a Phase III study, which is aimed at evaluation of safety, immunogenicity and lot-to-lot consistency of BBV87. The immunogenicity and safety data of 600 subjects randomized in Phase II study receiving BBV87 low dose /BBV87 high dose/placebo in a two-dose schedule, will be presented to the Data and Safety Monitoring Board (DSMB). Post approval from DSMB, the dose strength of BBV87 to be used in the Phase III study will be selected and the Phase III study will be initiated to randomize approximately 1000 subjects.
|
