CTRI Number |
CTRI/2017/05/008539 [Registered on: 12/05/2017] Trial Registered Prospectively |
Last Modified On: |
18/07/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Vaccine |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Phase 1 clinical trial to evaluate safety and effectiveness of ZIKA vaccine in healthy adults. |
Scientific Title of Study
|
A Phase 1, Multicenter, Double-Blind, Placebo-Controlled, Randomized (Intra-Group) Clinical Trial to Evaluate Two Doses of Three Sequentially Escalating Cohort of Zika Virus Vaccine Inactivated (Adsorbed) (BBV121) in Healthy Adult Dengue Sero-Negative and Dengue Sero-Positive Volunteers |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
BBIL/ZIKV/I/2016,Version 1.0, date 15 October 2016 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Sudhakar Bangera |
Address |
Clinical R&D
Bharat Biotech International Limited
Genome Valley
Hyderabad
Hyderabad ANDHRA PRADESH 500078 India |
Phone |
04023480422 |
Fax |
04023480560 |
Email |
sudhakar3425@bharatbiotech.com |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Dr Venkata Kishan Pokuri |
Address |
Medical Affairs
Bharat Biotech International Limited Genome Valley
Hyderabad
Hyderabad ANDHRA PRADESH 500078 India |
Phone |
04023480422 |
Fax |
04023480560 |
Email |
venkata6014@bharatbiotech.com |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Dr Sudhakar Bangera |
Address |
Clinical R&D
Bharat Biotech International Limited Genome Valley
Hyderabad
Hyderabad ANDHRA PRADESH 500078 India |
Phone |
04023480422 |
Fax |
04023480560 |
Email |
sudhakar3425@bharatbiotech.com |
|
Source of Monetary or Material Support
Modification(s)
|
Bharat Biotech International Ltd Genome valley Shameerpet Hyderabad 500078 |
|
Primary Sponsor
|
Name |
Bharat Biotech International Ltd |
Address |
Genome Valley
Hyderabad 500078 |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 3 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Sandhiya Selvarajan |
JIPMER Hospital |
Dhanvantri Nagar
Puducherry 605006 Pondicherry |
9443492922
sandhiya_s@jipmer.edu.in |
DrRVasudev |
King George Hospital |
Department of medicine Rajendra prasad ward 1st floor Maharanipeta Visakhapatnam 530002 Visakhapatnam |
9866739808
vasudev.kgh@gmail.com |
Dr Prabha Adhikari |
Yenepoya Medical College Hospital |
University Road
Deralakatte
Mangalore 575018 Dakshina Kannada |
9880991290
prabha.raghuveer@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
IEC-KGH |
Approved |
IEC-YUEC |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy Adult Dengue Sero-Negative and Dengue Sero-Positive male and female volunteers aged between 18 and 65 years of age |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
Placebo |
Placebo contains phosphate
buffered saline in place of active
ingredient 0.5ml on Day 0 and 28 administered Intramuscularly |
Intervention |
Zika virus vaccine |
Zika vaccine is an inactivated virus vaccine. Subjects will be assigned to sequential escalating dose level groups to receive vaccinations at 2.5 μg, 5 μg, or 10 μg on Day 0 and 28 with follow-up for 12 months from initial administration of the investigational product. vaccine will be administered through intramuscular route. |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1 Normal healthy male and female volunteers aged between 18 and 65 years weighing at least 50kgs of body weight
2 Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study
3 Signed written informed consent prior to inclusion in the study
4 Seronegative for Zika by ELISA
5 Dengue sero-negative at baseline by screening laboratory evaluation, confirmed by Dengue IgG by ELISA method for Group 1 participants
6 Dengue seropositive at baseline by screening laboratory evaluation, confirmed by Dengue IgG by ELISA method for Group 2 participants
7 Dengue vaccination or suffered from Dengue viral fever for Group 2 volunteers
8 No history of yellow fever vaccination
9 No history of vaccination to Japanese encephalitis vaccination
10 Since active (live) ZIKV infection is known to cause teratogenicity, women of child-bearing potential should agree to use medically effective contraception (oral contraception, barrier methods, spermicide, etc.), preferably double contraception or have a partner who is sterile from enrollment to 3 months following the last injection, or have a male partner who is medically unable to induce pregnancy.
11 Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception, preferably double contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or is medically unable to become pregnant.
12 A negative urine or serum pregnancy test before administration of investigational vaccine on day of screening (Serum Pregnancy Test), and Day 0 and Day 28 (both days Urine Pregnancy Test)
13 No history of clinically significant immunosuppressive or autoimmune disease.
14 Laboratory investigations must be within normal limits
a)Hemoglobin ≥10gm/dL
b)WBC (white blood cells) ≥4000/mm3
c)Platelets ≥100,000/mm3
d)Bilirubin and AST/ ALT <1.5 x ULN (upper limit of normal)
e)Creatinine <1.5 x ULN for the clinical laboratory
15 Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
16 Patients should be otherwise healthy as determined by physical examination, medical history, and no significant abnormality in any of the clinical parameters including ECG and Chest X-ray.
17 Willing to allow storage and future use of biological samples for Zika virus related research |
|
ExclusionCriteria |
Details |
1 Administration of an investigational vaccine or drug either currently or within 30 days of first BBV121 vaccination
2 Previous receipt of an investigational vaccine or drug for the treatment or prevention of Zika virus
3 Administration of any vaccine within 4 weeks of first dose
4 Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose of BBV121 vaccination
5 Administration of any blood product within 3 months of first dose
6 Pregnancy or breast feeding or plans to become pregnant during the study
7 Positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor
8 Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
9 Chronic liver disease or cirrhosis
10 Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation
11 Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day)
12 Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, and etanercept
13 Prior major surgery or any radiation therapy within 4 weeks of enrolment
14 Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome
15 Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator
16 Metal implants within 20 cm of the planned site(s) of injection
17 Presence of keloid scar formation or hypertrophic scar at the planned site(s) of injection
18 Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness
19 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
20 Blood donations/ losses within 2 months of screening
21 Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mmHg or more on standing)
22 Prior radiotherapy in 30 days or less
23 Significant pre-existing co-morbidities
i Cardiovascular
Myocardial infarction within the last 6 months
Congestive heart failure
Unstable angina
Active cardiomyopathy
Cardiac arrhythmia
Uncontrolled hypertension
History of familial long QT syndrome or sudden cardiac death
ii Pulmonary disease requiring oxygen
iii Neurologic and psychiatric
History of significant neurologic or psychiatric disorder that would preclude study compliance or ability to give informed consent
iv Rheumatic arthralgia
24 Participants not having adequate hematologic reserve
i Hemoglobin ≤10gm/dL
ii WBC (white blood cells) ≤4000/mm3
iii ANC (absolute neutrophils count) ≤2000/ mm3
iv Platelets ≤100,000/mm3
25 Inadequate hepatic function at screening as defined by:
i Bilirubin >1.5 x ULN (upper limit of normal)
ii AST/ ALT >1.5 x ULN
26 Inadequate renal function at screening as defined by:
i Creatinine >1.5 x ULN for the clinical laboratory
27 An unusual or abnormal diet, for whatever reason e.g. religious fasting
28 Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
To evaluate the safety and tolerability of two-doses of three-sequentially escalating cohort (2.5 µg, 5 µg and 10 µg) of BBV121 (inactivated Zika virus vaccine) compared with Placebo (Alum).
• Mean change from baseline in safety laboratory parameters
• Incidence of solicited AEs post-vaccination
• Incidence of unsolicited AEs post-vaccination
• Incidence of SAE
|
day0,day28,day56,day 180,day270 and day360 |
|
Secondary Outcome
Modification(s)
|
Outcome |
TimePoints |
To evaluate the magnitude and frequency of ZIKV-specific neutralizing antibodies as measured by PRNT50 method |
day0,day28,day56,day 180,day270 and day360 |
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48" |
Phase of Trial
Modification(s)
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
01/06/2017 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NA |
Brief Summary
|
Not applicable |