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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  
Name  Address 
NIL  NIL 
 
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)  
Status 
Approved/Obtained 
 
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 

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