Status:
COMPLETED
Safety and Immunogenicity of BBV121
Lead Sponsor:
Bharat Biotech International Limited
Conditions:
Zika Virus Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability, and immunogenicity of two-doses of three-sequentially escalating cohort (2.5 µg, 5 µg and 10 µg) of BBV121 (purified inactivated adsorbed Zika virus vaccine) comp...
Detailed Description
A phase 1, multicenter, double-blind, placebo-controlled, randomised (intra group) clinical trial to evaluate the safety, tolerability and immunogenicity of two-doses of three-sequentially escalating ...
Eligibility Criteria
Inclusion
- Normal healthy male and female volunteers aged between 18 and 65 years weighing at least 50kgs of body weight
- 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
- Signed written informed consent prior to inclusion in the study
- Seronegative for Zika by ELISA
- Dengue sero-negative at baseline by screening laboratory evaluation, confirmed by Dengue IgG by ELISA method for Group 1 participants
- Dengue seropositive at baseline by screening laboratory evaluation, confirmed by Dengue IgG by ELISA method for Group 2 participants
- Dengue vaccination or suffered from Dengue viral fever for Group 2 volunteers
- No history of yellow fever vaccination
- No history of vaccination to Japanese encephalitis vaccination
- 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.
- 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.
- 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)
- No history of clinically significant immunosuppressive or autoimmune disease.
- Laboratory investigations must be within normal limits
- Hemoglobin \>10gm/dL
- WBC (white blood cells) \>4000/mm3
- Platelets \>100,000/mm3
- Bilirubin and AST/ ALT \<1.5 x ULN (upper limit of normal)
- Creatinine \<1.5 x ULN for the clinical laboratory
- 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).
- 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.
- Willing to allow storage and future use of biological samples for Zika virus related research.
Exclusion
- Administration of an investigational vaccine or drug either currently or within 30 days of first BBV121 vaccination
- Previous receipt of an investigational vaccine or drug for the treatment or prevention of Zika virus
- Administration of any vaccine within 4 weeks of first dose
- Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose of BBV121 vaccination
- Administration of any blood product within 3 months of first dose
- Pregnancy or breast feeding or plans to become pregnant during the study
- 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
- Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
- Chronic liver disease or cirrhosis
- Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation
- 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)
- Current or anticipated treatment with TNF-alpha inhibitors such as infliximab, adalimumab, and etanercept
- Prior major surgery or any radiation therapy within 4 weeks of enrolment
- Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome
- Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator
- Metal implants within 20 cm of the planned site(s) of injection
- Presence of keloid scar formation or hypertrophic scar at the planned site(s) of injection
- Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness
- 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
- Blood donations/ losses within 2 months of screening
- 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)
- Prior radiotherapy in 30 days or less
- 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
- 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
- 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
- Inadequate renal function at screening as defined by:
- i. Creatinine \>1.5 x ULN for the clinical laboratory
- An unusual or abnormal diet, for whatever reason e.g. religious fasting
- 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
Key Trial Info
Start Date :
June 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04478656
Start Date
June 3 2017
End Date
November 15 2018
Last Update
October 22 2020
Active Locations (1)
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1
Bharat Biotech International Ltd
Hyderabad, Telangana, India, 500078