CTRI/2017/05/008539已完成1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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 screeni
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