A Prospective, Multicentre, Single Arm, Phase-IV Study to evaluate the Safety and Immunogenicity of Recombinant Hepatitis E Vaccine (E. Coli) in Healthy Adults
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong)
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- 1.To evaluate the safety of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed using solicited and unsolicited adverse events following immunization.
概览
简要总结
The study is a Prospective, Multicentre, Single Arm, Phase IV Study to evaluate the Safety and Immunogenicity of Recombinant Hepatitis E Vaccine (E. Coli) in Healthy Adults. The study will enrol 1000 healthy adults who will receive 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) at Day 0, Day 30, and Day 180. Each dose to be administered intramuscularly over the deltoid. Written informed consent will be taken from subjects/LAR before participation in the study. A total of 5 scheduled visits are planned for the study. Though every effort will be made to adhere to the schedule of visits, a window period will be permitted as mentioned below. The schedule of visits will be as follows: Visit 1: Screening within 14 days of First dose of vaccination (Screening visit), Visit 2 : Day 0, First Dose of Vaccination, Visit 3: Day 30 + 7,| Second dose of Vaccination, Visit 4: Day 180 + 14, Third dose of Vaccination, Visit 5: Day 210 + 14, End of Study
Note: A subject may come for an unscheduled visit in the event of any adverse events or any other clinical condition.
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian adults of either gender aged 18-65 years (both ends inclusive) who are seronegative for anti-HEV IgG antibody (as per the cut off values specified in kit brochure).
- •Subjects who are apparently healthy or having a clinically stable medical condition/disorder that would not interfere with evaluation of study vaccine.
- •Subjects who are willing to be available during the entire study period.
- •Subjects who agree to comply with trial requirements and are willing to provide written informed consent.
排除标准
- •History of hypersensitivity to study vaccine or their constituents, kanamycin or any other aminoglycoside.
- •History of administration of any other vaccine or immunoglobulin in past 1 month or planned immunization of any other vaccine in next 7 months.
- •Clinical or laboratory evidence of ongoing viral hepatitis.
- •History or evidence of uncontrolled epilepsy or any progressive neurological disorder in the subject or family.
- •History or evidence of thrombocytopenia, blood coagulation abnormality or concomitant administration of any anticoagulant drugs.
- •History or evidence of any congenital or acquired immunodeficiency viz.
- •HIV infection and/or concomitant administration of immunosuppressive drugs.
- •History or evidence of acute infections, acute flare of chronic infections or fever at the time of administration of vaccine.
- •History or evidence of any significant cardiovascular, hepatic, renal, neurological or neoplastic disorder which preludes participation of subject into the trial as per investigator discretion.
- •Subject who is pregnant as confirmed by positive UPT, or lactating female.
结局指标
主要结局
1.To evaluate the safety of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed using solicited and unsolicited adverse events following immunization.
时间窗: SafetY | 1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses. | 2. Incidence, severity and relationship of unsolicited AEs from the first dose administration till the end of study visit. | 3. Incidence of SAE from the first dose administration till the end of study visit. | Immunogenicity | 1. Proportion of subjects achieving seroconversion against Hepatitis E at one month after three dose vaccination. | 2. Geometric mean concentrations (GMCs) for anti-Hepatitis E antibodies at one month after three dose vaccination.
2. To evaluate the immunogenicity of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed by seroconversion rate from baseline to 30 days after third dose of vaccine administration.
时间窗: SafetY | 1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses. | 2. Incidence, severity and relationship of unsolicited AEs from the first dose administration till the end of study visit. | 3. Incidence of SAE from the first dose administration till the end of study visit. | Immunogenicity | 1. Proportion of subjects achieving seroconversion against Hepatitis E at one month after three dose vaccination. | 2. Geometric mean concentrations (GMCs) for anti-Hepatitis E antibodies at one month after three dose vaccination.
次要结局
- 1. To demonstrate safety and seroconversion with age and gender stratification (18 to 35 years, 36 to 50 years, and 51 to 65 years).(1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses in male and female subjects aged 18 to 35)
研究者
Dr Shiva Narang
UCMS & GTB Hospital