Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children (Phase I)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of subjects with Immediate reaction
研究概览
简要总结
This trial is an experimental, randomized, double blind, prospective intervention study
Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow:
For adult (18-40 years old)
详细描述
Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind.
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individu as determined by clinical judgment, including a medical history, physical exam, rontgen thorax and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.
- •Subjects have been informed properly regarding the study and signed the informed consent form
- •Subjects will commit to comply with the instructions of the investigator and the schedule of the trial
- •Healthy individu as determined by clinical judgment, including a medical history, physical exam and rontgen thorax which confirms the absence of a current or past disease state considered significant by the investigator.
- •Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form and
- •Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial
- •Any direct relatives relationship with the study team.
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
- •Known history of allergy to any component of the vaccines (based on anamnesis)
- •Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
- •History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
- •Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or corticosteroid therapy and other immunosuppresant).
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Pregnancy or planning a pregnancy within the next 3 months & lactation. (for Adults)
- •Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
- •HbsAg positive
- •Subjects with known history of Hepatitis B infection.
- •Subjects who have received Hepatitis B vaccination which proven by vaccination records.
- •Subject planning to move from the study area before the end of study period.
研究组 & 干预措施
Recombinant Hepatitis B (Bio Farma) Vaccine
Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment.
干预措施: Recombinant Hepatitis B (Bio Farma) Vaccine (Biological)
Control Product: Recombinant Hepatitis B (Bio Farma) Vaccine®
Registered Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment.
干预措施: Recombinant Hepatitis B (Bio Farma) Vaccine® (Biological)
结局指标
主要结局
Number of subjects with Immediate reaction
时间窗: 3 months
Number of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
percentage of subjects with Immediate reaction
时间窗: 3 months
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
次要结局
- Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination(3 months)
- Number of subjects with Adverse Events from 1 day to 28 days after vaccination(3 months)
- Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg)(3 months)
- Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination(3 Months)
- Protectivity of Hepatitis B vaccine (Geometic Mean Titers)(3 months)
- Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination(3 Months)
- Number of Lab Deviation for adults subjects in 7 days of immunization(7 Days After 1st Vaccination)
- Safety Comparison between each intervention group(3 months)
- Protectivity of Hepatitis B vaccine (4 times increasing antibody)(3 months)
- Anti-HBs description between groups(3 months)