An Open Label, Phase III Clinical Trial (Immunobridging Study) of INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated)) in Healthy Population Aged 12 to 17 Years Old
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Vaccine Neutralizing Antibody Profile
研究概览
简要总结
This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.
INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents.
详细描述
This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.
This study will have three interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues.
Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the 7 and 28 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 12 months after the second dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose.
The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adolescents, age 12 to 17 years old, males and females. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
- •Subjects and the parents or guardians have been informed properly regarding the study and signed the informed consent and assent forms
- •Subject and the parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial
- •Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
- •Subjects and the parents or guardians must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.
排除标准
- •Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial
- •Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5oC or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
- •Known history of allergy to any component of the vaccines
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- •Any autoimmune or immunodeficiency disease/condition
- •Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted.
- •Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator.
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
- •Individuals who previously receive any vaccines against Covid-19
- •Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose
- •Individuals who have a previously ascertained Covid-19 in the period of 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-
- •Positive test for SARS-CoV-2 (Antigen test or, if necessary, PCR test) at screening prior to first vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator.
- •Alcohol or substance abuse
- •HIV patients.
- •Malignancy patients within 2 years prior to first study vaccination.
- •Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
- •Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision.
- •Women who are pregnant or who plan to become pregnant during the study.
- •Participant has major psychiatric problem or illness
- •Participant cannot communicate reliably with the investigator
- •Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.
- •Participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
- •Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results
- •Study team members.
- •Subject planning to move from the study area before the end of study period.
研究组 & 干预措施
Experimental:
INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg
Study product are provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given 1 dose (0.5 ml) twice.
干预措施: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg (Biological)
结局指标
主要结局
Vaccine Neutralizing Antibody Profile
时间窗: 28 days after two doses vaccination of INAVAC.
SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days after two doses vaccination of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
次要结局
- Whole Genome Sequencing (WGS) of SARS-CoV-2(Throughout the study, an average of 1 year)
- Incidence of Adverse Events(30 minutes, 24 hours, 7 and 28 days following the first dose and 30 minutes, 24 hours, 7 and 28 days, 3, 6 and 12 months after the second doses of INAVAC)
- Persistence of Antibody Level(12 months after the second injection)
- Cellular Immunogenicity Profile(28 days, 3, 6, and 12 months, following vaccination with two doses of INAVAC)
- Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum(3, 6, and 12 months, following vaccination with two doses of INAVAC)
- Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA(28 days, 3, 6, and 12 months after the second vaccination of INAVAC)