The 8-week, Prospective, Randomized Controlled of IntraDermal Administration of Comirnaty® 6 Microgram Versus Intramuscular Comirnaty® 30 Microgram by 28 Days Interval Efficacy Study in Healthy Volunteer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Level of Anti RBD antibody
研究概览
简要总结
The 8-week, Prospective, Randomized controlled of IntraDermal administration of Comirnaty® 6 microgram compare to Intramuscular Comirnaty® 30 microgram by 28 days interval Efficacy Study in 4 groups of healthy volunteer ( 1 people who complete sinovac vaccination 2 people who received 1 dosage of AstraZeneca vaccine 3 naive vaccination 4 any other vaccination not in 1-3 with anti Spike antibody less than 650 AU/ ml) . Comparison of antibody level and T cell response to SAR-CoV-2 antigen in vitro after 28 day post vaccination is primary outcome and the side effect as well as infection rate in 8 weeks is secondary outcomes.
详细描述
The 8-week, Prospective, Randomized controlled of IntraDermal administration of Comirnaty® 6 microgram compare to Intramuscular Comirnaty® 30 microgram by 28 days interval Efficacy Study in healthy volunteer.To compare the AntiSpike antibody, ( Anti RBD ) neutralized antibody ( if possible) of SAR-CoV-2 and T-cell response after injection with Intradermal Comirnaty® 6 microgram versus Intramuscular Comirnaty® 30 microgram by 28 days interval in healthy volunteer in various immunological background groups.1000 patients with or with out vaccinated and with our without history of previous COVID-19 infection (in various immunological background ) will be recruited and received Comirnaty® 6 microgram versus Intramuscular Comirnaty® 30 microgram by 28 days interval
Inclusion Criteria:
- Signed informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures.
- Men and women, ≥18 years of age at time of enrollment.
- Able to follow up the vaccination schedule.
Exclusion Criteria:
- Patient with known hypersensitivity or intolerance to Comirnaty® or Polyethylene glycol (PEG).
- Patient with previous receiveing mRNA vaccine ( Pfizer, Moderna or other).
- Pregnancy with gestational age less than 12 weeks.
- Patient with History of immunosuppessive drug ( oral , IV, IM ) of which discontinue less than 6 month or any immunological abnormality which impact to Antibody production and T cell function ( eg hypergammaglobulinemia, active immne deficiency).
- Patient with previous used of Intravenous immunoglobulin in previous 6 month
- Patient with history of abnormal coagulation or contraindication for intramuscular injection or intradermal injection.
- Patient with end stage disease or disease with life expectancy less than 2 years
- Patient with previous use of medication interfere with serum interferon other cytokine system or disease with cytokine abnormalities.
- Patient with history of abnormal platelet or platelet dysfunction, blood coagulopathy abnormality.
- Patient with active pulmonary tuberculosis or systemic tuberculosis, atypical non mycobacterium tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures.
- •Men and women, ≥18 years of age at time of enrollment.
- •Able to follow up the vaccination schedule.
排除标准
- •Patient with known hypersensitivity or intolerance to Comirnaty® or Polyethylene glycol (PEG).
- •Patient with previous receiveing mRNA vaccine ( Pfizer, Moderna or other).
- •Pregnancy with gestational age less than 12 weeks.
- •Patient with History of immunosuppessive drug ( oral , IV, IM ) of which discontinue less than 6 month or any immunological abnormality which impact to Antibody production and T cell function ( eg hypergammaglobulinemia, active immne deficiency).
- •Patient with previous used of Intravenous immunoglobulin in previous 6 month
- •Patient with history of abnormal coagulation or contraindication for intramuscular injection or intradermal injection.
- •Patient with end stage disease or disease with life expectancy less than 2 years
- •Patient with previous use of medication interfere with serum interferon other cytokine system or disease with cytokine abnormalities.
- •Patient with history of abnormal platelet or platelet dysfunction, blood coagulopathy abnormality.
- •Patient with active pulmonary tuberculosis or systemic tuberculosis, atypical non mycobacterium tuberculosis.
结局指标
主要结局
Level of Anti RBD antibody
时间窗: 8 weeks
Level of Anti RBD antibody after first and second injection
Interferon gamma level
时间窗: 8 weeks
Interferon gamma level ( production of interferon gamma Againts SAR-CoV-2 antigen in vitro after injection for 28 days
次要结局
- adverse event after vaccination(8 weeks)
- COVID-19 infection(8 weeks)
- COVID-19 death(8 weeks)
研究者
Dr Subsai Kongsaengdao
Associate Professor Subsai Kongsaengdao, M.D.
Rajavithi Hospital