A Randomised Controlled Trial to Assess the Immunogenicity, Safety, and Reactogenicity of Standard-dose Versus Fractional Doses of COVID-19 Vaccines (Pfizer-BioNTech or Moderna) Given as an Additional Dose After Priming With Pfizer-BioNTech or AstraZeneca in Healthy Adults in Australia-MIACoV
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination
研究概览
简要总结
This is a single-blind, randomised controlled clinical trial to determine the reactogenicity and immunogenicity of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccines (Pfizer-BioNTech or Moderna) as booster dose in adults, who have previously received either Pfizer-BioNTech or AstraZeneca as their primary doses.
Both fractional and standard doses of Pfizer-BioNTech or Moderna will be tested.
The trial intervention will be given in line with Australian Technical Advisory Group on Immunisation (ATAGI) recommendations for booster vaccine doses which allows booster doses from 5 months onwards . There will be a total of 8 groups, with 100 individuals of even spread of participants above and below 50 years in each group. The trial will be single site, based at Royal Children's Hospital, Melbourne, Australia
详细描述
As per brief summary
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and those evaluating reactogenicity will be blinded to the vaccine allocation for the first 28 days following vaccination. After that, both clinical investigators and participants will be aware of their investigational product allocation. Laboratory staff will remain blinded to the investigational product allocation during the immunology testing.
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
- •Have completed two doses of Pfizer-BioNTech or AstraZeneca vaccines with the recommended schedule 6 months prior to the date of enrolment
- •Willing and able to give written informed consent
- •Aged 18 years or above
- •Willing to complete the follow-up requirements of the study
排除标准
- •Received 3 doses of COVID-19 vaccine
- •Received 2 doses of COVID-19 less than 6 months prior to the start of the trial
- •Received a different Covid-19 vaccine not available in Australia
- •Currently on immunosuppressive medication or anti-cancer chemotherapy
- •HIV infection
- •Congenital immune deficiency syndrome
- •Has received immunoglobulin or other blood products in the 3 months prior to vaccination
- •Study staff and their relatives
- •Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exception to receiving further COVID-19 vaccines
- •Cannot read or understand English
研究组 & 干预措施
Standard Pfizer-BioNTech booster group
Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
干预措施: Tozinameran - Standard dose (Biological)
Fractional Pfizer-BioNTech booster group
Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
干预措施: Tozinameran - fractional dose (Biological)
Standard Elasomeran booster group
Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
干预措施: Elasomeran - standard dose (Biological)
Fractional Elasomeran booster group
Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
干预措施: Elasomeran - fractional dose (Biological)
结局指标
主要结局
SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination
时间窗: 28-days post booster vaccination.
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units/mL and presented as geometric mean concentration and 95% confidence intervals
次要结局
未报告次要终点