Study of Immunogenicity Equivalence of a Homologous Third Dose of Covid-19 (Recombinante) Vaccine
2021年12月1日 更新者:The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study of Immunogenicity Equivalence After a Homologous Third Dose of Covid-19 (Recombinante) Vaccine, 6 Months After the Second Dose, Comparing Intervals of 8 and 12 Weeks Between the First Two Doses.
The purpose of this study is to evaluate the antibody response, safety and reactogenicity of a third dose Covid-19 (recombinante) vaccine, 6 months after a two-dose vaccine schedule using the same vaccine in all doses.
研究概览
详细说明
After being informed about the study and potential risks, all participants giving written informed consent will be evaluated for eligibility criteria.
At day 0, participants who meet the eligibility requirements will undergo a thorough medical evaluation and a urine pregnancy test (if applicable).
Previous vaccination information will be collected with the participant and checked via digital Covid-19 vaccine certification from the Brazilian public health national immunization program system (SI-PNI) ou from Fundação Oswaldo Cruz (Fiocruz) institutional occupational medicine data.
According to the data collected, participants will be placed in one of two groups: 8 or 12 weeks interval between the first two vaccine doses in the vaccine schedule.
Eligible and consenting participants will have a blood sample collected and receive immediately after a third dose of the Covid-19 (recombinante) vaccine.
Participants will be instructed to fill out an adverse events journal for solicited adverse events for 7 days and non-solicited adverse events for 28 days after the third dose.
The research team will contact the participant remotely at least once during the first two weeks.
The participant will return for a follow-up visit to the research center 28 days after the third dose, to evaluate adverse events, collect a second blood sample and undergo a thorough medical evaluation.
The participant will return to the research center to collect blood samples in three more follow-up visits: 3 months, 6 months and 12 months after the third dose.
研究类型
介入性
注册 (预期的)
662
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Robson Leite de Souza Cruz
- 电话号码:3689 (21) 3882-7000
- 邮箱:robson.cruz@bio.fiocruz.br
学习地点
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Rio de Janeiro、巴西、21040-900
- 招聘中
- Unidade de Ensaios Clínicos em Imunobiológicos
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接触:
- Maria Vitoria Hadland Seidl, MD
- 电话号码:(21)99711-1070
- 邮箱:maria.seidl@bio.fiocruz.br
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Employee of Fundação Oswaldo Cruz, stationed in Manguinhos campus, in Rio de Janeiro.
- Previous two-dose vaccine schedule with Covid-19 (recombinante) in both doses, with an interval of8 or 12 weeks between doses.
- A 6-month interval (5 to 7 month window) between the second and the third dose of Covid-19 (recombinante) vaccine.
- Availability to participate during the entire study, and ability to follow study protocol strictly.
- Consent to supply personal contact information, such as telephone numbers, address and other information so the research team may contact the participant (For example, in case the participant fails to attend a scheduled visit without previous notice)
- Ability to understand and sign the volunteered and informed consent form, and ability to fill in the adverse events journal at home, according to the evaluation of the principal investigator ou delegated research team members.
- Understanding the impossibility of participating in another clinical trial while participating in this clinical trial.
Exclusion Criteria:
- Receiving another Covid-19 vaccine after inclusion in the study
- Receiving any vaccine 28 days after administration of a third dose of Covid-19 (recombinante) vaccine.
- Refusal to sign the voluntary and informed consent form or refusal to permit collection of blood samples before the third dose of the Covid-19 (recombinante) vaccine.
- Receiving any other vaccine 28 days before the inclusion in the study
- Previous vaccine schedule with other Covid-19 vaccines, in the first and/or second dose.
- Covid-19 disease confirmed by RT-PCR (Real time polymerase chain reaction) up to 28 days before inclusion in the study.
- Covid-19 symptoms up to 10 days before the inclusion in the study.
- Fever (Axillary temperature above 37,8 º C / 100,04 °F) 72 hours before vaccination in the study.
- Contraindications to the Covid-19 (recombinante) vaccine - Fiocruz/AstraZeneca
- Use of immunosuppressive medication, such as systemic corticosteroids or chemotherapy, or immunosuppressive diseases. We will consider as immunosuppressive doses of systemic corticosteroids daily doses of prednisone of 10mg or more, for more than 14 days.
- Incapacitating mental illness
- Any discoveries made by the principal investigator that would enhance the risk of an adverse result following the participation in the study, or that in some other way justifies exclusion from the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:8 week interval
Third dose Covid-19 (recombinante) vaccine 6 months after the second dose of a two dose vaccine schedule with a 8 week interval between the first two doses.
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Third dose of the Covid-19 (recombinante) vaccine, 6 months after the second dose of a two dose Covid-19 (recombinante) homologous vaccine schedule.
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有源比较器:12 week interval
Third dose Covid-19 (recombinante) vaccine 6 months after the second dose of a two dose vaccine schedule with a 12 week interval between the first two doses.
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Third dose of the Covid-19 (recombinante) vaccine, 6 months after the second dose of a two dose Covid-19 (recombinante) homologous vaccine schedule.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine
大体时间:28 days
|
Equivalence of antibody IgG Anti-S response in geometric mean titers, measured immediately before and 28 days after a third dose of Covid-19 (recombinante) vaccine, administered 6 months after the second dose of a two-dose homologous Covid-19 (recombinante) vaccine schedule, between participants with an 8 and 12 week interval between the first two doses.
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28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months
大体时间:15 months
|
Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine.
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15 months
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Safety and reactogenicity of a third dose of Covid-19 (recombinate) vaccine
大体时间:15 months
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Safety and reactogenicity after a third dose of Covid-19 (recombinate) vaccine, 7 days for solicited adverse events, 28 days for non-solicited adverse events and 12 months for serious adverse events.
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15 months
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Neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample
大体时间:28 days
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Measure neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample of participants, immediately before and 28 days after the third dose.
|
28 days
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IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine by age groups
大体时间:1 month
|
Equivalence of antibody IgG Anti-S response in geometric mean titers, measured immediately before and 28 days after a third dose of Covid-19 (recombinante) vaccine, administered 6 months after the second dose of a two-dose homologous Covid-19 (recombinante) vaccine schedule, between participants with an 8 and 12 week interval between the first two doses.
Compare results between participants with 40 years or less, 40 to 60 years, or more than 60 years.
|
1 month
|
Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months by age groups
大体时间:15 months
|
Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine.
Compare results between participants with 40 years or less, 40 to 60 years, or more than 60 years.
|
15 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年11月9日
初级完成 (预期的)
2022年3月30日
研究完成 (预期的)
2023年3月30日
研究注册日期
首次提交
2021年11月30日
首先提交符合 QC 标准的
2021年12月1日
首次发布 (实际的)
2021年12月2日
研究记录更新
最后更新发布 (实际的)
2021年12月2日
上次提交的符合 QC 标准的更新
2021年12月1日
最后验证
2021年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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