Analysis of Immunization Time, Amplitude and Adverse Events of 7 Different Vaccines Against SARS-COV-2 Across 4 Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,870
- 试验地点
- 1
- 主要终点
- Seroconversion after first and second dose of SARS-COV2 vaccines
研究概览
简要总结
Background: Scarce information exists in relation to the comparison of seroconversion and adverse events following immunization (AEFI) with different SARS-COV2 vaccines. Our aim was to correlate the magnitude of the antibody response to vaccination with previous clinical conditions and AEFI.
Methods: A multicentric comparative study where SARS-CoV-2 spike 1-2 IgG antibodies IgG titers are being measured at baseline, 21-28 days after the first and second dose (when applicable), six months and a year of the following vaccines: BNT162b2 mRNA, mRNA-1273, Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV and Ad26.COV2. Mixed model and Poisson generalized linear models will be performed for the analyses.
详细描述
The aim of this study is to compare the seroconversion after the first and second dose (if applicable) between BNT162b2 mRNA, mRNA-1273, ChAdOx1-S, Ad26.COV2, Ad5-nCoV, Gam-COVID-Vac, and Coronavac through the measurement of SARS-CoV-2 spike 1-2 IgG antibodies using the same standardized assay.
Our secondary aims are to correlate the magnitude of the antibody response with previous clinical conditions (medical history) and previous diagnosis of SARS-CoV-2.
Our tertiary aim will be to compare the change in antibody levels after a third or fourth dose of any of the vaccines previously described
Also, we will investigate the differences across vaccines regarding adverse events after vaccination and determine the best predictors of systemic and severe adverse events.
This is a multicentric observational study of volunteers who will receive an approved complete scheme of BNT162b2 mRNA, mRNA-1273, ChAdOx1-S, Ad26.COV2, Ad5-nCoV, Gam-COVID-Vac, or Coronavac COVID-19 vaccine during 2021 in five hospital centers (Hospital Clinica Nova, Humanitas Clinical and Research Center, Fundación San Francisco Xavier, Ternium Health Center in Rio, Hospital Municipal San Jose, Hospital Interzonal de Agudos San Felipe) from four different countries: Mexico, Italy, Brazil and Argentina.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants of both genders at relevant vaccination places who consented to participate, planned to conclude the immunization regimen of any vaccine and agree to be followed-up for the duration of the study
排除标准
- •Previously given any SARS-CoV-2 vaccine prior to study entry
研究组 & 干预措施
BNT162b2 mRNA
Group of patients of any age, any sex, that will receive a complete scheme of approved BNT162b2 mRNA vaccination , assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.
干预措施: COVID-19 Vaccines (Drug)
mRNA-1273
Group of patients of any age, any sex, that will receive a complete scheme of approved mRNA-1273 vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.
干预措施: COVID-19 Vaccines (Drug)
ChAdOx1-S
Group of patients of any age, any sex, that will receive a complete scheme of approved ChAdOx1-S vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.
干预措施: COVID-19 Vaccines (Drug)
Ad26.COV2
Group of patients of any age, any sex, that will receive a complete scheme of approved Ad26.COV2 vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.
干预措施: COVID-19 Vaccines (Drug)
Ad5-nCoV
Group of patients of any age, any sex, that will receive a complete scheme of approved Ad5-nCoV vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.
干预措施: COVID-19 Vaccines (Drug)
Gam-COVID-Vac
Group of patients of any age, any sex, that will receive a complete scheme of approved Gam-COVID-Vac vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.
干预措施: COVID-19 Vaccines (Drug)
Coronavac
Group of patients of any age, any sex, that will receive a complete scheme of approved Coronavac vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.
干预措施: COVID-19 Vaccines (Drug)
结局指标
主要结局
Seroconversion after first and second dose of SARS-COV2 vaccines
时间窗: six months
seroconversion after the first and second dose (if applicable) between BNT162b2 mRNA, mRNA-1273, ChAdOx1-S, Ad26.COV2, Ad5-nCoV, Gam-COVID-Vac, and Coronavac through the measurement of SARS-CoV-2 spike 1-2 IgG antibodies using the same standardized assay
次要结局
- Adverse reaction after first and second dose of SARS-COV-2 vaccines(6 months)
研究者
Maria Elena Romero Ibarguengoitia
MD, MS, PHD
Hospital Clinica Nova