Immunogenicity of Heterologous Versus Homologous Prime Boost Schedule With mRNA and Inactivated COVID-19 Vaccines: a Single-blinded, Randomized, Parallel Group Superiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 10
- 主要终点
- Superiority of the heterologous prime-boost immunization with mRNA vaccine after vaccination with an inactivated vaccine versus homologous immunization with inactivated vaccines
研究概览
简要总结
This study is a randomized, simple-blinded comparative phase III clinical trial comparing the immunogenicity of two doses Coronovac to that of a first dose of Coronovac (Sinovac, Beijing, China) followed by a booster shot with the mRNA-based BNT162b2 SARS-CoV-2 vaccine (Comirnaty, Pfizer-BioNTech).
The purpose of this study is to evaluate the superiority, safety and immunogenicity of the heterologous prime-boost CoronaVac/BNT162b2 vaccination to the homologous CoronaVac/CoronaVac regimen.
详细描述
This study is a randomized simple-blinded comparative phase III clinical trial in COVID-19 vaccine naïve volunteers adults aged between 18 and 60 years. The purpose of this study is to evaluate the superiority, safety and immunogenicity of the heterologous prime-boost CoronaVac/BNT162b2 vaccination to the homologous CoronaVac/CoronaVac regimen. The study is conducted in four different sites located in the North of Tunisia.
A total of 240 eligible participants were included. Among them, the primary end point data were available for 100 participants randomly allocated to heterologous boost group versus 99 participants randomly allocated to homologous boost dose group.
Participants are assigned to receive either two injections of the CoronaVac vaccine (1st and 2nd vaccine), or CoronaVac as 1st dose and Pfizer as 2nd dose in 3 to 4 weeks interval.
A blood sample (5ml of the whole blood) is collected for each participant at the vaccination center before the first dose injection. After verifying the absence of a SARS-CoV-2 infection during the interrogation (a follow-up survey), a 2nd blood sample (5ml of whole blood) is taken for each participant at the vaccination center before the second dose injection. After the two injections, a 3rd blood sample (5ml of whole blood) will be taken for each participant between day 21 and day 35 after the second dose. Data collection and all samples are treated at Institute Pasteur of Tunis.
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)
盲法说明
Simple-Blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acceptance to participate in the study.
- •Age: 18-60 years old.
- •Non-inclusion criteria:
- •Presence of disability (mainly mental disability).
- •Pregnancy.
- •Patients under immunosuppressive treatment or immunocompromised individuals.
- •Prior Covid-19 infection.
排除标准
- •Occurrence of a serious adverse event (death, anaphylactic shock, ...).
- •Subjects wishing to withdraw from the study.
- •Occurrence of a SARS-CoV-2 symptomatic infection during the follow-up period.
结局指标
主要结局
Superiority of the heterologous prime-boost immunization with mRNA vaccine after vaccination with an inactivated vaccine versus homologous immunization with inactivated vaccines
时间窗: Between day 21 and day 35 after the second dose of vaccination
The primary end point for immunogenicity was the serum neutralizing antibody level with a percentage of inhibition at 90% at 21-35 days after boost. A difference of 25% between groups was considered clinically relevant.
次要结局
- Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) at day 21 +/- 3 days(At day 21 +/- 3 days after the first dose of vaccination)
- Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) at day 0 (at baseline)(At day 0 (at baseline))
- Safety indexes of adverse reactions at day 30(At day 30 after the second dose of vaccination)
- Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) between day 21 and day 35(Between day 21 and day 35 after the second dose of vaccination)
研究者
Samar Samoud
Principal Investigator, Head of immunoallergology unit, Clinical Immunology Department
Institut Pasteur de Tunis