Factors Influencing the COVID-19 Vaccine Immune Response (Reactogenicity and Immunogenicity) According to Age and Presence or Not of a Past History of COVID-19
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Anti-S neutralizing antibody titer
研究概览
简要总结
Age is the main risk factor associated with the severity of COVID-19. From the beginning of the vaccination campaign, elderly subjects are part of the priority population. However, immunosenescence appears to play a role in the natural post-COVID-19 immunity of convalescent elderly subjects and also in the post-vaccination response. However, vaccination recommendations for both naïve (2 doses of vaccine) and convalescent subjects (1 dose of vaccine) do not differ according to age. To date, there is little data to suggest that the response to the vaccine in naïve or convalescent subjects may vary according to age in terms of qualitative and quantitative response and duration.
详细描述
In addition, the reactogenicity following the vaccine, remains important with COVID-19 vaccines, whether using an Messenger RiboNucleic Acid (mRNA) technique or an adenovirus vector technique. A better understanding of the parameters of early inflammatory response explaining this reactogenicity would allow to optimize the formulation of future vaccines. There are still several unknowns concerning the post-vaccination immune response (immunogenicity and reactogenicity) in older subjects,depending on their history of COVID-19 and the type of vaccine administered. A better understanding of this immune response is necessary in order to propose the best vaccine strategies and regimens in this high-risk COVID-19 population.
Thus, in partnership with Sanofi Pasteur and Bioaster, the Group On Mucosal Immunity And Pathogens (GIMAP) and Circulating Immune Complexes (CIC) vaccinology team proposes to conduct a study comparing the humoral, cellular, mucosal and reactogenic post-vaccination immune response in subjects with a history of COVID-19 >3 months ago (convalescent, 1 dose of vaccine) versus subjects with no history of COVID-19 (naive, 1 or 2 doses of vaccine depending on the type of vaccine used) according to age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •For the group with a past history of COVID-19 (convalescents)= subject within ≥ 3 months after infection
- •For the NO past history of COVID-19 (naives), subject with no known history of COVID-19
- •Patient affiliated or entitled to a social security plan
- •Patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator
排除标准
- •Immunocompromised or under immunosuppressive treatment
- •Subject with a history of COVID hospitalized in intensive care
- •Subject allergic to one of the components of the vaccines used in the study
- •subject vaccinated for COVID-19
- •Subject with persistent symptoms of COVID-19 (long COVID)
- •Subjects with unstable chronic pathology
- •Persons deprived of liberty, hospitalized without consent
- •Pregnant or breastfeeding woman
研究组 & 干预措施
convalescent participants PFIZER
Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Pfizer vaccine
干预措施: COVID-19 vaccine Pfizer (2 doses) (Biological)
Naive participants PFIZER
Participant without past history of COVID-19 and vaccinated by anti-covid19 Pfizer vaccine
干预措施: COVID-19 vaccine Pfizer (3 doses) (Biological)
convalescent participants MODERNA
Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Moderna vaccine
干预措施: COVID-19 mRNA Vaccine Moderna (2 doses) (Biological)
Naive participants MODERNA
Participant without past history of COVID-19 and vaccinated by anti-covid19 Moderna vaccine
干预措施: COVID-19 mRNA Vaccine Moderna (3 doses) (Biological)
Boost only
Participant without past history of COVID-19 and vaccinated by anti-covid19 mRNA vaccine.
干预措施: COVID-19 mRNA Vaccine Moderna (1 dose) (Biological)
结局指标
主要结局
Anti-S neutralizing antibody titer
时间窗: Days : 15, 90, 180 after each dose of vaccine
The neutralizing antibody titer against protein S from the majority variants at the time of sampling and vaccine S will be evaluated in viral neutralization and pseudoneutralization
次要结局
- Kinetic of Anti-S antibody titer(Days : 15, 90, 180 after each dose of vaccine)
- Kinetic of Anti-N antibody titer(Days : 15, 90, 180 after each dose of vaccine)
- Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva(Days : 15, 90, 180 after each dose of vaccine)
- Kinetic of SARS-CoV-2 quantiferon value(Days : 15, 90, 180 after each dose of vaccine)
- CD4 and CD8 lymphocyte polarization specific to the vaccine S protein(Days : 15 (group Naive and convalescent), 180 (group Boost only) after last dose of vaccine)
- Anti-S neutralizing antibody titer(Days : 15, 90, 180 after each dose of vaccine)
- Kinetic of serum cytokine levels(At 24 and 72 hours after each dose of vaccine)
- Kinetic of C-reactive protein(At 24 and 72 hours after each dose of vaccine)
- Kinetic of vaccine-induced genes signatures(At 24 and 72 hours after each dose of vaccine)