Immunological Responses After Vaccination for COVID-19 With the Messenger Ribonucleic Acid (mRNA) Vaccine Comirnaty in Immunosuppressed and Immunocompetent Individuals. An Open and Non-randomized, Phase IV Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 539
- 试验地点
- 1
- 主要终点
- Assessment of Seroconversion, Defined as Development of Immunoglobulin G (IgG) Antibodies Against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) After Vaccination of 2 Doses in Seronegative Individuals.
研究概览
简要总结
The study is designed as an open, non-randomized, phase IV cohort study in which the mRNA vaccine Comirnaty will be given in two doses. Analyses will be performed on blood and saliva, investigating humoral and cellular vaccine responses. Occurence of local or systemic reactogenicity will be evaluated, as well as adverse events. The study will include persons with primary or secondary immunosuppressive disorders, as well as immunocompetent persons, with the aim of investigating if the immune responses after given Comirnaty mRNA vaccine against COVID-19.
详细描述
In this study with 450 patients with primary or secondary immunosuppressive disorders (patients with primary immunodeficiency, HIV infected patients, patients with allogenic stem cell transplantation/CAR T cell treated, solid organ transplanted, and patients with chronic lymphatic leukemia) from Karolinska University Hospital, and healthy controls of 90 individuals for comparison, we will investigate the safety and the immune responses after mRNA vaccination with Comirnaty after two doses, under 6 months of time for each participant. The study is In collaboration with research groups at Karolinska Institutet and SciLifeLab, with planned in-depth detailed analyses of antibody responses as well as cellular responses. The study has obtained permission from Swedish Medical Agency and Swedish Ethical Review Authority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •1. Individuals ≥18 years old
- •2a. In the opinion of the investigator, individuals with immunosuppressive disease who meet one of the following criteria:
- •Primary immunodeficiency
- •Human immunodeficiency virus (HIV)-infection
- •Allogeneic stem cell transplantation / Chimeric antigen receptor (CAR T cell) therapy
- •Solid organ transplant
- •Chronic lymphatic leukemia
- •2b. In the opinion of the investigator, individuals without immunosuppressive disease or treatment without significant co-morbidity
- •3. Provision of signed informed consent to participate in the study
排除标准
- •Previous or ongoing Coronavirus Disease-19 (COVID-19).
- •Coagulation disorders, other conditions associated with prolonged bleeding time or anticoagulant treatments, which according to the investigator contraindicate intramuscular injection. Conditions which can be corrected with measures such as platelet concentrate treatments, coagulation factors or other measures for people responsible for anticoagulants are not exclusion criteria.
- •Planned to receive another vaccine within 14 days before the first dose of the study vaccine, or during the period from the first dose of the study vaccine up to 14 days after the second dose of the study vaccine, and vaccination with another vaccine which in the investigator's opinion cannot be planned outside these time periods
- •Pregnancy or breast feeding.
- •Hypersensitivity to the active substance or to any of the excipients contained in the vaccine
- •Individuals who cannot understand the informed consent.
- •Individuals who for other reasons are considered by investigators as not suitable for inclusion
研究组 & 干预措施
Vaccination with Comirnaty according to standard of care treatment
All study participants will receive Comirnaty according to current approval.
干预措施: Comirnaty (COVID-19, mRNA vaccine) (Biological)
结局指标
主要结局
Assessment of Seroconversion, Defined as Development of Immunoglobulin G (IgG) Antibodies Against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) After Vaccination of 2 Doses in Seronegative Individuals.
时间窗: 2 weeks after second dose of vaccine.
Proportion (95% confidence interval, CI) seroconverting to positive response to SARS-CoV-2 IgG serology test after two doses of vaccine, measured 2 weeks after second dose of vaccine.
次要结局
- Assessment of Any Adverse Events (AE) of the Given Vaccine.(Duration of 0-14 days after the second vaccine dose.)
- Frequency of SARS-CoV-2 Infection Documented by PCR Test.(0 - 6 months)
- Frequency Who Experience Local and Systemic Reactions(After the second vaccin dose)
研究者
Soo Aleman
MD, PhD
Karolinska University Hospital