Safety and Immunogenicity of the SARS-CoV2 Vaccine in Solid Organ Transplantation (Lung and / or Liver) Adult Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Safety and reactogenicity
研究概览
简要总结
Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. In Italy, immunocompromised patients have received the indication to be administered mRNA vaccines only.
Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19
Visits and timepoints:
- T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status
- Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination
- T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity
- Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity
详细描述
Several studies indicate that solid organ transplant recipients are at increased risk of severe SARS-CoV2 disease (COVID19) and increased mortality from it (Pereira MR, AmJT 2020; Fernandez-Ruiz M, AmJT 2020; Kates OS, ClinInfectDis 2020).
Both ISHLT (International Society of Heart and Lung Transplantation) and AASLD (American Association for the Study of Liver Disease) guidelines recommend vaccination of all individuals undergoing lung and liver transplantation, starting from 3/6 months after transplantation.
In Italy, the Ministry of Health and the Italian Medicines Agency (AIFA) have established that immunosuppressed subjects following organ transplantation are worthy of vaccination with mRNA vaccines, since the latter are currently those with the greatest efficacy demonstrated among those approved in this country.
Within the Institution where this study will be conducted, patients undergoing lung and liver transplantation will be vaccinated, according to priority levels dictated by existing co-morbidities and by the time elapsed since transplantation, with the COMIRNATY mRNA vaccine (BNT162b2) administered according to the vaccination schedule of 2 doses at a distance of 21 days from each other or with the MODERNA vaccine (mRNA-1273) administered according to a vaccination schedule of 2 doses at a distance of 28 days from each other.
At present, no definitive data are available on the efficacy and the immunogenicity of anti-SARS-CoV-2 vaccines in solid organ transplant recipients, although the initial findings are reassuring. mRNA vaccines appear to be safe in the transplant population, and have not raised any concern at present about the possible onset of rejection or other serious adverse events in the first period after their administration (Boyarsky BJ, Transplantation 2021).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patient's written informed consent
排除标准
- •Lung transplant being performed in the previous 6 months
- •Liver transplant being performed in the previous 3 months
结局指标
主要结局
Safety and reactogenicity
时间窗: 365 days
Primary endpoints: * Incidence of systemic and local adverse events (and their degree) in the subsequent 7 days after each vaccine administration in this population * Incidence of unusual adverse events (and their degree) in the subsequent 28 days after each vaccine administration in this population * Incidence of serious adverse events (SAEs) and sentinel events (NOCMCs, new onset chronic medical conditions, and MAAEs, medically-attended adverse events) over a 1-year follow-up period after administration of the first vaccine dose in this population
次要结局
- Immunogenicity - Tcell response, using IGRA interferon-γ ELISpot, performed 60 days after the administration of the first vaccine dose(60 days)
- Immunogenicity and immunosuppression level(365 days)
- Immunogenicity - antibody response, using ImmunoAssay in ECLIA for the quantitative detection of anti-protein S1 (spike) antibodies (including IgG)(365 days)
- Prevention of COVID19(365 days)
- Prevention of severe COVID19(365 days)
研究者
Letizia Morlacchi
Principal Investigator; Respiratory Consultant, attending Lung Transplant clinic
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico