SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- Immune response of Coronavac vaccine in Thai cancer patients
研究概览
简要总结
Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.
详细描述
A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.
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
盲法说明
All participants, including patients with solid tumor and healthy volunteers will be received 2 doses of CoronaVac at National Cancer Institute of Thailand between 2020-2021. Blood samples will be collected after second dose of Sinovac for 15 days and the neutralizing antibody (NAb) titers will be detected using live-virus neutralization
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
- •Male or Female age at least 18 years
- •Patients with a diagnosis of solid tumors
- •Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
- •Willing and able to comply with the study procedures.
- •Willing to receive a Coronavac vaccine (Sinovac).
排除标准
- •Patients who cannot provide consent
结局指标
主要结局
Immune response of Coronavac vaccine in Thai cancer patients
时间窗: 15 days after 2 doses of vaccination
Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients
次要结局
未报告次要终点
研究者
Thanarath Imsuwansri, MD
Head of Research Division
National Cancer Institute, Thailand