IRCT20150303021315N28招募中未知
A single armed, open label, clinical trial to evaluate the immunogenicity of SpikoGen® vaccine as booster dose (Spike protein, produced by CinnaGen company) in kidney transplant patients being fully vaccinated with Sinopharm vaccine
Shahid Beheshti university of medical sciences Urology and Nephrology Research Center0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Men and women older than 18
- •Patients with history of kidney transplantation who vaccinated with two doses Sinopharm vaccine after transplantation
- •Women who are not pregnant or breast-feeding
- •People who have been transplanted for more than 6 months
排除标准
- •Subjects with active infection with signs of SARS-COV-2 at screening visit
- •History of covid-19 based on a previous positive PCR
- •Treatment of active Cytomegalovirus (CMV) infection
- •History of receiving rituximab during the past 6 months
- •History of receiving IVIg during the past 6 months
- •Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs
- •Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial
- •History of transplant rejection during the past 30 days
- •Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion
研究者
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