IRCT20150303021315N23招募中2 期
A phase II, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen®) produced by CinnaGen Co. (Two doses of 25µg with dosing interval of 21 days)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
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 or women =18 years
- •Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations and tests
- •Healthy adults or adults with stable medical conditions.
- •Women eligible to participate in the study who are not pregnant or breastfeeding.
排除标准
- •Subjects with active infection with SARS-COV-2 signs at the screening visit.
- •Subjects with body temperature equal or more than 38 degrees centigrade, during 72 hours before screening visit or at the visit.
- •Subjects with any progressive or severe neurological disorder, seizures, or a history of Guillain-Barre syndrome.
- •Subjects who receive immunosuppressive or cytotoxic medications.
- •Pregnant women, or breastfeeding mothers, or women who plan to become pregnant during the study.
- •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.
- •Subjects who have been vaccinated with other vaccines against the SARS-CoV-2 virus.
- •Subjects who received other authorized vaccines within 28 days prior to the screening visit in this study or intend to receive any vaccines up to 14 days after the second vaccination.
- •Subjects who have any known bleeding disorder or may have problems with the intramuscular injection according to the researcher's opinion.
- •Subjects who have received or intend to receive any blood / plasma or immunoglobulin products 90 days prior to the screening visit.
- •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.
- •Subjects who have donated =450 ml of blood or blood products 28 days prior to the screening visit.
研究者
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