TCTR20230809003已完成2 期
Immune responses of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike (NDV-HXP-S) with heterologous booster after 12 months in adults
ational Research Council of Thailand (NRCT)0 个研究点目标入组 130 人开始时间: 2023年8月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
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 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Eligible adult on the day of signing the ICF who participated in NDV-HXP-S Vaccine project in Thailand and had received 2 doses of 3 micrograms, 3 micrograms plus cPG 1018 or 10 micrograms vaccine.
- •2. Verified and documentation of past COVID-19 vaccination who have received two doses of NDV-HXP-S and the booster dose of AstraZeneca vaccine or Pfizer mRNA vaccine or Moderna mRNA for interval at least 12 months.
- •3. Women of childbearing potential who are test negative with a highly sensitive urine pregnancy test at Visit 1, prior to study vaccine administration.
- •4. Subject has provided written informed consent prior to performance of any study-specific procedures and is willing and has means to be contacted and to contact the investigator during the study.
- •5. The participant is in good health or has stable and well-controlled medical conditions.
排除标准
- •1. The participant has a clinically significant acute illness, this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection or is a patient under investigation or has a body temperature more than 38.0 degrees C or 100.4 degrees F within 24 hours prior to the planned study vaccination. Assignment may be made at a later date is permitted at the discretion of the investigator.
- •2. Contraindication to mRNA COVID-19 vaccine according to labelling of the product. For example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients.
- •3. Participant has a history or current condition as follows
- •3.1 Known documented history of COVID-19 infection within 4 months prior to enrollment
- •3.2 Any confirmed or suspected immunosuppressive or immunodeficient state.
- •3.3 Acute polyneuropathy for example Guillain Barre syndrome.
- •3.4 Contraindication to IM injections and blood draws for example, bleeding disorders.
- •3.5 An underlying clinically significant acute or chronic medical condition or physical examination findings for which in the opinion of the investigator or participation would not be in the best interest of the participant for example, compromise the well-being or that could prevent or limit or confound the protocol-specified assessments.
- •3.6 Major psychiatric illness which in the opinion of investigator would compromise the safety or compliance of participant with the study procedures.
- •4. If the participant received or plans to receive
- •4.1 Licensed live attenuated vaccines within 28 days before or after planned administration of study vaccine.
- •4.2. Other none live licensed vaccines within 14 days before or after planned administration of study vaccine.
- •4.3. Treatment with immunoglobulins in the 3 months or exogenous blood products in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study.
- •5. If the participant cannot communicate reliably with the investigator or in the opinion of the investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of vaccination and observation.
- •6. Employee of the study center directly involved with the proposed study or with study investigators.
研究者
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