ISRCTN07766359
已完成
1 期
A phase I study to assess the safety and immunogenicity of a new Leishmania vaccine candidate ChAd63-KH
York Hospital HNS Trust (UK)0 个研究点目标入组 20 人2013年5月3日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- York Hospital HNS Trust (UK)
- 入组人数
- 20
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28498840
研究者
入排标准
入选标准
- •1\. Male and female aged 18 to 50 years on the day of screening
- •2\. Available for the duration of the study
- •3\. Willing and able to give written informed consent
- •4\. In good health as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified Clinical Investigator
- •5\. Judged, in the opinion of a medically qualified Clinical Investigator, to be able and likely to comply with all study requirements as set out in the protocol
- •6\. Willing to undergo screening for HIV, Hepatitis B and Hepatitis C
- •7\. Agree to refrain from blood donation for the duration of the study
- •8\. Have been registered with a GP for at least the past 3 months and willing to allow a clinical investigator to discuss the volunteer?s medical history with their GP
- •9\. For females only, using a reliable method of contraception (methods defined as one of; combined oral contraceptive pill, desogestrel\-containing progesterone only pill (Cerazette), intra\-uterine contraceptive device or system, injectable contraceptive or progesterone implant) from 14 days prior to the vaccination until 90 days after vaccination
- •10\. For females only, willing to undergo urinary pregnancy tests on the day of screening, on the day of vaccination (prior to vaccination) and 28 and 90 days after vaccination
排除标准
- •1\. Prior receipt of a recombinant adenoviral\-vectored vaccine
- •2\. Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned enrolment during the study period
- •3\. Receipt of a live attenuated vaccine within 60 days or other vaccine within 14 days of screening
- •4\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •5\. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or a history of severe or multiple allergies to drugs or pharmaceutical agents
- •6\. History of clinically significant contact dermatitis
- •7\. Any history of severe local or general reaction to vaccination as defined as:
- •7\.1\. Local : extensive, indurated redness and swelling involving most of the antero\-lateral thigh or the major circumference of the arm, not resolving within 72 hours
- •7\.2\. General : fever \= 39\.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 48 hours
- •8\. Females ? pregnancy, less than 12 weeks postpartum, lactating or willingness/intention to become pregnant during the study and for 3 months following vaccination
结局指标
主要结局
未指定
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