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 人开始时间: 2013年5月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28498840
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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
- •11. For males only, willing to use barrier contraception (male condoms) with every act of sexual intercourse until 28 days after the vaccination. The clinical site will provide condoms.
- •12. Agree to registration on a national database of trial volunteers to prevent over-volunteering (TOPS) which includes the taking of a photograph to be kept at the trial site
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
- •9. Seropositive for hepatitis B surface antigen (HBsAg) or Hepatitis C (antibodies to HCV)
- •10. Any history of Leishmaniasis or positive antibody response on the InBios leishmania strip test
- •11. Significant concern raised by GP in relation to participation
- •12. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- •13. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (only mild to moderate topical steroids as listed in the BNF are allowed)
- •14. Any other significant disease, disorder or finding, which, in the opinion of a medically qualified Clinical Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer?s ability to participate in the study
- •15. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent
- •16. Unlikely to comply with the study protocol
研究者
相似试验
已完成
1 期
HIVIS 03: A phase I/II trial to assess the safety and immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate among volunteers in Dar es Salaam, TanzaniaHIV-1Infections and InfestationsUnspecified human immunodeficiency virus [HIV] diseaseISRCTN90053831Swedish Institute for Infectious Disease Control (SMI) (Sweden)60
已完成
1 期
A phase 1 study of VLPCOV-01 in COVID-19 vaccinated healthy subjectsPrevention of infectious disease caused by SARS-CoV-2JPRN-jRCT2051210164obuaki Sato92
已完成
不适用
TaMoVac-01PACTR2010050002122368Swedish Institute for Infectious Disease Control120
进行中（未招募）
1 期
A clinical trial to assess the safety, immune response, and protection against infection of novel malaria vaccines.Plasmodium falciparum infectionEUCTR2017-001049-28-GBniversity of Oxford, CTRG18
进行中（未招募）
不适用
A phase I/IIa study to assess the safety and immunogenicity of new malaria vaccine candidates AdCh63 MSP1 alone and with MVA MSP1 - A study of the safety and effectiveness of two new malaria vaccinesPlasmodium Falciparum MalariaEUCTR2009-012591-27-GBniversity of Oxford16