EUCTR2017-001049-28-GB进行中（未招募）1 期
A Phase I/II Study to assess the safety, immunogenicity and protective efficacy of novel malaria vaccine candidates ChAdOx1 LS2 and MVA LS2 in healthy UK adults - A Safety and Efficacy Study of ChAdOx1 LS2 and MVA LS2 (VAC067)
niversity of Oxford, CTRG0 个研究点目标入组 18 人开始时间: 2017年5月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •The volunteer must satisfy all the following criteria to be eligible for the study:
- •Healthy adults aged 18 to 45 years
- •Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner
- •For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- •Agreement to refrain from blood donation during the course of the study
- •Provide written informed consent to participate in the trial.
- •Additional inclusion criteria for group 2 and control groups A&B
- •Agreement to refrain from blood donation during the course of the study and for at least 3 years after the end of their involvement in the study.
- •Reachable (24/7) by mobile phone during the period between CHMI and completion of antimalarial treatment.
- •Willingness to take a curative anti-malaria regimen following CHMI.
- •For volunteers not living in Oxford: agreement to stay in a hotel room close to the trial centre during a part of the study (from at least day 6.5 post mosquito bite until anti-malarial treatment is completed).
- •Answer all questions on the informed consent quiz correctly.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 31
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The volunteer may not enter the study if any of the following apply:
- •History of clinical malaria (any species).
- •Travel to a clearly malaria endemic locality during the study period or within the preceding six months
- •Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
- •Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data as assessed by the investigator. This may include non-malaria adenovirus vectored experimental vaccine. If any volunteers in Group 2 undergo rechallenge, this exclusion criterion does not extend to the vaccines previously received in the VAC067 trial.
- •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 (inhaled and topical steroids are allowed).
- •Use of immunoglobulins or blood products within 3 months prior to enrolment.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products, Kathon) or malaria infection.
- •Any history of anaphylaxis post vaccination.
- •History of clinically significant contact dermatitis.
- •Pregnancy, lactation or intention to become pregnant during the study.
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •History of serious psychiatric condition that may affect participation in the study.
- •Any other serious chronic illness requiring hospital specialist supervision.
- •Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 standard UK units every week.
- •Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- •Hepatitis B surface antigen (HBsAg) detected in serum.
- •Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
- •Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested.
- •Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
- •Additional exclusion criteria for group 2 and control groups A&B
- •Clinically significant disturbances of electrolyte balance, eg, hypokalaemia or hypomagnesaemia
- •Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).
- •History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait or any haematological condition that
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