EUCTR2019-002872-14-GB进行中（未招募）1 期
A Phase I/IIa clinical trial to assess the safety, immunogenicity and efficacy of the blood-stage Plasmodium vivax malaria vaccine candidate PvDBPII in Matrix M1 in healthy adults living in the UK - VAC079: Safety and efficacy of the PvDBPII in Matrix M1 vaccine
niversity of Oxford / Clinical Trials and Research Governance0 个研究点目标入组 24 人开始时间: 2019年10月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- 性别
- All
入选标准
- •Healthy adult aged 18 to 45 years.
- •Red blood cells positive for the Duffy antigen/chemokine receptor (DARC).
- •Normal serum levels of Glucose-6-phosphate dehydrogenase (G6PD).
- •Negative haemoglobinopathy screen
- •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.
- •Women only: Must practice continuous effective contraception* for the duration of the study
- •Agreement to permanently refrain from blood donation
- •Written informed consent to participate in the trial.
- •Reachable (24/7) by mobile phone during the period between CHMI and completion of all antimalarial treatment.
- •Willing to take a curative anti-malarial regimen following CHMI.
- •Willing to reside in Oxford for the duration of the study, until antimalarials have been completed.
- •Answer all questions on the informed consent quiz correctly at first or second attempt.
- •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 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •History of clinical malaria (any species).
- •Travel to a clearly malaria endemic locality during the study period or within the preceding six months.
- •Current or planned treatment with long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
- •Chronic use of antibiotics with antimalarial effects (e.g. tetracyclines for dermatologic patients, trimethoprim-sulfamethoxazole for recurrent urinary tract infections, etc.).
- •Weight less than 50kg, as measured at the screening visit
- •Receipt of immunoglobulins within the three months prior to planned administration of the vaccine candidate.
- •Receipt of blood products (e.g., blood transfusion) at any time in the past.
- •Peripheral venous access unlikely to allow twice daily blood testing (as determined by the Investigator).
- •Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
- •Concurrent involvement in another clinical trial or planned involvement during the study period
- •Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.
- •Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt during the study period
- •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).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine e.g. egg products, Kathon
- •History of allergic disease or reactions likely to be exacerbated by malaria infection.
- •History of clinically significant contact dermatitis
- •Any history of anaphylaxis in reaction to vaccinations
- •Pregnancy, lactation or intention to become pregnant during the study.
- •Use of medications known to cause prolongation of the QT interval and existing contraindication to the use of Malarone.
- •Use of medications known to have a potentially clinically significant interaction with Riamet and Malarone.
- •Any clinical condition known to prolong the QT interval.
- •History of cardiac arrhythmia, including clinically relevant bradycardia.
- •Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
- •Family history of congenital QT prolongation or sudden death.
- •Contraindications to the use of both of the proposed anti-malarial medications; Riamet Malarone.
- •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 25 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 or (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).
- •Positive family history in both 1st AND 2nd degree relatives < 50 years old for cardiac disease.
- •Volunteers unable to be closely fol
研究者
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