EUCTR2007-005389-11-GB进行中（未招募）1 期
A Phase I/IIa Study of the Safety, Immunogenicity and Parasite Growth Inhibitory Activity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum Malaria - AMA1-C1/CPG Blood Stage Challange
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- •Subject is willing and able to give informed consent for participation in the study
- •Healthy, non pregnant adult aged 18 - 50 years
- •Resident in or near Oxford for the duration of the challenge study
- •Seropositive for CMV and EBV
- •Female subjects of child bearing potential must be willing to ensure that they practice
- •effective contraception during the study
- •Males must be willing to use barrier contraception from day of first vaccination onwards until 3 months after the second vaccination
- •Able (in the Investigator’s opinion) and willing to comply with all study requirements
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be
- •notified of participation in the study
- •Agreement to permanently refrain from blood donation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or
- •in urine analysis as defined in Appendix B
- •Female patient/subject who is pregnant, lactating or planning pregnancy during the
- •course of the study
- •Healthy volunteers who have participated in another research study involving an
- •investigational product in the past 12 weeks
- •Subjects who have previously received an investigational malaria vaccine
- •History of malaria chemoprophylaxis with chloroquine within 5 months prior to the
- •planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet®
- •within 2 weeks prior to the challenge
- •Travel to a malaria endemic area within the previous 6 months
- •Planned travel to malarious areas during the study period
- •Any history of malaria
- •Contraindication to both ant-malarial drugs (Riamet and Chloroquine)
- •Concomitant use of other drugs known to cause QT-interval prolongation (e.g. macrolides, quinolones, amiodarone etc)
- •An estimated ten year risk of fatal cardiovascular disease of greater than or equal to 5%, as estimated by the Systemic Coronary Risk Evaluation (SCORE) system (Conroy 2003)
- •Any history of severe allergic reaction or anaphylaxis
- •History of a known allergy to nickel
- •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
- •History or evidence of pre-existing autoimmune or antibody mediated disease or
- •laboratory evidence of possible autoimmune disease (defined as anti-dsDNA = 25
- •Seropositive for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus
- •Any on-going chronic illness requiring hospital specialist supervision
- •Administration of immunoglobulins and/or any blood products within the three
- •months preceding the planned administration of the vaccine candidate
- •History of or current intravenous drug abuse
- •Suspected or known current alcohol abuse as defined by an alcohol intake of greater
- •than 42 units every week
- •Any other significant disease or disorder which, in the opinion of the Investigator,
- •may either put the subject at risk because of participation in the study, or may
- •influence the result of the study, or the subject’s ability to participate in the study.
- •Investigator assessment of lack of willingness to participate and comply with all
- •requirements of the protocol
研究者
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