NL-OMON53441尚未招募不适用
Coadministration of genetically attenuated Plasmodium falciparum *mei2 (GA2) sporozoites with adjuvants - a proof of principle study - CoGA - Coadministration of GA2 sporozoites with adjuvants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •In order to be eligible to participate in this study, a participant must meet
- •all of the following criteria:
- •1. Participant is aged >=18 and <=35 years and in good health.
- •2. Participant has adequate understanding of the procedures of the study and
- •agrees to abide strictly thereby.
- •3. Participant is able to communicate well with the investigator
- •4. Participant is available to attend all essential study visits.
- •5. Participant agrees that his/her general practitioner (GP) will be informed
- •about participation in the study.
- •6. Participant agrees to refrain from blood donation to Sanquin or for other
- •purposes throughout the study period and for a defined period thereafter
- •according to Sanquin guidelines.
- •7. Participants of child bearing potential (i.e., have an uterus and are
- •neither surgically sterilized nor post-menopausal) agree to use adequate
- •contraception and to not breastfeed for the duration of study.
- •8. Participant agrees to refrain from intensive physical exercise
- •(disproportionate to the participants* usual daily activity or exercise
- •routine) for twenty-one days following the immunization and during the malaria
- •challenge period.
- •9. Participant signs informed consent.
排除标准
- •1. Any history, or evidence at screening, of clinically significant symptoms,
- •physical signs or abnormal laboratory values suggestive of systemic conditions
- •which could compromise the health of the participant during the study or
- •interfere with the interpretation of the study results. These include, but are
- •not limited to, any of the following: a. Body Mass Index (BMI) >35.0 kg/m2 at
- •screening. b. An elevated risk of cardiovascular disease, defined as: i. An
- •estimated ten-year risk of fatal cardiovascular disease of >=5% at screening, as
- •determined by the Systematic Coronary Risk Evaluation 2 (SCORE2) . See Appendix
- •1 for the SCORE2 risk classification; ii. History, or evidence at screening, of
- •clinically significant arrhythmia*s, prolonged QT-interval or other clinically
- •relevant ECG abnormalities; or iii. A positive family history of cardiac events
- •in first- or second-degree relatives (according to the system used in medical
- •genetics) <50 years old. c. Known functional asplenia, sickle cell
- •trait/disease, thalassemia trait/disease or G6PD deficiency. d. History of
- •epilepsy in the period of five years prior to study onset, even if no longer on
- •medication. e. Positive HIV, HBV or HCV screening tests. f. Chronic use of i)
- •immunosuppressive drugs, ii) antibiotics, iii) or other drugs that might have
- •an influence on the immune system (excluding inhaled and topical
- •corticosteroids and incidental use of oral anti-histamines), within three
- •months prior to study onset or expected use of such during the study period. g.
- •Skin disease affecting the site of administration in such a way that
- •administration of mosquito bites or adjuvants is deemed impossible by
- •investigator. h. History of malignancy of any organ system (other than
- •localized basal cell carcinoma of the skin), treated or untreated, within the
- •past five years. i. Any history of treatment for severe psychiatric disease by
- •a psychiatrist in the past year. j. History of drug or alcohol abuse
- •interfering with normal social functioning in the period of one year prior to
- •study onset, positive urine toxicology test for cocaine or amphetamines at
- •screening. 2. For participants of child bearing potential: breastfeeding, or
- •positive urine pregnancy test prior to immunization or prior to CHMI. 3. Any
- •history of malaria or previous participation in any malaria (vaccine) study or
- •CHMI. 4. Known hypersensitivity to or contra-indications for both
- •atovaquone/proguanil or artemether/lumefantrine. QT prolonging drugs are only
- •considered an exclusion criterion when QT prolongation is observed at the ECG
- •at screening. 5. A history of severe (allergic) reactions to mosquito bites. 6.
- •Any history of infection with mycobacteria or BCG vaccination (only in stage B
- •and C). 7. Any history of infection with yellow fever virus or yellow fever
- •vaccination (only in stage B and C). 8. Planned vaccination two weeks before
- •immunization. When necessary due to medical reasons, exceptions can be made in
- •accordance with the PI. 9. For participants in skin biopsy group: increased
- •risk of complications after skin biopsy (e.g.use of anticoagulants,
- •immunosuppressive medication or having tattoo's on the biopsy region) 10.
- •Participation in any other clinical study assessing an investigational medical
- •product in the 30 days prior to the start of the study
研究者
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