- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00442377
Study to Investigate the Induction of an Protective Immune Response to Malaria
Exposure of Human Volunteers to Live Malaria Sporozoites Under Chloroquine Prophylaxis
연구 개요
상세 설명
Efforts to develop vaccines against malaria still represent a substantial focus of current research activities. Factors that have hampered the development of a subunit vaccine include the complexity of the malaria life cycle, the wide variety of immune response induced by the malaria parasite, and an incomplete knowledge of protective immunity. This study is therefore aimed at inducing protective immunity against malaria in 15 healthy volunteers. Volunteers will be exposed to the bites of infectious mosquitoes 3 times with live P. falciparum sporozoites under chloroquine prophylaxis. Challenge with infected mosquitoes will be given after stopping chloroquine prophylaxis.
Five volunteers will form a control group; they will be exposed to non-infectious mosquitoes under chloroquine prophylaxis.
Endpoints include the time and height of parasitemia after challenge, the development of fever and immunological parameters.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nijmegen, 네덜란드, 6500 HB
- Radboud University Nijmegen Medical Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age > 18 and < 45 years healthy volunteers (males or females).
- General good health based on history and clinical examination.
- All volunteers have to sign the informed consent form.
- Negative pregnancy test.
- Use of adequate contraception for females
- Reachable by phone during the whole study period.
- Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the trial
Exclusion Criteria:
- History of malaria or residence in malaria endemic areas within the past six months.
- Positive serology for P. falciparum
- Previously participated in any malaria vaccine study
- Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers.
- Cardiovascular risk >10% according to European guidelines, taking into account sex, age, cholesterol, weight, smoking habits, blood pressure, diabetes
- Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests.
- Volunteers should not be enrolled in any other clinical trial during the whole trial period.
- Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period.
- Pregnant or lactating women.
- Volunteers unable to give written informed consent.
- Volunteers unable to be closely followed for social, geographic or psychological reasons.
- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study.
- Known hypersensitivity for anti-malaria drugs
- Volunteers are not allowed to travel to malaria endemic countries during the study period.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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A significant difference in time of thick smear positivity between exposed and control groups
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A significant difference in parasitemia as measured by 18S Pf NASBA between exposed and control group
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A significant difference in kinetics of parasitemia between exposed and control groups as measured by 18S Pf NASBA.
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A difference in occurrence or height of fever between exposed and control groups.
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2차 결과 측정
결과 측정 |
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Significant differences in immune response between exposed and control volunteers (including NK-cell reactivity, TLR reactivity and regulatory T-cell reactivity)
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Significant differences in the outcome of in vitro functional malaria assays between exposed and control volunteers
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Significant differences in cellular reactivity against Pf antigens
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Significant differences in parasite VAR gene expression during infection
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The identification of immune mechanisms that correlate with protection
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6. The identification of potential vaccine candidates that correlate with protection
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Sauerwein, Prof, Radboud University Medical Center
간행물 및 유용한 링크
일반 간행물
- Coffeng LE, Hermsen CC, Sauerwein RW, de Vlas SJ. The Power of Malaria Vaccine Trials Using Controlled Human Malaria Infection. PLoS Comput Biol. 2017 Jan 12;13(1):e1005255. doi: 10.1371/journal.pcbi.1005255. eCollection 2017 Jan.
- Roestenberg M, McCall M, Hopman J, Wiersma J, Luty AJ, van Gemert GJ, van de Vegte-Bolmer M, van Schaijk B, Teelen K, Arens T, Spaarman L, de Mast Q, Roeffen W, Snounou G, Renia L, van der Ven A, Hermsen CC, Sauerwein R. Protection against a malaria challenge by sporozoite inoculation. N Engl J Med. 2009 Jul 30;361(5):468-77. doi: 10.1056/NEJMoa0805832.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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