- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00666380
A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya
Phase 1a Open-label Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Candidate Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered Intramuscularly With GSK Biologicals' Adjuvant AS01B in Healthy Malaria-Naïve Adults
연구 개요
상세 설명
The study begins with the US phase in which 26 volunteers aged 18 to 50 years will be enrolled to receive an investigational malaria vaccine. The vaccine is made of a malaria protein FMP010 mixed in the adjuvant AS01B. Since this vaccine has not yet been in humans, first, 5 volunteers will get a small (10 µg) dose of FMP010 in AS01B. If it is safe, then 20 volunteers will get 50 µg FMP010 in AS01B. Vaccinations are given IM in the deltoid of the non-dominant arm, every month for 3 months. After each vaccination, the subjects will follow up at clinical trials for evaluation of any adverse events. There will be blood draws to assess safety of the vaccine as well as the level of immune response generated to the vaccine.
Upon receipt of preliminary safety results, the Kenya phase begins in which 30 volunteers who are randomized to receive either 50 µg FMP010 in AS01B (20) or the rabies vaccine (10). Vaccination and is on the same schedule as in the US phase and follow-up is for 112 days.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening
- Free of significant health problems as established by medical history and clinical examination before entering into the study
- Available to participate for duration of study (approximately seven months)
- If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of each vaccination, and must agree to continue such precautions for two months after completion of the vaccination series.
- If the volunteer indicates he/she is active duty military (on the DCT sign-in page and intake form), approval from their supervisor through the Division Director using the Statement of Supervisor's Approval Form must be signed and on file prior to receipt of any test product
- Written informed consent must be obtained from the subject before screening procedures.
- Test of Understanding
- Prior to entry into this study, subjects must score at least 80% correct on a 10- question multiple-choice quiz that assesses their understanding of this study. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them to ensure comprehension, and they will have the opportunity to retest. If a volunteer fails to correctly answer 8 of 10 questions after two attempts they will be excluded from the study.
Exclusion Criteria:
- Prior receipt of any investigational malaria vaccine
- Prior receipt of a vaccine containing either QS-21, MPL or AS02 or AS01
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the study vaccine
- Any past history of malaria
- Planned travel to malarious areas during the study period
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- A family history of congenital or hereditary immunodeficiency
- Chronic or active neurologic disease including seizure disorder
- History of splenectomy
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or abnormal baseline laboratory screening tests
- ALT above normal range
- Creatinine above normal range
- Hemoglobin below normal range
- Platelet count below normal range
- Total white cell count below normal range
- Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory infection without fever, i.e., Oral temperature < 37.5°C.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness
- Seropositive for HIV, Hepatitis C virus (antibodies to HCV) and/or HBsAg
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
- Pregnant or lactating female
- Suspected or known current alcohol abuse/drug abuse as obtained by history and physical examination
- Female who is willing or intends to become pregnant during the study
- Any history of allergic reaction or anaphylaxis to previous vaccination
- Inability to make follow-up visits or complete diary cards
- Allergy to kanamycin, nickel, or imidazole
- Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 10 ug of FMP010 antigen in 0.5 mL AS01B adjuvant
|
백신 항원은 Plasmodium falciparum FVO strain의 merozoite surface protein-1 (MSP-1)을 기반으로 한 재조합 단백질이며, adjuvant AS01B는 GSK의 독점 adjuvant입니다.
|
실험적: 50 ug of FMP010 antigen in 0.5 mL AS01B adjuvant
|
백신 항원은 Plasmodium falciparum FVO strain의 merozoite surface protein-1 (MSP-1)을 기반으로 한 재조합 단백질이며, adjuvant AS01B는 GSK의 독점 adjuvant입니다.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of solicited adverse events
기간: 7 days
|
Occurrence and intensity of solicited symptoms on day of vaccination and Days 1-7 after each vaccination
|
7 days
|
Number of unsolicited adverse events
기간: 30 days
|
Occurrence and intensity of unsolicited symptoms over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination
|
30 days
|
Number of serious adverse events
기간: 1 year
|
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percent parasite growth inhibition
기간: Up to 112 days
|
Functionality of antibodies elicited as measured by percent parasite growth inhibition in GIA against homologous (FVO) and heterologous (3D7) parasites
|
Up to 112 days
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Michele D Spring, MD, M.S.P.H., Walter Reed Army Institute of Research (WRAIR)
- 수석 연구원: Nekoye N. Otsyula, M.B. Ch. B., Kenya Medical Research Institute
간행물 및 유용한 링크
일반 간행물
- Bashir IM, Otsyula N, Awinda G, Spring M, Schneider P, Waitumbi JN. Comparison of PfHRP-2/pLDH ELISA, qPCR and microscopy for the detection of plasmodium events and prediction of sick visits during a malaria vaccine study. PLoS One. 2013;8(3):e56828. doi: 10.1371/journal.pone.0056828. Epub 2013 Mar 15.
- Otsyula N, Angov E, Bergmann-Leitner E, Koech M, Khan F, Bennett J, Otieno L, Cummings J, Andagalu B, Tosh D, Waitumbi J, Richie N, Shi M, Miller L, Otieno W, Otieno GA, Ware L, House B, Godeaux O, Dubois MC, Ogutu B, Ballou WR, Soisson L, Diggs C, Cohen J, Polhemus M, Heppner DG Jr, Ockenhouse CF, Spring MD. Results from tandem Phase 1 studies evaluating the safety, reactogenicity and immunogenicity of the vaccine candidate antigen Plasmodium falciparum FVO merozoite surface protein-1 (MSP1(42)) administered intramuscularly with adjuvant system AS01. Malar J. 2013 Jan 23;12:29. doi: 10.1186/1475-2875-12-29.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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. .
Plasmodium falciparum 말라리아 단백질 010 (FMP010)에 대한 임상 시험
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U.S. Army Medical Research and Development CommandGlaxoSmithKline; United States Agency for International Development (USAID); Walter Reed... 그리고 다른 협력자들완전한