Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
Phase I Study of the Safety and Immunogenicity of rDEN1delta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1
연구 개요
상세 설명
More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading cause of hospitalization and death in children in several tropical Asian countries. This study will evaluate the safety and immunogenicity of a live, attenuated dengue virus called rDEN1delta30, which is derived from the Western Pacific DEN1 serotype.
This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30 or placebo.
After vaccination, participants will be asked to monitor their temperature every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by 4 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21205
- Center for Immunization Research, Johns Hopkins School of Public Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Willing to be followed for the duration of the study
- Willing to use acceptable methods of contraception
- Good general health
Exclusion Criteria:
- Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
- Liver, renal, or hematologic disease
- Alcohol or drug abuse within 12 months of study entry
- History of severe allergic reaction or anaphylaxis
- Emergency room visit or hospitalization for severe asthma within 6 months of study entry
- HIV-1 infected
- HCV infected
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.
- Live vaccine within 4 weeks of study entry
- Killed vaccine within 2 weeks of study entry
- Blood products within 6 months of study entry
- Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial
- Previously received a licensed or experimental yellow fever or dengue vaccine
- Surgical removal of spleen
- History of dengue virus infection or other flavivirus infection
- Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
- Pregnancy or breastfeeding
- Plan to travel to an area where dengue infection is common
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
One subcutaneous vaccination with rDEN1delta30 vaccine (10^3 PFU dose) into the deltoid region of either arm.
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Live attenuated rDEN1delta30 vaccine
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실험적: 2
One subcutaneous vaccination with rDEN1delta30 vaccine (10^5 PFU dose) into the deltoid region of either arm.
This arm may enroll after Arm 1 depending on the effect of the vaccine on subjects in Arm 1.
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Live attenuated rDEN1delta30 vaccine
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위약 비교기: 3
One subcutaneous vaccination with placebo into the deltoid region of either arm.
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RDEN1delta30에 대한 위약
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Determine the frequency of vaccine related AEs for each dose graded by severity
기간: Throughout study
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Throughout study
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Determine the amount of dengue 1 neutralizing antibody induced by the vaccine
기간: At Day 42
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At Day 42
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2차 결과 측정
결과 측정 |
기간 |
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항체 반응의 지속성을 평가하기 위해
기간: 180일째
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180일째
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연구된 각 용량 코호트에서 바이러스 혈증의 빈도, 양 및 기간을 평가하기 위해
기간: 공부하는 내내
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공부하는 내내
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To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN1delta30 vaccine virus with that of uninfected volunteers and placebo recipients
기간: Throughout study
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Throughout study
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If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups
기간: At study completion
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At study completion
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피부 생검을 받을 의향이 있는 지원자에서 백신 관련 발진의 면역병리학적 기전을 평가하기 위해
기간: 공부하는 내내
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공부하는 내내
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공동 작업자 및 조사자
수사관
- 수석 연구원: Anna Durbin, MD, Center for Immunization Research, John Hopkins School of Public Health
간행물 및 유용한 링크
일반 간행물
- Jacobs M, Young P. Dengue vaccines: preparing to roll back dengue. Curr Opin Investig Drugs. 2003 Feb;4(2):168-71.
- Pang T. Vaccines for the prevention of neglected diseases--dengue fever. Curr Opin Biotechnol. 2003 Jun;14(3):332-6. doi: 10.1016/s0958-1669(03)00061-2.
- Rothman AL. Dengue: defining protective versus pathologic immunity. J Clin Invest. 2004 Apr;113(7):946-51. doi: 10.1172/JCI21512.
- Sun W, Edelman R, Kanesa-Thasan N, Eckels KH, Putnak JR, King AD, Houng HS, Tang D, Scherer JM, Hoke CH Jr, Innis BL. Vaccination of human volunteers with monovalent and tetravalent live-attenuated dengue vaccine candidates. Am J Trop Med Hyg. 2003 Dec;69(6 Suppl):24-31. doi: 10.4269/ajtmh.2003.69.6_suppl.0690024.
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CIR 199
- H.22.04.04.23.B2
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rDEN1delta30에 대한 임상 시험
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National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public Health완전한
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National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public Health완전한