- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00426712
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
A Phase 1, Randomized, Observer-blind, Dose-escalating Study in Adult End-stage Renal Failure Patients to Explore the Safety, Tolerability, Pharmacokinetics and Immune Response to Recombinant Hepatitis B Virus Surface Antigen (rHBsAg) Co-administered With Dynavax Immunostimulatory Phosphorothioate Oligodeoxyribonucleotide (1018 ISS)
연구 개요
상태
정황
상세 설명
Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis. Hemodialysis and pre-dialysis patients with kidney failure have multiple immune defects that make them more likely to develop a chronic infection. In addition, hemodialysis increases the risk of exposure to HBV. Existing HBV vaccines are effective in preventing infection in healthy adults. However, poor responses occur in people who are over 40 years of age and have end-stage kidney failure.
This study will evaluate the safety, tolerability and immune response of three escalating dose levels of HEPLISAV™, compared with a commercially available HBV vaccine, Engerix-B®, in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease and are expected to eventually go on hemodialysis. About 72 patients will be included in the study. Once patients have been consented, screened, and randomized to treatment, they will receive four injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Patients will receive treatment with one of three escalating dose levels of HEPLISAV™ or the comparator vaccine, Engerix-B®.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Costa Mesa, California, 미국, 92626
- West Coast Clinical Trials
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Minnesota
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Brooklyn Center, Minnesota, 미국, 55430
- Twin Cities Clinical Research
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Texas
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Austin, Texas, 미국, 78727
- Covance
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Virginia
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Charlottesville, Virginia, 미국, 22908
- University of Virginia Health System, Nephrology Clinical Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Willing and able to give written informed consent
- Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis
- Body mass index of 31 or less
Exclusion Criteria:
- Received previous vaccination with any HBV vaccine (1 or more doses)
- Any history of HBV infection
- Pregnant or breast-feeding, or planning a pregnancy during the study
- Has autoimmune disease
- Diagnosis of chronic kidney failure due to autoimmune disease
- Receiving hemodialysis treatment at the time of enrollment
- Received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
- Ever received an injection with DNA plasmids or oligonucleotides
- Received erythropoietin within 7 days prior to the first study injection
- Received vaccination with any vaccines during the 4 weeks prior to study entry
- Received any other investigational medicinal agent during the 4 weeks prior to study entry
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1
저용량
|
Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
다른 이름들:
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활성 비교기: 4
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IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24
다른 이름들:
|
실험적: 2
중간 용량
|
Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
다른 이름들:
|
실험적: 삼
고용량
|
Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
부작용 발생 및 국소 및 전신 반응률
기간: 28주
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28주
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Portion of subjects who have a seroprotective immune response (anti-HBsAg antibody ≥ 10 mIU/mL)
기간: 28 days
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28 days
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공동 작업자 및 조사자
수사관
- 연구 책임자: Eduardo Martins, MD, DPhil, Dynavax Technologies Corporation
간행물 및 유용한 링크
유용한 링크
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DV2-HBV-09
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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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