- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02926430
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
2019년 2월 18일 업데이트: Janssen Vaccines & Prevention B.V.
A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF,
administered intramuscularly to elderly adults given approximately 12 months apart.
연구 개요
연구 유형
중재적
등록 (실제)
73
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Miami, Florida, 미국
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
60년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; and not intending to conceive by any methods
- From the time of first vaccination until 3 months after the first dose of study vaccine, and from the second vaccination through 3 months after, a man who has not had a vasectomy (or if a vasectomy was performed less than 1 year ago and the absence of sperm cannot be verified)
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grades 1 or 2 according to the US Food and Drug Administration (FDA) toxicity tables (for tests in the FDA table ), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Exclusion Criteria:
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree celsius within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
- Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1
Participants will receive 5*10^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
다른 이름들:
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실험적: Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2
Participants will receive 5*10^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
다른 이름들:
Participants will receive placebo as formulation buffer.
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실험적: Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3
Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
다른 이름들:
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실험적: Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4
Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
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Participants will receive placebo as formulation buffer.
Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
다른 이름들:
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실험적: Placebo (Day 1 and Day 365): Group 5
Participants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Participants will receive placebo as formulation buffer.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
기간: 7 days after each vaccination (Day 1)
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7 days after each vaccination (Day 1)
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Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
기간: 7 days after each vaccination (Day 365)
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7 days after each vaccination (Day 365)
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Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
기간: 7 days after each vaccination (Day 1)
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7 days after each vaccination (Day 1)
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Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
기간: 7 days after each vaccination (Day 365)
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7 days after each vaccination (Day 365)
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Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
기간: 28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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Number of Participants With Serious Adverse Events (SAEs) Throughout Study
기간: Up to 730 days
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Up to 730 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Respiratory Syncytial Virus (RSV) Neutralization A2
기간: Days 1, 29, 183, 365, 393, 547, 730
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Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed.
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Days 1, 29, 183, 365, 393, 547, 730
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RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay
기간: Days 1, 29, 183, 365, 393, 547, 730
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Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form.
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Days 1, 29, 183, 365, 393, 547, 730
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Intracellular Cytokine Staining
기간: Day 1, 29, 183, 365, 393, 547, 730
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The activation of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV protein peptide stimulation (including, but not limited to CD4/CD8, interleukin [IL-2], interferon gamma [IFN gamma], tumor necrosis factor alpha [TNF-alpha] and/or activation markers, memory, T-helper [cells] Th1/Th2 subtyping).
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Day 1, 29, 183, 365, 393, 547, 730
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 11월 8일
기본 완료 (실제)
2018년 3월 14일
연구 완료 (실제)
2019년 1월 29일
연구 등록 날짜
최초 제출
2016년 9월 22일
QC 기준을 충족하는 최초 제출
2016년 10월 5일
처음 게시됨 (추정)
2016년 10월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 2월 18일
마지막으로 확인됨
2019년 2월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CR108214
- VAC18193RSV1003 (기타 식별자: Janssen Vaccines & Prevention B.V.)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 기기 제품 연구
아니
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. .