- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04786457
ADVP005; Dengue CVD 12000 - Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC)
2021년 10월 27일 업데이트: Kirsten Lyke, University of Maryland, Baltimore
A Phase 1, Open-Label Clinical Trial With Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC) Assessment of Healthy U.S. Adults Previously Primed With Tetravalent Dengue Virus Purified Inactivated Vaccine (TDEN-PIV) and Boosted With Tetravalent Dengue Virus Live Attenuated Vaccine Formulation (TDEN LAV)
The purpose of this research study is to test the protection of volunteers previously vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum and boosted with TDEN live attenuated vaccine (LAV) formulation against a weakened form of an experimental dengue virus challenge.
The Investigators will also include people that have not received the study vaccine.
The Investigators are collecting information about how the vaccine protects against a dengue virus challenge as well as adding to knowledge about the safety of the challenge.
연구 개요
상세 설명
The purpose of this research study is to test the protection of volunteers previously vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum and boosted with TDEN live attenuated vaccine (LAV) formulation against a weakened form of an experimental dengue virus challenge.
The Investigators will also include people that have not received the study vaccine.
The Investigators are collecting information about how the vaccine protects against a dengue virus challenge as well as adding to knowledge about the safety of the challenge.
The information will help Investigators develop vaccines to protect people from dengue.
Participation is voluntary.
The duration of participation will last for 180 days (six months).
After participants are exposed to the weakened dengue virus, the Investigators will follow them closely to measure their symptoms.
Like the flu, participants might expect to have a headache, rash, body aches, fever and chills or they may experience no symptoms whatsoever.
If a participant does develops symptoms, the Investigators will monitor him/her closely in a local hotel or a wing of our hospital to ensure safety and to treat symptoms if they occur.
Participants will be compensated for their time.
연구 유형
중재적
등록 (실제)
17
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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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- 1. Male or non-pregnant, non-breastfeeding female between 18 and 50 years of age (inclusive) at the time of consent.
- 2. Tetravalent dengue antibody response at 28 days following final vaccination for vaccinated groups of volunteers.
- 3. Volunteers must be able and willing to provide written informed consent.
- 4. Volunteers must be healthy as established by medical history and clinical examination at study entry.
- 5. Volunteers must pass a comprehension test and be able to comply with all study requirements.
- 6. Female volunteers of non-childbearing potential (non-childbearing potential is defined as having had one of the following: a tubal ligation at least 3 months prior to enrollment, a hysterectomy, an oophorectomy, or is post-menopausal).
- 7. Female volunteers of childbearing potential may be enrolled in the study, if all of the following apply:
- Practiced adequate contraception (see Definition of Terms, section 5.4.2.3.) for 30 days prior to challenge
- Has a negative urine pregnancy test on the day of DHIM
- Agrees to continue adequate contraception until two months after completion of the DHIM
- 8. Provide consent for release of medical history records from primary care physician, college or university medical center, urgent care, or emergency room visit
Exclusion Criteria:
- 1. Planned travel during the study period (180 days) which would interfere with the ability to complete all study visits
- 2. Recent (in the past 4 weeks) travel to any dengue endemic area. These potential volunteers may be eligible for enrollment a minimum of 4 weeks later
- 3. Volunteer seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
- 4. Unvaccinated volunteers positive for antibodies to flaviviruses (FV) to include dengue virus, West Nile virus, Yellow Fever virus, Zika virus, and Japanese encephalitis virus.
- 5. Any history of FV infection or FV vaccination except for participation in the ADVP003 or ADVP004 dengue vaccination studies; during the study period (Note: Late time point serology from the trials can be tested concomitant to screening serology to clarify if incident FV infection has occurred between vaccination and challenge)
- 6. Medical history of, or current, diabetes, chronic obstructive pulmonary disease, peptic ulcer disease, coronary artery disease, cardiac arrhythmia, cardiomyopathy, pericarditis, or auto-immune disease
- 7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- 8. History of Guillain-Barré syndrome (GBS)
- 9. History of bipolar disorder, schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the volunteer from participating in the study
- 10. Safety laboratory test results at screening that are deemed clinically significant or more than Grade 1 deviation from normal with the exception of PT/PTT, fibrinogen decrease, ALT/AST increase (<1.1 x ULN acceptable), platelet decrease which will be exclusionary at Grade 1 or higher
- 11. Significant screening physical examination abnormalities at the discretion of the investigator, including a BMI > 35 kg/m2
- 12. Women who intend to become pregnant or men who intend to father a child during the study period (approximately 6 months)
- 13. Female: pregnant, lactating or history of heavy menstrual bleeding menstrual periods lasting consistently and regularly longer than 6 days, or consistently and regularly requiring 5 or more pads or tampons per day, and volunteer to the opinion and review of the investigator.
- 14. Female volunteers using an intrauterine device (IUD) or Mirena®
- 15. Female volunteers with a history of clinically significant fibroids or uterine polyps, endometriosis, dysmenorrhea, adenomyosis, and uterine scarring (e.g. after D&C), unless treated, with no active clinically significant disease
- 16. Allergy (hives, shortness of breath, swelling of the lips or throat), or hospitalization related to a previous vaccination, anaphylaxis of unknown etiology, or allergy to specific medications/animals for which antigens may be in the virus preparations to include: Shellfish allergy, Fetal Bovine Serum, L-Glutamine, Neomycin and Streptomycin
- 17. Recent blood donation within prior 56 days of inoculation or planning to donate blood in the one 1 year following inoculation with dengue virus
- 18. Receipt of blood products or antibodies within 90 days of inoculation or during the study period
- 19. Any personal beliefs that bar the administration of blood products, transfusions, or serum albumin
- 20. Participation in the 4 weeks preceding inoculation, or planned participation during the present trial period, in another clinical trial investigating a vaccine except for participation in the ADVP003 or ADVP004 study, drug, medical device, or medical procedure
- 21. Planned administration of a licensed or study vaccine not planned in the study protocol during the period starting 30 days prior to the DHIM for a live vaccine or 14 days prior to DHIM for inactivated vaccines and extending until 56 days after study completion
- 22. Planned or current administration of an HMG-CoA reductase inhibitor (i.e., lovastatin, simvastatin, atorvastatin, etc.)
- 23. Currently taking methadone or suboxone
- 24. Currently regularly taking anti-coagulant medication, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
- 25. Chronic migraine headaches, defined as more than 15 headache days per month over a 3-month period of which more than 8 are migraines, in the absence of medication over use
- 26. Chronic or recent acute medical condition that, in the opinion of the investigator, impacts volunteer safety.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Dengue 1 Live Virus Human Challenge (DENV-1-LVHC)
open-label injection of DENV-1-LVHC to 15-20 adults who were previously vaccinated and 5 adults who have never received a dengue vaccination
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one subcutaneous injection of Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) at 0.5 mL of 6.5 x 10^3 PFU/mL
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
비정상적인 실험실 측정의 발생률
기간: 약 6개월
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바이러스 접종 후 28일 또는 입원 후 7일 중 더 늦은 시점까지 비정상적인 실험실 측정의 발생률
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약 6개월
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Solicited Injection Site Adverse Events
기간: approximately six months
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solicited injection site adverse event until 7 days post virus inoculation
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approximately six months
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Unsolicited Injection Site Adverse Events
기간: approximately six months
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unsolicited injection site adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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approximately six months
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Solicited Systemic Adverse Events
기간: approximately six months
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solicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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approximately six months
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Dengue-Related Adverse Events
기간: approximately six months
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dengue-related like adverse events until 28 days post virus inoculation or 7 days post inpatient whichever is later
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approximately six months
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Unsolicited Systemic Adverse Events
기간: approximately six months
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unsolicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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approximately six months
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Short-Term SAEs
기간: approximately six months
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Number of SAEs until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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approximately six months
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Long-Term SAEs
기간: approximately seven months
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Number of SAEs until 6 months post virus inoculation
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approximately seven months
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Fever
기간: approximately seven months
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The occurrence of fever defined as greater than or equal to 38°C (100.4°
F) measured at least 2 times at least 4 hours apart
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approximately seven months
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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)
2020년 11월 30일
기본 완료 (실제)
2021년 7월 9일
연구 완료 (실제)
2021년 7월 9일
연구 등록 날짜
최초 제출
2020년 11월 24일
QC 기준을 충족하는 최초 제출
2021년 3월 3일
처음 게시됨 (실제)
2021년 3월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 10월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 10월 27일
마지막으로 확인됨
2021년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HP-00088798
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
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. .
Dengue 1 Live Virus Human Challenge (DENV-1-LVHC)에 대한 임상 시험
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U.S. Army Medical Research and Development CommandState University of New York - Upstate Medical University완전한
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State University of New York - Upstate Medical...Walter Reed Army Institute of Research (WRAIR); U.S. Army Medical Research and Development...모집하지 않고 적극적으로
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