- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02154061
Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics (VAX-002)
Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics
The purpose of the study is to better understand how the use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu) vaccine.
In particular, the investigators will be looking at certain markers in blood after vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before vaccination.
There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days prior to vaccination and continue taking antibiotics the day of vaccination and one day after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine) and will not take any antibiotics.
The investigators hope to enroll 50 subjects at Emory.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30030
- Emory Vaccine Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy individuals aged 18-40 years.
- Able to understand and give informed consent.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after TIV vaccination
Exclusion Criteria:
- You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks.
- You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015.
- You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination.
- You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination.
- You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after
- You had an allergic response or sensitivity to past vaccinations.
- You have health conditions that weaken your body's ability to fight infections or you are taking drugs like steroids that weaken your body's ability to fight infections.(Some nasal and topical steroids are allowed.).
- You have a chronic medical problem including (but not limited to) insulin dependent diabetes, severe heart disease including arrhythmias, severe lung disease, auto immune diseases and or grade 4 uncontrolled hypertension.
- Chronic neurological conditions such as seizure disorder, Parkinson disease, myasthenia gravis, neuropathy, or histories of encephalopathy, meningitis or ototoxicity.
- Any history of gastrointestinal disease, kidney or liver diseases.
- Alcohol or drug abuse or psychiatric conditions that in the opinion of the investigator would compromise your participation in this trial.
- Pregnant or are breast feeding.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: IIV Flu Vaccine with Antibiotics
This arm will receive antibiotics prior and after IIV administration.
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This is an FDA approved and tested Inactivated Flu Vaccine.
다른 이름들:
This is a standard antibiotic
다른 이름들:
This is a standard antibiotic.
This is a standard antibiotic.
다른 이름들:
|
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활성 비교기: IIV Flu Vaccine
This arm will not take antibiotics in conjunction with IIV.
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This is an FDA approved and tested Inactivated Flu Vaccine.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
기간: At day 30
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Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples
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At day 30
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공동 작업자 및 조사자
스폰서
간행물 및 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
- IRB00074239
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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