Improving Rotavirus Vaccine Immune Response
2013년 4월 4일 업데이트: International Centre for Diarrhoeal Disease Research, Bangladesh
Improving the Immune Response to Rotavirus Vaccine
Rotavirus is the leading cause of severe gastroenteritis in infants and young children worldwide and is estimated to account for 600,000 deaths in children <5 years of age.
However, live oral enteric vaccines (e.g.
OPV, cholera vaccines, typhoid vaccine) have been less immunogenic in poor communities with high levels of malnutrition and poor sanitation.
Rotavirus vaccines also appear to be less immunogenic in the setting where they are most needed.
High maternal antibody (IgG) to rotavirus and breast feeding near the time of vaccination may inhibit rotavirus vaccine effectiveness.
We propose a quick study to look at practical ways to improve the immunogenicity of rotavirus vaccine in our own setting in Bangladesh.
The objectives are to assess if delaying Rotarix vaccination will improve the immune response to the vaccine and to assess if avoiding breastfeeding in the 45 minutes before and after vaccine administration will improve the immune response to administration of Rotarix vaccine.
The study will be conducted in the urban Dhaka Mirpur Community, a setting where previous rotavirus vaccine immunogenicity studies have been successfully conducted.
A total of 300 infant will be randomly assigned to one of the following groups: 1) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
2) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
3) Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
4) Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Blood and stool samples will be collected from infants and breast milk from mothers.
The primary outcome is to determine the sero-conversion rate of anti-rotavirus IgA in different groups of infants.
연구 개요
상태
완전한
상세 설명
The study will be conducted in a suburb of Dhaka in the area of Mirpur. Mirpur is one of the 14 Thanas of Dhaka cities with a population of about one million in an area of 59 square kilometers. Mirpur Thana of Dhaka city is divided into several sections. There are 14 sections in Mirpur Thana. The area is densely populated and located 20 minutes away from the lCDDR,B's Dhaka Hospital . The population is stable with low socioeconomic conditions. The average income in the slum areas of Mirpur is Tk.4200 (about US $ 62) per month per family. 25% of fathers and 15% of mothers have more than 5 years of formal education. The study will be conducted in section 11 and 12 of Mirpur which has a population of about 500,000. We recently conducted phase I and II of the rotavirus vaccine study in this site. Several other studies (phase II ETEC, killed cholera vaccine) are ongoing in this area. Children will be identified through active surveillance of new births in the community and the study subjects will be recruited through home visits by the locally recruited field workers.
2.2 .Design : Randomized intervention trial
Study groups:
- Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
- Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
- Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
- Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Samples collected:
- Blood draw at the time of first dose of Rotavirus vaccine and 4 weeks after the second dose
- Breast milk sample at 6 weeks for the mothers in study groups A and B, and at 14 weeks for mothers in study groups C and D (see below for groups).
- Stool sample prior to dose one and on day 3 and 7 after each dose to look for vaccine virus shedding
연구 유형
중재적
등록 (실제)
300
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Dhaka, 방글라데시, 1216
- Mirpur
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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
1개월 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- male or female,
- aged 6 weeks at the time of enrollment,
- written informed consent,
- free of chronic or serious medical condition as determined by history and physical exam and plan to stay in community for at least 6 months
Exclusion Criteria:
- fever (>38 C),
- acute or chronic illness,
- use of antimicrobial drug within previous 14 days,
- hypersensitivity to any of the vaccine components (see vaccine composition),
- use of any investigational drug during previous 30 days,
- any uncorrected congenital malformation of the gastrointestinal tract,
- use of any immunosuppressing drugs during the last 14 days (likelihood is remote),
- any evidence by physical exam of immunosuppresing condition,
- administration of gamma globulin or any other blood product,
- previous intussusception or abdominal surgery.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 6 weeks RV & normal breast feeding
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
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Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
|
실험적: 6 weeks RV & delayed breastfeeding
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
|
실험적: 14 weeks RV & Normal breastfeeding
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
|
실험적: 14 weeks RV & delayed breastfeedin
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
|
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus.
Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Immunogenicity of Rotavirus Vaccine
기간: 24 months
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Sero-conversion rate of anti-rotavirus IgA
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24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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anti-rotavirus IgA
기간: 24 months
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Geometric mean concentration of anti-rotavirus IgA Enterovirus excretion in children at the time of vaccination
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24 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
2010년 7월 1일
기본 완료 (실제)
2011년 4월 1일
연구 완료 (실제)
2011년 12월 1일
연구 등록 날짜
최초 제출
2013년 4월 2일
QC 기준을 충족하는 최초 제출
2013년 4월 4일
처음 게시됨 (추정)
2013년 4월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 4월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 4월 4일
마지막으로 확인됨
2009년 12월 1일
추가 정보
이 연구와 관련된 용어
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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