Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease
研究概览
详细说明
Although guidelines exist for immunization of patients with inflammatory bowel disease, few studies exist demonstrating vaccine efficacy in this population. In patients with inflammatory bowel disease, lower than normal humoral responses have been shown with the tetanus toxoid booster, oral cholera, and influenza vaccinations. It is currently uncertain whether women with inflammatory bowel disease (IBD) have an increased risk of cervical dysplasia and cancer. Gardasil, a vaccine against human papilloma viruses (HPV) 6, 11, 16, and 18, has been approved for the prevention of cervical dysplasias and cancers in women ages 9-26 years. However, its immune response in immunocompromised or immunosuppressed patients is unknown.
Young women with inflammatory bowel disease who have not received the HPV vaccine will receive the vaccine. The vaccine is given in 3 doses over 6 months. Response to the vaccine will be measured 6 months after completing the vaccine series.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women 9-26 years of age
- Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)
Exclusion Criteria:
- Pregnancy
- Taking corticosteroids
- Allergy to yeast aluminum component of the HPV vaccine
- Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Human Papillomavirus Vaccine
The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
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0.5mL intramuscular for 3 doses at 0, 2, and 6 months
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])
大体时间：One year
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Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).
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One year
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Human Papillomavirus Vaccine的临床试验
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Arash Asher, MDVoxxLife完全的
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SENAI CIMATEC招聘中
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Imperial College LondonCambridge University Hospitals NHS Foundation Trust; University of Edinburgh; University of Manchester 和其他合作者终止
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University of ConnecticutUnited States Department of Defense; AMP Human; Park City, UT完全的
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University of ConnecticutUnited States Department of Defense; AMP Human; Park City, UT完全的