Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells
研究概览
简要总结
Vaccines for human papillomavirus (HPV) have been available in the United States since 2006. Early studies have shown a high rate of effectiveness of these vaccines, however it is not known how long this protection will last. The IMAP study will look at various parts of the immune system and potential markers for long lived immune responses to this vaccine.
详细描述
Three groups of patients will be recruited for this study. One group will be women who have completed all three vaccinations. The second group will be women who are overdue for their final vaccination. We also recruit women who have not been vaccinated previously.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female ages 18-26 inclusive (18-30 for women who have been previously vaccinated
- •If sexually active and enrolled in unvaccinated group, must use a reliable form of birth control for the first seven months of the study. For the purposes of this protocol a reliable form will be hormonal or barrier contraception. Intrauterine devices and a history of sterilization will also be considered reliable forms of birth control. Abstaining from sex is also a reliable form of contraception.
- •Able to give informed consent
- •Negative urine pregnancy test at enrollment
排除标准
- •Currently pregnant, breast feeding or planning a pregnancy
- •Underlying immunological disease, such as previously diagnosed HIV infection or history of transplantation, history of splenectomy
- •Use of medications with potential immunological effects such as systemic corticosteroids or chemotherapy
- •Prior therapy for cervical dysplasia or cervical cancer such as loop excision, laser ablation, cryotherapy or hysterectomy
- •Unable to comply with protocol
- •Severe allergic reaction (e.g., anaphylaxis) after a previous vaccine dose or to a vaccine component
- •An acute illness, including an oral temperature of 100.4 degrees F within three days of visit
- •other more specific exclusions may apply to one of the three cohorts
研究组 & 干预措施
Previously received two doses of HPV vaccine
This group will consist of 78 women ages 18 to 30 who have received two doses of the HPV vaccine. The second dose must have been received six or more months ago.
干预措施: quadrivalent HPV vaccine (Drug)
结局指标
主要结局
To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells
时间窗: 2 years after first vaccination
次要结局
未报告次要终点