Human Papillomavirus Antibody Response After GARDASIL 9 Vaccination in Patients After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7)
研究概览
简要总结
This phase IV trial studies how well Gardasil 9 vaccine works in preventing human papillomavirus (HPV) infection in patients with hematologic malignancies who are undergoing donor stem cell transplant. Vaccines, such as Gardasil 9, may help the body build an effective immune response to kill cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine the immunogenicity of recombinant human papillomavirus nonavalent vaccine (GARDASIL 9) administered after allogeneic stem cell transplant (SCT) in patients with hematologic malignancy by comparing HPV 9-plex competitive Luminex immunoassay (9-plex cLIA) titers before and after GARDASIL 9 administration.
II. To evaluate the safety and tolerability of GARDASIL 9 administered after allogeneic SCT in patients with hematologic malignancy.
OUTLINE:
Patients undergo standard of care allogeneic stem cell transplant. 6-12 months following transplant, patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) on day 0 and at 2 and 6 months in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All English-speaking adult MD Anderson patients with hematologic malignancy at 6-12 months +/- 8 weeks post allogeneic stem cell transplantation who will receive usual post-stem cell transplant vaccinations
- •All patients from approved protocol 2015-0795 will be invited to this vaccine study
排除标准
- •Prior allogeneic SCT
- •Platelet count less than or equal to 25,000 K/uL
- •Absolute neutrophil count less than or equal to 500/uL
- •Patients who have ever received HPV vaccination (at least one dose of HPV vaccine)
- •Patients with a prior history of HPV-related malignancy
- •Female patients who tested positive for pregnancy during pre-SCT evaluation
研究组 & 干预措施
Prevention (Gardasil 9 vaccine)
Patients undergo standard of care allogeneic stem cell transplant. 6-12 months following transplant, patients receive recombinant human papillomavirus nonavalent vaccine IM on day 0 and at 2 and 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Recombinant Human Papillomavirus Nonavalent Vaccine (Biological)
结局指标
主要结局
Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7)
时间窗: At 1 month post-dose 3
Antibody response at 1 month post-dose 3 (month 7) will be compared with baseline antibody level. The study will use results from the 9-plex competitive Luminex immunoassay (9-plex cLIA) test to estimate the antibody response rate at dose 3 with 95% confidence interval (CI). Will apply Student t-test/Wilcoxon test to compare continuous variables between patients who obtained antibody response as defined in the primary endpoint (responders) and those who did not respond (non-responders), and the chi-square test or the Fisher's exact test to assess the association between response status and patients' demographic and clinical characteristics. Logistic regression analysis will be used to assess the multivariate relationship between patient demographic and clinical characteristics on the probability of antibody response.
次要结局
- Antibody persistence at 6 months post-dose 3(At 6 months post-dose 3)
- Human papillomavirus (HPV) vaccination completion rate(Up to 3 days post-intervention)
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03(Up to 3 days post-intervention)
- Estimation of antibody titers(At 6-12 months post-transplant, and at 1 and 6 months post-dose 3)