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临床试验/NCT03451071
NCT03451071已完成4 期

Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2019年4月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
195
试验地点
1
主要终点
Patient Indication of Willingness to Accept the Vaccine Based on Survey

研究概览

简要总结

Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
16 Years 至 26 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital
  • •Exclusion criteria
  • •Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid use, preeclampsia, non-English speaking

排除标准

  • 未提供

研究组 & 干预措施

Gardasil9

Experimental

干预措施: Gardasil9 (Drug)

结局指标

主要结局

Patient Indication of Willingness to Accept the Vaccine Based on Survey

时间窗: 1 day (at the time of initial recruitment /survey)

This was established using a survey to indicate willingness to receive vaccine.

次要结局

  • Serum Titers of Vaccine-specific HPV Types(baseline and 7 months)
  • Uptake of the Vaccine Doses(at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haller Smith

Professor

University of Alabama at Birmingham

研究点 (1)

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