A Single-Arm, Open-Label Pilot Study of the Safety and Immunogenicity of the Merck Quadrivalent Human Papillomavirus Vaccine Among HIV-Positive Women in India
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
研究概览
简要总结
RATIONALE: Vaccines made from virus proteins may help the body build an effective immune response to prevent cervical cancer.
PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine and how well it works in preventing cervical cancer in women in India with HIV-1 infection.
详细描述
OBJECTIVES:
Primary
- Assess the safety of the Gardasil® quadrivalent human papillomavirus (HPV) (types 6, 11, 16,18) virus-like-particle vaccine with vs without prior exposure to one or more of the HPV types in the vaccine in HIV-positive women in Chennai, India.
- Determine the effect of the vaccine on HIV viral load and CD4+/CD8+ levels in these patients.
- Determine the proportion of these patients who respond serologically to the HPV vaccine and the kinetics of their response.
Secondary
- Determine the prevalence and incidence of cervical intraepithelial neoplasia in these patients.
- Determine the spectrum of cervical HPV types in these patients at baseline, 9 months, and 1 year after vaccination.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot before study entry
- •HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
- •Meets 1 of the following criteria:
- •Nadir CD4 level of ≤ 350 cells/mm³ and receiving highly active antiretroviral therapy (HAART) for at least 6 months before study entry
- •Nadir CD4 level of > 350 cells/mm³ and not receiving HAART at the time of study entry
- •No known history of high-grade CIN or cervical cancer
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •ANC > 750 cells/mm³
- •Hemoglobin ≥ 9.0 g/dL
- •Platelet count ≥ 100,000/mm³
- •Serum creatinine ≤ 3 times upper limit of normal (ULN)
- •AST and ALT ≤ 3.0 times ULN
- •Conjugated (direct) bilirubin ≤ 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the site Investigator
- •No serious illness requiring systemic treatment and/or hospitalization within the past 45 days
- •No allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 45 days since prior systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin
- •Routine standard of care, including hepatitis B, influenza, and tetanus vaccines are allowed
排除标准
- 未提供
结局指标
主要结局
Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
时间窗: 52 weeks from study entry
Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28
时间窗: Week 28
Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline
Number of Patients With Detectable Antibodies to HPV-6
时间窗: 28 weeks
Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline
Number of Patients With Detectable Antibodies to HPV-18
时间窗: 28 weeks
Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline
Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count
时间窗: Screening/Week 0, Weeks 2, 10, 26, and 52.
Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests
Number of Patients With Detectable Antibodies to HPV-11
时间窗: 28 weeks
Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline
Number of Patients With a Significant Increase in HIV Viral Load
时间窗: Screening/week 0, weeks, 2, 10, 26 and 52
Number of patients with a significant increase in HIV viral load defined as \> 1 log increase in HIV load from baseline on 2 consecutive occasions
次要结局
未报告次要终点