NCT01386164已完成4 期
Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA)
研究概览
简要总结
The purpose of this study is to analyze and compare the immunogenicity of Bivalent and Tetravalent vaccines against Human Papillomavirus in HIV-infected adult persons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •HIV positive subjects.
- •Age above 18 at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •Subjects whom the investigator believes can and will comply with the requirements of the protocol.
- •If currently on antiretroviral therapy (ART), subjects must be compliant to triple therapy (highly active ART) and have undetectable viral load for a period of six months prior to study entry.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject has a negative pregnancy test at screening and on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period.
排除标准
- •Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 12).
- •Pregnant or breastfeeding female.
- •Previous enrollment in the study.
- •Subjects whom the investigator believes cannot and/or will not comply with the requirements of the protocol (i.e. because of abuse of drugs or alcohol, dementia or given medical, psychiatric, social or work related conditions).
- •Chronic administration of immunosuppressive drugs
- •Cancer or autoimmune disease
- •Previous allergic reaction to vaccination
- •Known allergy towards on or more components of either of the test drugs.
结局指标
主要结局
Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA)
时间窗: Day 0, Day 45, Day 180, Day 210 and Day 365
次要结局
- Geometric mean titres of serum HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58 antibody measured by Pseudovirion-Based Neutralization Assay (PBNA)(Day 0, Day 45, Day 180, Day 210 and Day 365)
- Avidity of HPV-16 and -18 serum antibodies measured by ELISA(Day 0, Day 45, Day 180, Day 210 and Day 365)
- Frequencies of HPV-16 and HPV-18 T-cells measured by flow cytometry(Day 0, Day 45, Day 180, Day 210 and Day 365)
- Frequencies of HPV-16 and -18 specific B-cells measured by B-cell ELISPOT(Day 0, Day 45, Day 180, Day 210 and Day 365)
- B-cell profile measured by Flow cytometry(Day 0, Day 45, Day 180, Day 210 and Day 365)
- Secretion of pro- and antiinflammatory cytokines from PBMC's stimulated with innate stimuli measured by Luminex or Elisa(Day 0, Day 45, Day 180, Day 210 and Day 365)
- Type-specific HPV-DNA from cervical and genital swab material(Day 0 and Day 210)
- CD4 cell count and HIV viral load(Day 0, Day 45, Day 180, Day 210 and Day 365)
- Geometric mean titres of HPV-16 and HPV-18 and total Immunoglobulin G (IgG) titers in cervicovaginal secretion (CVS) from female participants(Day 0, Day 210 and Day 365)
- Occurrence and intensity of solicited local symptoms(Day 0-6 after each vaccination)
- Occurrence, intensity and relationship to vaccination of solicited general symptoms(Day 0-6 after each vaccination)
- Occurrence of SAEs(Throughout the active phase of the study (up to Day 210))
- Occurrence of clinically relevant abnormalities in hematological and biochemical parameters(Throughout the active phase of the study (up to Day 210))
- Geometric mean titres of serum HPV-6 and HPV-11 antibody measured by a competitive Luminex immunoassay (cLIA)(To be measured at day 0, day 45, day 180, day 210 and day 365)
- % of participants seropositive for anti-HPV-6, -11 -18, -31, -33, -45, -52 and -58(Day 0, Day 45, Day 180, Day 210, Day 365)
研究者
研究点 (2)
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