NCT00710593已完成2 期
Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 27
- 主要终点
- HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 23 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Young women age 16 years and 0 days to 23 years and 364 days
- •HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA polymerase chain reaction (PCR), or plasma HIV-1 RNA > 1,000 copies/ml
- •HIV treatment history that falls in one of the following categories:
- •Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry
- •Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on antiretroviral (ARV) medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.
- •Anticipated ability and willingness to complete all study vaccines and evaluations
- •Ability and willingness to participate in the study by providing written informed consent
排除标准
- •History of any prior vaccination with an HPV vaccine
- •Active anogenital warts within three months prior to study entry) or history of cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)
- •Previous allergic reaction to any constituents of the HPV vaccine
- •Pregnancy
- •Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
- •Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
- •Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
- •Receipt of any routine vaccine within four weeks prior to study entry
- •Receipt of any immune globulin or plasma product within six months prior study entry
- •Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
- •Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry
- •Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry
- •Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection
- •Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of prednisone or equivalent for > 2 consecutive weeks)
- •Receipt of corticosteroid therapy at the above dose and duration within 3 months preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or topical corticosteroids are not exclusion criteria
- •Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy
- •If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment
结局指标
主要结局
HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)
时间窗: Week 28
The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.
HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)
时间窗: Week 28
The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.
HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)
时间窗: Week 28
The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.
HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)
时间窗: Week 28
The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.
次要结局
- Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11(Week 28)
- Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.(Week 48)
- Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).(Week 48)
- Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).(Week 48)
- Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6(Week 28)
- Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.(Week 48)
- Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.(Week 48)
- Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).(Week 24)
- Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).(Week 48)
- Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure)(Week 48)
- Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine(Entry, Week 8, and Week 24)
- Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.(Week 48)
- Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).(Week 48)
- Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).(Week 24)
- Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.(Day 1 through Week 24)
- Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16(Week 28)
- Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18(Week 28)
- Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).(Week 24)
- Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).(Week 24)
- Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination(Week 48)
- Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).(Day 1 through Week 24)
研究者
研究点 (27)
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