NCT02910284已完成不适用
A Long-term Follow-up Study of Efficacy and Immunogenicity of GEN-003 in Subjects With Genital Herpes Simplex Virus Type 2 (HSV-2) Infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 13
- 主要终点
- Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (magnitude of HSV-2 viral shedding by PCR)
研究概览
简要总结
This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of Study GEN-003-002
- •Receipt of at least 1 dose of GEN-003 (any dose combination) in Study GEN-003-
- •Collection of at least 45 of 56 anogenital swabs during the Month 11 to 12 swab collection period in Study GEN-003-
- •Willing and able to provide written informed consent.
- •Willing to perform and comply with all study procedures, including attending clinic visits as scheduled.
- •For each swab collection period, willing to not use HSV-2 antiviral therapy from 14 days before the swab collection period through the end of the period.
排除标准
- •Any important protocol deviation in Study GEN-003-
- •Use of HSV-2 antiviral therapy within 14 days before the beginning of Swab Collection Period
- •Use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of Swab Collection Period
- •Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days before the beginning of Swab Collection Period
- •Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months before the Visit 1, any dose of corticosteroids within 30 days before Visit 1, or high-dose inhaled corticosteroids [>960 µg/day of beclomethasone diproprionate or equivalent]) or other immunosuppressive agents.
- •Presence or history of autoimmune disease, regardless of current treatment.
- •Receipt of a vaccine containing HSV-2 antigens other than GEN-
- •Pregnant women.
- •History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
- •Onset of an AESI since Month 12 in study GEN-003-
- •Other active, uncontrolled comorbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
结局指标
主要结局
Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (magnitude of HSV-2 viral shedding by PCR)
时间窗: Up to 48 months post-dose
Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (percent of anogenital swabs positive for HSV-2 DNA by PCR)
时间窗: Up to 48 months post-dose
次要结局
- Long-term immune responses to GEN-003 (Serum IgG levels assessed by ELISA)(Up to 48 months post-dose)
- Long-term immune responses to GEN-003 (Serum HSV-2 neutralizing antibody levels assessed by a colorimetric neutralization assay)(Up to 48 months post-dose)
- Long-term effect of GEN-003 on HSV-lesion rate (percent of days with genital lesions present) during the swab collection periods(Up to 48 months post-dose)
- Long-term immune responses to GEN-003 (Spot-forming units (SFUs), fold rise, responder rate assessed by GrB ELISPOT)(Up to 48 months post-dose)
研究者
研究点 (13)
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