A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 16
- 主要终点
- Percentage of Days With Genital Herpes Lesions
研究概览
简要总结
The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.
详细描述
This study is a randomized, double-blind, placebo-controlled clinical trial of GEN-003 in subjects who have received previous doses of GEN-003 in the GEN-003-003 clinical trial. Eligible subjects will be randomized in a 1:1 ratio to receive 1 intramuscular (IM) dose (the maintenance dose) of GEN-003 or placebo.
Subjects will use a daily electronic reporting tool for reporting the presence or absence of genital herpes lesions, and severity of genital herpes symptoms.
GEN-003-005 was originally designed to follow subjects for 12 months after the maintenance dose but a business decision, unrelated to product safety, was made by Genocea Biosciences in 3Q2017 to cease GEN-003 spending and activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Study GEN-003-003
- •Received all 3 GEN-003 doses (any dose combination) in Study GEN-003-003
- •Received last dose of GEN-003 within 11 to 18 months prior
- •Reported data in the daily electronic reporting period on at least 80% of days in Study GEN-003-003
- •Collected at least 45 swabs (of 56 total expected swabs) during the Month 11 to 12 swab collection period in Study GEN-003-003
- •Willing and able to provide written informed consent
- •Willing to perform and comply with all study procedures
- •Postmenopausal or willing to practice a highly effective method of contraception for 28 days before and 90 days after enrollment
排除标准
- •Did not meet all eligibility criteria in Study GEN-003-003, or received incorrect treatment in Study GEN-003-003
- •Use of suppressive antiviral medication within 14 days prior
- •Use of topical steroids or antiviral medication in the anogenital region within 14 days prior
- •Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV recurrence frequency or intensity within 14 days prior
- •History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
- •Immunocompromised individuals
- •Diagnosis or suspicion of an AESI
- •Diagnosis or suspicion of any other autoimmune disease not listed in Appendix 4 of the protocol
- •Vaccine-related SAE in GEN-003-003
- •Known current infection with HIV or hepatitis B or C virus
- •History of hypersensitivity to any component of the vaccine
- •Prior receipt of another vaccine containing HSV-2 antigens other than GEN-003
- •Receipt of any IP within 30 days prior to the maintenance dose of GEN-003/placebo
- •Receipt of any blood product within 90 days prior to the maintenance dose
- •Receipt of a live vaccine within 28 days prior to or any other vaccine within 14 days prior to maintenance dose
- •Planned use of any vaccine from the maintenance dose to 28 days after the maintenance dose
- •Pregnant or nursing women
- •History of drug or alcohol abuse
- •Other active, uncontrolled comorbidities
- •Changes to medication used to manage an underlying comorbidity within 60 days prior
研究组 & 干预措施
GEN-003
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
干预措施: Matrix-M2 (Biological)
Placebo
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
干预措施: 0.9% normal saline (Other)
GEN-003
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
干预措施: GEN-003 (Biological)
结局指标
主要结局
Percentage of Days With Genital Herpes Lesions
时间窗: The 6-month period after vaccination
Subject-reported via electronic diary
次要结局
- Duration of Genital Herpes Recurrences(The 6-month period after vaccination)
- Number of Genital Herpes Recurrences(The 6-month period after vaccination)
- Number of Subjects Without Genital Herpes Recurrence(6 months after vaccination)
- Days Until First Genital Herpes Recurrence(The 6-month period after vaccination)