Safety and Efficacy of 4 Investigational HSV 2 Vaccines Administered by Intramuscular Route in Adults With Recurrent Genital Herpes Caused by HSV 2
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- Number of participants with unsolicited adverse events
研究概览
简要总结
The primary objectives of the study are:
- To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2).
- To evaluate the efficacy of the investigational vaccine regimens with respect to:
- the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule
- the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule
The secondary objectives of the study are:
- To describe the impact of each of the investigational vaccine regimens in terms of total number of days with genital lesion up to 6 months after vaccination 2 and number of recurrences 60 days after the second vaccination compared with the placebo group
- To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit plus 60 days following the second vaccination visit compared with the placebo group
- To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit compared with the placebo group
详细描述
Study duration per participant is approximately 16 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants with unsolicited adverse events
时间窗: Within 30 days after vaccination
An unsolicited adverse event is an event that does not fulfill the conditions prelisted in the Case Report Book in terms of diagnosis and/or onset post-vaccination
Number of participants with adverse events of special interest (AESIs)
时间窗: From Day 0 to Month 14
AESIs are collected throughout the study
Number of participants with medically-attended adverse events (MAAEs)
时间窗: From Day 0 to Month 14
An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department
Number of participants with serious adverse events (SAEs)
时间窗: From Screening to Month 14
SAEs are collected throughout the study
Genital HSV recurrence
时间窗: 6 months following the second vaccination
Proportion of participants free of genital HSV recurrence following the second vaccination
Number of participants with immediate adverse events
时间窗: Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination
Unsolicited systemic adverse events occurring immediately after vaccination
Number of participants with solicited injection site and systemic reactions
时间窗: Within 7 days after vaccination
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
Number of participants with out-of-range biological test results
时间窗: From Day 8 to Day 30
Out-of-range biological test results area assessed at Days 8 and 30 after each vaccination and 15 days prior to second vaccination in Part A and Days 8 and 30 after each vaccination in Part B
Viral genital shedding rate
时间窗: 60 days before first vaccination and 60 days after the second vaccination
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination and those collected after the second vaccination visit
次要结局
- Genital HSV recurrence(60 days following the second vaccination)
- Change in serum HSV 2-antibody levels(Before and 30 days after the first and second vaccinations and 6 months after the second vaccination)
- Viral genital shedding rate after the first and second vaccination(60 days before first vaccination, and 60 days after the first vaccination, plus 60 days after the second vaccination)
- Change in level of HSV 2-specific cellular immune responses(Before and 8 days after the first and second vaccination and 6 months after the second vaccination)
- Genital lesion rate(6 months after the second vaccination)
- Viral genital shedding rate after the first vaccination(60 days before and 60 days after the first vaccination)