临床试验/NCT02837575

NCT02837575已完成2 期

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection

Vical30 个研究点分布在 1 个国家目标入组 261 人开始时间: 2016年9月1日最近更新: 2019年2月27日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Vical
入组人数: 261
试验地点: 30
主要终点: Lesion recurrences

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).

详细描述

To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•HSV-2 seropositive
•A minimum of 1 year of reported history of genital herpes with recurrences.

排除标准

•History of receiving an investigational HSV vaccine
•Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
•Pregnant or breastfeeding

结局指标

主要结局

Lesion recurrences

时间窗: Up to Day 450

次要结局

Proportion of subjects recurrence-free(Up to Day 450)
Number of participants with adverse events(Up to Day 450)
Time to first recurrence(Up to Day 450)

研究者

发起方

Vical

申办方类型

Industry

责任方

Sponsor

研究点 (30)

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