Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- A single application of an immune modulating gel will enhance the protective response against hepatitis B disease when vaccination is given at the same time as gel as evidenced by increased HB antibody and T-cell response.
研究概览
简要总结
This study will look at what happens to the level of protection against hepatitis B (HB) disease if a 'helper' gel is applied to the skin over the injection site of a small dose of hepatitis B vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously vaccinated with conventional hepatitis B vaccine series 10 or more years ago
- •Generally healthy
- •Is and has been free of HB disease and/or is negative to core antibody
- •Known to have sero-converted to positive after vaccine series (without extra doses)
- •Speaks and understands English adequately
- •Available for all 4 visits within the designated timelines (30 days)
- •No allergies to HB vaccine or components
- •No blood or blood components within previous 6 months
- •Not pregnant or breastfeeding
排除标准
- 未提供
研究组 & 干预措施
1
2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds.
干预措施: Resiquimod gel (Biological)
2
3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds.
干预措施: Resiquimod gel (Biological)
3
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds.
干预措施: Resiquimod gel (Biological)
结局指标
主要结局
A single application of an immune modulating gel will enhance the protective response against hepatitis B disease when vaccination is given at the same time as gel as evidenced by increased HB antibody and T-cell response.
时间窗: at 30 days after vaccination
次要结局
- Minimal adverse effects to gel application as noted by laboratory assessment of liver enzyme and complete blood count (CBC) and physical assessment of the site/surrounding area and solicited local and general post vaccine events.(at 7 and 30 days post vaccine)