A Safety and Immunogenicity Extension Study of GPNV-001
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serious adverse events
研究概览
简要总结
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.
详细描述
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completion of study GPNV-001 as per protocol with no significant deviations.
- •Has provided written informed consent.
排除标准
- •Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
- •A potential participant has had an episode of pneumonia since completing Study GPNV-001
研究组 & 干预措施
Gamma-PN3 50 mcg
In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks
干预措施: Gamma-PN3 (Biological)
Gamma-PN3 250 mcg
In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks
干预措施: Gamma-PN3 (Biological)
Gamma-PN3 1000 mcg
In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks
干预措施: Gamma-PN3 (Biological)
Pneumovax 23
In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later
干预措施: Pneumovax-23 (Biological)
Prevenar-13
In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later
干预措施: Prevenar-13 (Biological)
Placebo
In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.
干预措施: Placebo (Biological)
结局指标
主要结局
Serious adverse events
时间窗: 6 months and 12 months
Serious adverse events occurring after day 57 of study GPNV-001
Serum IgG titre to Gamma-PN3
时间窗: 6 months and 12 months
Serum IgG titre to the vaccine
次要结局
- Opsonophagocytic antibodies to pneumococcal strains(6 months and 12 months)