Conducting an Early Phase Clinical Trial to Assess for HPV Antigen Presentation Therapeutic Biological Product Mix Activity That Suggests the Potential for Clinical Benefits of HPV Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 20 HPV Participants with HPV testing by standard PCR assay
研究概览
简要总结
Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients.
- Treat Infection of Multiple HPV Virus Strains via Trained Immunity.
- Activate human HPV Antigen Presentation Reaction.
- The human antigen presenting cells (APCs) can treat the HPV virus protein antigens into small peptide fragments, and then clear HPV virus in vivo.
详细描述
- Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients
- 20 Cervical HPV Infection Patients
- Positive testing HPV by standard PCR assay
- HPV infection without symptoms
- No clinical signs indicative of oncology
- TB negative participant is negative IGRA blood test with TB antigens
- 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix
- By the percutaneous route with the multiple puncture device
- Negative testing HPV by standard PCR assay after percutaneous 21 days
- Positive IGRA blood test with HPV protein antigen after percutaneous use 21 days
- Our trial duration will be 12-week duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 24 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of HPV patients.
- •20 Cervical HPV Infection Patients
- •Inclusion Criteria:
- •Cervical HPV Infection Patients
- •Positive testing HPV by standard PCR assay
- •HPV infection without symptoms
- •No clinical signs indicative of oncology
- •TB negative participant is negative IGRA blood test with TB antigens
排除标准
- •Thrombosis
- •TB positive participant is positive IGRA blood test with TB antigens
- •Symptoms of HPV infection
- •Clinical signs suggestive of other infection
- •Symptoms suggestive of other infection
- •Clinical signs indicative of oncology
- •Evidence of critical illness
研究组 & 干预措施
Assess for HPV Antigen Presentation
Therapeutic Biological Product Mix activity 9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG
干预措施: 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use (Biological)
结局指标
主要结局
20 HPV Participants with HPV testing by standard PCR assay
时间窗: Duration at least 28 days
Negative testing HPV by standard PCR assay after percutaneous 21 days
20 HPV Participants with IGRA blood test with HPV protein antigen
时间窗: Duration at least 28 days
Positive IGRA blood test with HPV protein antigen after percutaneous use 21 days
20 HPV Participants with IGRA blood test with TB antigens
时间窗: Duration at least 28 days
* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days
次要结局
未报告次要终点
研究者
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair
Medicine Invention Design, Inc