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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 20 HPV Participants with HPV testing by standard PCR assay
Study Overview
Brief Summary
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.
Detailed Description
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Open Label
Eligibility Criteria
- Ages
- 24 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Assess for HPV Antigen Presentation
Therapeutic Biological Product Mix activity 9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG
Intervention: 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use (Biological)
Outcomes
Primary Outcomes
20 HPV Participants with HPV testing by standard PCR assay
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
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