HPV Infection
Conditions
Keywords
HPV, Antigen Presentation, APC, IGRA, Trained Immunity, Innate Immune Memory, Cervical
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. 1. Treat Infection of Multiple HPV Virus Strains via Trained Immunity. 2. Activate human HPV Antigen Presentation Reaction. 3. 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.
Interventions
BIOLOGICAL9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use
By the percutaneous route with the multiple puncture device - 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix
Sponsors
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
UnitedHealthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open Label
Intervention model description
Single Group Assignment * Single Usage * Single Dosage
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 64 Years
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
* Pregnant * Thrombosis * Bleeding * Allergy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 20 HPV Participants with HPV testing by standard PCR assay | 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 | 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 | 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 |
Countries
United States
Contacts
STUDY_CHAIRHan ID Xu, MD/PhD/FAPCR
Medicine Invention Design Incorporation
STUDY_DIRECTORHan Xu, MD/PhD/FAPCR
Medicine Invention Design Incorporation
PRINCIPAL_INVESTIGATORHan Xu, MD/PhD/FAPCR
Medicine Invention Design Incorporation
Outcome results
None listed