Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV

Study Overview
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Brief Summary
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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
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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 PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours Our trial duration will be 12-week duration. 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix By the percutaneous route with the multiple puncture device Our trial duration will be 12-week duration Negative testing HPV by standard PCR assay after percutaneous 21 days

Official Title
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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.

Conditions
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HPV Infection

Intervention / Treatment
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* Biological: 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use


Participation Criteria
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Eligibility Criteria
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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 PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours. Exclusion Criteria: Pregnant Thrombosis Allergy PPD positive participant is 10 TU skin test reading > 5 mm induration at 48 hours Symptoms of HPV infection Clinical signs suggestive of other infection Symptoms suggestive of other infection Clinical signs indicative of oncology Evidence of critical illness

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Single Usage Single Dosage
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assess for HPV Antigen Presentation Therapeutic Biological Product Mix activity<br>9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG | Biological: 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use<br>* By the percutaneous route with the multiple puncture device 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix<br>* Other names: 9vHPV Vaccine plus BCG Organism Mix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20 Participants with HPV testing by standard PCR assay | Negative testing HPV by standard PCR assay after percutaneous 21 days | Duration at least 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Antigen Presentation, APC, Trained Immunity, Innate Immune Memory, Cervical