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

Early Phase 1Active Not RecruitingNCT06959563

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair20 enrolled

Overview

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.

* 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 Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

HPV Infection

Interventions

9vHPV Vaccine plus BCG Vaccine Mix for percutaneous useBIOLOGICAL

By the percutaneous route with the multiple puncture device - 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix

Eligibility

Sex: FEMALEMin age: 24 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Medicine Invention Design, Inc.

Rockville, Maryland, United States

Outcomes

Primary Outcomes

20 HPV Participants with HPV testing by standard PCR assay

Negative testing HPV by standard PCR assay after percutaneous 21 days

Time frame: Duration at least 28 days

20 HPV Participants with IGRA blood test with HPV protein antigen

Positive IGRA blood test with HPV protein antigen after percutaneous use 21 days

Time frame: Duration at least 28 days

20 HPV Participants with IGRA blood test with TB antigens

* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days

Time frame: Duration at least 28 days

Data from ClinicalTrials.gov

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