Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV (9vHPV-BCG)

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

Status and phase: Active, not recruiting; Early Phase 1

Conditions: HPV Infection

Treatments: Biological: 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06959563

NPI-1831468511 (Registry Identifier)

IRB00009424 (Registry Identifier)

FWA00015357 (Registry Identifier)

IND 169135 (Registry Identifier)

NPI-1023387701 (Registry Identifier)

IORG0007849 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Assess for HPV Antigen Presentation

Experimental group

Description:

Therapeutic Biological Product Mix activity 9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG

Treatment:

Biological: 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use