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

NCT06959563 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 6 other identifiers: IND 169135NPI-1831468511NPI-1023387701FWA00015357IORG0007849IRB00009424
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Treat Infection of Multiple HPV Virus Strains via Trained Immunity.
2. 2.Activate human HPV Antigen Presentation Reaction.
3. 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.

Conditions

HPV Infection

Keywords

HPV; Antigen Presentation; APC; IGRA; Trained Immunity; Innate Immune Memory; Cervical

Outcome Measures

Primary Outcomes (3)

• 20 HPV Participants with HPV testing by standard PCR assay

  Negative testing HPV by standard PCR assay after percutaneous 21 days

  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

  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

  Duration at least 28 days

Study Arms (1)

Assess for HPV Antigen Presentation

EXPERIMENTAL

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

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

Interventions

9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use BIOLOGICAL

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

Also known as: 9vHPV Vaccine plus BCG Organism Mix

Assess for HPV Antigen Presentation

Eligibility Criteria

• Age: 24 Years - 64 Years
• Gender Eligibility Details: Cervical is a female organ.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair: lead
• UnitedHealthcare: collaborator

Study Sites (1)

Medicine Invention Design, Inc.

Rockville, Maryland, 20853, United States

Location

Related Links

• IORG0007849
• IRB00009424
• FWA00015357

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Han ID Xu, MD/PhD/FAPCR

  Medicine Invention Design Incorporation

  STUDY CHAIR

• Han Xu, MD/PhD/FAPCR

  Medicine Invention Design Incorporation

  STUDY DIRECTOR

• Han Xu, MD/PhD/FAPCR

  Medicine Invention Design Incorporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Model Details: Single Group Assignment * Single Usage * Single Dosage

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)