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Active, Not Recruiting

NCT Number: NCT06959563

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

24 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Medicine Invention Design, Inc.

Rockville, Maryland, 20853, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: 9vHPV Vaccine plus BCG Organism Mix

Primary outcomes

  1. 20 HPV Participants with HPV testing by standard PCR assay

    Time frame: Duration at least 28 days

    Negative testing HPV by standard PCR assay after percutaneous 21 days

  2. 20 HPV Participants with IGRA blood test with HPV protein antigen

    Time frame: Duration at least 28 days

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

  3. 20 HPV Participants with IGRA blood test with TB antigens

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • UnitedHealthcare

Registry information

Official study title

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

Acronym: 9vHPV-BCG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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