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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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. 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.

Eligibility

Primary outcome measure(s)

• 20 HPV Participants with HPV testing by standard PCR assay — Duration at least 28 days
  Negative testing HPV by standard PCR assay after percutaneous 21 days
• 20 HPV Participants with IGRA blood test with HPV protein antigen — Duration at least 28 days
  Positive IGRA blood test with HPV protein antigen after percutaneous use 21 days
• 20 HPV Participants with IGRA blood test with TB antigens — 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

Trial sites (1)

More Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair trials in the USA

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