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Active, not recruitingNCT069595639vHPV-BCGUpdated May 20, 2026

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

An Early Phase 1 interventional study of 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use in HPV Infection, sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. Active, not recruiting at 1 site in United States. Open to female participants aged 24 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Early Phase 1, Interventional, and Health services research

Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
24 Years to 64 Years
Sex
Female
01

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.
Read the detailed 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.
02

Conditions studied

  • HPV Infection

Keywords

  • HPV
  • Antigen Presentation
  • APC
  • IGRA
  • Trained Immunity
  • Innate Immune Memory
  • Cervical
03

In context

Papillomavirus Infections

576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.

This study's planned enrollment of 20 is below the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Assess for HPV Antigen Presentation

    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

  • Biological9vHPV 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

    Also known as: 9vHPV Vaccine plus BCG Organism Mix

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • Medicine Invention Design, Inc.
    Rockville, Maryland 20853, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06959563
Lead sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Collaborators
UnitedHealthcare
Responsible party
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair (M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair, Medicine Invention Design, Inc) — Sponsor-investigator
First posted
May 6, 2025
Start date
Apr 28, 2025
Primary completion
Oct 18, 2026 (estimated)
Completion
Oct 28, 2026 (estimated)
Last update
May 20, 2026

Study contacts

Han ID Xu, MD/PhD/FAPCR
study chair · Medicine Invention Design Incorporation
Han Xu, MD/PhD/FAPCR
study director · Medicine Invention Design Incorporation
Han Xu, MD/PhD/FAPCR
principal investigator · Medicine Invention Design Incorporation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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