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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2026-09-28

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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HPV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

* Single Usage
* Single Dosage

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Open Label

Study Groups

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Assess for HPV Antigen Presentation

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

Group Type EXPERIMENTAL

9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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9vHPV Vaccine plus BCG Organism Mix

Eligibility Criteria

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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

Minimum Eligible Age

24 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Han ID Xu, MD/PhD/FAPCR

Role: STUDY_CHAIR

Medicine Invention Design Incorporation

Han Xu, MD/PhD/FAPCR

Role: STUDY_DIRECTOR

Medicine Invention Design Incorporation

Han Xu, MD/PhD/FAPCR

Role: PRINCIPAL_INVESTIGATOR

Medicine Invention Design Incorporation

Locations

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Medicine Invention Design, Inc.

Rockville, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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