Clinical trial NCT06959563: Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: HPV Infection
Keywords: HPV
Antigen Presentation
APC
IGRA
Trained Immunity
Innate Immune Memory
Cervical
Lead sponsor: Medicine Invention Design, Inc
Sponsor class: INDUSTRY
Collaborators: name: UnitedHealthcare
First posted: 2025-05-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment

* Single Usage
* Single Dosage
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 20 HPV Participants with HPV testing by standard PCR assay
timeFrame: Duration at least 28 days
measure: 20 HPV Participants with IGRA blood test with HPV protein antigen
timeFrame: Duration at least 28 days
measure: 20 HPV Participants with IGRA blood test with TB antigens
timeFrame: Duration at least 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Medicine Invention Design, Inc.
state: Maryland
Study officials:
affiliation: Medicine Invention Design Incorporation
name: Han ID Xu, MD/PhD/FAPCR
role: STUDY_CHAIR
affiliation: Medicine Invention Design Incorporation
name: Han Xu, MD/PhD/FAPCR
role: STUDY_DIRECTOR
affiliation: Medicine Invention Design Incorporation
name: Han Xu, MD/PhD/FAPCR
role: PRINCIPAL_INVESTIGATOR
References: