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| ID | Type | Description | Link |
|---|---|---|---|
| IND 169135 | Registry Identifier | FDA, Investigational New Drug Application (IND) | |
| NPI-1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI-1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| FWA00015357 | Registry Identifier | HHS, Human Protections Administrator | |
| IORG0007849 | Registry Identifier | HHS, IORG | |
| IRB00009424 | Registry Identifier | HHS, IRB |
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| Name | Class |
|---|---|
| UnitedHealthcare | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assess for HPV Antigen Presentation | Experimental | Therapeutic Biological Product Mix activity 9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 20 HPV Participants with HPV testing by standard PCR assay | Negative testing HPV by standard PCR assay after percutaneous 21 days | Duration at least 28 days |
| 20 HPV Participants with IGRA blood test with HPV protein antigen | Positive IGRA blood test with HPV protein antigen after percutaneous use 21 days | Duration at least 28 days |
| 20 HPV Participants with IGRA blood test with TB antigens |
| Duration at least 28 days |
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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:
Exclusion Criteria:
Cervical is a female organ.
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| Name | Affiliation | Role |
|---|---|---|
| Han ID Xu, MD/PhD/FAPCR | Medicine Invention Design Incorporation | Study Chair |
| Han Xu, MD/PhD/FAPCR | Medicine Invention Design Incorporation | Study Director |
| Han Xu, MD/PhD/FAPCR | Medicine Invention Design Incorporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design, Inc. | Rockville | Maryland | 20853 | United States |
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| Label | URL |
|---|---|
| IORG0007849 | View source |
| IRB00009424 | View source |
| FWA00015357 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2025 | May 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2025 | May 7, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 5, 2025 | May 7, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Single Group Assignment
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Open Label
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |