HPV InfectionEarly Phase 19vHPV-BCGNCT06959563
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV
A Early Phase 1 study testing 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use in people with HPV Infection, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 64 years, women only
- Conditions the study is for
- HPV Infection
- What is being tested?
- 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 28 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Thrombosis
- Bleeding
- Allergy
- TB positive participant is positive IGRA blood test with TB antigens
- Symptoms of HPV infection
Show all 10Show fewer
- Clinical signs suggestive of other infection
- Symptoms suggestive of other infection
- Clinical signs indicative of oncology
- Evidence of critical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Medicine Invention Design, Inc.
Rockville, Maryland, 20853
About this study
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
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.
- Treat Infection of Multiple HPV Virus Strains via Trained Immunity.
- Activate human HPV Antigen Presentation Reaction.
- 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.
- Conditions
- HPV Infection
- Being tested
- 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use
- Keywords
- HPV, Antigen Presentation, APC, IGRA, Trained Immunity, Innate Immune Memory, Cervical
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9vHPV Vaccine plus BCG Vaccine Mix for percutaneous useBiological
Also called 9vHPV Vaccine plus BCG Organism Mix
By the percutaneous route with the multiple puncture device - 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix
| Study group | Role | What they receive |
|---|---|---|
| Assess for HPV Antigen Presentation | Experimental | Therapeutic Biological Product Mix activity 9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG Receives: Biological: 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use |
What is being measured
The primary outcome is the main question the study is designed to answer.
20 HPV Participants with HPV testing by standard PCR assay
Negative testing HPV by standard PCR assay after percutaneous 21 days
Measured: 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
Measured: Duration at least 28 days
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
Measured: Duration at least 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start28 Apr 2025
- Primary completion18 Oct 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment * Single Usage * Single Dosage
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UnitedHealthcare
- Responsible party
- Sponsor-investigator, Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc
- Investigators
- Han ID Xu, MD/PhD/FAPCR, Study chair, Medicine Invention Design IncorporationHan Xu, MD/PhD/FAPCR, Study director, Medicine Invention Design IncorporationHan Xu, MD/PhD/FAPCR, Principal investigator, Medicine Invention Design Incorporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959563
- Sponsor's protocol ID
- IND 169135
- Other IDs
- IND 169135, NPI-1831468511, NPI-1023387701, FWA00015357, IORG0007849, IRB00009424
- Acronym
- 9vHPV-BCG
- Status last verified
- May 2026
- First submitted
- 28 Apr 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06959563
- Acronym / sponsor ID
- 9vHPV-BCG / IND 169135
- Conditions
- HPV Infection
- Keywords
- HPV, Antigen Presentation, APC, IGRA, Trained Immunity, Innate Immune Memory, Cervical
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairIndustry (pharma, biotech, devices)
- Collaborators
- UnitedHealthcare
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 18 Oct 2026 (estimated)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Treat Infection of Multiple HPV Virus Strains via Trained Immunity.
- Activate human HPV Antigen Presentation Reaction.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment * Single Usage * Single Dosage
| Arm | Type | Receives |
|---|---|---|
| Assess for HPV Antigen Presentation | Experimental | Biological: 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous useTherapeutic Biological Product Mix activity 9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG |
Who may qualify
- Ages
- 24 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnant
- Thrombosis
- Bleeding
- Allergy
- TB positive participant is positive IGRA blood test with TB antigens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous useAlso: 9vHPV Vaccine plus BCG Organism MixBy the percutaneous route with the multiple puncture device - 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix | Biological | Assess for HPV Antigen Presentation |
Primary outcome
20 HPV Participants with HPV testing by standard PCR assay
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- IORG0007849Link provided by the sponsor.
- IRB00009424Link provided by the sponsor.
- FWA00015357Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use in people with HPV Infection, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20 HPV Participants with HPV testing by standard PCR assay (time frame: Duration at least 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.