Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV (9vHPV-BCG)

October 4, 2023 updated by: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

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.

  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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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
  • PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours
  • Our trial duration will be 12-week duration.
  • 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix
  • By the percutaneous route with the multiple puncture device
  • Our trial duration will be 12-week duration
  • Negative testing HPV by standard PCR assay after percutaneous 21 days

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20853
        • Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 74 years (Adult)

Accepts Healthy Volunteers

No

Description

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
  • PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours.

Exclusion Criteria:

  • Pregnant
  • Thrombosis
  • Allergy
  • PPD positive participant is 10 TU skin test reading > 5 mm induration at 48 hours
  • Symptoms of HPV infection
  • Clinical signs suggestive of other infection
  • Symptoms suggestive of other infection
  • Clinical signs indicative of oncology
  • Evidence of critical illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  • By the percutaneous route with the multiple puncture device
  • 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix
Other Names:
  • 9vHPV Vaccine plus BCG Organism Mix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
20 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
Duration at least 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Investigators

  • Study Chair: HAN XU, MD/PhD/FAPCR, IRB00009424--NPI-1831468511
  • Study Director: HAN XU, MD/PhD/FAPCR, IORG0007849--NPI-1023387701
  • Principal Investigator: HAN XU, MD/PhD/FAPCR, IORG0007849--FWA00015357

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2021

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

March 15, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimated)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 169135 (Registry Identifier: FDA, Investigational New Drug Application (IND))
  • FWA00015357 (Registry Identifier: HHS, Human Protections Administrator)
  • IORG0007849 (Registry Identifier: HHS, IORG)
  • IRB00009424 (Registry Identifier: HHS, IRB)
  • NPI-1831468511 (Registry Identifier: HHS, Health Care Provider Individual)
  • NPI-1023387701 (Registry Identifier: HHS, Health Care Provider Organization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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