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

Primary Purpose

HPV Infection

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use
Sponsored by
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HPV Infection focused on measuring HPV, Antigen Presentation, APC, Trained Immunity, Innate Immune Memory, Cervical

Eligibility Criteria

24 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Conducting an early phase clinical trial to assess COVID-19 Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of COVID-19 patients.

20 Lighter Than Mild COVID-19 Patients

Inclusion Criteria:

  • Lighter Than Mild COVID-19 Patients
  • Positive testing COVID-19 by standard RT-PCR assay
  • COVID-19 infection without symptoms
  • Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea
  • No clinical signs indicative of Moderate, Severe, or Critical Severity
  • PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours.

Exclusion Criteria:

  • Pregnant
  • Thrombosis
  • Myocarditis
  • Pericarditis
  • Allergy
  • PPD positive participant is 10 TU skin test reading > 5 mm induration at 48 hours
  • Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
  • Clinical signs suggestive of moderate illness with COVID-19
  • Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress
  • Clinical signs indicative of severe systemic illness with COVID-19
  • Evidence of critical illness
  • Respiratory failure
  • Shock
  • Multi-organ dysfunction / failure

Sites / Locations

  • Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assess for HPV Antigen Presentation Therapeutic Biological Product Mix activity

Arm Description

9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG

Outcomes

Primary Outcome Measures

20 Participants with HPV testing by standard PCR assay
Negative testing HPV by standard PCR assay after percutaneous 21 days

Secondary Outcome Measures

Full Information

First Posted
March 15, 2015
Last Updated
October 4, 2023
Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
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1. Study Identification

Unique Protocol Identification Number
NCT02403505
Brief Title
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV
Acronym
9vHPV-BCG
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection
Keywords
HPV, Antigen Presentation, APC, Trained Immunity, Innate Immune Memory, Cervical

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single Usage Single Dosage
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assess for HPV Antigen Presentation Therapeutic Biological Product Mix activity
Arm Type
Experimental
Arm Description
9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG
Intervention Type
Biological
Intervention Name(s)
9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use
Other Intervention Name(s)
9vHPV Vaccine plus BCG Organism Mix
Intervention Description
By the percutaneous route with the multiple puncture device 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix
Primary Outcome Measure Information:
Title
20 Participants with HPV testing by standard PCR assay
Description
Negative testing HPV by standard PCR assay after percutaneous 21 days
Time Frame
Duration at least 28 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Cervical is a female organ.
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
IRB00009424--NPI-1831468511
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
IORG0007849--NPI-1023387701
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
HAN XU, MD/PhD/FAPCR
Organizational Affiliation
IORG0007849--FWA00015357
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20853
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc
Description
IORG0007849
URL
http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc
Description
IRB00009424
URL
http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc
Description
FWA00015357

Learn more about this trial

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

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