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

HPV Infection Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02403505
• Other study ID #: IND 169135
• Secondary ID: FWA00015357IORG0
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 28, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: October 2023
• Source: Medicine Invention Design, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The human antigen presenting cells (APCs) can treat the HPV virus protein antigens into small peptide fragments, and then clear HPV virus in vivo.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• HPV Infection
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
United States	Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701	Rockville	Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20 Participants with HPV testing by standard PCR assay	Negative testing HPV by standard PCR assay after percutaneous 21 days	Duration at least 28 days

External Links

•   FWA00015357
•   IORG0007849
•   IRB00009424