Clinical Trials Logo
  1. Home
  2. HPV Infection
  3. NCT02403505
  4. Details
NCT02403505 Clinical Trial

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Recruiting NCT04098744 - Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) Phase 2
Completed NCT04083196 - A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years Phase 1
Completed NCT04191967 - Thermocoagulation for Treatment of Precancerous Cervical Lesions N/A
Withdrawn NCT04430907 - HPV Vaccine in Postpartum Women
Recruiting NCT02593968 - Yallaferon in Chinese Population Phase 2
Completed NCT04711265 - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Completed NCT02263378 - A New Supplement for the Immune Response to HPV Infection N/A
Completed NCT05234112 - Prevention and Screening Towards Elimination of Cervical Cancer N/A
Completed NCT04590521 - HPV Vaccine Immunity in High-risk Women Phase 4
Recruiting NCT05829629 - Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women Phase 1
Recruiting NCT06052033 - Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection N/A
Recruiting NCT05051852 - HPV Viral Load in Predicting the Prognosis of LSIL
Completed NCT04155294 - Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
Active, not recruiting NCT06452004 - Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC) N/A
Completed NCT06177236 - Clinic or Self-Sampling for Cervical Cancer Screening N/A
Active, not recruiting NCT04794660 - The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa" Phase 3
Recruiting NCT05509413 - DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections N/A
Recruiting NCT06137950 - Interferon Alpha Therapy for Cervical CINI and HPV Infection Phase 1
Recruiting NCT04171505 - Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
Active, not recruiting NCT05524025 - The SPOT-HPV Study

External Links