20 Participants Needed

9vHPV + BCG Vaccine Mix for Human Papillomavirus

(CEA+RC-BCG Trial)

Recruiting at 2 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients. 1. Treat CEA positive rectal cancer via Trained Immunity. 2. Activate human CEA Protein Antigen Presentation Reaction. 3. The human antigen presenting cells (APCs) can treat the CEA protein antigen into small peptide fragments, and then kill CEA positive rectal cancer cells in vivo.

Research Team

HX

HAN XU, MD/PhD/FAPCR

Principal Investigator

IORG0007849--FWA00015357

HX

HAN XU, MD/PhD/FAPCR

Principal Investigator

IRB00009424--NPI-1831468511

HX

HAN XU, MD/PhD/FAPCR

Principal Investigator

IORG0007849--NPI-1023387701

Eligibility Criteria

This trial is for individuals with cervical HPV infection confirmed by PCR, without symptoms or signs of cancer. Participants must have a negative PPD skin test (less than 5 mm swelling at 48 hours). It's not open to those allergic, critically ill, pregnant, showing thrombosis or oncology signs, or having symptoms/infections other than HPV.

Inclusion Criteria

You recently had a test for tuberculosis and the result was negative.
I show no signs of cancer.
I have an HPV infection in my cervix.
See 2 more

Exclusion Criteria

I have had a blood clot.
I show signs that suggest I have cancer.
You have a positive skin test for tuberculosis with a certain size of bump after 48 hours.
See 6 more

Treatment Details

Interventions

  • ABIRATERONE - Group 1
  • ABIRATERONE - Group 2
  • Ad26 COVID-19 Spike plus TICE® BCG Mix for Intradermal Injection
  • Invitrogen COVID-19 Spike Protein plus TICE® BCG Mix for percutaneous use
  • Recombinant COVID-19 Spike Protein plus TICE® BCG Mix for percutaneous use
Trial OverviewThe study tests a mix of the 9vHPV vaccine and BCG vaccine applied through the skin to see if it can treat multiple strains of HPV by training the immune system to better recognize and clear the virus.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activityExperimental Treatment1 Intervention
CEA protein antigen 0.05 mg add into BCG Organism 50 MG

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
6
Recruited
2,400+

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

Lead Sponsor

Trials
4
Recruited
1,200+

PPD

Industry Sponsor

Trials
162
Recruited
36,600+
Dr. Austin Smith profile image

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons profile image

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

UnitedHealthcare

Collaborator

Trials
5
Recruited
594,000+