9vHPV + BCG Vaccine Mix for Human Papillomavirus
(CEA+RC-BCG Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byHAN XU, MD/PhD/FAPCR

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

No Placebo Group

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.

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 (Other)
ABIRATERONE - Group 2 (Other)
Ad26 COVID-19 Spike plus TICE® BCG Mix for Intradermal Injection (Virus Therapy)
Invitrogen COVID-19 Spike Protein plus TICE® BCG Mix for percutaneous use (Virus Therapy)
Recombinant COVID-19 Spike Protein plus TICE® BCG Mix for percutaneous use (Virus Therapy)

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