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

Phase 1
Waitlist Available
Led By HAN XU, MD/PhD/FAPCR
Research Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cervical HPV Infection Patients
Positive testing HPV by standard PCR assay
Must not have
Thrombosis
Symptoms of HPV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 time per 180 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a treatment that could potentially help COVID-19 patients by directly attacking the virus.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like redness and swelling, flu-like symptoms such as fever and fatigue, and possibly mild local skin reactions due to percutaneous administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an HPV infection in my cervix.
Select...
I tested positive for HPV.
Select...
I have HPV but no symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a blood clot.
Select...
I show symptoms of an HPV infection.
Select...
I am critically ill.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 time per 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 time per 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
20 Rectal Cancer Participants with CEA blood test
20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen
20 Rectal Cancer Participants with IGRA blood test with TB antigens
Secondary study objectives
The Number of Participants with Adverse Events as a Measure of Safety
Other study objectives
The Number of Participants with ABIRATERONE drug target gene SNPs associated to Adverse Events in Peripheral blood WBCs as a Measure of Safety
The Number of Participants with ABIRATERONE drug target gene SNPs associated to Effective Events in prostate cancer cells as a Measure of Efficacy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairLead Sponsor
5 Previous Clinical Trials
2,420 Total Patients Enrolled
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB ChairLead Sponsor
3 Previous Clinical Trials
1,220 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,371 Total Patients Enrolled
UnitedHealthcareOTHER
4 Previous Clinical Trials
593,748 Total Patients Enrolled
HAN XU, MD/PhD/FAPCRPrincipal InvestigatorIORG0007849--FWA00015357
2 Previous Clinical Trials
1,200 Total Patients Enrolled
HAN XU, M.D., Ph.D.Study ChairIRB00009424
3 Previous Clinical Trials
1,220 Total Patients Enrolled

Media Library

ABIRATERONE - Group 1 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02403505 — Phase 1
Colorectal Cancer Research Study Groups: Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity
Colorectal Cancer Clinical Trial 2023: ABIRATERONE - Group 1 Highlights & Side Effects. Trial Name: NCT02403505 — Phase 1
ABIRATERONE - Group 1 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02403505 — Phase 1
~1 spots leftby Feb 2025
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