9vHPV + BCG Vaccine Mix for Human Papillomavirus
(CEA+RC-BCG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat rectal cancer by training the immune system to recognize and attack cancer cells. It combines components of the HPV vaccine with the tuberculosis vaccine (BCG vaccine) to determine if this can enhance the body's ability to fight cancer. The trial targets patients with rectal cancer who test positive for a protein called CEA, commonly found in cancer cells. Those with early-stage rectal cancer, without symptoms or spread, and a negative tuberculosis test may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that the BCG vaccine is well-tolerated and offers general protection against various infections, beyond its original design. This suggests it might help strengthen the immune system. Research also shows that combining the COVID-19 spike protein with the BCG vaccine can trigger immune responses. However, limited safety data exists for the specific combination used in this clinical trial.
This trial tests different combinations of COVID-19 spike proteins with the BCG vaccine. Generally, the BCG vaccine has a positive track record, with few reported side effects. The COVID-19 spike protein has been widely studied in vaccines and is generally well-tolerated.
Since this trial is in an early phase, the safety of the treatment is still under evaluation. Early phase trials often focus on ensuring treatments are safe for people, so participants will be closely monitored for any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment because it explores a novel combination of vaccines for boosting immune responses against both HPV and COVID-19. Unlike standard HPV vaccines, this approach mixes the 9-valent HPV vaccine with the BCG vaccine, known for its immune-stimulating properties. This combination aims to enhance the body's ability to present antigens, potentially improving the effectiveness of vaccination. Additionally, integrating the COVID-19 spike protein in various formulations introduces a dual-target strategy, possibly offering broader protection against multiple viruses with a single regimen.
What evidence suggests that this trial's treatments could be effective for CEA positive rectal cancer?
Research suggests that combining the COVID-19 spike protein with the BCG vaccine might strengthen the immune system. In this trial, participants will receive a mix of the COVID-19 spike protein and the BCG vaccine to assess its potential in helping the body identify and fight cancer cells, especially those producing CEA, a protein often found in rectal cancer. Past studies have shown that BCG can trigger a broad immune response, aiding the body in combating various diseases. COVID-19 spike proteins in vaccines have demonstrated strong immune reactions. Although direct evidence for CEA-positive rectal cancer is limited, this treatment aims to train the immune system to target and destroy these cancer cells.23467
Who Is on the Research Team?
HAN XU, MD/PhD/FAPCR
Principal Investigator
IORG0007849--FWA00015357
HAN XU, MD/PhD/FAPCR
Principal Investigator
IRB00009424--NPI-1831468511
HAN XU, MD/PhD/FAPCR
Principal Investigator
IORG0007849--NPI-1023387701
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CEA protein antigen and BCG organism mix via percutaneous route
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Lead Sponsor
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
Lead Sponsor
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
UnitedHealthcare
Collaborator