pBI-11 Vaccine for Human Papillomavirus Infection

Overseen By Kimberly Levinson, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CIN2, Immunosuppression, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new DNA vaccine, pBI-11, for women with persistent infections of certain types of human papillomavirus (HPV16+ or HPV18+), which can lead to cervical cancer. The goal is to determine if the vaccine can safely boost the immune system to combat these HPV infections. Participants will receive either the vaccine or a placebo, a harmless substance used for comparison. Women with persistent HPV16 or HPV18 infections and normal cervical cell results might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the pBI-11 DNA vaccine, designed to treat HPV types 16 and 18, appears safe. Studies on similar HPV vaccines have shown that serious side effects are rare. Recipients of the HPV vaccine did not experience more side effects than those who did not receive it, suggesting it is generally well-tolerated.

In one study with a similar vaccine, patients handled multiple doses with only minor side effects. HPV vaccines have a strong safety record, with health organizations consistently finding them safe after many years of monitoring. This history provides reassurance about the safety of the pBI-11 vaccine. However, since pBI-11 is still being tested in clinical trials, ongoing studies are needed to confirm its safety and effectiveness for this specific use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for HPV, which typically include vaccines like Gardasil and Cervarix, the pBI-11 vaccine is unique because it uses the TriGrid Delivery System to administer its doses. This new delivery method enhances the immune response by improving how the vaccine is delivered into the body. Researchers are excited because this approach could potentially increase the vaccine's effectiveness and provide stronger and longer-lasting protection against HPV infection. The combination of a novel vaccine formulation with an advanced delivery system sets pBI-11 apart from existing options.

What evidence suggests that the pBI-11 vaccine might be an effective treatment for HPV?

Research shows that the pBI-11 DNA vaccine is designed to help the immune system combat HPV types 16 and 18, which are linked to cervical cancer. Earlier studies have demonstrated that vaccines targeting these HPV types can reduce related infections by up to 90%. In this trial, one group of participants will receive three doses of pBI-11, while another group will receive two doses of placebo followed by one dose of pBI-11. The vaccine targets specific parts of the virus, known as proteins E6 and E7, enabling the body to recognize and attack infected cells. These findings suggest that pBI-11 could effectively treat ongoing HPV infections. ^{2 3 6 7 8}

Who Is on the Research Team?

Kimberly Levinson, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

I agree to use effective birth control before and after the study.

I have tested positive for HPV16 or HPV18.

I am fully active or have only minor limitations in daily activities.

Exclusion Criteria

I have been diagnosed with CIN2, CIN3, or cervical cancer.

Receiving any other investigational agents within 28 days prior to the first dose of study vaccine

I do not have any serious uncontrolled illnesses or infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 doses of pBI-11 or placebo via electroporation, with doses administered four weeks apart

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and HPV16/18 clearance

12 months

What Are the Treatments Tested in This Trial?

Interventions

• pBI-11

How Is the Trial Designed?

Group I: Arm 2: Placebo + Placebo + pBI-11 Experimental Treatment 2 Interventions

Will receive 2 doses of placebo and 1 dose of pBI-11 using the TriGrid Delivery System

Group II: Arm 1: pBI-11 + pBI-11 + pBI-11 Experimental Treatment 1 Intervention

Will receive 3 doses of pBI-11 using the TriGrid Delivery System.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

PapiVax Biotech, Inc.

Collaborator

Trials

6

Recruited

120+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

cidrap.umn.edu

cidrap.umn.edu/human-papillomavirus-hpv/evidence-review-finds-hpv-vaccines-be-safe-extremely-effective

Evidence review finds HPV vaccines to be safe, extremely ...

Men and boys who received the HPV vaccine from ages nine to 26 were nearly 50% less likely to develop cancers of the head and neck, esophagus, ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS6118

Phase II trial assessing safety, efficacy and immune ...

There is a 90% overall survival for HPV+/p16+ OPSCC (40% for HPV-/p16- OPSCC), which can be cured with multimodality care. For patients with R/M ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05799144

NCT05799144 | pBI-11 & TA-HPV (With Pembrolizumab as ...

This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV) vaccines in combination with pembrolizumab work in treating ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8706722/

Human Papillomavirus Vaccine Efficacy and Effectiveness ...

Maximal reductions of approximately 90% for HPV 6/11/16/18 infections, approximately 90% for genital warts, approximately 45% for low-grade cytological cervical ...

5.

cdc.gov

cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html

HPV Vaccine Safety and Effectiveness Data

More than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.

6.

cdc.gov

cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety

HPV vaccine continues to have a strong safety record, and CDC continues to recommend that all preteen girls and boys receive three doses of this ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4667712/

Safety of human papillomavirus vaccines: a review - PMC

Expert opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) ...

8.

papivax.com

papivax.com/our-technologies/pbi-medicines-pipeline/

PBI Medicines Pipeline

The PVX-8 immunotherapy regimen (pBI-11 DNA vaccine) is to treat patients with known chronic HPV16/18 cervical infection associated with low-grade precancerous ...