9vHPV + BCG Vaccines for Human Papillomavirus

(9vHPV-BCG Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

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

Disqualifiers: Pregnant, Thrombosis, Bleeding, Allergy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat multiple strains of the human papillomavirus (HPV) by boosting the body's immune response. It combines the 9vHPV vaccine, which targets nine HPV strains, with the BCG vaccine, typically used against tuberculosis, to enhance immune activity. The goal is to determine if this combination can help the body more effectively attack and clear the HPV virus. Individuals with a cervical HPV infection, confirmed by a standard test and without symptoms, might be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination 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 treatment is likely to be safe for humans?

Research has shown that the 9-valent HPV (9vHPV) vaccine is generally safe and very effective. Studies have found that over 99.8% of recipients develop a strong immune response, helping the body fight off the virus.

The BCG vaccine, often used for tuberculosis, boosts the immune system. When combined with the 9vHPV vaccine, the goal is to enhance the body's ability to fight HPV infections.

Some side effects have been observed with the 9vHPV vaccine, including fainting, brain inflammation (encephalitis), and skin reactions like hives (urticaria). These side effects are rare, but it is important to be informed.

The combination of the 9vHPV and BCG vaccines remains under investigation. As this is an early phase trial, researchers are beginning to study how these vaccines work together in people. Safety is a top priority, and further studies are needed to fully understand how well people tolerate this vaccine mix. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using a combination of the 9vHPV vaccine and the BCG vaccine to tackle Human Papillomavirus (HPV) because it offers a fresh approach. Most treatments for HPV focus on preventing infection with vaccines like the traditional HPV vaccines. However, this new treatment combines the 9vHPV vaccine with the BCG vaccine, which is typically used for tuberculosis, potentially boosting the immune response against HPV. The unique mix aims to enhance antigen presentation, which might improve the body's ability to target and eliminate HPV-infected cells. This novel approach could offer a more robust and comprehensive defense compared to standard vaccines alone.

What evidence suggests that the 9vHPV + BCG Vaccine Mix could be effective for HPV?

Research has shown that the 9-valent HPV vaccine (9vHPV) is highly effective, with a success rate of over 99.8% in helping the body produce antibodies against all types included in the vaccine. This enhances the immune system's ability to combat the HPV virus. Studies have found that the vaccine can reduce certain HPV infections and related health issues by up to 90%. In this trial, participants will receive a combination of the 9vHPV vaccine and the BCG vaccine, which might further boost the immune response. This combination aims to enhance the body's ability to recognize and fight HPV virus proteins. Early results suggest this method could more effectively clear the HPV virus from the body. ^{1 2 6 7 8}

Who Is on the Research Team?

Han ID Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design Incorporation

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design Incorporation

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design Incorporation

Are You a Good Fit for This Trial?

This trial is for individuals who are at risk of or currently have HPV infection. Participants should be healthy with no history of allergic reactions to vaccines. Specific details about age, gender, and health status may apply but are not provided here.

Inclusion Criteria

I have an HPV infection in my cervix.

I tested positive for HPV.

I have HPV but no symptoms.

Exclusion Criteria

I have had a blood clot.

Pregnant

I am currently experiencing bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the 9vHPV Vaccine and BCG Organism mix via percutaneous route for 21 days

3 weeks

Multiple visits for percutaneous administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including IGRA blood tests and HPV testing by PCR assay

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 9vHPV Vaccine plus BCG Vaccine Mix

Trial Overview The study tests a combination of the 9vHPV vaccine and BCG vaccine applied through the skin to see if it can boost immunity against multiple strains of HPV by enhancing the body's antigen presentation process.

How Is the Trial Designed?

Group I: Assess for HPV Antigen Presentation Experimental Treatment 1 Intervention

Therapeutic Biological Product Mix activity 9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

6

Recruited

2,400+

UnitedHealthcare

Collaborator

Trials

5

Recruited

594,000+

Published Research Related to This Trial

The 9-valent HPV vaccine (Gardasil 9®) significantly increases protection against cervical cancer by covering 9 oncogenic HPV types, raising potential protection from about 70% to 90%, based on clinical trials involving young women.

Clinical trials demonstrated that the 9vHPV vaccine has a comparable safety profile and immunogenicity to the original 4-valent vaccine, with a 2-dose regimen showing similar effectiveness in younger boys and girls compared to the standard 3-dose regimen for older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. Zhang, Z., Zhang, J., Xia, N., et al.[2019]

The 9-valent HPV vaccine (9vHPV) is safe and highly effective, showing over 99.8% seroconversion rates for all vaccine types in both groups of a study involving 1054 participants aged 11-15 years.

Administering the 9vHPV vaccine alongside the REPEVAX vaccine did not interfere with the immune response to either vaccine, indicating that this approach can safely reduce the number of vaccination visits needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age. Kosalaraksa, P., Mehlsen, J., Vesikari, T., et al.[2015]

In a study of 569 postpartum inpatients, 23.1% of vaccine-eligible patients received the nine-valent HPV (9vHPV) vaccine during their hospital stay, indicating that integrating vaccination into postpartum care can increase uptake.

The study found that certain demographics, particularly Hispanic, Spanish-speaking, and publicly insured patients, were more likely to receive the vaccine, suggesting that targeted approaches in postpartum care could help reduce vaccination disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation. Murphy, EC., Alimena, S., Pelletier, A., et al.[2023]

The 9-valent HPV vaccine (9vHPV) can potentially increase the prevention of cervical cancer from 70% to 90% by covering additional HPV types (31, 33, 45, 52, and 58) not included in earlier vaccines.

In addition to cervical cancer, the 9vHPV vaccine could prevent 85-95% of HPV-related vulvar, vaginal, and anal cancers, highlighting its broad efficacy in reducing the overall cancer burden associated with HPV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

9-Valent HPV vaccine for cancers, pre-cancers and genital warts related to HPV. Pitisuttithum, P., Velicer, C., Luxembourg, A.[2022]

The 9-valent HPV vaccine (9vHPV) is highly immunogenic in females aged 12-26 who previously received the quadrivalent HPV vaccine (qHPV), with over 98% showing seropositivity for additional HPV types 31/33/45/52/58 after the third dose.

While injection-site adverse events were more common in the 9vHPV group (91.1%) compared to placebo (43.9%), systemic adverse events were similar between both groups, indicating that the 9vHPV vaccine is generally well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Garland, SM., Cheung, TH., McNeill, S., et al.[2016]

The 9-valent HPV vaccine demonstrated a high efficacy of 92.3% in preventing high-grade cervical, vulvar, and vaginal dysplasia related to HPV types 31, 33, 45, 52, and 58 in a study involving 5,312 participants aged 9-26 years.

The vaccine was well tolerated, with over 99% of recipients developing antibodies for all 9 HPV types, and most adverse events were mild to moderate, supporting its use in vaccination programs in Latin America.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Ruiz-Sternberg, ÁM., Moreira, ED., Restrepo, JA., et al.[2021]

Citations

1. 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 ...

2. withpower.com withpower.com/trial/early-phase-1-human-papilloma-virus-hpv-3-2025-dd2a2

9vHPV + BCG Vaccines for Human Papillomavirus The 9-valent HPV vaccine (9vHPV) is safe and highly effective, showing over 99.8% seroconversion rates for all vaccine types in both groups of a study involving ...

3. publications.aap.org publications.aap.org/pediatrics/article/152/4/e2022060993/193886/Ten-Year-Follow-up-of-9-Valent-Human

Ten-Year Follow-up of 9-Valent Human Papillomavirus ... These data demonstrate long-term immunogenicity, effectiveness, and safety of the 9vHPV vaccine, 10 years after its administration. These end-of ...

4. mdpi.com mdpi.com/2077-0383/12/23/7317

Efficacy of Human Papillomavirus Vaccines for Recalcitrant ... After 12 months, 85% of patients of group A versus 33% of group B had positive clinical outcomes (0.004). Our findings suggest a possible ...

5. cdc.gov cdc.gov/vaccines/vpd/hpv/hcp/vaccines.html

HPV Vaccine Efficacy More than 98% of recipients develop an antibody response to HPV types included in the respective vaccines 1 month after completing a full vaccination series.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9762803/

A study in Zhejiang, China from 2019 to 2021 - PMC This study found a positive signal association between 9vHPV immunization and adverse events such as syncope, encephalitis, sterile abscess, and urticaria.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X23009908

Prophylactic HPV vaccines in patients with HPV-associated ... The 4vHPV and 9vHPV vaccines also protect against HPV6 and 11, which cause approximately 90 % of cases of HPV-related genital warts (GW) [5].

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

Human Papillomavirus (HPV) Vaccine Safety The 9vHPV vaccine adds 5 additional antigens, providing protection against 9 types of cancer-causing human papillomaviruses. Studies of 2vHPV (Cervarix) have ...