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

20 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment 9vHPV Vaccine plus BCG Vaccine Mix for Human Papillomavirus?

The 9-valent HPV vaccine (9vHPV) is highly effective in preventing infections and diseases caused by various HPV types, significantly reducing the risk of cervical and other HPV-related cancers. It has shown a safety profile and strong immune response in clinical trials, making it a valuable tool in preventing HPV-related health issues. ^{1 2 3 4 5}

Is the 9vHPV vaccine safe for humans?

The 9-valent HPV vaccine (9vHPV) has been shown to be generally safe in humans, with most adverse events being mild or moderate, such as minor reactions at the injection site. Some studies reported rare cases of more serious reactions like syncope (fainting) and urticaria (hives), but no new safety concerns have been identified. ^{1 4 6 7 8}

How is the 9vHPV + BCG vaccine treatment different from other treatments for HPV?

The 9vHPV + BCG vaccine treatment is unique because it combines the 9-valent HPV vaccine, which protects against nine types of HPV, with the BCG vaccine, traditionally used for tuberculosis, potentially enhancing the immune response against HPV. This combination is novel as it aims to boost the body's defense mechanisms beyond what the HPV vaccine alone can achieve. ^{1 3 8 9 10}

What is the purpose of this trial?

Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients. 1. Treat Infection of Multiple HPV Virus Strains via Trained Immunity. 2. Activate human HPV Antigen Presentation Reaction. 3. The human antigen presenting cells (APCs) can treat the HPV virus protein antigens into small peptide fragments, and then clear HPV virus in vivo.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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 (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 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]

References

1. United States 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. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019]

4. Netherlands 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. [2016]

5. England pubmed.ncbi.nlm.nih.gov

9-Valent HPV vaccine for cancers, pre-cancers and genital warts related to HPV. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Real-world safety profile of the 9-valent human papillomavirus vaccine: A study in Zhejiang, China from 2019 to 2021. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of quadrivalent and 9-valent human papillomavirus vaccines in Indian clinical trial participants. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Post-marketing surveillance for the safety of the 9-valent human papillomavirus vaccine: a retrospective real-world study in China. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. [2021]