V540B Vaccine for HPV Prevention

Recruiting at 4 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Abnormal Pap smears, Genital lesions, Cancer, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later. A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540B in healthy adults and if people tolerate it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the V540B treatment for HPV prevention?

Research shows that similar HPV vaccines, which target specific HPV types, have been highly effective in preventing HPV infections and related diseases, such as cervical cancer and genital warts, in both women and men. ^{1 2 3 4 5}

Is the V540B vaccine for HPV prevention safe for humans?

The V540B vaccine, also known as the AS04-HPV-16/18 vaccine, has been studied for safety in humans. Over a 10-year follow-up, no serious adverse events were linked to the vaccine, indicating an acceptable long-term safety profile. ^{6 7 8 9 10}

How does the V540B vaccine for HPV prevention differ from existing HPV vaccines?

The V540B vaccine is unique because it is a new development in the field of HPV prevention, potentially offering broader protection or improved accessibility compared to existing vaccines like Gardasil and Cervarix, which target specific HPV types. While existing vaccines are effective, new vaccines like V540B may address limitations such as cost and distribution, making them more accessible, especially in developing countries. ^{1 11 12 13 14}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy adults who are in good health as determined by their medical history, physical exams, vital sign measurements, and ECGs performed before randomization. Specific details on age or other factors aren't provided.

Inclusion Criteria

I am in good health as confirmed by recent medical exams.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vaccinations with either GARDASIL®9 (G9) or V540B

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• V540B (Cancer Vaccine)

Trial Overview The study is testing a new vaccine called V540B designed to prevent HPV-related cancers. It aims to protect against more types of HPV than the existing GARDASIL®9 (G9) vaccine. The main focus is on safety and tolerability in healthy adults.

Participant Groups

Group I: V540B Experimental Treatment 1 Intervention

Participants will receive vaccinations with V540B.

Group II: GARDASIL®9 (G9) Active Control 1 Intervention

Participants will receive vaccinations with G9.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Prophylactic HPV vaccines, particularly the quadrivalent vaccine targeting types 6, 11, 16, and 18, have shown very high efficacy in preventing HPV infections and associated diseases, including high-grade cervical lesions and genital warts, in diverse populations including young women and men.

The vaccines have a favorable safety profile and are being introduced globally to reduce HPV-related morbidity and mortality, with the ultimate goal of implementing cervical cancer control programs, especially in less-developed countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV prophylactic vaccination: The first years and what to expect from now. Villa, LL.[2022]

Prophylactic HPV virus-like particle (VLP) vaccines have shown consistent effectiveness in preventing infections and lesions caused by specific HPV types, based on early randomized controlled trials.

The bivalent HPV-16/18 and quadrivalent HPV-6/11/16/18 vaccines are in phase III trials and are expected to receive regulatory approval, potentially leading to significant reductions in HPV-related health issues globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chapter 13: Current findings from prophylactic HPV vaccine trials. Koutsky, LA., Harper, DM.[2006]

The study assessed the safety of the quadrivalent HPV vaccine in 189,629 females and found that it was associated with an increased risk of syncope (fainting) on the day of vaccination and skin infections in the first two weeks after vaccination.

Despite these associations, the study did not find evidence of new safety concerns for females aged 9 to 26 years following HPV4 vaccination, indicating that the vaccine is generally safe for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Klein, NP., Hansen, J., Chao, C., et al.[2022]

While clinical trials have shown that HPV vaccines are highly effective, their effectiveness in the general population is still not fully understood, highlighting the need for further research.

A comprehensive review of HPV-related clinical outcomes suggests that tracking these outcomes at the population level is crucial for evaluating the real-world effectiveness of HPV vaccines, as many large trials are nearing completion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the impact of human papillomavirus vaccines. Chang, Y., Brewer, NT., Rinas, AC., et al.[2009]

In a study of 178 women under 45 years old with a history of HPV disease, those who received the quadrivalent HPV vaccine after treatment had a significantly lower recurrence rate of HPV-linked disease (3.4%) compared to those who did not receive the vaccine (13.5%).

The results indicate that HPV vaccination during follow-up can effectively reduce the risk of disease recurrence, suggesting that it should be considered as part of post-treatment management for women with HPV-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indication of prophylactic vaccines as a tool for secondary prevention in HPV-linked disease. Pieralli, A., Bianchi, C., Auzzi, N., et al.[2019]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

There are three licensed HPV vaccines: bivalent, quadrivalent, and nonavalent, with the nonavalent vaccine introduced in 2014, yet vaccination coverage remains low in many developed countries due to safety concerns.

This review aims to clarify the safety profiles of all three HPV vaccines by summarizing data from both pre- and post-licensure studies, particularly focusing on the newer nonavalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. Quattrone, F., Canale, A., Filippetti, E., et al.[2018]

Over 4 years of post-licensure safety surveillance of the HPV-16/18 vaccine (Cervarix) showed that the most commonly reported adverse events were consistent with those expected in the general population, indicating a favorable safety profile.

No significant patterns of serious immune-mediated diseases were found, and the incidences of conditions like Bell's palsy and Guillain-Barré syndrome were within expected ranges, reinforcing the vaccine's acceptable benefit-risk profile for adolescent girls and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Angelo, MG., Zima, J., Tavares Da Silva, F., et al.[2021]

Both Gardasil and Cervarix HPV vaccines have shown outstanding efficacy in preventing infections and related conditions in young women, with excellent safety profiles and only mild to moderate side effects reported.

Neither vaccine is effective in treating existing HPV infections or lesions, but they provide strong protection against specific HPV types for at least four years, with Gardasil also preventing genital warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. Schiller, JT., Castellsagué, X., Villa, LL., et al.[2022]

The introduction of the quadrivalent vaccine Gardasil and the bivalent vaccine Cervarix has significantly advanced the prevention of HPV-related diseases, including various cancers and benign conditions like genital warts.

A new multivalent vaccine, Gardasil 9, has been approved and shows promise in providing broader protection against nine HPV subtypes, with ongoing efforts to improve vaccine accessibility and reduce production costs, especially in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation prophylactic HPV vaccines: current options and future strategies for vaccines development. Fruscalzo, A., Londero, AP., Bertozzi, S., et al.[2016]

The nonavalent HPV vaccine (9vHPV) has shown over 90% efficacy in preventing cervical, vulvar, and vaginal precancers caused by HPV types 16, 18, and five additional cancer-causing types (31, 33, 45, 52, 58) in Phase III clinical studies.

9vHPV has the potential to prevent up to 93% of cervical cancer cases and has demonstrated lasting antibody responses for at least five years, indicating its long-term effectiveness in reducing the burden of HPV-related cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant human papillomavirus nonavalent vaccine in the prevention of cancers caused by human papillomavirus. Toh, ZQ., Kosasih, J., Russell, FM., et al.[2020]

The quadrivalent HPV vaccine, which protects against HPV types 6, 11, 16, and 18, has been shown to be safe and well-tolerated in phase IIb and III trials, providing high protection against persistent HPV infection and cervical lesions in HPV-naive women.

Despite the effectiveness of the HPV vaccine, cervical screening will still be necessary for women already infected with the virus types included in the vaccine, highlighting the importance of ongoing monitoring and future studies to assess long-term protection and screening policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of current knowledge on HPV vaccination: an appendix to the European Guidelines for Quality Assurance in Cervical Cancer Screening. Arbyn, M., Dillner, J.[2007]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

HPV prophylactic vaccination: The first years and what to expect from now. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Chapter 13: Current findings from prophylactic HPV vaccine trials. [2006]

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

Safety of quadrivalent human papillomavirus vaccine administered routinely to females. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating the impact of human papillomavirus vaccines. [2009]

5. Germany pubmed.ncbi.nlm.nih.gov

Indication of prophylactic vaccines as a tool for secondary prevention in HPV-linked disease. [2019]

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

A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. [2015]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

Second-generation prophylactic HPV vaccines: current options and future strategies for vaccines development. [2016]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Recombinant human papillomavirus nonavalent vaccine in the prevention of cancers caused by human papillomavirus. [2020]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Review of current knowledge on HPV vaccination: an appendix to the European Guidelines for Quality Assurance in Cervical Cancer Screening. [2007]