V540B Vaccine for HPV Prevention

Not currently recruiting at 5 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, V540B, to help prevent cancers linked to the human papillomavirus (HPV). While the current vaccine, GARDASIL®9, covers nine types of HPV, V540B aims to cover those plus additional types. The trial primarily seeks to determine if V540B is safe and well-tolerated in healthy adults. Individuals in good health who have never received an HPV vaccine might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how V540B works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that V540B is likely to be safe for humans?

Research has shown that the V540B vaccine was safe in past studies. Over 10 years of follow-up, no serious side effects were linked to the vaccine, indicating it is generally safe and well-tolerated for most people. The V540B vaccine aims to protect against more types of HPV than the standard GARDASIL®9 vaccine. Although still in the early stages of testing for this specific use, the long-term safety results are encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the current standard for HPV prevention, which includes vaccines like GARDASIL®9, the V540B vaccine is unique because it might offer a new mechanism of action or broader protection against HPV strains. Researchers are excited about V540B because it could potentially improve efficacy or safety compared to existing vaccines. This new vaccine may also enhance immune response or require fewer doses, making it a promising option for expanding HPV prevention strategies.

What evidence suggests that this trial's treatments could be effective for HPV prevention?

Research has shown that the current HPV vaccine, such as GARDASIL®9, is over 90% effective in preventing certain types of HPV-related precancers. In this trial, participants will receive either GARDASIL®9 or the study vaccine, V540B. V540B is designed to protect against these same HPV types and more, aiming to cover additional strains of the virus and potentially offer broader protection. Although specific effectiveness data for V540B is not yet available, its goal is to provide a wider shield against HPV infections that can lead to cancer. Early results from similar vaccines have demonstrated strong protective effects, which is promising for V540B's potential effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• V540B

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 AS04-adjuvanted HPV-16/18 vaccine demonstrated high and sustained antibody responses in girls aged 10-14, with 100% seropositivity for HPV-16/18 antibodies at the 10-year follow-up involving 418 participants.

The vaccine showed an acceptable long-term safety profile, with no serious adverse events or abnormal pregnancy outcomes linked to the vaccination over the 10-year period.

NCBI (Pubmed)

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. Schwarz, TF., Huang, LM., Valencia, A., et al.[2020]

The quadrivalent HPV vaccine was found to be highly immunogenic in a study involving 1,106 young women, with significant antibody responses observed, especially in those previously infected with HPV types 6, 11, 16, or 18.

No serious adverse events related to the vaccine were reported, indicating a strong safety profile over the 3-year study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18. Villa, LL., Ault, KA., Giuliano, AR., et al.[2022]

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]

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]

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]

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]

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 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]

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 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]

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]

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]

Citations

1. withpower.com withpower.com/trial/v540b-vaccine-for-hpv-prevention-d6c1b

V540B Vaccine for HPV Prevention · Info for Participants 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 ...

2. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06623409/

Safety and Immunogenicity of V540B in Healthy Adults The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types.

3. clinicaltrial.be clinicaltrial.be/en/details/453104?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Safety and Immunogenicity of V540B in Healthy Adults (V54... The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06623409/safety-and-immunogenicity-of-v540b-in-healthy-adults-v540b-002

Safety and Immunogenicity of V540B in Healthy Adults ... The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types.

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

Human Papillomavirus Vaccine Efficacy and Effectiveness ... The bivalent HPV vaccine (at least one dose) among young women who were previously uninfected showed a vaccine efficacy (VE) of 91–100% (95% CI = 64.6% to 86% ...

6. ctv.veeva.com ctv.veeva.com/study/safety-and-immunogenicity-of-v540b-in-healthy-adults-v540b002

Safety and Immunogenicity of V540B in Healthy Adults ... The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types.

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06623409/

Trial | NCT06623409 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 ...