V540D Vaccine for Cancer Prevention

Recruiting at 3 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: HPV vaccines

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

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, V540D, to determine if it can prevent more types of human papillomavirus (HPV) infections that could lead to cancer, compared to the current GARDASIL®9 vaccine. HPV is a virus that some bodies cannot clear on their own, potentially leading to cancer over time. The study aims to determine if the V540D vaccine is safe and well-tolerated in healthy adults. Participants should be healthy and must not have had any HPV-related health issues or received an HPV vaccine before. As a Phase 1 trial, this research focuses on understanding how the new V540D vaccine works in people, offering participants the unique opportunity to be among the first to receive this innovative 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 is best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the V540D vaccine is being tested to protect against more types of HPV than the current GARDASIL®9 vaccine. As a Phase 1 study, it is in the early stages of testing. Researchers are primarily assessing the vaccine's safety and how well participants tolerate it. This phase involves healthy adults to ensure there are no harmful effects.

Solid data on V540D's safety is not yet available due to the early stage of testing. However, since GARDASIL®9 is already approved for preventing certain HPV-related cancers, V540D aims to offer even broader protection, suggesting some confidence in its potential safety. Researchers will closely monitor participants for any side effects to ensure the vaccine's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about V540D because it offers a new approach to cancer prevention, potentially improving upon existing vaccines like GARDASIL®9. Unlike current options that target a limited number of cancer-causing viruses, V540D is designed to provide broader protection against a wider range of cancer types. This could lead to more comprehensive prevention, reducing the risk of cancers not covered by existing vaccines. Additionally, researchers are keen to see if V540D's innovative formulation might enhance the immune response, offering better long-term protection.

What evidence suggests that this trial's treatments could be effective for preventing HPV-related cancers?

Research has shown that the standard HPV vaccine, GARDASIL®9, protects against nine types of HPV, helping to prevent related cancers. In this trial, participants will receive either GARDASIL®9 or V540D, a new vaccine under testing. V540D aims to cover the same HPV types as GARDASIL®9, plus additional ones. Although V540D remains in early testing, it seeks to provide broader protection against more types of HPV. If successful, it could further reduce the risk of developing HPV-related cancers compared to current vaccines. ^{1 2 6 7 8}

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 pass a medical exam, including vital sign checks and ECGs. It's designed to test the safety of a new HPV vaccine called V540D, which aims to protect against more types of HPV than the current GARDASIL®9 vaccine.

Inclusion Criteria

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

Exclusion Criteria

I have had abnormal Pap smears or HPV-related issues.

I have had cancer before.

I have received or will receive an HPV vaccine outside of this study.

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 or V540D

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• V540D

Trial Overview The study compares the standard HPV vaccine GARDASIL®9 with a new vaccine candidate, V540D. The goal is to see if V540D is safe and tolerated well by participants while potentially offering broader protection against additional HPV types.

How Is the Trial Designed?

Group I: V540D Experimental Treatment 1 Intervention

Participants will receive vaccinations with V540D.

Group II: GARDASIL®9 Active Control 1 Intervention

Participants will receive vaccinations with GARDASIL®9.

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

In a study of 816 cancer patients, the BNT162b2 vaccine demonstrated a high serologic response rate of 94.2% after the second dose, indicating effective immunization against COVID-19.

The vaccine was well tolerated, with only 3.5% and 1.3% of patients experiencing severe adverse events after the first and second doses, respectively, suggesting it is safe for use in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and Safety of COVID-19 Vaccine BNT162b2 for Patients with Solid Cancer: A Large Cohort Prospective Study from a Single Institution. Di Noia, V., Pimpinelli, F., Renna, D., et al.[2021]

Vaccines designed to enhance tumor antigen recognition in non-small cell lung cancer patients show promising results, including prolonged stable disease and tumor shrinkage, with no reported toxicity.

Specific vaccines such as LBLP25, TGF-beta2 antisense gene vaccine, and GVAX have demonstrated potential benefits that warrant further Phase III clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of vaccine clinical trials for non-small cell lung cancer. Nemunaitis, J., Nemunaitis, J.[2019]

Cancer vaccines, such as the HPV vaccine, are effective in preventing diseases like cervical cancer, while therapeutic vaccines have shown promise in treating existing cancers, like melanoma and prostate cancer.

In clinical trials, patients with recurrent melanoma who received a peptide vaccine combined with high-dose IL-2 had improved survival compared to those receiving IL-2 alone, and dendritic cell vaccines for prostate cancer also demonstrated increased survival rates compared to placebo, highlighting the potential of vaccine therapy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer vaccine]. Kageyama, S.[2011]

Vaccines have shown significant success in preventing cancer, particularly those associated with oncogenic viruses like human papillomavirus and hepatitis B virus, which help prevent cancers such as cervical cancer and liver cancer.

Research is ongoing for cancer-preventive vaccines targeting nonviral antigens, and while progress is being made, challenges remain in maximizing the effectiveness of these vaccines in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccines for immunoprevention of cancer. Enokida, T., Moreira, A., Bhardwaj, N.[2023]

The Phase I trial of the p53-targeting modified vaccinia Ankara (p53MVA) vaccine showed that it can enhance T-cell recognition of the p53 protein in patients with refractory gastrointestinal cancers.

However, the T-cell response was temporary, indicating that combining p53MVA with immunomodulatory agents may be necessary to achieve lasting clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming immunosuppression to enhance a p53MVA vaccine. Hardwick, N., Chung, V., Cristea, M., et al.[2021]

The CVADD 2009 conference highlighted the gap between high immune response rates from cancer vaccines and their limited clinical effectiveness, emphasizing the need for better application strategies to enhance their impact.

Discussions at the conference suggested that combining cancer vaccines with agents that counter tumor tolerance and conventional therapies could improve treatment outcomes, indicating a shift towards multimodal approaches in cancer vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Third International Conference on Cancer Vaccines/Adjuvants/Delivery for the Next Decade (CVADD 2009). Kyte, JA.[2018]

Preventive vaccines are a highly effective strategy for cancer prevention, as they can stimulate the immune system to create lasting memory against cancer-causing agents, significantly reducing cancer incidence, as seen with HBV and HPV vaccines.

Recent research suggests that antigens from microorganisms could be used to develop vaccines not only for virus-induced cancers but also for cancers with similar tumor-associated antigens, highlighting the potential for broader applications in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microorganisms-derived antigens for preventive anti-cancer vaccines. Buonaguro, L., Cavalluzzo, B., Mauriello, A., et al.[2023]

The CV9202 mRNA vaccine targets six specific antigens associated with advanced non-small cell lung cancer (NSCLC) and aims to enhance immune responses when combined with local radiation therapy, potentially improving treatment outcomes for patients with stage IV NSCLC.

The trial will primarily evaluate the safety of CV9202 by monitoring for severe treatment-related adverse events, while also assessing immune responses and efficacy, providing insights into the vaccine's potential as a durable therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase Ib study evaluating a self-adjuvanted mRNA cancer vaccine (RNActive®) combined with local radiation as consolidation and maintenance treatment for patients with stage IV non-small cell lung cancer. Sebastian, M., Papachristofilou, A., Weiss, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06688058

Study Details | NCT06688058 | A Trial to Evaluate ... The study vaccine (called V540D) is designed to protect against the same HPV types that G9 protects against plus other HPV types.

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-11-2024-30562

V540D Vaccine for Cancer Prevention In a study of 816 cancer patients, the BNT162b2 vaccine demonstrated a high serologic response rate of 94.2% after the second dose, indicating effective ...

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

Human Papillomavirus Vaccine Efficacy and Effectiveness ... The bivalent HPV vaccine efficacy against prevent persistent HPV 16/18 infection in adult, previously uninfected women was 83% (95% CI = 71% to 90%) and 43% (95 ...

4. mdanderson.org mdanderson.org/newsroom/research-newsroom/-esmo-2025--mrna-based-covid-vaccines-generate-improved-response.h00-159780390.html

ESMO 2025: mRNA-based COVID vaccines generate ... In the first group, 180 patients with advanced non-small cell lung cancer who received a vaccine had a median survival of 37.33 months, compared ...

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. trialx.com trialx.com/clinical-trials/listings/323231/a-trial-to-evaluate-tolerability-and-immunogenicity-of-v540d-in-healthy-adults-v540d-004/

A Trial to Evaluate Tolerability and Immunogenicity of ... The study vaccine (called V540D) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal ...

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06688058/

Trial | NCT06688058 A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Trial to Evaluate, Tolerability, and Immunogenicity of V540D in Healthy Adults.

8. 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.