Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Merck Sharp & Dohme LLC
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 V540D) 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 V540D in healthy adults and if people tolerate it.
What data supports the effectiveness of the V540D treatment for cancer prevention?
Research on cancer vaccines, like the p53MVA and other mRNA vaccines, shows they can help the immune system recognize and fight cancer cells. While these vaccines often need to be combined with other treatments to be more effective, they have shown potential in improving survival and reducing tumor size in some cancer patients.
13457How does the V540D vaccine differ from other cancer prevention treatments?
The V540D vaccine is unique because it focuses on preventing cancer by targeting specific antigens (substances that trigger an immune response) associated with tumors, similar to how vaccines for viruses like HPV and HBV prevent virus-related cancers. This approach is different from traditional cancer treatments that focus on eliminating existing cancer rather than preventing it.
12678Will 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.
Eligibility Criteria
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.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.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: V540DExperimental Treatment1 Intervention
Participants will receive vaccinations with V540D.
Group II: GARDASIL®9Active Control1 Intervention
Participants will receive vaccinations with GARDASIL®9.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Research Centers of America ( Hollywood ) ( Site 0001)Hollywood, FL
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Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
References
A review of vaccine clinical trials for non-small cell lung cancer. [2019]Recent evidence suggests that vaccines which enhance tumour antigen recognition may provide clinical benefit to subsets of non-small cell lung cancer patients. In this review, a variety of peptide-, gene- and cell-based clinical vaccine approaches targeting non-small cell lung cancer patients are reviewed. Results consistently demonstrate lack of toxicity. Examples of prolonged stable disease, tumour shrinkage response and survival benefit in comparison with historical and low-dose control groups have been demonstrated. Specific vaccines fulfilling justification for Phase III evaluation based on these results include LBLP25, TGF-beta2 antisense gene vaccine and GVAX.
Third International Conference on Cancer Vaccines/Adjuvants/Delivery for the Next Decade (CVADD 2009). [2018]The Third International Conference on Cancer Vaccines/Adjuvants/Delivery for the Next Decade (CVADD), chaired by Malcolm S Mitchell, was hosted in Dublin, Ireland, on 11-13 November 2009. The conference was intended to aid the translation of basic research into clinical progress and to bridge the gap between academia and industrial innovation. In total, 44 speakers gave presentations on preclinical and clinical vaccine development, mostly focusing on cancer vaccination. The present report does not represent a comprehensive review of all topics covered, but highlights selected points of particular novelty and interest. Within the field of cancer vaccines, the considerable discrepancy between high immune response rates and limited clinical effects has led to increased focus on how vaccines may best be applied to maximize their clinical impact. This challenge emerged at the forefront of the conference, reflected by fruitful discussions on adjuvants, delivery systems, strategies for countering tumor tolerance and on combination with conventional therapy. The studies presented at CVADD 2009 support the argument for combining active immunization with agents countering tumor tolerance and with conventional cancer treatment, while also pointing to a need for improved knowledge on how to develop these multimodal regimes.
[Cancer vaccine]. [2011]Cancer vaccine is an intervention for therapeutic or prophylactic option by activating antitumor immune responses in vivo. Vaccine to human papillomavirus is clinically available, which prevents women from developing cervical cancer. Therapeutic cancer vaccines have been studied in randomized clinical trials. Melanoma vaccine using a gpl00 -peptide has been analyzed in recurrent disease patients. Patients treated with peptide vaccine with high-dose IL-2 lived longer than those with IL-2 alone. Another clinical trial covered hormone-resistant prostate cancer patients who were treated with dendritic cell (DC) vaccine of prostate-acid protein plus GM-CSF. DC-vaccinated patients significantly lived longer than those with placebo, though no difference of disease progression was seen between the two groups. Worldwide phase III study of MAGE-A3 vaccine for non-small cell lung cancer has been initiated. Its analysis on clinical benefits will be expected. Vaccine therapy for cancer would be another option for clinical practice in near
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. [2023]Advanced non-small cell lung cancer (NSCLC) represents a significant unmet medical need. Despite advances with targeted therapies in a small subset of patients, fewer than 20% of patients survive for more than two years after diagnosis. Cancer vaccines are a promising therapeutic approach that offers the potential for durable responses through the engagement of the patient's own immune system. CV9202 is a self-adjuvanting mRNA vaccine that targets six antigens commonly expressed in NSCLC (NY-ESO-1, MAGEC1, MAGEC2, 5 T4, survivin, and MUC1).
Overcoming immunosuppression to enhance a p53MVA vaccine. [2021]A Phase I trial of a p53-targeting modified vaccinia Ankara (p53MVA) vaccine in patients afflicted with refractory gastrointestinal cancers demonstrated enhanced T-cell recognition of p53 following vaccination. However, this effect was transient suggesting that p53MVA requires combination with immunomodulatory agents to deliver clinical benefit. Here, we outline our rationale for combining p53MVA with immunomodulatory chemotherapy in a forthcoming trial.
Vaccines for immunoprevention of cancer. [2023]The immunoprevention of cancer and cancer recurrence is an important area of concern for the scientific community and society as a whole. Researchers have been working for decades to develop vaccines with the potential to alleviate these health care and economic burdens. So far, vaccines have made more progress in preventing cancer than in eliminating already established cancer. In particular, vaccines targeting oncogenic viruses, such as the human papillomavirus and the hepatitis B virus, are exceptional examples of successful prevention of virus-associated cancers, such as cervical cancer and hepatocellular carcinoma. Cancer-preventive vaccines targeting nonviral antigens, such as tumor-associated antigens and neoantigens, are also being extensively tested. Here, we review the currently approved preventive cancer vaccines; discuss the challenges in this field by covering ongoing preclinical and clinical human trials in various cancers; and address various issues related to maximizing cancer vaccine benefit.
Immunogenicity and Safety of COVID-19 Vaccine BNT162b2 for Patients with Solid Cancer: A Large Cohort Prospective Study from a Single Institution. [2021]We assessed the immunogenicity and safety of the BNT162b2 vaccine in a large cohort of patients with cancer (CP).
Microorganisms-derived antigens for preventive anti-cancer vaccines. [2023]Cancer prevention is one of the aim with the highest priority in order to reduce the burden of cancer diagnosis and treatment on individuals as well as on healthcare systems. To this aim, vaccines represent the most efficient primary cancer prevention strategy. Indeed, anti-cancer immunological memory elicited by preventive vaccines might promptly expand and prevent tumor from progressing. Antigens derived from microorganisms (MoAs), represent the obvious target for developing highly effective preventive vaccines for virus-induced cancers. In this respect, the drastic reduction in cancer incidence following HBV and HPV preventive vaccines are the paradigmatic example of such evidence. More recently, experimental evidences suggest that MoAs may represent a "natural" anti-cancer preventive vaccination or can be exploited for developing vaccines to prevent cancers presenting highly homologous tumor-associated antigens (TAAs) (e.g. molecular mimicry). The present review describes the different preventive anti-cancer vaccines based on antigens derived from pathogens at the different stages of development.