Evaluation of CVGBM Vaccine Efficacy and Safety in Patients with Surgically Resected Glioblastoma or Astrocytoma with Unmethylated Glioblastoma Signature

The primary objective of this study is to evaluate the **efficacy** and **safety** of the CVGBM vaccine at varying doses in patients who have undergone surgical resection for **glioblastoma** or **astrocytoma** with a molecular signature of unmethylated glioblastoma. This is clinically relevant as it aims to determine the optimal dosing strategy for enhancing patient outcomes and minimizing adverse effects in this population.

The clinical trial involves participants diagnosed with **surgically resected glioblastoma** (GBM) or astrocytoma characterized by a molecular signature of unmethylated glioblastoma. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically encompass adults and older adults. The trial population is noted to include vulnerable groups, although specific details regarding the selection process or lifestyle considerations such as diet or physical activity are not provided. The sponsor has not disclosed the total number of participants involved in the study.

The clinical trial is designed to evaluate the efficacy and safety of the **CVGBM vaccine** at varying doses in patients who have undergone surgery for **glioblastoma** or **astrocytoma** with a molecular signature of unmethylated glioblastoma. The study follows a randomized, double-blind, controlled trial design to ensure unbiased results and reliable data. The trial is expected to commence recruitment on May 1, 2023, and is projected to conclude by October 31, 2025, encompassing a total duration of approximately 30 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive review of the patient's medical history, physical examination, and necessary laboratory tests to confirm the diagnosis and suitability for the trial. Following successful inclusion, participants will be randomly assigned to receive either the investigational vaccine or a control, with neither the participants nor the investigators aware of the group assignments to maintain the double-blind nature of the study.

Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' health, assess the vaccine's efficacy, and record any adverse events. These visits will include clinical evaluations, imaging studies, and laboratory assessments to gather data on the vaccine's impact on disease progression and patient safety. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes of the trial.

The expected length of participant involvement will vary depending on individual response and the occurrence of any adverse events. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any medical condition that, in the investigator's judgment, warrants discontinuation for the participant's safety. The trial's rigorous design and comprehensive monitoring aim to ensure the collection of high-quality data to inform future therapeutic strategies for surgically resected glioblastoma or astrocytoma.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available. Additionally, details about drug administration, dosing schedules, and participant compliance monitoring are not included in the source data. As such, no further information can be provided regarding the substances used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on May 1, 2023, and is estimated to conclude by October 31, 2025. The trial is categorized under phase 7, indicating a specific stage in the clinical research process. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to determine the treatment's impact on the targeted medical condition. The methodology for efficacy assessment will adhere to standard clinical trial protocols, ensuring rigorous and objective evaluation of outcomes. The trial's design will incorporate appropriate tools and instruments to measure efficacy, although these are not specified in the available data. The trial's duration and phase suggest a comprehensive approach to evaluating the treatment's effectiveness over an extended period.