Evaluation of Safety and Immunogenicity of CD40.Pan.CoV Vaccine, With or Without Adjuvant, as a Booster in Healthy Adult Participants

The primary objective of this phase 1/2a multicenter trial is to evaluate the **safety** and **immunogenicity** of the CD40.Pan.CoV vaccine, with or without an adjuvant, when administered as a booster in adult participants. This study is clinically relevant as it aims to assess the potential of the vaccine to enhance immune response and ensure safety in healthy individuals, which is crucial for the development of effective booster strategies against COVID-19.

The clinical trial involves a study population comprising **healthy participants** of both genders, with an age range categorized as 3, which typically includes adults. The total number of participants is not specified, as the sponsor has not provided this information. The trial population was selected without targeting any vulnerable groups, ensuring a general representation of the healthy adult population. No specific lifestyle considerations such as diet, physical activity, or habits have been highlighted as relevant to the study. The absence of detailed inclusion or exclusion criteria suggests a broad eligibility for participation, focusing primarily on the health status of the individuals. The study does not emphasize any particular demographic or lifestyle factors beyond the general health and age range of the participants.

The clinical trial is designed as a **phase 1/2a multicenter study** to evaluate the safety and immunogenicity of the CD40.Pan.CoV vaccine, either adjuvanted or not, as a booster in adult participants. The trial will employ a **randomized, double-blind, controlled** methodology to ensure the reliability and validity of the results. The estimated duration of the trial spans from the recruitment start date on February 17, 2025, to the anticipated end date on June 30, 2026.

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 evaluation to ensure participants meet the necessary health requirements. Following successful inclusion, participants will be randomized into different study arms. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' health status, vaccine safety, and immune response. These visits are crucial for collecting data on primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will conclude with an end-of-study visit, where final assessments will be conducted to gather comprehensive data on the vaccine's long-term effects.

The expected length of participant involvement will vary depending on the specific study arm and follow-up schedule, but it is anticipated to last until the trial's conclusion in June 2026. Conditions that may lead to early termination from the study include adverse reactions to the vaccine, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is focused on healthy participants, and the inclusion and exclusion criteria will be strictly adhered to, ensuring the safety and integrity of the study.

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.

Due to the lack of specific information, additional relevant details about drug administration, dosing schedules, and participant compliance monitoring are also not included. The absence of data on the **experimental medication** and non-experimental treatments limits the ability to provide a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of February 17, 2025, and an estimated end date of June 30, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically focus on assessing safety, tolerability, and pharmacokinetics, which may indirectly inform efficacy assessments. The trial will likely involve regular monitoring and data collection at predetermined intervals to evaluate these parameters. The methods and tools for measuring efficacy are not specified, but standard practices in clinical trials include the use of validated scales, laboratory tests, and possibly patient-reported outcomes. The analysis of collected data will adhere to rigorous scientific standards to ensure the reliability and validity of the findings.