Phase 1/2 Multicenter Randomized Study on Safety and Immunogenicity of CD40.RBDv Bivalent COVID-19 Vaccine in Healthy Volunteers

The primary objective of the study is to evaluate the **safety** and **immunogenicity** of a sub-unit protein CD40.RBDv bivalent COVID-19 vaccine, adjuvanted or not, as a booster in healthy volunteers. This is clinically relevant as it aims to determine the potential of the vaccine to enhance immune response and ensure safety in individuals who have previously been vaccinated or exposed to COVID-19. The study is conducted in a phase 1/2 multicenter, randomized setting, which is crucial for assessing the vaccine's effects in a controlled and systematic manner.

The clinical trial involves a total of **25 participants** who are categorized as **healthy volunteers**. The study population includes both **male and female** subjects, with an age range spanning from **18 to 65 years**. Participants were selected based on their general health status, ensuring they do not belong to any vulnerable population. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The selection process was designed to include a diverse group of healthy individuals, without any significant inclusion or exclusion criteria provided by the sponsor.

The clinical trial is a **randomized**, phase 1/2 study designed to evaluate the safety and immunogenicity of a sub-unit protein CD40.RBDv bivalent COVID-19 vaccine, which may be adjuvanted, as a booster in **healthy volunteers**. The trial is conducted in a multicenter setting and is expected to span from September 1, 2023, to September 1, 2025. The study employs a **double-blind** and controlled methodology to ensure unbiased results and reliable data collection.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility is assessed based on predefined criteria. Following successful screening, participants will be randomized into different study arms. The trial includes multiple follow-up visits to monitor the participants' health status, vaccine safety, and immune response. These visits are scheduled at regular intervals throughout the study duration. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to gather comprehensive data on the vaccine's effects.

The expected length of participant involvement is approximately two years, aligning with the overall trial duration. However, certain conditions may lead to early termination from the study, such as adverse reactions to the vaccine, withdrawal of consent, or non-compliance with study protocols. The trial is structured to ensure participant safety and the integrity of the collected data, adhering to ethical standards and regulatory requirements.

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 absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the experimental medication's maximum daily dose, maximum total dose, or maximum treatment period. Furthermore, there is no information regarding whether the formulation is pediatric or if the product is classified as an orphan drug.

As the source data lacks comprehensive details about the trial's treatments, this description remains limited to the information provided. Any further elaboration on the substances involved in the trial is not possible without additional data.

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 September 1, 2023, and an estimated end date of September 1, 2025. The efficacy assessment will be conducted at predetermined intervals throughout the trial duration. Specific parameters or endpoints for evaluating efficacy have not been detailed in the provided data. The trial will adhere to standard protocols for data collection and analysis, ensuring that all measurements are conducted using validated methods and instruments. The results will be analyzed to determine the efficacy of the intervention under investigation, following the guidelines and objectives set forth in the trial protocol.