Phase 1 Study on Safety and Immunogenicity of OVX033 Vaccine in Sarbecovirus Diseases in Healthy Adults Aged 18-49

The primary objective of this study is to evaluate the **safety** and **immunogenicity** of three dose levels of the OVX033 vaccine following intramuscular administration in healthy subjects aged 18-49 years. This is a first-in-human, phase 1, single-center, randomized, double-blind, placebo-controlled study. The clinical relevance of this objective lies in determining the potential of the OVX033 vaccine to elicit an immune response and its safety profile in the context of **Sarbecovirus diseases**. No secondary objectives are provided for this study.

The clinical trial involves participants diagnosed with **Sarbecovirus diseases**. The study population includes both male and female subjects, with an age range categorized as 3, which typically corresponds to adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been detailed in the available data. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is a **randomized**, **double-blind**, **placebo-controlled** study designed to evaluate the safety and immunogenicity of three dose levels of the OVX033 vaccine. This first-in-human phase 1 trial will be conducted at a single center and involves healthy subjects aged 18-49 years. The study targets **Sarbecovirus diseases**, including **Coronavirus infection**. The trial is scheduled to commence recruitment on December 1, 2023, and is expected to conclude by October 31, 2024.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational vaccine or a placebo. The trial design ensures that neither the participants nor the investigators are aware of the group assignments, maintaining the double-blind nature of the study. Subsequent follow-up visits will be conducted to monitor the participants' health, assess the vaccine's safety profile, and evaluate immunogenicity responses. The end-of-study visit will mark the completion of the trial for each participant, where final assessments will be conducted.

The expected duration of participant involvement in the trial is approximately 11 months, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent by the participant, or any other medical or safety concerns as determined by the investigators. The trial's methodology and design are structured to ensure the collection of robust and reliable data, contributing to the understanding of the vaccine's safety and immunogenicity in the target population.

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 **disease** being studied, the trial's main objective, or any other pertinent details that would typically be included in a clinical trial description.

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 December 1, 2023, and an estimated end date of October 31, 2024. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically focus on safety, tolerability, and pharmacokinetics, which may indirectly inform efficacy assessments. The trial will likely involve systematic data collection and analysis at predetermined intervals, utilizing validated methods and instruments appropriate for the investigational product and the condition under study. The results will contribute to understanding the investigational product's potential efficacy and inform subsequent trial phases.