Safety and Immunogenicity of Experimental Versus Authorized mRNA SARS-CoV-2 Vaccine Candidates as a Booster Dose in Previously Vaccinated Healthy Adults

The primary objective is to evaluate the safety and immunogenicity of experimental SARS-CoV-2 vaccine candidates compared to authorized mRNA vaccines when administered as a booster dose. This assessment is clinically relevant for determining the reactogenicity and immune response profile of novel vaccine formulations in individuals with prior immunization. Secondary objectives include the monitoring of safety markers and the characterization of the immune response in healthy participants.

This study involves 16 healthy volunteers. The study population includes both males and females. The participants belong to age ranges 3 and 4.

This Phase 1, multicenter, trial is designed to evaluate the safety and immunogenicity of experimental versus authorized SARS-CoV-2 vaccine candidates administered as a booster dose. The study focuses on healthy participants who have previously received authorized mRNA vaccines. The research methodology involves a sequence of study visits, beginning with a screening visit to assess eligibility. Following the intervention, participants will attend scheduled follow-up visits to monitor clinical outcomes and immune responses, concluding with an end-of-study visit. The total duration of participant involvement is determined by the established protocol, though participation may be subject to early termination based on predefined clinical conditions or safety criteria.

The assessment of efficacy in this Phase 1 clinical trial is not specified.