Evaluation of a Live Attenuated Vaccine for Single Dose Administration in Patients with Rift Valley Fever Infection

The primary objective of the study titled "Live Attenuated Rift Valley Fever Vaccine for Single Shot Administration (LARISSA)" is to evaluate the efficacy and safety of a **live attenuated vaccine** for the prevention of **Rift Valley fever (RVF) infection**. This objective is clinically relevant as RVF is a significant zoonotic disease that can lead to severe health outcomes in humans, including hemorrhagic fever, encephalitis, and retinitis. The development of an effective single-dose vaccine could substantially reduce the incidence of RVF, thereby decreasing morbidity and mortality associated with the infection. No secondary objectives are provided for this study.

The clinical trial involves participants diagnosed with **Rift Valley fever (RVF) infection**. The study population includes both male and female subjects, with an age range of 18 to 65 years. The general health status of the participants is not specified, and the sponsor has not provided information regarding the total number of participants. The trial population was selected without targeting any vulnerable groups. Lifestyle considerations such as diet, physical activity, or habits have not been detailed. The sponsor has not disclosed specific inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate a **live attenuated vaccine** for the prevention of **Rift Valley fever (RVF) infection**. This study is structured as a Phase 1 trial, which is typically focused on assessing the safety and immunogenicity of the investigational vaccine. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from August 1, 2022, to December 31, 2024, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit. During this visit, eligibility criteria will be assessed to determine participant suitability for the trial. Following successful inclusion, participants will receive the investigational vaccine and will be monitored through scheduled follow-up visits. These visits are critical for evaluating the vaccine's safety profile and immune response. The trial will conclude with an end-of-study visit, where final assessments will be conducted to gather conclusive data on the vaccine's efficacy and safety.

The expected length of participant involvement in the trial is contingent upon the study's timeline, with individual participation potentially lasting until the end of the trial period. However, certain conditions may necessitate early termination from the study, such as adverse reactions to the vaccine or withdrawal of consent by the participant. The trial's design and procedures are meticulously crafted to ensure the collection of robust and reliable data, contributing to the understanding of the vaccine's potential in preventing Rift Valley fever.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements cannot be provided.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included in the provided data. As such, these aspects cannot be detailed in the current context.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating its primary focus on safety and dosage rather than efficacy. However, preliminary efficacy data may still be collected to inform future studies. The trial is scheduled to commence recruitment on August 1, 2022, with an estimated completion date of December 31, 2024. Although specific efficacy endpoints are not detailed, typical Phase 1 trials may involve the collection of data related to pharmacokinetics and pharmacodynamics, which can provide insights into the biological activity of the investigational product. The data collection and analysis will likely follow standard protocols for Phase 1 trials, utilizing validated methods and instruments appropriate for the investigational product and the condition under study. The trial's design will ensure that any efficacy-related data is systematically gathered and analyzed to support the development of subsequent trial phases.