Evaluation of a Sublingual Vaccine's Induction of Trained Immunity in Peripheral Blood Cells of Healthy Adult Males and Non-Pregnant Females

The primary objective of this study is to evaluate the ability of a **sublingual vaccine** to induce the expression of trained immunity in peripheral blood cells. This is clinically relevant as trained immunity can enhance the body's innate immune response, potentially providing broader protection against infections. The study involves healthy adult males and non-pregnant females, focusing on the immunological effects of the vaccine in this population.

The clinical trial involves **healthy adult males and non-pregnant females**. The study population includes both genders, with an age range classified under category code "3," which typically represents adults. Participants are in good general health, as indicated by the inclusion of healthy individuals. The trial does not involve 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 specified in the available data.

The clinical trial is designed to evaluate the ability of a sublingual vaccine to induce the expression of **trained immunity** in peripheral blood cells. The study will involve **healthy adult males and non-pregnant females**. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The estimated recruitment start date is September 7, 2023, with the trial expected to conclude by December 31, 2025, making the overall duration approximately 28 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation to ensure participants meet the necessary health standards. Following successful screening, participants will be randomized into either the treatment or control group. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health and the vaccine's effects on their immune response. These visits will include clinical assessments, blood sample collection, and monitoring for any adverse events. The end-of-study visit will occur at the trial's conclusion, where final assessments will be conducted to evaluate the primary and secondary endpoints.

The expected length of participant involvement will vary depending on the specific schedule of follow-up visits, but it will generally span the entire duration of the trial. 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 ethical reasons deemed necessary by the study investigators. The trial will adhere to all regulatory and ethical guidelines to ensure the safety and well-being of all participants throughout the study period.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is set to conclude by December 31, 2025, with recruitment having commenced on September 7, 2023. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the trial duration. The absence of explicit endpoints suggests a focus on comprehensive data collection to evaluate the therapeutic impact of the intervention under investigation. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy assessments.