Evaluation of the Impact of Anti-Rheumatic Treatments on Herpes-Zoster Vaccine Immunogenicity in Patients with Inflammatory Rheumatic Diseases

The primary objective of this study is to evaluate the impact of **anti-rheumatic treatments** on the immunogenicity of the **herpes-zoster vaccine** (Shingrix) in patients with **inflammatory rheumatic diseases** (IRD), including rheumatoid arthritis, systemic lupus erythematosus (SLE), spondylarthropathies, psoriatic arthritis, systemic vasculitis, or systemic sclerosis. This is clinically relevant as it aims to determine how these treatments may affect the vaccine's ability to elicit an immune response, which is crucial for providing protection against herpes-zoster infection in this patient population.

The clinical trial involves participants diagnosed with **inflammatory rheumatic diseases** such as rheumatoid arthritis, systemic lupus erythematosus (SLE), spondylarthropathies, psoriatic arthritis, systemic vasculitis, or systemic sclerosis, as well as those undergoing vaccination. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or the selection process for the trial population. No specific lifestyle considerations such as diet, physical activity, or habits have been highlighted in the available data.

The clinical trial is designed to evaluate the impact of anti-rheumatic treatments on the **immunogenicity** of the herpes-zoster vaccine (Shingrix) in patients with **inflammatory rheumatic diseases** (IRD), including rheumatoid arthritis, systemic lupus erythematosus (SLE), spondylarthropathies, psoriatic arthritis, systemic vasculitis, or systemic sclerosis. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the actual vaccine or a placebo, thereby minimizing bias. The trial is set to commence recruitment on January 1, 2024, and is expected to conclude by December 31, 2029, providing a comprehensive evaluation period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough review of the participant's medical history and current health status. Following successful inclusion, participants will attend scheduled follow-up visits to monitor their response to the vaccine and any potential side effects. These visits are crucial for collecting data on the vaccine's efficacy and safety in the context of IRD. The study will culminate in an end-of-study visit, where final assessments will be conducted to evaluate the long-term effects of the vaccination.

The expected duration of participant involvement in the trial is contingent upon the study's timeline, with individual participation potentially lasting several years, depending on the timing of their enrollment. Conditions that may lead to early termination from the study include the occurrence of adverse events, withdrawal of consent, or any significant deviation from the study protocol that could impact the integrity of the trial data. The trial's design and procedures are meticulously crafted to ensure the collection of robust and reliable data, contributing valuable insights into the interaction between anti-rheumatic treatments and vaccine efficacy in this patient population.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is set to commence recruitment on January 1, 2024, with an estimated completion date of December 31, 2029. The trial is categorized under phase 6, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and 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 trial's design will ensure that data collection and analysis are conducted systematically to provide reliable and valid results regarding the efficacy of the intervention under investigation.