Clinical Research Directory

FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland

Ticks in Finland can carry several microbes that may infect humans. The best known tick-borne diseases are Lyme borreliosis and tick-borne encephalitis (TBE). In recent years, scientists have also found other microbes in Finnish ticks, such as Anaplasma, Rickettsia, Neoehrlichia, Borrelia miyamotoi, and Babesia. Infections caused by these microbes are called emerging tick-borne diseases. Climate change may also increase the number of ticks and expand their range further north. This could lead to more tick-borne diseases in the future. The public health impact of these emerging infections is still unclear. Some of them may cause severe illness, especially in people with weakened immune systems or without a spleen. However, we still know little about how common these infections are, how they develop in the body, and what symptoms they cause. Some people may have no symptoms, while others may become seriously ill. Good diagnostic tests are also lacking. More knowledge is also needed about Lyme borreliosis and TBE. Some forms of Lyme disease, such as arthritis, heart inflammation, or eye problems, may be underdiagnosed. In addition, TBE cases have increased in Finland in recent years. This study will examine the symptoms, recovery, and quality of life of patients with these infections. Another goal is to improve laboratory diagnostics. Current tests for Lyme disease and TBE mainly detect antibodies. These tests cannot always tell when the infection occurred or distinguish a past Lyme borreliosis infection from a current one. This also makes it difficult to detect reinfections in Lyme borreliosis or TBE-infections in vaccinated individuals. By collecting samples from patients, we aim to develop better diagnostic methods. The main goal of the study is to improve knowledge about tick-borne diseases in Finland. We will study how common emerging infections are, what symptoms they cause, and whether people can have more than one tick-borne infection at the same time. We will also examine how the immune system responds to these infections and how this relates to disease severity and recovery. This study includes both children and adults who are being examined for a suspected tick-borne disease. Participants will be followed for six months using questionnaires at initiation, one, three, and six months. Blood samples and other samples, depending on the patient's symptoms, will be collected together with routine clinical samples. The samples will be analyzed to detect tick-borne pathogens and antibodies against them. Molecular tests (PCR) will look for the genetic material of the microbes. Researchers will also search for new biological markers of these diseases and study the immune response using advanced laboratory methods. The study will be conducted in collaboration with the SWETICK study.

Experiences and Care Pathways Shared on Social Media Regarding 5 Conditions Causing Chronic Pain

Chronic pain is a major symptom shared by several medical conditions. This study focuses on five well-defined chronic diseases : Lyme Borreliosis (LB), Post-Acute COVID-19 Syndrome (PACS or "long COVID"), fibromyalgia, endometriosis, and rheumatoid arthritis. Although all of these conditions are associated with chronic pain, they differ in several important aspects, justifying their choice for a comparison. The overall objective of this study was to describe the symptoms, treatments, and healthcare pathways associated with these five conditions, as reported by patients on social media platforms and online forums. The specific objectives were to compare PTLDS with the four other conditions across the following aspects: (i) Incompatible symptoms reported by patients; (ii) Different components of pain : physical, emotional, and social; (iii) Healthcare pathways; and (iv) Adherence to treatment recommendations.

Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.

Lyme borreliosis, commonly known as Lyme disease, has been clinically described for more than a century, but has been officially recognized for 40 years, with the detection of the Borrelia bacterium by W. Burgdorfer, in ticks of the Ixodes ricinus complex, identified a few years before.

Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.

Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes

Lyme borreliosis diagnosis currently relies on clinical assessment and detection of Borrelia-specific antibodies. However, serology does not allow reliable assessment of active infection. Evaluation of the cellular immune response through Borrelia-specific T lymphocyte monitoring may provide complementary diagnostic and prognostic information. This study aims to assess Borrelia afzelii-specific T-cell responses using multiparameter flow cytometry after stimulation with standardized peptide pools. This approach enables the characterization of CD4+ and CD8+ T cells, including polyfunctional immune responses. The diagnostic and prognostic value of this immunomonitoring strategy will be evaluated in patients with acrodermatitis chronica atrophicans, a late manifestation of Lyme borreliosis associated with B. afzelii.

A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults

The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points. This study is seeking participants who: * are generally healthy and between 18 and 44 years of age, * have never had a vaccine for Lyme disease before, * are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners, and * are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine. All participants in this study will receive a total of 5 doses through a shot in the upper arm. Four doses will be the study vaccine (VLA15), and 1 dose will be saltwater. The study will compare the experiences of people receiving the study vaccine at different time points. This will help see if the study vaccine is safe and will help understand its effect on the body. Participants will take part in this study for about 2 years. During this time, the participants will have 11 planned visits - 8 will be at the study clinic and 3 will be done over the phone. The clinic visits may include having a health check, giving a small amount of blood (about 20 mL or 4 teaspoons), and getting the study vaccine or saltwater as a shot.

Clinicaly Manifested Reinfections with Borrelia Burgdorferi Sensu Lato

Data on reinfections with B. burgdorferi sensu lato in humans are scarce; they are limited to case reports and a few small groups of patients, mostly from the USA and less frequently from Europe. In these reports, the clinical manifestation of reinfection was usually erythema migrans and was most often documented after successful treatment of a previous infection (almost always erythema migrans). The clinical manifestations of Lyme disease in reinfection appear to be similar to those of primary infection, but there are no studies on possible differences in serological or immunological responses. The current study has 3 primary objectives: * To determine the frequency of clinically detectable reinfections and to identify the circumstances under which they occur; * To determine possible differences between primary and reinfection in clinical presentation, disease course and outcome, and specific serum antibody response; * To determine the aetiology of clinically detectable reinfections by comparing Borrelia isolates recovered from the skin of the same patient at primary and reinfection.

Risk of Exposure and Prevention of Ticks and Tick-borne Diseases Among Foresters in Alsace

Ticks are blood-sucking arthropods that feed on vertebrate hosts. Although wild and domestic animals are the primary source of tick blood meals, humans can be an accidental host. During a blood meal, a microorganism can be transmitted to the host who can develop a disease. All infectious diseases transmitted by ticks are referred to as tick-borne diseases (TBDs). They are the most prevalent vector-borne diseases in the Northern Hemisphere. Among these diseases, Lyme borreliosis is the most common. In Europe, Lyme borreliosis does not cause high fevers (\> 38°C). Therefore, when a patient presents with a high fever with the notion of exposure to ticks, another etiology must be suspected. Anaplasma phagocytophilum and the tick-borne encephalitis virus are classically described as causing febrile syndromes. In France, ticks and tick-borne diseases are increasing, particularly those associated with the Ixodes ricinus tick. This tick is mainly present in forest ecosystems with a peak of activity in May. Foresters represent a population with biting ticks and tick-borne diseases, notably Lyme borreliosis.