Clinical trials: Lyme Disease
Lyme Disease
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms.
- Trial name
- NCT00001539
- Where
- United States
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lyme Disease
Searching for Persistence of Infection in Lyme Disease
Background: Lyme disease is an infection caused by Borrelia burgdorferi, a bacteria that is transmitted to humans by ticks. It can cause many different symptoms including rash, fever, headache, meningitis (infection of the…
- Trial name
- NCT01143558
- Testing
- Lyme Disease Xenodiagnosis
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lyme Disease
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
This study is designed to establish a population of patients with Lyme disease for evaluation, treatment and follow-up to learn more about the infection. Patients with active Lyme disease may be eligible for this study.
- Trial name
- NCT00028080
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lyme Borreliosis, Fibromyalgia
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…
- Conditions
- Lyme Borreliosis, Fibromyalgia, Rheumatoid Arthritis (RA), Post Acute COVID 19 Syndrome
- Trial name
- NCT07871578
- Where
- France
- Volunteers
- 501 people
- Sponsor
- Central Hospital, Nancy, France
Lyme Borreliosis, Physical Activity
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.
- Conditions
- Lyme Borreliosis, Physical Activity, Lyme Borreliosis, Nervous System
- Trial name
- LyMouv' (NCT05641116)
- Testing
- physical activity program, Advice and recommendations of physical activity at home
- Where
- 2 sites in France
- Volunteers
- 62 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome
The Precision Mito- Mito Map COMPASS Study
Mito Map is a research tool that produces an Energy Score from information provided by a participant. This remote observational study has an initial enrollment target of 400 adults across seven prespecified cohorts: healthy…
- Conditions
- Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome, Post-COVID-19 Condition, Postural Orthostatic Tachycardia Syndrome
- Trial name
- COMPASS (NCT07856121)
- Testing
- Mito Map Energy Score and Home Functional Assessments
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- AI Agent Vault, Inc. d/b/a Precision Mito
Post-Treatment Lyme Disease
Tetracycline Treatment Tolerability Trial
Randomized, double-blind, placebo-controlled study (with a one-week washout period) where subjects receive either 3 months of tetracycline or 3 months of placebo.
- Trial name
- T-4 (NCT05219929)
- Testing
- Tetracycline 500 Mg
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Johns Hopkins University
Tick-borne Diseases, Tick Resistance
Human Immune Response to Ixodes Scapularis Tick Bites
Background: Each year, the number of cases of tick-borne diseases increases. The deer tick (Ixodes scapularis) is the vector of at least 7 pathogens that cause human diseases, including Lyme disease.
- Conditions
- Tick-borne Diseases, Tick Resistance, Lyme Disease
- Trial name
- NCT05036707
- Testing
- Xenodiagnosis Ticks, skin biopsy, blood draw
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gut Microbiome, Gastrointestinal Microbiome
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
- Conditions
- Gut Microbiome, Gastrointestinal Microbiome, Autism, Autism Spectrum Disorder
- Trial name
- NCT04031469
- Testing
- There is no intervention in this study
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- ProgenaBiome
Lyme Borreliosis
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…
- Trial name
- NCT04801420
- Testing
- VLA15
- Where
- 19 sites in United States
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Pfizer
Lyme Disease
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)
This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.
- Trial name
- NCT07561294
- Testing
- mRNA-1982
- Where
- 8 sites in Canada
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Lyme Disease
A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age
The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.
- Trial name
- NCT05975099
- Testing
- mRNA-1975, mRNA-1982
- Where
- 20 sites in United States
- Volunteers
- 807 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Lyme Borreliosis, Lyme Disease
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.
- Trial name
- LyTLymICS-AIM (NCT07703787)
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France
Lyme Disease
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
- Trial name
- NCT07562087
- Testing
- TP-05 (lotilaner) Low Dose, TP-05 (lotilaner) High Dose
- Where
- 19 sites in United States
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Lyme Disease, Post Treatment Lyme Disease
Navigating Pregnancy and Parenthood With Lyme Disease
This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome…
- Conditions
- Lyme Disease, Post Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections
- Trial name
- NCT06397794
- Testing
- Quantitative surveys and qualitative interview
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Children's National Research Institute
Lyme Disease, Post-Treatment Lyme Disease
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero.
- Conditions
- Lyme Disease, Post-Treatment Lyme Disease, Chronic Lyme Disease, Tick-Borne Infections
- Trial name
- NCT06026969
- Testing
- Neurodevelopmental assessments and follow-up
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Children's National Research Institute
Lyme Disease
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe.
- Trial name
- VALOR (NCT05477524)
- Testing
- VLA15, Saline
- Where
- 129 sites in United States, Canada and 5 more
- Volunteers
- 12,546 people, healthy volunteers welcome
- Sponsor
- Pfizer
Post-treatment Lyme Disease Syndrome, Chronic Pain
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain. The Sana PR is a device comprised of one main component (Mask with Earbuds) and two ancillary components (Charger and…
- Trial name
- NCT06655844
- Testing
- Sana Pain Reliever
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Post-Treatment Lyme Disease Syndrome
Ceftriaxone for Post-Treatment Lyme Disease
Lyme disease is a public health crisis in the US. It is estimated that over 400,000 cases occur every year with 10-20% of those infected going on to develop Post-Treatment Lyme disease Syndrome (PTLDS).
- Trial name
- NCT06785402
- Testing
- Ceftriaxone treatment
- Where
- United States
- Sponsor
- Hackensack Meridian Health
Lyme Disease
Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
This study is to understand if the study vaccine (called VLA15) is safe in healthy children. We are looking for children who: are healthy are age 5 through 17 have not been diagnosed with any form of Lyme disease in the past have…
- Trial name
- NCT05634811
- Testing
- VLA15, Normal Saline
- Where
- 65 sites in United States
- Volunteers
- 3,547 people, healthy volunteers welcome
- Sponsor
- Pfizer