Clinical trials: Borrelia Infection
Lyme Disease
Novel Diagnostics for Early Lyme Disease
There are more than 300,000 new cases of Lyme disease every year in the US. Lyme disease is a dangerous bacterial infection transmitted by tick bites and it becomes increasingly severe as the infection progresses.
- Trial name
- NCT03963635
- Testing
- MicroB-plex Lyme Immunoassay
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- MicroB-plex, Inc.
Lyme Borreliosis
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.
- Trial name
- NCT07226882
- Testing
- VLA15
- Where
- 6 sites in United States
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteer
A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05
This is a Phase 2a, randomized, double-blind, proof-of-concept, single-center study evaluating the safety, tolerability, and whole blood concentration of TP-05 (lotilaner) in the killing of ticks after they have attached to human…
- Trial name
- NCT05387083
- Testing
- Low Dose TP-05, High Dose TP-05
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Lyme Borreliosis
Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.
This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted in two study phases: a run-in phase and a main study phase.
- Trial name
- NCT03769194
- Testing
- VLA15
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 572 people, healthy volunteers welcome
- Sponsor
- Pfizer
Lyme Disease, Tick-Borne Diseases
Lyme Disease Prevention Program
This is a large study of an educational program on Lyme disease prevention for passengers on ferry boats going to Nantucket Island during the period from Memorial Day until Labor Day.
- Trial name
- NCT00000432
- Testing
- Education about disease prevention
- Where
- United States
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Erythema Migrans
Patient's Pretreatment Expectations About Post-Lyme Symptoms
The investigators will focus on pretreatment expectations of patients with early Lyme disease manifested as erythema migrans with the aim of assessing the association between pretreatment expectations quantified with a…
- Trial name
- NCT03462329
- Testing
- Antibiotics (preferentially oral doxycycline 100 mg bid)
- Where
- Slovenia
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
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.
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
Erythema Chronicum Migrans
Duration of Antibiotic Treatment of Erythema Migrans
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
- Trial name
- NCT00910715
- Testing
- doxycycline
- Where
- Slovenia
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
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.
Erythema Chronicum Migrans
Duration of Doxycycline Treatment in MEM Patients
The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.
- Trial name
- NCT03337932
- Testing
- Doxycycline 100 milligram Oral Tablet bid, 7 days, Doxycycline 100 milligram Oral Tablet bid, 14 days, Controls without a history of lyme disease.
- Where
- Slovenia
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
Lyme Disease
A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
The purpose of this study is to learn about the safety effects of the Lyme disease vaccine (called VLA15), and its ability to protect people from Lyme disease after a 5th dose of the vaccine.
- Trial name
- NCT07500506
- Testing
- VLA15
- Where
- 22 sites in United States, Canada
- Volunteers
- 1,712 people, healthy volunteers welcome
- Sponsor
- Pfizer
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)
Patients With Different Manifestations of Lyme Borreliosis, Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum
Anti-phospolipid Antibodies in Lyme Borreliosis
Background Lyme borreliosis, caused by Borrelia burgdorferi sensu lato is transmitted to humans through the bite of an infected Ixodes tick. B.
- Conditions
- Patients With Different Manifestations of Lyme Borreliosis, Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum, Blood Donors
- Trial name
- NCT06929546
- Testing
- Anti-phospholipid antibodies
- Where
- Slovenia
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
Lyme Disease, Healthy
Lyme Disease Diagnostic Assay - Collection of Whole Blood
The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for…
- Trial name
- NCT05041595
- Testing
- Lyme diagnostic assay
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- DiaSorin Inc.
Lyme Disease
Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers
- Trial name
- NCT04835792
- Testing
- Stool and blood collection
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- FlightPath Biosciences, Inc.
Relapsing Fever, Tick-borne, Jarisch Herxheimer Reaction
Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Abstract Background Tick-Borne Relapsing Fever (TBRF) is an acute febrile illness. In Israel, TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks.
- Trial name
- NCT00237016
- Testing
- doxycycline treatment
- Where
- Israel
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Medical Corps, Israel Defense Force
Lyme Disease
Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation
IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.
- Trial name
- IXO-01 (NCT01243008)
- Testing
- Application of SHB001
- Where
- Switzerland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Lyme Disease, Lyme Neuroborreliosis
PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics
Overview PEMF Therapy for relief or reduction of lingering symptoms after antibiotic treatment of Lyme disease of participants in the UK.
- Conditions
- Lyme Disease, Lyme Neuroborreliosis, Lyme Arthritis, Unknown Origin Fever
- Trial name
- PEMF (NCT04577053)
- Testing
- Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical device
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Kasey Phifer
Rheumatic Diseases, Adult Onset Still Disease
Rheumatology Patient Registry and Biorepository
To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.
- Conditions
- Rheumatic Diseases, Adult Onset Still Disease, Ankylosing Spondylitis, Psoriatic Arthritis
- Trial name
- NCT04402086
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Yale University