Clinical trials: Lyme Disease
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
Acute Bacterial Infections, Acute Viral Infections
300 Antibody Diagnostic Test Kit
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections.
- Trial name
- Antibody 300 (NCT01646411)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- The Plasma Source
Erythema Migrans of Lyme Disease
Effect of Saccharomyces Boulardii CNCM I-745 on Gut Microbiota in Patients Undergoing Antibiotic Therapy (in the Context of Erythema Migrans (Early Skin Form of Lyme Borreliosis))
The aim of this study is to assess the effect of Saccharomyces boulardii CNCM I-745 on gut microbiota in patients undergoing antibiotic therapy (in the context of erythema migrans (early skin form of Lyme borreliosis)).
- Trial name
- SUBLYME (NCT06451913)
- Testing
- Amoxicillin + Saccharomyces boulardii CNCM I-745, Stool samples, BSFS : Bristol Stool Form Scale
- Where
- Slovenia
- Volunteers
- 120 people
- Sponsor
- Biocodex
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
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.
Bell's Palsy, Ramsay Hunt Syndrome
Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
- Conditions
- Bell's Palsy, Ramsay Hunt Syndrome, Lyme Disease, Facial Palsy
- Trial name
- Paralysis (NCT06542289)
- Testing
- BlinkER device.
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Neurotrigger Ltd
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
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.
- Trial name
- NCT03581279
- Testing
- T2Lyme Panel testing
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- T2 Biosystems
Lyme Disease
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease. This is an 8 month study.
- Trial name
- ALSIBDT (NCT02741609)
- Testing
- Borrelia Diagnostic Test
- Where
- 16 sites in United States
- Volunteers
- 218 people
- Sponsor
- Advanced Laboratory Services, Inc.
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 Borreliosis, Nervous System
Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without…
- Trial name
- NCT03010228
- Testing
- VLA15 with Alum, VLA15 without Alum
- Where
- 5 sites in United States, Belgium
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Pfizer
Lyme Borreliosis
Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System.
- Trial name
- NCT03873974
- Testing
- DualDur dark-field microscopic test, DualDur dark-field automatic microscopic test, Western blot IgM and IgG
- Where
- 8 sites in Austria, Czechia and 4 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Lyme Diagnostics Ltd.
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.
Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)
Sofia 2 Lyme FIA Whole Blood Clinical Study
The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate…
- Trial name
- NCT03238274
- Testing
- Sofia 2 Lyme FIA testing
- Where
- 11 sites in United States
- Volunteers
- 597 people
- Sponsor
- Quidel Corporation
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
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.
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
Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo.
- Trial name
- NCT03970733
- Testing
- VLA15
- Where
- 5 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Understanding Tick-borne Diseases
Ticks are the major arthropod vectors transmitting pathogenic agents to humans and domestic animals in Europe, and currently, the incidence of tick-borne disease is rising.
- Trial name
- OHTICKS (NCT03501407)
- Testing
- Blood samples, skin biopsy
- Where
- France
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur