Clinical trials: Borrelia Infection
- Condition Borrelia Infection
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
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.
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 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
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
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
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 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 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
Lyme Disease
Lyme Test Indication Combinations (LyTIC) Study
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis
- Trial name
- LyTIC (NCT03201042)
- Testing
- PCR based assay, Serology based assay, Tcell based assay
- Where
- 60 sites in United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Oxford Immunotec
Prophylaxis of Lyme Borreliosis
Phase 1/2 Lyme Vaccine Study
Section 1: The purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adjuvant in seronegative healthy…
- Trial name
- NCT01504347
- Testing
- Multivalent recombinant OspA Lyme Borreliosis Vaccine
- Where
- 8 sites in Austria, Germany
- Volunteers
- 1,630 people, healthy volunteers welcome
- Sponsor
- Baxalta now part of Shire
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.
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.
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
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
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
Amyotrophic Lateral Sclerosis (ALS), Angina, Stable
Quest to Analyze One Thousand Humans Meditating
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and…
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Angina, Stable, Anxiety, Asthma
- Trial name
- QUANTUM (NCT06583395)
- Testing
- Advanced multi-component meditation practice
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Tobias Moeller-Bertram
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