Clinical trials: Borrelia Infection
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
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
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
ImmuneSense Lyme Study
ImmuneSense Lyme is a study, which is designed to better understand the immune response to Lyme disease. This is critically important because the immune system may be able to tell us important information about how our own bodies…
- Trial name
- NCT04422314
- Testing
- T-Detect Lyme
- Where
- 34 sites in United States
- Volunteers
- 893 people
- Sponsor
- Adaptive Biotechnologies
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 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
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.