Clinical trials: Borrelia Infection
- Condition Borrelia Infection
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
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
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
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
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 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