ImmuneSense Lyme Study

Lyme Disease Clinical Trial

Official title:

ImmuneSense Lyme Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422314
• Other study ID #: PRO-00717
• Status: Completed
• Start date: July 9, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: April 2022
• Source: Adaptive Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 detect and respond to the disease that current tests cannot. Data collected from this study may accelerate the development of better diagnostics for Lyme disease and improve outcomes for many.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 893
• Est. completion date: October 30, 2021
• Est. primary completion date: October 29, 2021
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

Cohort 1:

• Participants at or above the age of 7

• Arm A: Participants with an EM rash = 5 cm (confirmed by Lyme disease independent expert) with or without other signs and symptoms of Lyme disease

• Arm B: Participants who do not have an EM rash >/= 5 cm (either not confirmed by a Lyme disease independent expert or lacking a rash), but who have signs and symptoms suggestive of Lyme disease that warrants further testing, such as, but not limited to fever, myalgias, malaise, lymphadenopathy, rigors, arthralgias, peripheral and radiculoneuropathy, encephalopathy, intermittent arthritis, meningitis, heart block, carditis, etc

Cohort 2:

• Individuals in general good health, who reside in Lyme disease endemic regions

Cohort 3:

• Individuals in general good health, who reside in a region that is non-endemic for Lyme disease

Cohort 4:

Sourced from a sample repository

• Biorepositories with documented consent from participants for secondary use of their sample by a third party

• Confirmed, documented diagnoses for one of the following diseases:

• Viral: Epstein-Barr virus (EBV), cytomegalovirus (CMV), influenza, or COVID-19

• Tick-borne diseases: babesiosis, rocky mountain spotted fever, anaplasmosis, or ehrlichiosis

• Bacterial infection: syphilis

• Autoimmune/rheumatologic/neurologic diseases: Systemic Lupus Erythematous (SLE), Rheumatoid Arthritis (RA), Multiple Sclerosis (MS), chronic fatigue syndrome

• For infections, active infections are preferred and should be prioritized. Past infections will be acceptable for infections that are difficult to obtain.

Prospective collection Inclusion criteria

• Confirmed, documented diagnoses for one of the following diseases:

• Viral: Epstein-Barr virus (EBV), cytomegalovirus (CMV), influenza, or COVID-19

• Tick-borne diseases: babesiosis, rocky mountain spotted fever, anaplasmosis, or ehrlichiosis

• Bacterial infection: syphilis

• Autoimmune/rheumatologic/neurologic diseases: Systemic Lupus Erythematous (SLE), Rheumatoid Arthritis (RA), Multiple Sclerosis (MS), or chronic fatigue syndrome

• For infections, active infections are preferred and should be prioritized. Past infections will be acceptable for infections that are difficult to obtain.

Cohort 5:

• Participants ages 18 and above

• Arm A: Participants with an EM rash = 5 cm (confirmed by Lyme disease independent expert) with or without other signs and symptoms of Lyme disease

• Arm B: Participants who do not have an EM rash >/= 5 cm (either not confirmed by a Lyme disease independent expert or lacking a rash), but who have signs and symptoms suggestive of Lyme disease that warrants further testing, such as, but not limited to fever, myalgias, malaise, lymphadenopathy, rigors, arthralgias, peripheral and radiculoneuropathy, encephalopathy, intermittent arthritis, meningitis, heart block, carditis, etc

Exclusion Criteria:

• Participants will be excluded from the study if they meet any of the following criteria:

• Participant is a pregnant woman, prisoner, mentally disabled person, or ward-of-the state.

• Participant has any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study.

• Participant has been exposed to an investigational drug (new chemical entity) within 60 days prior to enrollment at the discretion of the investigator.

• Participant has donated more than one pint or 500cc of blood in the past two months or weight-based limits for pediatric populations.

• Received the Lyme disease vaccine

• Chronic infection with HIV, Tuberculosis, Hepatitis C, or Hepatitis B

• Active malignancy

Related Conditions & MeSH terms

• Lyme Disease

Intervention

Diagnostic Test:
• T-Detect Lyme
T-Detect Lyme is an investigational use test that uses multiplex PCR and NGS to assess rearranged T-cell receptor beta (TRB) gene sequences from genomic DNA isolated from human peripheral blood.

Locations

Country	Name	City	State
United States	Adaptive Biotechnologies Investigational Site	Altoona	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Altoona	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Baton Rouge	Louisiana
United States	Adaptive Biotechnologies Investigational Site	Beverly	Massachusetts
United States	Adaptive Biotechnologies Investigational Site	Binghamton	New York
United States	Adaptive Biotechnologies Investigational Site	Burke	Virginia
United States	Adaptive Biotechnologies Investigational Site	Dakota Dunes	South Dakota
United States	Adaptive Biotechnologies Investigational Site	Danbury	Connecticut
United States	Adaptive Biotechnologies Investigational Site	Danville	Virginia
United States	Adaptive Biotechnologies Investigational Site	Elkridge	Maryland
United States	Adaptive Biotechnologies Investigational Site	Endwell	New York
United States	Adaptive Biotechnologies Investigational Site	Freehold	New Jersey
United States	Adaptive Biotechnologies Investigational Site	Hatboro	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Kingwood	West Virginia
United States	Adaptive Biotechnologies Investigational Site	Lewiston	Maine
United States	Adaptive Biotechnologies Investigational Site	Macon	Georgia
United States	Adaptive Biotechnologies Investigational Site	Methuen	Massachusetts
United States	Adaptive Biotechnologies Investigational Site	Morgantown	West Virginia
United States	Adaptive Biotechnologies Investigational Site	New Windsor	New York
United States	Adaptive Biotechnologies Investigational Site	Norfolk	Virginia
United States	Adaptive Biotechnologies Investigational Site	Pittsburgh	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Pittsburgh	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Rapid City	South Dakota
United States	Adaptive Biotechnologies Investigational Site	Rockville	Maryland
United States	Adaptive Biotechnologies Investigational Site	Savannah	Georgia
United States	Adaptive Biotechnologies Investigational Site	Scottdale	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Smithfield	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Springfield	Massachusetts
United States	Adaptive Biotechnologies Investigational Site	Syracuse	New York
United States	Adaptive Biotechnologies Investigational Site	Tipton	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Towson	Maryland
United States	Adaptive Biotechnologies Investigational Site	Uniontown	Pennsylvania
United States	Adaptive Biotechnologies Investigational Site	Warwick	Rhode Island
United States	Adaptive Biotechnologies Investigational Site	Wauwatosa	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Adaptive Biotechnologies	Iqvia Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT	Diagnostic sensitivity is defined as the percentage of persons who have a given disorder who are identified by the assay as positive for Lyme disease.	Baseline
Primary	To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT	Diagnostic specificity is defined as the percentage of persons who do not have a given condition who are identified by the assay as negative for Lyme disease.	Baseline