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 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.

Study Overview

• Status: Completed
• Conditions: Lyme Disease
• Intervention / Treatment: Diagnostic test: T-Detect Lyme

• Study Type: Observational
• Enrollment (Actual): 893

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Adaptive Biotechnologies Investigational Site
  • Georgia
    • Macon, Georgia, United States, 31210
      • Adaptive Biotechnologies Investigational Site
    • Savannah, Georgia, United States, 31406
      • Adaptive Biotechnologies Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Adaptive Biotechnologies Investigational Site
  • Maine
    • Lewiston, Maine, United States, 04240
      • Adaptive Biotechnologies Investigational Site
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Adaptive Biotechnologies Investigational Site
    • Rockville, Maryland, United States, 20854
      • Adaptive Biotechnologies Investigational Site
    • Towson, Maryland, United States, 21204
      • Adaptive Biotechnologies Investigational Site
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Adaptive Biotechnologies Investigational Site
    • Methuen, Massachusetts, United States, 01844
      • Adaptive Biotechnologies Investigational Site
    • Springfield, Massachusetts, United States, 01101
      • Adaptive Biotechnologies Investigational Site
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Adaptive Biotechnologies Investigational Site
  • New York
    • Binghamton, New York, United States, 13901
      • Adaptive Biotechnologies Investigational Site
    • Endwell, New York, United States, 13760
      • Adaptive Biotechnologies Investigational Site
    • New Windsor, New York, United States, 12553
      • Adaptive Biotechnologies Investigational Site
    • Syracuse, New York, United States, 13210
      • Adaptive Biotechnologies Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16601
      • Adaptive Biotechnologies Investigational Site
    • Altoona, Pennsylvania, United States, 16801
      • Adaptive Biotechnologies Investigational Site
    • Hatboro, Pennsylvania, United States, 19040
      • Adaptive Biotechnologies Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15236
      • Adaptive Biotechnologies Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15243
      • Adaptive Biotechnologies Investigational Site
    • Scottdale, Pennsylvania, United States, 15683
      • Adaptive Biotechnologies Investigational Site
    • Smithfield, Pennsylvania, United States, 15478
      • Adaptive Biotechnologies Investigational Site
    • Tipton, Pennsylvania, United States, 16684
      • Adaptive Biotechnologies Investigational Site
    • Uniontown, Pennsylvania, United States, 15401
      • Adaptive Biotechnologies Investigational Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Adaptive Biotechnologies Investigational Site
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Adaptive Biotechnologies Investigational Site
    • Rapid City, South Dakota, United States, 57702
      • Adaptive Biotechnologies Investigational Site
  • Virginia
    • Burke, Virginia, United States, 22015
      • Adaptive Biotechnologies Investigational Site
    • Danville, Virginia, United States, 24541
      • Adaptive Biotechnologies Investigational Site
    • Norfolk, Virginia, United States, 23502
      • Adaptive Biotechnologies Investigational Site
  • West Virginia
    • Kingwood, West Virginia, United States, 26537
      • Adaptive Biotechnologies Investigational Site
    • Morgantown, West Virginia, United States, 26501
      • Adaptive Biotechnologies Investigational Site
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Adaptive Biotechnologies Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants include male and female participants, of any race and ethnicity, ages 7 and above (inclusive) at the time of enrollment. For Cohort 5 only, participants must be 18 years of age or older.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Lyme disease testing cohort	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.
Cohort 2; Endemic, asymptomatic controls	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.
Cohort 3; Non-endemic, asymptomatic controls	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.
Cohort 4; Potential cross-reactive disease states	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.
Cohort 5; Lyme disease testing cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Adaptive Biotechnologies
• Collaborators: Iqvia Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2020
• Primary Completion (ACTUAL): October 29, 2021
• Study Completion (ACTUAL): October 30, 2021

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: erythema migrans rash; bullseye rash; early acute Lyme disease
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; Lyme Disease
• Other Study ID Numbers: PRO-00717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No