ImmuneSense Lyme Study

• ClinicalTrials.gov Identifier: NCT04422314
• Recruitment Status: Completed
• First Posted: June 9, 2020
• Last Update Posted: April 15, 2022
• Sponsor: Adaptive Biotechnologies
• Collaborator: Iqvia Pty Ltd
• Information provided by (Responsible Party): Adaptive Biotechnologies

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Lyme Disease	Diagnostic Test: T-Detect Lyme

Study Design

• Study Type: Observational
• Actual Enrollment: 893 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ImmuneSense Lyme Study
• Actual Study Start Date: July 9, 2020
• Actual Primary Completion Date: October 29, 2021
• Actual Study Completion Date: October 30, 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT [ Time Frame: Baseline ]
   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.
2. To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT [ Time Frame: Baseline ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 7 Years and older (Child, Adult, Older Adult)
• Sexes 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.

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Adaptive Biotechnologies Investigational Site

Danbury, Connecticut, United States, 06810

United States, Georgia

Adaptive Biotechnologies Investigational Site

Macon, Georgia, United States, 31210

Adaptive Biotechnologies Investigational Site

Savannah, Georgia, United States, 31406

United States, Louisiana

Adaptive Biotechnologies Investigational Site

Baton Rouge, Louisiana, United States, 70806

United States, Maine

Adaptive Biotechnologies Investigational Site

Lewiston, Maine, United States, 04240

United States, Maryland

Adaptive Biotechnologies Investigational Site

Elkridge, Maryland, United States, 21075

Adaptive Biotechnologies Investigational Site

Rockville, Maryland, United States, 20854

Adaptive Biotechnologies Investigational Site

Towson, Maryland, United States, 21204

United States, Massachusetts

Adaptive Biotechnologies Investigational Site

Beverly, Massachusetts, United States, 01915

Adaptive Biotechnologies Investigational Site

Methuen, Massachusetts, United States, 01844

Adaptive Biotechnologies Investigational Site

Springfield, Massachusetts, United States, 01101

United States, New Jersey

Adaptive Biotechnologies Investigational Site

Freehold, New Jersey, United States, 07728

United States, New York

Adaptive Biotechnologies Investigational Site

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

United States, Pennsylvania

Adaptive Biotechnologies Investigational Site

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

United States, Rhode Island

Adaptive Biotechnologies Investigational Site

Warwick, Rhode Island, United States, 02886

United States, South Dakota

Adaptive Biotechnologies Investigational Site

Dakota Dunes, South Dakota, United States, 57049

Adaptive Biotechnologies Investigational Site

Rapid City, South Dakota, United States, 57702

United States, Virginia

Adaptive Biotechnologies Investigational Site

Burke, Virginia, United States, 22015

Adaptive Biotechnologies Investigational Site

Danville, Virginia, United States, 24541

Adaptive Biotechnologies Investigational Site

Norfolk, Virginia, United States, 23502

United States, West Virginia

Adaptive Biotechnologies Investigational Site

Kingwood, West Virginia, United States, 26537

Adaptive Biotechnologies Investigational Site

Morgantown, West Virginia, United States, 26501

United States, Wisconsin

Adaptive Biotechnologies Investigational Site

Wauwatosa, Wisconsin, United States, 53226

Sponsors and Collaborators

Adaptive Biotechnologies

Iqvia Pty Ltd

Investigators

• Study Director: Namita Singh, MD; Medical Director, Clinical Development

More Information

• Responsible Party: Adaptive Biotechnologies
• ClinicalTrials.gov Identifier: NCT04422314
• Other Study ID Numbers: PRO-00717
• First Posted: June 9, 2020
• Last Update Posted: April 15, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Adaptive Biotechnologies:

erythema migrans rash; bullseye rash; early acute Lyme disease

Additional relevant MeSH terms:

Lyme Disease; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases