ImmuneSense Lyme Study

Completed

• Conditions: Lyme Disease
• Interventions: Diagnostic Test: T-Detect Lyme

• Registration Number: NCT04422314
• Lead Sponsor: Adaptive Biotechnologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Study Start: 2020-07-09
• Primary Completion: 2021-10-29
• Study Completion: 2021-10-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 893

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 4	T-Detect Lyme	Potential cross-reactive disease states
Cohort 1	T-Detect Lyme	Lyme disease testing cohort
Cohort 2	T-Detect Lyme	Endemic, asymptomatic controls
Cohort 3	T-Detect Lyme	Non-endemic, asymptomatic controls
Cohort 5	T-Detect Lyme	Lyme disease testing cohort

Primary Outcome Measures

Name	Time	Method
To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT	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.
To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT	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.

Trial Locations

Locations (1)

Adaptive Biotechnologies Investigational Site; 🇺🇸 Wauwatosa, Wisconsin, United States