Clinical trial NCT04422314: ImmuneSense Lyme Study
Official title: ImmuneSense Lyme Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lyme Disease
Keywords: erythema migrans rash
bullseye rash
early acute Lyme disease
Lead sponsor: Adaptive Biotechnologies
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2020-06-09
Enrollment: 893
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT
timeFrame: Baseline
measure: To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Danbury
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Connecticut
city: Macon
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Georgia
city: Baton Rouge
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Louisiana
city: Lewiston
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Maine
city: Elkridge
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Maryland
city: Towson
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Maryland
city: Beverly
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Massachusetts
city: Methuen
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Massachusetts
city: Freehold
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: New Jersey
city: Binghamton
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: New York
city: Endwell
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: New York
city: New Windsor
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: New York
city: Syracuse
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: New York
city: Altoona
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Altoona
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Hatboro
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Scottdale
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Smithfield
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Tipton
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Rhode Island
city: Dakota Dunes
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: South Dakota
city: Rapid City
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: South Dakota
city: Burke
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Virginia
city: Danville
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Virginia
city: Kingwood
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: West Virginia
city: Morgantown
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: West Virginia
city: Wauwatosa
country: United States
facility: Adaptive Biotechnologies Investigational Site
state: Wisconsin
Study officials:
affiliation: Medical Director, Clinical Development
name: Namita Singh, MD
role: STUDY_DIRECTOR
References: