Trial Outcomes & Findings for Xenodiagnosis After Antibiotic Treatment for Lyme Disease (NCT NCT02446626)
NCT ID: NCT02446626
Last Updated: 2024-06-03
Results Overview
Recovered ticks after feeding on research participants were tested for presence of B. burgdorferi using at least one of three procedures: 1. Test ticks by polymerase chain reaction (PCR) and culture - Injection of tick lysate into severe combined immunodeficiency (SCID) mice with subsequent PCR and culture testing 2. Test ticks using isothermal amplification reaction included in the PCR electrospray ionization mass spectroscopy 3. Test ticks by PCR using the Tick-borne disease Capture Sequencing Assay (TBDCapSeq)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
3-6 days post tick placement
Results posted on
2024-06-03
Participant Flow
Of the 72 participants consented, one participant was screen failure and 71 participants started the study.
Participant milestones
| Measure |
Cohort #1: Patients With Lyme Disease, Post-therapy
Participants with Lyme disease, post-therapy had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #2: Patients With Post-treatment Lyme Disease Symptoms (PTLDs)
Participants with post-treatment Lyme disease symptoms (PTLDS) at least 12-months from initial treatment had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #3: New Acute Erythema Migrans
Participant with new onset of acute erythema migrans had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Acute erythema migrans participant (possible positive control)
|
Cohort #4: Untreated Lyme Arthritis
Participant with untreated Lyme arthritis had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Lyme Arthritis participant (possible positive control)
|
Cohort #5: Healthy Volunteers
Healthy volunteers with no history of Lyme disease had 25-30 clean laboratory-reared larval ticks applied to a body site that was comfortable for participant. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Healthy Volunteers (negative control)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
1
|
1
|
9
|
|
Overall Study
COMPLETED
|
40
|
20
|
1
|
1
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Xenodiagnosis After Antibiotic Treatment for Lyme Disease
Baseline characteristics by cohort
| Measure |
Cohort #1: Patients With Lyme Disease, Post-therapy
n=40 Participants
Participants with Lyme disease, post-therapy had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #2: Patients With Post-treatment Lyme Disease Symptoms (PTLDs)
n=20 Participants
Participants with post-treatment Lyme disease symptoms (PTLDS) at least 12-months from initial treatment had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #3: New Acute Erythema Migrans
n=1 Participants
Participant with new onset of acute erythema migrans had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Acute erythema migrans participant (possible positive control)
|
Cohort #4: Untreated Lyme Arthritis
n=1 Participants
Participant with untreated Lyme arthritis had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Lyme Arthritis participant (possible positive control)
|
Cohort #5: Healthy Volunteers
n=9 Participants
Healthy volunteers with no history of Lyme disease had 25-30 clean laboratory-reared larval ticks applied to a body site that was comfortable for participant. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Healthy Volunteers (negative control)
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
9 Participants
n=390 Participants
|
57 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
14 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
31 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
5 Participants
n=390 Participants
|
40 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
5 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
65 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
7 Participants
n=390 Participants
|
68 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
3 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 3-6 days post tick placementPopulation: Participants in cohorts 1 \& 2 as pre-specified in the protocol.
Recovered ticks after feeding on research participants were tested for presence of B. burgdorferi using at least one of three procedures: 1. Test ticks by polymerase chain reaction (PCR) and culture - Injection of tick lysate into severe combined immunodeficiency (SCID) mice with subsequent PCR and culture testing 2. Test ticks using isothermal amplification reaction included in the PCR electrospray ionization mass spectroscopy 3. Test ticks by PCR using the Tick-borne disease Capture Sequencing Assay (TBDCapSeq)
Outcome measures
| Measure |
Cohort #1: Patients With Lyme Disease, Post-therapy
n=419 Ticks
Participants with Lyme disease, post-therapy had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #2: Patients With Post-treatment Lyme Disease Symptoms (PTLDs)
n=319 Ticks
Participants with post-treatment Lyme disease symptoms (PTLDS) at least 12-months from initial treatment had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #3: New Acute Erythema Migrans
Participant with new onset of acute erythema migrans had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Acute erythema migrans participant (possible positive control)
|
Cohort #4: Untreated Lyme Arthritis
Participant with untreated Lyme arthritis had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Lyme Arthritis participant (possible positive control)
|
Cohort #5: Healthy Volunteers
Healthy volunteers with no history of Lyme disease had 25-30 clean laboratory-reared larval ticks applied to a body site that was comfortable for participant. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Healthy Volunteers (negative control)
|
|---|---|---|---|---|---|
|
Detection of Borrelia Burgdorferi in Ticks After Xenodiagnosis Procedure
Positive
|
1 Ticks
|
0 Ticks
|
—
|
—
|
—
|
|
Detection of Borrelia Burgdorferi in Ticks After Xenodiagnosis Procedure
Negative
|
418 Ticks
|
319 Ticks
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30-days after tick removalPopulation: All participants in who started the study
Safety of xenodiagnosis in humans was assessed by number of participants with adverse event related to the application of ticks. Adverse event was assessed using participants self-reported diary cards and clinical interview.
Outcome measures
| Measure |
Cohort #1: Patients With Lyme Disease, Post-therapy
n=40 Participants
Participants with Lyme disease, post-therapy had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #2: Patients With Post-treatment Lyme Disease Symptoms (PTLDs)
n=20 Participants
Participants with post-treatment Lyme disease symptoms (PTLDS) at least 12-months from initial treatment had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #3: New Acute Erythema Migrans
n=1 Participants
Participant with new onset of acute erythema migrans had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Acute erythema migrans participant (possible positive control)
|
Cohort #4: Untreated Lyme Arthritis
n=1 Participants
Participant with untreated Lyme arthritis had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Lyme Arthritis participant (possible positive control)
|
Cohort #5: Healthy Volunteers
n=9 Participants
Healthy volunteers with no history of Lyme disease had 25-30 clean laboratory-reared larval ticks applied to a body site that was comfortable for participant. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Healthy Volunteers (negative control)
|
|---|---|---|---|---|---|
|
Participants With Adverse Event Related to the Application of Ticks (Xenodiagnosis)
Application site itching
|
24 Participants
|
13 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Participants With Adverse Event Related to the Application of Ticks (Xenodiagnosis)
Other application site reaction
|
13 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Cohort #1: Patients With Lyme Disease, Post-therapy
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Cohort #2: Patients With Post-treatment Lyme Disease Symptoms (PTLDs)
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort #3: New Acute Erythema Migrans
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort #4: Untreated Lyme Arthritis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort #5: Healthy Volunteers
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort #1: Patients With Lyme Disease, Post-therapy
n=40 participants at risk
Participants with Lyme disease, post-therapy had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #2: Patients With Post-treatment Lyme Disease Symptoms (PTLDs)
n=20 participants at risk
Participants with post-treatment Lyme disease symptoms (PTLDS) at least 12-months from initial treatment had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #3: New Acute Erythema Migrans
n=1 participants at risk
Participant with new onset of acute erythema migrans had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Acute erythema migrans participant (possible positive control)
|
Cohort #4: Untreated Lyme Arthritis
n=1 participants at risk
Participant with untreated Lyme arthritis had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Lyme Arthritis participant (possible positive control)
|
Cohort #5: Healthy Volunteers
n=9 participants at risk
Healthy volunteers with no history of Lyme disease had 25-30 clean laboratory-reared larval ticks applied to a body site that was comfortable for participant. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Healthy Volunteers (negative control)
|
|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Infections and infestations
Infection
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
Other adverse events
| Measure |
Cohort #1: Patients With Lyme Disease, Post-therapy
n=40 participants at risk
Participants with Lyme disease, post-therapy had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #2: Patients With Post-treatment Lyme Disease Symptoms (PTLDs)
n=20 participants at risk
Participants with post-treatment Lyme disease symptoms (PTLDS) at least 12-months from initial treatment had 25-30 clean laboratory-reared larval ticks applied as close as possible to the previous site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
|
Cohort #3: New Acute Erythema Migrans
n=1 participants at risk
Participant with new onset of acute erythema migrans had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Acute erythema migrans participant (possible positive control)
|
Cohort #4: Untreated Lyme Arthritis
n=1 participants at risk
Participant with untreated Lyme arthritis had 25-30 clean laboratory-reared larval ticks applied as close as possible to the site of Lyme disease manifestation. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Lyme Arthritis participant (possible positive control)
|
Cohort #5: Healthy Volunteers
n=9 participants at risk
Healthy volunteers with no history of Lyme disease had 25-30 clean laboratory-reared larval ticks applied to a body site that was comfortable for participant. Ticks were secured under a retention dressing and allowed to attach to the research participant. Ticks were removed 3 - 6 days after the placement.
Healthy Volunteers (negative control)
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • Up to 30 days post tick removal
|
10.0%
2/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Eye disorders
Photophobia
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Eye disorders
Uveitis
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Eye disorders
Visual disturbance NOS
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • Up to 30 days post tick removal
|
20.0%
4/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Gastrointestinal disorders
Nausea
|
15.0%
6/40 • Up to 30 days post tick removal
|
10.0%
2/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
11.1%
1/9 • Up to 30 days post tick removal
|
|
Gastrointestinal disorders
Pyrosis
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
General disorders
Application Site Discharge
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
General disorders
Application site erythema
|
5.0%
2/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
General disorders
Application site pain
|
20.0%
8/40 • Up to 30 days post tick removal
|
10.0%
2/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
22.2%
2/9 • Up to 30 days post tick removal
|
|
General disorders
Application Site Papule
|
2.5%
1/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
General disorders
Application site pruritus
|
60.0%
24/40 • Up to 30 days post tick removal
|
65.0%
13/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
100.0%
1/1 • Up to 30 days post tick removal
|
55.6%
5/9 • Up to 30 days post tick removal
|
|
General disorders
Application site redness
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
11.1%
1/9 • Up to 30 days post tick removal
|
|
General disorders
Application site swelling
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
General disorders
Application site tenderness
|
12.5%
5/40 • Up to 30 days post tick removal
|
30.0%
6/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
100.0%
1/1 • Up to 30 days post tick removal
|
11.1%
1/9 • Up to 30 days post tick removal
|
|
General disorders
Application site vesicles
|
0.00%
0/40 • Up to 30 days post tick removal
|
10.0%
2/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
11.1%
1/9 • Up to 30 days post tick removal
|
|
General disorders
Fatigue
|
10.0%
4/40 • Up to 30 days post tick removal
|
10.0%
2/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
100.0%
1/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
General disorders
Fever
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
General disorders
Malaise
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
General disorders
Pain
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
11.1%
1/9 • Up to 30 days post tick removal
|
|
General disorders
Thirst
|
2.5%
1/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Infections and infestations
Infection
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
3/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
1/40 • Up to 30 days post tick removal
|
10.0%
2/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Injury, poisoning and procedural complications
Injury
|
5.0%
2/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Injury, poisoning and procedural complications
Insect bite NOS
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Metabolism and nutrition disorders
Anorexia
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.5%
7/40 • Up to 30 days post tick removal
|
15.0%
3/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
22.2%
2/9 • Up to 30 days post tick removal
|
|
Musculoskeletal and connective tissue disorders
Muscle ache
|
5.0%
2/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
6/40 • Up to 30 days post tick removal
|
15.0%
3/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
22.2%
2/9 • Up to 30 days post tick removal
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
7.5%
3/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Nervous system disorders
Cognitive function abnormal
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Nervous system disorders
Headache
|
30.0%
12/40 • Up to 30 days post tick removal
|
20.0%
4/20 • Up to 30 days post tick removal
|
100.0%
1/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
44.4%
4/9 • Up to 30 days post tick removal
|
|
Nervous system disorders
Paraesthesia
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Nervous system disorders
Sleep disturbances
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Psychiatric disorders
Mood alteration NOS
|
5.0%
2/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
11.1%
1/9 • Up to 30 days post tick removal
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
1/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
11.1%
1/9 • Up to 30 days post tick removal
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.5%
1/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
4/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/9 • Up to 30 days post tick removal
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • Up to 30 days post tick removal
|
5.0%
1/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
22.2%
2/9 • Up to 30 days post tick removal
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/40 • Up to 30 days post tick removal
|
0.00%
0/20 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
0.00%
0/1 • Up to 30 days post tick removal
|
11.1%
1/9 • Up to 30 days post tick removal
|
Additional Information
Marques, Adriana
National Institute of Allergy and Infectious Diseases
Phone: +1 301 435 7668
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place