The study*s primary objective is to collect a range of clinical specimens for assay development, qualification, and validation from participants with suspected Lyme Borrelia infection and/or Lyme disease. Secondary objective: To describe the…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of participants who had clinical specimen(s) collected at each
specified visit.
Secondary outcome
Proportion of participants presenting with various manifestations of suspected
Lyme disease.
Background summary
Lyme disease is caused by the bacteria species Borrelia burgdorferi sensu lato
and is the most common tick-borne disease in temperate northern latitudes, with
infection and disease occurring primarily during early spring into late
summer/fall. Lyme disease generally presents with a localized skin rash or
with distinct progressive phases, with the latter stages having increased
severity (eg, arthritis, carditis, neuroborreliosis), which if left untreated
can result in permanent disabling sequalae.
Pfizer is developing a vaccine to prevent Lyme disease. As a part of the
clinical development approach, diagnostics with optimal sensitivity and
specificity will be required for efficacy studies. Two diagnostic platforms
are envisioned: a serological diagnostic assay to detect exposure to the Lyme
disease pathogen and a diagnostic assay to detect the Borrelia bacteria
directly. The following prospective clinical study aims to collect samples
from participants with suspected Lyme disease for the purpose of diagnostic
assay development and optimization.
Study objective
The study*s primary objective is to collect a range of clinical specimens for
assay development, qualification, and validation from participants with
suspected Lyme Borrelia infection and/or Lyme disease.
Secondary objective: To describe the clinical manifestation of suspected Lyme
disease cases.
Study design
This prospective, nontreatment, nonrandomized study will be conducted in the
United States, Canada, and Europe. The purpose of this study is to collect
samples for method development (serological assay, PCR, urine antigen
detection). Approximately 300 to 400 participants with suspected Lyme disease
will be enrolled over 1 or more tick seasons.
Participants who provide informed consent and meet eligibility criteria will
have blood and urine samples collected at enrollment (Visit 1), 1 month after
enrollment (Visit 2), and 2 months after enrollment (Visit 3). At Visit 1, for
participants presenting with an EM rash, multiple EM rashes, or ACA, three 2-mm
skin punch biopsies will be taken from the EM rash or ACA. For participants
presenting without skin manifestations, no biopsy will be taken at enrollment
(Visit 1). Skin punch biopsies will only be taken at 2 months after enrollment
(Visit 3) if participants provide supplemental consent. For participants who
present with a skin manifestation at Visit 1, separate 2-mm skin punch biopsies
will be taken from the original site of infection as well as from an irrelevant
noninfection site (eg, contralateral site or other site from a previous skin
punch biopsy) at Visit 3. For participants presenting without a skin
manifestation at Visit 1, a single skin punch biopsy will be taken from the
deltoid area (uppermost portion of arm) of the nondominant arm at Visit 3. AEs,
SAEs, and RRIs will be collected through Visit 3.
If samples (ie, CSF, synovial fluid) are obtained from a participant as a part
of clinical care, a request would be made for the sites to provide residual
sample material to the sponsor, as available. In addition, if local laboratory
assessments are performed as a part of clinical care, a request would be made
for the sites to provide laboratory values to the sponsor, as available.
Duration of participation in the study will be approximately 2 months.
Participants dropping out before completion will not be replaced.
Study burden and risks
The risks for this study are limited to the standard risks of blood draws and
skin biopsies. There is no (direct) benefit to the patient.
East 42nd Street 235
New York NY 10017
US
East 42nd Street 235
New York NY 10017
US
Listed location countries
Age
Inclusion criteria
Participants must meet all of the following inclusion criteria to be eligible
for inclusion in the study:
1. Males and females *18 years of age with suspected Lyme disease.
2. Evidence of a personally signed and dated ICD indicating that the
participant has been informed of all pertinent aspects of the study.
3. Participants who are willing and able to comply with scheduled visits and
study procedures.
Exclusion criteria
Participants meeting any of the following criteria will not be included in the
study:
1. Previous vaccination with a licensed Lyme disease vaccine or previous
participation in a clinical trial involving the administration of a Lyme
disease vaccine candidate.
2. Use of a systemic antimicrobial for any indication or topical antimicrobial
at the rash site initiated greater than 2 days prior to enrolment in the study.
3. Any chronic skin condition that the investigator feels may be confounding.
4. Known or suspected defect of the immune system, such as congenital or
acquired immunodeficiency, including poorly controlled infection with human
immunodeficiency virus or receipt of immunosuppressive therapy within 30 days
prior to Visit 1. Use of systemic corticosteroids (*20 mg a day for *10 days
within the prior 4 weeks) is prohibited. Nonsystemic corticosteroid use, such
as topical and inhaled steroids, is permitted.
5. Received blood or blood-derived products (eg, plasma or intravenous
immunoglobulin) within 6 months prior to Visit 1 or planned receipt during the
study.
6. Contraindication to skin biopsies or receiving anticoagulant medication,
such as heparin, LMW heparin, warfarin, antiplatelets, novel oral
anticoagulants (eg, apixaban), antiplatelet medication (eg, clopidogrel), or
medications known to cause thrombocytopenia (unless considered safe to stop and
washout for the duration of the study), prior to Visit 1 and through the last
study visit. NSAIDs and low-dose acetylsalicylic acid will not be considered
antiplatelet therapy.
7. A current or past medical history of conditions associated with
thrombocytopenia, coagulopathy, or platelet dysfunction.
8. Monoclonal antibody therapy within the 4 months before Visit 1 and through
the last study visit.
9. Any acute or chronic medical or psychiatric condition, including recent
(within the past year) or active suicidal ideation or behavior, or laboratory
abnormality that may increase the risk associated with study participation or
may interfere with the interpretation of study results and, in the judgment of
the investigator, would make the participant inappropriate for entry into this
study.
10. Investigator site staff or Pfizer employees directly involved in the
conduct of the study, site staff otherwise supervised by the investigator, and
their respective family members.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74400.018.20 |