# A Prospective Study of Persistent Symptoms of Lyme Disease

> **NIH NIH P01** · TUFTS UNIVERSITY BOSTON · 2024 · $3,019,293

## Abstract

ABSTRACT: OVERALL
Despite years of research, there is no diagnostic test for post-treatment Lyme disease syndrome (PTLDS);
there is no consensus treatment for PTLDS; there is no agreement on the mechanisms causing disease or
even how frequently it happens. And while there have been intriguing findings by many outstanding
researchers, they have not been independently confirmed and have mostly been done in small populations that
have identified PTLDS patients retrospectively without serial follow up after the diagnosis of acute Lyme
disease. It is highly unlikely that there will be a breakthrough in understanding the disease without a major
change in the way we approach studying the disease.
We hypothesize that one of the reasons why PTLDS has been so intractable to understand is that the causes
are multifactorial and involve a confluence of events including prior/concurrent exposures, immunological
responses and specific bacterial characteristics. In this case, researchers examining only one potential aspect
of the disease are unlikely to uncover the full complexity of the origins of disease. We are proposing a
prospective study of PTLDS, enrolling and following subjects from the time they are diagnosed with acute
Lyme disease until they recover or develop PTLDS. We have assembled a unique team of clinicians,
epidemiologists, immunologists, microbiologists and statisticians with a deep understanding of Lyme disease
and a history of collaboration to tackle the understanding of PTLDS together. Subjects will undergo a battery
of tests, taking advantage of new technologies allowing unbiased analysis of both human immune and
bacterial factors. These high-throughput tests will be supplemented with focused testing of hypotheses that
have arisen through prior research, by our group as well as others. Though these studies we will understand
the differences in co-infections with other tick-borne diseases, specific inflammatory patterns, distribution of cell
types and their reactions, autoantibody formation, auto-reacting T cells, antibiotic resistance and persistence of
B. burgdorferi, binding and dissemination of B. burgdorferi strains and shedding of peptidoglycan between
patients with PTLDS and RLD. In addition, as part of this process, we will also be developing one of the
largest, well characterized specimen banks that will be shared with the research community for additional
testing in a way that results can be aggregated to continually broaden our understanding of PTLDS.
Our highly experienced group is operating under no illusions about how difficult and complex this study will be
to complete. However, we believe that this type of effort is needed to move the field-- which is essentially no
closer to a consensus understanding of PTLDS today that it was 30 years ago-- and to make progress for the
health of the afflicted patients.

## Key facts

- **NIH application ID:** 10862287
- **Project number:** 1P01AI181934-01
- **Recipient organization:** TUFTS UNIVERSITY BOSTON
- **Principal Investigator:** Linden T Hu
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $3,019,293
- **Award type:** 1
- **Project period:** 2024-09-05 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10862287

## Citation

> US National Institutes of Health, RePORTER application 10862287, A Prospective Study of Persistent Symptoms of Lyme Disease (1P01AI181934-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10862287. Licensed CC0.

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