P01AI181934

A prospective study of persistent symptoms of Lyme disease - 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 than it was 30 years ago-- and to make progress for the health of the afflicted patients.

Trustees Of Tufts College

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Boston, Massachusetts 021111817 United States

Single Zip Code

NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed) (PAR-22-225)

Amendment Since initial award the total obligations have increased 150% from $3,019,293 to $7,539,599.