# Multiplex treatment outcomes test for Chagas disease

> **NIH NIH R01** · UNIVERSITY OF GEORGIA · 2020 · $998,476

## Abstract

Abstract
Infection with the protozoan parasite Trypanosoma cruzi is generally controlled but often not eliminated by host immune
responses. In humans and many other hosts, this persistent infection ultimately results in muscle tissue damage known
as Chagas disease. Although several partially effective drugs exist to treat the infection, it is estimated that only ~1% of
infected subjects receive treatment. The main barrier to the wider use of current drugs and the development of better
therapeutics in Chagas disease is the absence of reliable methods to definitively determine the efficacy of treatment.
The goal of this project is to validate and improve tests of cure for T. cruzi infection, relying primarily on the changing
pattern of antibody responses to a panel of defined T. cruzi antigens following effective treatment. Our previous ~10
year have validated this approach using a limited set of antigens using a robust, but expensive Luminex bead-based
approach. In this project, we will use protein and glycan microarrays to select additional high quality targets for
measurement of anti-T. cruzi antibodies, expanding from the current 15 parameters in the Luminex assay to 50 or more
parameters. This increase in target number and diversity will improve the quality and the speed of determination of
treatment efficacy and assure that all exposed subjects are identified. Using this expanded panel of T. cruzi antigens and
the much reduced cost of testing provided by an array format, we will develop and validate a test of cure. The initial test
parameters (e.g. the number and selection of target antigens, proteins and/or glycans, and number of serial samples
required and over what follow-up period) will be established using sera from long-term infected macaques treated with
benznidazole and sampled multiple times before and at 6 week intervals after treatment for up to a year post-treatment,
at which time the cure status is definitively determined as assisted by immunosuppression. These parameters will be
validated using sera serially sampled from humans for up to 15 years post-treatment wherein the conversion to negative
conventional serology, the currently accepted measure of cure, will be applied. Finally, we will apply the validated test
prospectively to subjects newly enrolled in treatment programs in 2 sites in Argentina and 1 in Brazil. The overall goal of
this process will be to identify the fewest number of samples collected per patient over the shortest period of time post-
treatment that are needed to discriminate between treatment success and failure using the fewest number of target
antigens. Using a combination of historical stored samples and recent samples from the same subjects and the test of
cure, we will also assess the rate of spontaneous cure in untreated subjects. Identification of seropositive persons who
have spontaneously resolved the infection is important for prognosis /counseling and to prevent their exposure to
treatment and ...

## Key facts

- **NIH application ID:** 9961497
- **Project number:** 5R01AI125738-05
- **Recipient organization:** UNIVERSITY OF GEORGIA
- **Principal Investigator:** Rick L Tarleton
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $998,476
- **Award type:** 5
- **Project period:** 2016-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9961497

## Citation

> US National Institutes of Health, RePORTER application 9961497, Multiplex treatment outcomes test for Chagas disease (5R01AI125738-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9961497. Licensed CC0.

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