# In Vivo Efficacy Testing Core

> **NIH NIH U19** · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2020 · $396,522

## Abstract

Abstract: Core C
In vivo efficacy testing is an essential part of medical countermeasure (MCM) development. For
hemorrhagic fever viruses (HFV), where human clinical trials are difficult or unethical to conduct,
the Food and Drug Administration (FDA) instituted the animal rule. Licensure via the FDA animal
rule requires efficacy testing in at least two surrogate animal models of human disease. In support
of overall Prometheus objectives, Core C will execute in vivo efficacy testing of antibody-based
MCMs derived from Projects I, II, and III in rodent and nonhuman primate (NHP) models of
filovirus, hantavirus, and nairovirus disease. Rodent models of ebolavirus, hantavirus, and
nairovirus disease will serve as the first in vivo screening mechanism to down-select monoclonal
antibody (mAb)-based MCMs for further assessment in higher animal models. Hamster models
of hantavirus infection and mouse models of CCHFV infection will be utilized to evaluate newly
discovered mAbs from Project I and down-select lead mAbs for NHP testing. Core C will evaluate
in vivo efficacy of mAbs with altered Fc effector functions from Project II in rodent models of
disease to identify mAb modifications with optimal in vivo potency. The prophylactic efficacy of
Project III DMAbs expressing ebolavirus, hantavirus, and CCHFV-specific mAbs will be evaluated
first in rodent models of disease and lead DMAbs will be tested in NHPs. In vivo efficacy results
from all Core C efforts will be funneled into Projects I, II, and III and Cores A and B for
identification of lead mAb cocktails and/or DMAb constructs for advanced development
discussions.

## Key facts

- **NIH application ID:** 9872998
- **Project number:** 5U19AI142777-02
- **Recipient organization:** ALBERT EINSTEIN COLLEGE OF MEDICINE
- **Principal Investigator:** Kartik Chandran
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $396,522
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9872998

## Citation

> US National Institutes of Health, RePORTER application 9872998, In Vivo Efficacy Testing Core (5U19AI142777-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9872998. Licensed CC0.

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