# Core C - The University of Texas Medical Branch at Galveston

> **NIH NIH U19** · HENRY M. JACKSON FDN FOR THE ADV MIL/MED · 2020 · $852,988

## Abstract

Abstract
Among viruses that cause disease in humans the henipaviruses, Hendra virus (HeV) and Nipah virus (NiV),
stand out for their impressive lethality. These viruses are among the most deadly human pathogens known to
man with case fatality rates averaging about 75% for NiV. Significantly, there is evidence of multiple rounds of
person-to-person transmission of NiV. In addition to natural outbreaks of HeV in Australia and NiV primarily in
India and Bangladesh, there is concern that HeV and NiV could be used as agents of bioterrorism. Currently,
there are no henipavirus vaccines or treatments approved for human use. For these reasons Nipah and
henipaviral diseases are one of only eight pathogens listed on the new World Health Organization R&D
Blueprint list of epidemic threats needing urgent R&D action (http://www.who.int/blueprint/ priority-
diseases/en/). All three of the Research Projects within the CETR focus on developing broad spectrum
vaccines or therapeutics against HeV and NiV. RP1 employs a HeV soluble G (sG)-based vaccines that is
currently licensed for horses in Australia. RP2 focuses on anti-henipavirus monoclonal antibodies, and RP3
focuses on attenuated henipavirus vaccines. A unique aspect of this CETR is that these approaches include
the most promising vaccine (HeV sG) and the most promising antiviral (human monoclonal antibody m102.4)
that have shown the ability to provide complete preventive and postexposure protection of nonhuman primates
(NHPs) against henipaviruses, respectively. All three CETR Research Projects and Core B require that
countermeasures be evaluated in animals. Federal law requires that HeV and NiV be handled in an approved
Biosafety Level (BSL)-4 containment laboratory. Core C provides an approved BSL-4 facility and a trained and
highly experienced team of BSL-4 investigators and staff to perform studies that support RP1-RP3 and Core B.
Core C will perform “well-documented” NHP efficacy studies and “pivotal” NHP studies that will be conducted
in accordance with a GLP-based quality agreement that will be supported by a dedicated quality
assurance/quality control team. The services provided by Core C will include 1) a secure repository of well
characterized seed stocks of BSL-4 henipaviruses 2) in vitro antiviral activity assays; 3) procurement of UTMB
IACUC approval of animal protocols; 3) procurement, housing, and husbandry of animals; 5) virus challenge,
treatment, and collection of samples from animals; 6) technical expertise and equipment to conduct clinical
pathological and virological analysis of samples and to perform necropsies in BSL-4 containment; 7)
histopathological analysis of tissues collected from animals infected with henipaviruses; and 8) quality systems
management of all records and data collected from NHP studies.
Relevance
The BSL-4 Evaluation Core (Core C) provides BSL-4 resources and expertise for RP1, RP2, RP3, and Core B.
The goal of Core C is to work closely with Research Project Lead...

## Key facts

- **NIH application ID:** 9897481
- **Project number:** 5U19AI142764-02
- **Recipient organization:** HENRY M. JACKSON FDN FOR THE ADV MIL/MED
- **Principal Investigator:** Thomas William Geisbert
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $852,988
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9897481

## Citation

> US National Institutes of Health, RePORTER application 9897481, Core C - The University of Texas Medical Branch at Galveston (5U19AI142764-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9897481. Licensed CC0.

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