# Correlates of protective immunity to HCV and rational vaccine design: Clinical Core

> **NIH NIH U19** · EMORY UNIVERSITY · 2024 · $116,532

## Abstract

Core B: Clinical Core
Abstract
Hepatitis C virus (HCV) is a virus that infects the liver and is transmitted through contaminated blood. HCV
infection is still a public health priority and a major cause of liver disease worldwide, especially in developing
countries like Egypt. New HCV infections are also on the rise in North America in association with the opioid
epidemic. While new antiviral drug can cure >95% of infected individuals, many do not know that they are
infected and remain at risk of developing liver disease and an active source of new infections. Furthermore,
successful treatment does not prevent reinfection if the individual is re-exposed to the virus. Hence, there is an
urgent need for vaccines that can protect against this virus. Unfortunately, despite our knowledge about the
immune response against HCV, we still do not have an effective vaccine. Recent results from the only vaccine
candidate that made it into a large scale (Phase 2) clinical trial did not show any protection in people who inject
drugs at risk of HCV infection. This means that we need to understand better the immune factors and cells that
protect against HCV in cohorts of patients who are able to clear the virus spontaneously. The main goal of this
proposal is to define these factors that are essential to achieve protective immunity. The aim of this clinical core
is to oversee and manage two cohorts of subjects that are infected with HCV to define these protective immune
factors. The first cohort is located in Montreal and is a cohort of people who inject drugs who were able to clear
two subsequent infections with HCV, a response that we would like to simulate in a vaccine. This cohort is
already established (15 years), will recruit new subjects throughout the project and already has banked samples
from many reinfection cases to start the projects right away. It will also include a smaller subcohort of PWID,
primarily infected with genotypes 1 and 3, undergoing antiviral treatment. The second is a large cohort of
individuals undergoing antiviral therapy for HCV from Egypt, the country with the highest number of HCV
infections in the world. This second cohort is primarily infected with genotype 4 and will allow us to understand
whether curing HCV infection using antiviral treatments will enhance these protective immune factors and cells.
By collecting well defined blood samples and clinical data about disease progression and virus from these
precious cohorts, we will be able to study the HCV-specific immune response and identify the immune factors
that should be targeted in novel vaccines.

## Key facts

- **NIH application ID:** 10835025
- **Project number:** 5U19AI159819-04
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** NAGLAA H. SHOUKRY
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $116,532
- **Award type:** 5
- **Project period:** 2021-04-15 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10835025

## Citation

> US National Institutes of Health, RePORTER application 10835025, Correlates of protective immunity to HCV and rational vaccine design: Clinical Core (5U19AI159819-04). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10835025. Licensed CC0.

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