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(CRI-0844) Effects of Persistent Innate Immune Activation on Vaccine Efficacy

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Effects of Persistent Innate Immune Activation on Vaccine Efficacy

Principal Investigator:
Charles M. Rice Ph.D.


Contact Information:
Recruitment Specialist
1230 York Ave
New York, NY 10065
Telephone: 1800RUCARES
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
Hepatitis C is an infectious disease affecting primarily the liver, caused by the hepatitis C virus (HCV). HCV is spread primarily by blood-to-blood contact associated with intravenous drug use, poorly sterilized medical equipment and transfusions. An estimated 150–200 million people worldwide are infected with hepatitis C. The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years. In some cases, those with cirrhosis will go on to develop liver failure, liver cancer or life-threatening esophageal and gastric varices (enlargement of veins that may rupture and cause serious blood loss). As people chronically infected with HCV are at increased risk of serious liver disease, it is recommended that they receive the hepatitis B virus (HBV) vaccine, which can protect them from infection by HBV, another virus that targets the liver. Researchers at the Rockefeller University Hospital are doing this study to learn more about how the immune systems of people with chronic HCV infection are activated to make antibodies in response to receiving Hepatitis B virus (HBV) vaccination as compared to the immune response of healthy volunteers when given the HBV vaccination. An antibody is a protein that is produced by cells in the immune system to identify and protect against foreign substances like bacteria and viruses. Many vaccines work by stimulating the immune system with non-infectious examples of foreign substances that trigger antibody production. We are going to look at immune stimulation in response to the HBV vaccine with a technique called RNA sequencing (RNA-Seq), which uses sequences from your cells’ RNA (copies of your genes) to measure expression levels (how much genes are turned on and turned off) for all of the genes in your immune cells at once. People with chronic HCV are generally not considered to have compromised immune systems yet they demonstrate high failure rates to produce Rockefeller University Institutional Review Board antibodies to the HBV vaccination. Understanding the differences between the antibody response to the HBV vaccination in chronic HCV and in healthy volunteers may provide key insights towards overcoming them. This will help guide vaccination strategies for Hepatitis C patients and other individuals with chronic inflammatory disease. It will also help in the design of new vaccines for other infections.

Detailed Description of Protocol:

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

1. Chronically infected with HCV 2. Never on HCV treatment 3. Not HIV or Hepatitis B positive 4. Never received the Hepatitis B vaccine



Children permitted to participate:

Potential Benefits.....
Cost-free vaccination against Hepatitis B

Compensation is provided