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(QWA-0947) Abs against HBV


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Identification and Characterization of HBV-Neutralizing Antibodies from HBV-vaccinated and previously HBV-infected individuals

Principal Investigator:
Qiao Wang PhD

Investigators:

Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 212-327-7722
Email: RUCARES@Rockefeller.edu
Enrollment Status:
Completed/Closed

Brief Summary of Protocol:
Antibodies are made by the human body to protect and fight against many infectious diseases and are responsible for the effectiveness of most vaccinations. New laboratory methods allow researchers to identify and describe these antibodies directly from human samples. Specific antibody molecules with interesting qualities have been found in many infectious diseases and shown to be successful as treatments. For example, broad neutralizing antibodies (antibodies that reduce the effect of a disease) against the human immunodeficiency virus (HIV) have been shown to effectively control the amount of virus in mice and monkeys, and are currently being tested in human clinical trials.
Hepatitis B is an infectious disease caused by the Hepatitis B virus (HBV). It can cause both acute and chronic infections. Most adults clear the acute infection naturally and do not usually require treatment. However, there are some individuals who do not clear the HBV infection and develop chronic HBV which may result in their developing cirrhosis (loss of liver cells and irreversible scarring of the liver) and liver cancer. The infection has been preventable by vaccination since 1982, and vaccines have been widely used in about 180 countries since 2006. Currently, the disease is still common in East Asia and Africa where between 5-10% of adults are chronically infected, while in Europe and North America the rates are less than 1%. However, none of the drugs, including vaccination, can clear the infection in HBV chronically infected individuals. Currently available antiviral medications can only be used to stop HBV virus from replicating in liver cells (hepatocytes), thus minimizing liver damage. Therefore, potential therapeutic approaches are needed to eliminate chronic HBV infection.



Detailed Description of Protocol:
In this protocol, we want to study the HBV antibodies found in individuals who cleared their HBV infection naturally and in those who have received the HBV vaccination series, and then describe the HBV neutralization activity of these antibodies. Potentially, these neutralizing antibody against HBV could be used to treat other chronically infected patients.



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

- Are between the ages of 21 and 65
- Received the Hepatitis B vaccine series (3 injections)
OR
- Cleared your Hepatitis B infection without treatment
- Do not have HIV, chronic Hepatitis B or C infection


Gender:
Both

Age(s):
21-65

Children permitted to participate:
No

Potential Benefits.....
There are no direct benefits to taking part in the study.



Compensation:
Compensation is provided.