NIAID HIV and Emerging Infectious Diseases Program

HIPP Study

Study name

A Pilot Study for Collection of Anti-Influenza A Immune Plasma

Study number:

09-I-0226

Goal of Study

Influenza is a virus (a type of germ) that can cause infections in people. Most people infected with this virus have mild symptoms including fever, cough, muscle aches, diarrhea, and headaches. Some people get very sick from this virus. These people tend to be older and have chronic medical problems, but it can affect younger people too. It is estimated that 36,000 people in the US die each year from influenza. Our goal is to develop a possible new treatment for influenza which uses antibodies against this virus. Antibodies are natural proteins made by the body that attack influenza and other germs. These antibodies are found in plasma, the yellow clear part of the blood. The primary goal of this study is to collect antibodies from people who have high levels of the antibodies either because they have been infected with the novel H1N1 influenza virus or because they have been vaccinated against the infection.

If you are found to have high amounts of these antibodies to the new type of influenza, we would like to collect these antibodies by a procedure called apheresis. This is a type of blood donation, where we just collect the proteins and antibodies from your blood by separating out the blood cells from the liquid part of your blood called plasma. Volunteers in this protocol are asked to undergo 3 sessions of apheresis, though if willing, they can volunteer to participate in up to 20 sessions. After we collect your plasma we will test it again to make certain that it can be safely used in an effort to treat patients who are infected with novel H1N1 flu. We may use your plasma to treat patients with the plasma. Plasma units that cannot be used for treatment due to low antibody titer or are expired may be processed and concentrated to produce a product called “IVIG" or “Intravenous Hyperimmune Globulin.” Either way, the product made from your plasma will only be used in future research studies and will not be used to produce a commercial product. Blood from approximately 1500 volunteers will be collected for this study.

Study Regimen

We will recruit healthy males between 18 and 60 years of age who are eligible to donate blood. Individuals must have previously either recovered from novel H1N1 influenza or have been vaccinated against the infection. Eligible participants will undergo apheresis, an outpatient procedure in which researchers will collect plasma containing antibodies against the influenza virus by drawing blood into a special machine that separates blood cells from the liquid portion under sterile conditions and then returns the blood cells to the donor. Volunteers will be compensated.

Eligibility Criteria:

• You are a male age 18-60 years old, and are HIV-negative
• You have either had H1N1 flu or you received the influenza vaccination in 2012-2013
• You are healthy
• You are eligible to donate blood, and you have adequate veins for blood collection
• You do not abuse drugs or alcohol

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