Development of Immune Globulin Treatment for Avian Flu

Influenza Clinical Trial

Official title: A Phase II Vaccine Dose Finding Pilot Study for Development of an Anti-Influenza A (H5N1) Intravenous Hyper-Immune Globulin

Status Terminated

Clinical Trial Summary

This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins made by the body that attack the influenza virus. This study will use an experimental bird flu vaccine to stimulate immune globulin production in healthy people. The vaccine is similar to the regular influenza vaccine and has been studied in more than 450 people. This study will use high doses of the vaccine to generate high antibody levels that can be collected for producing the new treatment.

Healthy adults between 18 and 60 years of age who weigh at least 110 pounds may be eligible for this study. Candidates are screened with a medical history and physical examination.

Participants are given one of three doses of the vaccine, depending on when they enter the study. The first 25 people enrolled receive a dose of 90 micrograms (mcg). If this dose is well tolerated, the next 25 people receive 120 mcg, and if this dose is also well tolerated, the last 25 people receive 180 mcg. Vaccination consists of either two shots (one in the muscle of each arm) or one shot in the buttock on four occasions. Subjects are vaccinated on four occasions, each 4 weeks apart. On the day of each vaccination, subjects provide a blood sample to evaluate blood counts, chemistries, and antibody levels, and to test for HIV, hepatitis B and C, syphilis, and antibody against avian flu. For 7 days after each vaccination, subjects keep a diary card to record any symptoms, such as pain, fever, muscle aches, or others. At the end of the 7 days, they are contacted by study staff to report the symptoms.

In addition to the vaccinations, subjects undergo apheresis to collect IVIG once their blood test shows moderately high antibody levels. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates the blood cells from the antibodies and protein. The antibodies and protein are collected and the rest of the blood is returned to the body. Subjects are asked to undergo at least three apheresis procedures.

Clinical Trial Description

Avian influenza presents a threat of a future pandemic. Over 200 people have been infected with the influenza A H5N1 virus, and the mortality is near 60 percent. Optimal therapy is not known, and failures of and resistance to currently available anti-virals have been reported.

The primary purpose of this Protocol is to determine the optimal vaccination schedule that creates a pool of hyper immunized individuals with high titer anti-influenza A (H5N1) antibodies. The Protocol will consist of a dose escalation study to determine the optimal vaccination dose and number of vaccinations. There are stopping rules based on the number and severity of adverse events that occur between the doses and between the cohorts. The optimal vaccination schedule that is determined could then be used in a larger population to develop a high titer anti-influenza A (H5N1) intravenous hyper-immune globulin (IVIG).

After all vaccinations have occured, and if an adequate antibody titer is reached in this study population, subjects will begin apheresis. Each subject will be asked to participate in 3 apheresis sessions, but may participate in up to 10 apheresis sessions. ;

Related Conditions & MeSH terms

• Avian Flu
• Communicable Diseases
• Infection
• Infectious Diseases
• Influenza
• Influenza, Human

• NCT number: NCT00383071
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Terminated
• Phase: Phase 2
• Start date: August 2006
• Completion date: December 2014