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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00383071 |
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.
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Condition | Intervention | Phase |
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Infectious Diseases Influenza Avian Flu |
Drug: H5N1 Vaccine Procedure: Apheresis |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Vaccine Dose Finding Pilot Study for Development of an Anti-Influenza A (H5N1) Intravenous Hyper-Immune Globulin |
Estimated Enrollment: | 155 |
Study Start Date: | August 2006 |
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.
Ages Eligible for Study: | 18 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
Heart rate between 40-100 beats per minute
3. Weight greater than or equal to 110 pounds (50kg)
4. Adequate peripheral venous access for plasmapheresis (as judged by the examiner)
5. Females of child-bearing potential must (one of the following):
EXCLUSION CRITERIA:
Has a medical history of
History of cancer that meets any one of the following criteria:
Medication history that includes any of the following:
Has ever had any of the following:
Within the last 8 weeks:
- Was vaccinated with the small pox vaccine, or was in close contact with someone who was vaccinated (i.e., close family member).
Within the last 3 months has:
- Current or previous participation in any other apheresis procedures/protocols (not related to this protocol).
Within the last 4 months has had:
- A blood donation of a double unit of red cells.
Within the last 12 months has:
Within the last 12 months has had sexual contact with (any of the following):
Participation in medical research that includes:
APHERESIS CRITERIA (all of the following):
Adequate clinical parameters (must meet all of the criteria below):
Adequate laboratory parameters (must meet all of the criteria below):
Quantitative immune globulin levels (all of the following):
Negative tests for blood borne pathogens (must meet all of the criteria below):
DAY OF DONATION SCREENING
DAY OF DONATION - INCLUSION CRITERIA:
Quantitative immune globulin levels performed in the 4 months prior to the day of donation (and all of the following):
DAY OF DONATION - EXCLUSION CRITERIA:
In the opinion of the interviewer, a donor that: (either of the following)
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | ( RCHSPB ) |
Study ID Numbers: | 060235, 06-I-0235 |
Study First Received: | September 29, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00383071 |
Health Authority: | United States: Federal Government |
Apheresis Avian Flu Healthy Volunteers Infectious Diseases |
IVIG Healthy Volunteer HV |
Virus Diseases Signs and Symptoms Antibodies Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Hyperkinesis Influenza in Birds Healthy Orthomyxoviridae Infections Immunoglobulins |
Communicable Diseases RNA Virus Infections Immunologic Factors |
Physiological Effects of Drugs Infection Pharmacologic Actions |