Safety Study of Avian Flu Vaccine

Completed · Phase 1

Conditions studied: Influenza A Virus, H5N1 Subtype, Influenza A Virus, Influenzavirus A, Orthomyxoviridae, H5N1 Virus

In brief

This study will determine if an experimental avian flu (bird flu) vaccine is safe, whether it has side effects and if it can stimulate an immune response in people. The vaccine being tested in this study is made from DNA (genetic material) that codes for an influenza protein called hemagglutinin 5 (H5), which is based on the protein from the bird flu virus. The study will determine if the body creates resistance or immunity to the H5 protein. The hope is that an immune response to this protein may protect against bird flu virus infection. Healthy people between 18 and 60 years old who have been vaccinated with the current season's influenza vaccine may be eligible for this study. Participants are randomly assigned to receive injections of one of the following: 1) study vaccine at 1 mg dose, 2) study vaccine at 4 mg dose, or 3) placebo (salt-water solution). They receive three injections about 4 weeks apart in the upper arm muscle. Participants record their temperature and symptoms at home for 5 days after each injection, either on a diary card or electronically using the Internet, and report any side effects to a study physician or nurse as soon as possible. They return to NIH for clinic visits every 2 weeks for the first 12 weeks, then at week 26 and at week 42 to check for health changes or problems. Blood is drawn at all visits and urine samples are collected through week 10. If a participant develops serious side effects, the study physician may decide that he or she should not receive any further injections. However, all participants are asked to continue the follow-up visits even if they do not get the full set of three injections. ...

Key facts

Study ID

NCT00408109

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

45

Starts

2006-12-04

Expected to finish

2008-08-28

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A volunteer will be excluded if one or more of the following conditions apply.
• Women Specific:
• Breast-feeding or planning to become pregnant during the study.
• Volunteer has received any of the following substances:
• Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. [With the exceptions that use of corticosteroid nasal spray for rhinitis; topical corticosteroids for an acute uncomplicated dermatitis; short-acting beta-agonist use in controlled asthmatics; or a short course (10 days or less) of corticosteroids for a non-chronic condition at least 2 weeks prior to enrollment in this study will not exclude study participation.]
• Blood products within 120 days prior to HIV screening.
• Immunoglobulin within 60 days prior to HIV screening.
• Live attenuated vaccines within 30 days prior to initial study vaccine administration.
• Investigational research agents within 30 days prior to initial study vaccine administration.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.
• Current anti-TB prophylaxis or therapy.
• Previous H5 avian influenza investigational vaccine.
• Volunteer has a history of any of the following clinically significant conditions:
• Autoimmune disease or immunodeficiency.
• Contraindication to receiving an FDA approved 2006-2007 seasonal influenza vaccination (e.g., egg allergy).
• Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
• A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• History of thyroidectomy or thyroid disease that required medication within the past 12 months.
• Idiopathic urticaria within the past 2 years.
• Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
• Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
• Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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