Phase I Open-Label Study of Recombinant DNA Plasmid Vaccine, VRC-AVIDNA036-00-VP, Encoding for Influenza Virus H5 Hemagglutinin Protein Given Intradermally

Completed · Phase 1

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

In brief

This study will evaluate the safety and effectiveness of a vaccine to prevent avian influenza (bird flu). About 25 to 50 million cases of influenza occur a year in the U.S., leading to 150,000 hospitalizations and 30,000 to 40,000 deaths. Globally, a pandemic influenza may be 1 billion flu cases, with 3 to 5 million cases of severe illness and up to half a million deaths annually. There is potential threat of a pandemic from emerging virus strains for which the population has little or no preexisting immunity. Avian influenza A (H5N1) viruses causing serious disease have emerged recently, affecting domestic and wild bird populations. Patients ages 18 to 60 who are in good health and not pregnant or breast feeding may be eligible for this study. The study will be done at the NIH Clinical Center by staff of the Vaccine Research Center. It will last about 32 weeks for each person. A traditional needle or a needle-free device called Biojector 2000 will be used. Intramuscular (in the muscle) and subcutaneous (in fat below the skin) delivery of vaccine via Biojector is cleared for use by the Food and Drug Administration and is not considered investigational. Intradermal (in the skin) delivery of vaccine by Biojector in this study is deemed investigational but has been evaluated in humans before, and found safe and well tolerated in other trials. There will be about 10 clinic visits in this study, and it is important to stay on schedule. Visits are about 2 hours, though on injection days, visits are about 4 hours. Injections are given on day 0 and at weeks 4 and 8. The vaccine is given by injections in the skin on the upper arms. Clinic staff will observe patients for 30 minutes after each vaccination. One to 2 days after the first injection, there will be a clinic visit. One to 3 days after the second and third injections, patients need to telephone clinic staff to report on how they are doing. Patients will complete a diary card at home, recording temperature and symptoms, and looking at the injection site daily for 5 days. Patients should report any side effects to one of the study physicians or nurses as soon as possible. They will return to the clinic 2 weeks after each injection. A needle-free system uses the pressure of carbon dioxide, instead of a needle, to inject the vaccine into the skin. Discomfort can result from either the needle-free device or the needle. There may be stinging, pain, soreness, swelling, bruising, or a small cut in the skin.

Key facts

Study ID

NCT00489931

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

44

Starts

2007-06-18

Expected to finish

2009-04-15

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.
• [Note: The following will NOT exclude study participation:
• use of corticosteroid nasal spray for rhinitis
• topical corticosteroids for an acute uncomplicated dermatitis
• short-acting beta-agonists in controlled asthmatics
• a short course (10 days or less) of corticosteroids for a non-chronic condition completed at least 2 weeks prior to enrollment in this study]
• 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.
• 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

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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