Influenza A Virus Clinical Trial
Official title:
A Phase I Open-Label Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine, VRC-AVIDNA036-00-VP, Encoding for the Influenza Virus H5 Hemagglutinin Protein Administered Intradermally in Healthy Adults
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.
Study Design: This is a Phase I study to evaluate safety, tolerability, and immunogenicity of
a recombinant DNA vaccine against the influenza virus H5 hemagglutinin by intradermal (ID)
delivery. The hypothesis is that this vaccine will be safe for human administration by ID
delivery by either needle/syringe or Biojector and will elicit antibody and T cell responses
against the H5 protein. Primary objectives are to evaluate safety and tolerability of the
vaccine at 500 micrograms ID administered by needle and syringe or by Biojector and at 1 mg
ID administered by Biojector as two injections in the same or in different arms in healthy
adults. Secondary and exploratory objectives are related to immunogenicity.
Product Description: The vaccine is composed of a single closed-circular DNA plasmid that
encodes the H5 protein with a CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each
injection will be 125 microliters (500 micrograms) administered ID over the deltoid muscle
using the Biojector® (Registered Trademark) 2000 Needle-Free Injection Management System
(Biojector) or needle and syringe.
Subjects: A total of 40 healthy adults, ages 18-60 years will be enrolled.
Study Plan: Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four
groups as shown in the schema. The protocol requires ten clinic visits and three telephone
follow-up contacts.
Study Duration: Each participant will complete 32 weeks of clinical follow up.
Study Endpoints: The primary endpoint is safety and tolerability of the regimen. The
secondary immunogenicity endpoint is H5-specific antibody as measured by hemagglutination
inhibition (HAI) assay and H5 neutralizing antibody assay at Study Week 12. Other
immunogenicity assays at timepoints throughout the study may also be completed as exploratory
evaluations.
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