Active clinical trials for "Influenza in Birds"

This study will evaluate the safety and immunogenicity of VAX161B [STF2.HA5 H5N1], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

Background:<TAB> - Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Researchers want to test a new vaccination strategy, combining two different vaccine types, the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one of two combinations offer better protection against a certain type of bird flu in humans when compared to vaccination using two doses of MIV alone. Objectives: To see if 2 vaccines for bird flu, are safe and tolerable for humans. To study immune responses to these vaccines. Eligibility: - Healthy adults 18 60 years old. Design: Participants will be screened through a separate protocol. Participants will be randomly assigned to 1 of 3 groups. Each group will get a different combination of vaccines. Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be drawn at some visits. Urine samples may be collected. Participants will receive vaccinations at 2 of the visits, 16 weeks apart. The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA vaccine will be injected in the upper arm using a device that delivers the vaccine through the skin by pressure instead of a needle. Participants will be observed for at least 30 minutes after each vaccination. Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for evaluation, and complete a diary at home for 1 week. They will record their temperature and symptoms and look at the injection site daily. Participants will have follow-up blood tests.

This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years. Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.

This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation. The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine. The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.

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.

UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults. Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.

DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. The investigators have developed a DNA vaccine, VGX-3400X, which includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, since animal studies have shown that this delivery method increases the immune response to vaccine. The vaccine will be given to 30 healthy adult subjects. It is hypothesized that VGX-3400X + EP will be well tolerated and immunogenic.

The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.

Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2 doses separated by approximately 21 days.

The purpose of this research study is to compare how the body reacts to different strengths of an H5N1 flu vaccine when given by different routes of injection (injection into the skin or into the muscle). It will also compare how antibodies (proteins produced by the body's immune system that recognize and help fight infections and other foreign substances in the body) are made after receiving the H5N1 flu vaccine. Participants will include 100 healthy adults, ages 18-40 years. Study procedures include blood samples and completing a memory aid documenting daily oral temperature and side effects for 7 days following each vaccination. Participants may be involved in the study for up to 13 months.