Active clinical trials for "Influenza in Birds"

Every year the human population suffers from seasonal outbreaks of influenza resulting in both illness and death. However, the rates of illness and death from seasonal outbreaks are significantly lower than those suffered during times of influenza pandemic, such as those experienced in 1918, 1957, and 1968. The reason for this difference lies in presence of immunity within a population. With seasonal outbreaks of influenza most people have some immunity to the circulating strain and usually only those with weakened immune systems experience serious complications. Influenza pandemics, in contrast, are the result of a completely new viral subtype to which nobody possesses an immunity, leaving everyone vulnerable to the most serious of complications. It has been estimated that the next flu pandemic could cause over 200,000 deaths and over 700,000 hospitalizations in the US alone. The need for an effective viral vaccine is high. The purpose of this study is to test the safety and immunogenicity of a live influenza A strain vaccine, which would be able to combat an influenza pandemic.

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.

The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1 vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9 months, which includes screening. Participants will receive 2 doses of vaccine or placebo injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8 scheduled study visits.

The purpose of this study is to determine whether having received an H5 vaccine in the past primes the immune system to respond rapidly to another dose of H5 vaccine. One hundred seventeen participants in a previous vaccine study (involving the A/Hong/Kong/97 virus) during the fall of 1998 at the University of Rochester will be eligible to enroll in this study. Participation in this study will up to 64 days and will involve donation of small samples of blood 7, 28, and 56 days after vaccination.

This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent will be used to achieve the targeted dosage. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.

This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants. This study will be conducted at 6 sites and enroll 150 (up to 380) males and non-pregnant females, 19 to 64 years old, inclusive who are in good health and meet all eligibility criteria. The entire study duration is approximately 24 months and each subject participation duration is approximately 13 months. The primary objectives are: 1) To assess the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately 21 days apart. 2) To assess the serum HAI and Neut antibody responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately 21 days apart.

Recombinant H7 (rH7) vaccine has been shown to be poorly immunogenic in previous human clinical trials. This study will test approaches to improve the immunogenicity of H7 vaccine, namely use of a three dose regimen, use of a modified H7 HA sequence from which the Tregitope has been removed (rH7m), and inclusion of delta inulin adjuvant adjuvant in the vaccine

Phase I randomized, double-blind, placebo-controlled trial in 50 males and non-pregnant females, 18 to 49 years old, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of inactivated A/H5N1 influenza vaccine administered intradermally (ID) with topical Aldara or control cream as a 2-dose regimen. The vaccine will be administered using the MicronJet600(TM) device. Subjects will be assigned to 2 treatment arms (25 subjects per treatment arm). Group A will receive two doses of A/H5N1 IIV ID with pre-application of topical Aldara on Days 1 and 22. Group B will receive two doses of A/H5N1 IIV ID with pre-application of topical control cream on Days 1 and 22. The duration of this study will be approximately 20 months with patient participation duration approximately 7 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity after 2 doses of A/H5N1 IIV vaccine containing 9 mcg HA per dose administered ID approximately 21 days apart with topical Aldara or control cream; 2) to assess the serum HAI antibody responses 21 days after receipt of the 2nd dose of A/H5N1 IIV administered ID at 9 mcg HA per dose with topical Aldara or control cream.

The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.

Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without immunosuppressive conditions.