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Background: Influenza is a very common infectious disease. Influenza is also called flu. Vaccines teach the body to prevent or fight an infection. When the body learns to fight an infection, this is called an immune response. Researchers want to develop a vaccine against flu. They want to test two new vaccines to help the body make an immune response to flu. Participants will get the vaccines (shots) in the upper arm muscle. One vaccine, the Influenza HA Ferritin vaccine, will be given to all participants with needle injection. The other vaccine, Influenza DNA vaccine, will be given to participants in Group 3 by a needle-free device that uses high pressure to push the vaccine through the skin and into the muscle. Objective: To test the safety and side effects of two new vaccines for prevention of H2 influenza (flu). Eligibility: Part I: Healthy adults at least 18 years old and born after 1969. Part II: Healthy adults ages 18 70, but not born in 1966 1969. Design: Volunteer participants will be tested for eligibility in a screening study. In Part I, all participants will get shots of HA Ferritin vaccine. Five participants in Group 1 will get one shot of low dose vaccine at Day 0 to test if it is safe and has no serious side effects. Then, five additional participants in Group 2 will get two shots of a higher dose at Day 0 and 4 months later. Part II will study responses of adults born before 1966 and those born after 1969. Also, Part II will compare responses to 2 different vaccine plans. Group 3 will get a DNA Influenza vaccine at Day 0 and the HA Ferritin vaccine 4 months later. Group 4 will get HA Ferritin vaccine at Day 0 and 4 months later. Participants will record their temperature and look at the injection site(s) each day for 7 days after each injection- they will write any symptoms at home on a paper diary or enter this data online. Participants may choose to have leukapheresis. This is a procedure where the blood will be removed through a needle in an arm. A machine will separate some of the white blood cells from the blood. The rest of the blood will be returned through a needle into the other arm. The leukapheresis procedure lasts 3-4 hours. There will be about 9 to 10 clinic visits over 10 months. At each visit, participants will be asked about health changes or problems. They will have a short physical exam. Blood will be taken. Participants might have extra visits and blood tests if they have changes in their health. Vaccination visits will last approximately 4-6 hours; other visits will last approximately 1 hour.
FLU-v is a broad spectrum influenza vaccine that targets regions in the influenza virus that are conserved among many different influenza strains.This study aims to assess efficacy of FLU-v vaccine in protecting healthy FLU-v vaccinated volunteers against an influenza challenge delivered intranasally under quarantine. Efficacy of FLU-v will be assessed by measuring the incidence and severity of the disease in the treatment groups compared to the placebo group. In addition, the immune responses of the volunteers to FLU-v will also be explored.
This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.
This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.
This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.
The study will test whether a high dose influenza vaccination results in improved immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single center prospective observer-blind randomized controlled trial conducted at the Toronto General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario, Canada.
LAIV shedding studies in children could be an important way to confirm whether impediments to viral replication do indeed explain these observed reductions in vaccine effectiveness(VE), whether prior vaccination has any influence on replication and what future implications (if any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children will be dependent on virological and host factors. The virus factors include replicative fitness of individual strains and the susceptibility to inhibition by other replicating strains (ability to compete). Host factors which may influence this include pre-existing specific immunity as a result of prior infection or previous vaccination (with either LAIV or IIV), and innate immune factors including mucosal immunity. Understanding the relative importance of different factors over two seasons when the strain composition of the A/H1N1pdm09 LAIV virus will change and by comparing previously unvaccinated and highly vaccinated groups (with both LAIV and IIV), can potentially give unique insights into their contribution to the US LAIV observations. With the change of the A/H1N1pdm09 vaccine strain in 2017/18, demonstrating improved performance (in terms of VE, virus shedding and immunogenicity) and what contribution prior vaccination might make will be key evidence for both the UK, but also the US. Information presented at the ACIP in June 2018 from the 2016/17 and 2017/18 seasons will be key to inform US future decisions around use of LAIV. This is a parallel group, non randomised study which will enrol at least 400 children. Both written informed consent from parent/ guardian and written assent from the child will be in place prior to any study procedure. The two groups will be defined by previous influenza vaccination history, with around half the children naïve to any influenza vaccination (LAIV or IIV) and half having had at least three doses of LAIV with or without IIV. All will follow the same schedule of vaccination and oral fluid collection at day 0 (by the nurse in the home or at the GP surgery); nasal swab collection (by the parent at home on days 1,3,6); day 21 oral fluid collection (by nurse or parent at home or at GP surgery).
This randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season appropriate), or licensed inactivated trivalent influenza vaccine (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20 will receive TIV.
The purpose of the study is to investigate and compare the cell responses to influenza vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles of genetics and environment in the response to flu vaccination.
This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.