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The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture. The secondary aims are to: Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms. Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test. Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.
The study consists of two arms (PHARM and PEER) designed to educate participants about three vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will consist of a 60-minute presentation about the three vaccine-preventable diseases and their vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion supplemented by video clips of community members discussing their experiences around vaccination, as well as physicians underscoring the importance of vaccination. PEER will consist of a 60-minute small-group session led by a peer educator which includes scripted roleplaying exercises designed to reinforce learnings pertaining to these three vaccine-preventable diseases and their vaccinations. The components of these interventions will be designed to address specific barriers to vaccination identified by literature search and our prior work in the area of community-based vaccine education. Both arms will focus primarily on pneumococcal disease and zoster but will include limited content on influenza because participants are likely to have questions about how the flu and its vaccination differ from pneumococcal diseases and zoster. The study will be implemented in an older, predominantly African-American (AA) population, consistent with our prior work in this area.
This phase I/II, randomized, modified double-blind, multi-center study will assess the safety and immunogenicity of a high-dose quadrivalent influenza vaccine (QIV-HD) in older adults (≥65 years).
This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be screened within 28 days of randomization (Day 1).
Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in 1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. Early determination of the severity of influenza is a critical step to avoid in appropriate treatment and care for patients and to improve their survival. Viral, human but also environmental factors have been described as having an important role in determining this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in the incidence and severity of respiratory viral infections. During influenza infection, the respiratory microbiota is significantly altered. In animal models, particularly murine models, the microbiota regulates the immune response to influenza virus infection. In a retrospective preliminary study, the investigators showed that the composition of the nasopharyngeal bacterial microbiota is different between children who develop a severe or moderate influenza. This difference was observed on respiratory specimens at admission to pediatric emergencies within two days of onset of symptoms. Hypotheses : - The respiratory microbiome is a determining factor in the clinical course of influenza infection (benign vs. severe with respiratory or neurological complication) - The respiratory microbiome can be used as a prognostic biomarker of the clinical course of influenza Originality: There are currently no clinical and / or virological markers to predict the clinical course of influenza infection. This study will define biomarkers of the respiratory microbiome to discriminate patients who will develop a severe influenza from those who will develop a moderate influenza. These prognostic biomarkers could be used to rapidly refer patients at risk to intensive care units, thus improving patient management and care. Moreover, at the fundamental level, this study will specify the role of the microbiome in the severity of influenza infection.
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.