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79 active trials for Influenza

Influenza Immunization in Adults Over Age 75

The immune system is the part of the body that protects against infection. The immune system often doesn't work as effectively as people get older. This research is being done to find out how the immune systems in older people who are over age 75 respond to influenza vaccine (flu shot). We also want to find out if chronic cytomegalovirus (CMV) infection, a common virus infection in older persons affects the immune response in people older than 75 years of age who receive a flu shot. The Flu Shot is a vaccine approved for the prevention of influenza ("Flu") infections and is recommended every year for all persons 50 years and older. People who are older than 75 years of age are considered healthy or frail may join. A total of 525 persons will be participating in this study. In order to determine if you are qualified for the study, we would ask you to answer a few questions over the phone that will take approximately 5 minutes. If you qualify and agree to proceed, you will be asked to come to Johns Hopkins Bayview Medical Center or, if you are unable to come to Bayview, one of our staff can visit you at your home. During that visit we obtain consent, review your medical history, and measure your vital signs, walking speed and grip strength. We will also administer a few brief questionnaires and collect urine and blood samples. We will then give you the Flu shot for free. Three to four weeks after you receive the Flu shot, you will have another visit at Johns Hopkins Bayview or your home where we will repeat some of the questionnaires, vital signs, and collect a second blood sample. Throughout the study, we will call you once a week to ask about your general health and any Flu-like symptoms. These calls will be made throughout the Flu season which typically lasts through the end of May. If you begin to have any influenza like symptoms at any time during the study, we ask that you call our office to report these symptoms so that we may perform a nasal swab to confirm influenza, and a third blood draw to look at the immune response and protection of influenza vaccine.

Start: March 2014
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

Background: The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy volunteers into clinical studies to study infectious diseases. Viruses can be highly infectious and contagious. They cause considerable illness in the United States each year and a good example of this is influenza (the flu). The LID CSU performs clinical studies to learn about these viral infections and assist in the development of vaccines and treatments for the infections. These clinical studies include influenza "challenge studies" as well as natural history studies and phase I trials involving vaccines for viruses carried by mosquitos such as Zika or Dengue virus. In influenza challenge studies studies, doctors expose a person to a flu virus. Then they study the flu through the body's natural healing process. This information will help to find better ways to prevent the flu and may also improve treatments for the flu. Natural history studies and phase I trials of new vaccines are performed so the researchers can learn how some viral infections occur and if new vaccines are safe and potentially effective in preventing the infections. In some of these studies, participants experience insect bites with special clean (non-infected) insects (such as mosquitos) to better understand the role of insects in these infections. Objectives: - To screen healthy volunteers for future CSU studies. Eligibility: - Healthy people between the ages of 18 and 65 Design: The 3- to 5-hour screening exam includes the following: Medical history and physical exam Standard blood tests including pregnancy, Hepatitis B and C, and HIV tests Standard urine drug testing Electrocardiogram (ECG) to test heart rhythm and function Chest x-ray Eligible volunteers are enrolled in the study for up to 1 year, until they take part in a CSU study or are found to be ineligible to participate. Volunteers may withdraw from the study pool at any time.

Start: July 2011
Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination

Title: Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults after Vaccination Study Description: Yearly influenza vaccination is necessary due to short-lasting influenza immunity and changing strains of circulating influenza. With limited effectiveness of yearly influenza vaccines and the ongoing potential for an influenza pandemic, there is a need for a better understanding of influenza immunity to develop improved vaccines. Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccines have been developed in response to the coronavirus disease 2019 (COVID-19) pandemic. There is a critical need to also understand the changes in long-term immunity in those who receive a SARS CoV-2 vaccine to develop improved vaccines. We will investigate the changes in long-term immunity of NIH workers after vaccination with influenza and/or SARS-CoV-2 and throughout the following year via blood and nasal sampling. Objectives: Primary Objectives: Characterize the systemic anti-influenza humoral immune response to vaccination over 1 year. Characterize the systemic anti-SARS-CoV-2 humoral immune response to vaccination over 1 year. Secondary Objectives: Characterize the nasal mucosal anti-influenza humoral immune response to vaccination over 1 year. Characterize the nasal mucosal anti-SARS-CoV-2 humoral immune response to vaccination over 1 year. Endpoints: Primary Endpoints: Systemic anti-influenza antibodies as measured by: Hemagglutination inhibition (HAI) antibody titers Neuraminidase inhibition (NAI) antibody titers Anti-Hemagglutinin (HA) head antibody quantitative enzyme linked immunosorbent assay (ELISA) (immunoglobulin [Ig] M, IgG, IgA) Anti-HA stalk antibody quantitative ELISA (IgM, IgG, IgA) Anti-Neuraminidase (NA) antibody quantitative ELISA (IgM, IgG, IgA) Systemic anti-SARS-CoV-2 antibodies as measured by: Anti-SARS-CoV-2 spike antibody quantitative ELISA (IgM, IgG, IgA) Anti-SARS-CoV-2 receptor binding domain (RBD) antibody quantitative ELISA (IgM, IgG, IgA) Secondary Endpoints: Mucosal anti-influenza antibodies from nasal samples as measured by: Anti-HA head antibody quantitative ELISA (IgA, IgG) Anti-HA stalk antibody quantitative ELISA (IgA, IgG) Anti-NA antibody quantitative ELISA (IgA, IgG) Mucosal anti-SARS-CoV-2 antibodies from nasal samples as measured by: Anti-SARS-CoV-2 spike antibody quantitative ELISA (IgA, IgG) Anti-SARS-CoV-2 RBD antibody quantitative ELISA (IgA, IgG) Study Population: NIH staff (N=100) who are 18 years and older. NIH staff may include employees and contractors, fellows and volunteers. Accrual ceiling N=150. Description of Sites/Facilities Enrolling Participants: Participants will be enrolled at the NIH Clinical Center (CC). Study Duration: 5 years

Start: June 2021
Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Background: Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want to use them to learn how respiratory viruses affect people in different ways. Objective: To use digital devices to collect data from participants in challenge studies that could indicate subtle changes in health during an infection that might otherwise go unnoticed. Eligibility: Healthy adults who have enrolled in a challenge study. Design: Participants will stay at NIH for at least 9 days and then they will have outpatient visits. While at NIH, participants will wear a smartwatch at all times. It will record data like temperature, heart rate, breathing rate, and movements. Participants will have 2 smartphones. One will be recording at all times to listen for coughing. Participants will use the other smartphone to check their vital signs. They will collect data like heart rate, temperature, and the level of oxygen in the blood every 4 hours during the daytime. Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take pictures and videos of their face. A bedside sensor will record participants while they sleep. It will record heart rate and breathing rate. It will also look at sleep activity, such as movements participants make during sleep and how deeply they sleep. Participants sharing the same room will be exposed to the same challenge virus. For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks. Participation will last from 10 weeks to 1 year. ...

Start: June 2021
First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults

Background: Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and sometimes the lungs. Vaccines are given to teach the body to prevent or fight infection. Researchers want to study a new vaccine to prevent the seasonal flu. Objective: To see if the FluMos-v1 vaccine is safe and how the body responds to it. Eligibility: Healthy adults ages 18-50 who received at least one licensed flu vaccine from 2016 through the 2019-2020 influenza season. Design: Participants will be screened through a separate protocol. Participants will be tested for COVID-19. They may have a pregnancy test. Participants will receive the FluMos-v1 vaccine or the Flucelvax vaccine. It will be injected in the upper arm. Participants will complete a diary card for 7 days. They will record any symptoms they have. They will be given a thermometer to check their temperature. They will also be given a ruler to measure any skin changes at the injection site. Participants will have about 10 study visits. They will be asked how they are feeling and if they have taken any medications. They will have blood drawn. Participants will have oral mucosal samples collected using a thin swab. They may have nose and throat secretions collected using a thin swab. Some participants will have optional apheresis. Blood will be removed through a needle in a vein in one arm. A machine will separate the white blood cells. The rest of the blood will be returned through a needle in a vein in the other arm. Participation will last for 40 weeks.

Start: May 2021
Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections

Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals demonstrated a reduction of inflammation in all lung and sinus diseases, in patients with COPD, Pulmonary fibrosis, CF, asthma, sinusitis , the flu and nasal inflammation and congestion. Inhaled sodium pyruvate reduces inflammation, congestion and in our phase III clinical study with Idiopathic Pulmonary Fibrosis patients we demonstrated statistically and clinical significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (form 52% to 86%) and a decrease in hypoxemia, and a reduction in coughing. Inhaled sodium pyruvate alleviated the symptoms associated with COVID-19 patients in Pulmonary Fibrosis, and may be a solution to the lingering COVID-19 symptoms in patients that had the COVID-19 infection for example long haulers. In flu and COVID infected mice, nebulized sodium pyruvate decreased morbidity, weight loss, inflammatory cytokines and decreased viral titers compared to placebo controls. The study to be done at Missouri State University is titled ( Two week sub-chronic double-blinded placebo controlled trial designed to determine if sodium pyruvate nasal spray will reduce the symptoms, duration and replication of COVID-19 and influenza infections)

Start: April 2021