Influenza Clinical Trials

The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures Read Less

This study examines how the immune system responds to the flu virus (H3N2) during and after infection and how the flu virus is transmitted in the environment. The study will used a flu virus called the H3N2 influenza challenge virus which was produced specifically for use in clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy subjects. Mild to moderate symptoms are expected based on previous studies with this strain of influenza. Read Less

Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined. The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV. Read Less

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. Read Less

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age. Read Less

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, were recently enrolled, or are scheduled to enroll in a challenge study. Design: Participants will stay at NIH for the duration of the challenge study (at least 9 days) and then will have outpatient follow-up visits (2-4). 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 a smartphone that records at all times to listen for coughing and changes in voice. Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take videos of their face. They will play a game to test their reflexes and focus. They will measure their head temperature with their smartwatch. For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks. Participants will be sent a smartwatch to wear at home at night to collect additional healthy data. Participation will last the duration of each challenge study, and may range from 10 weeks to 2 years. Read Less

The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times. Read Less

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 1025 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 Influenza vaccine for free. 7 days post receiving your Influenza Vaccine we will collect a small blood sample for further immune system testing. also, you will be asked to complete a 12-question survey which will assess your symptoms over the past 7 days (post receiving the Influenza vaccine). Also 4 weeks post receiving your Influenza vaccine you will be asked to complete a third visit that will include follow up health questionnaires and an influenza symptoms assessment questionnaire and vital signs. A third blood draw will be collected (approximately 10 teaspoons) to measure immune responses to the influenza vaccine. In addition, you will receive your test result (CBC/w/Diff.) from visit #1. Throughout the influenza study season, 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 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 vital signs, nasal swab to confirm influenza, and a fourth blood draw to look at the immune response and protection of influenza vaccine. Read Less

The main purpose of this study is to understand: * the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses) * the potential effects of COVID-19 vaccines in people with COVID-19 This study will enroll participants who are: * 18 years or older * reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS pharmacy COVID-19 or influenza test sites. The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during multiple follow-ups over a 6-month period. Read Less

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29. Read Less

The purpose of this study is to evaluate the virus-specific immune response in people who are symptomatic with confirmed influenza or COVID-19. We will study the immune response of people who have and who have not been vaccinated with the seasonal influenza and COVID-19 vaccines within the past year. All participants will have data collected and blood, saliva, and nasal swabs performed at five separate visits; 1) at study enrollment, 2) on study day 7, 3) on or between study days 10 to 28, 4) on study day 90, and 5) on study day 180. For participants who agree to the optional sub-study, bronchoscopy with bronchoalveolar lavage (BAL) and endobronchial biopsy (EBBx) will be performed once between study days 10 and 28 and once at study day 180. As part of the bronchoscopy procedure, two chest x-rays will be performed. The bronchoscopy and chest x-ray procedures are not required for participation in the study. Read Less

This study is designed to help us better understand how the immune system responds to the flu and how flu is transmitted in the environment. The ultimate goal is to develop better vaccines and drugs to protect against or fight the flu. This study will describe how the body's immune system responds to the flu virus during and after infection and how the flu virus is transmitted in the environment. The study will use a flu virus called A/Texas/71/2017 (H3N2), clade 3C3a produced specifically for clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy participants. Mild to moderate symptoms are expected based on previous studies with this strain of influenza. Study volunteers will be recruited and screened from the general population of metro Atlanta through advertisements or identified from a database of research participants who have previously agreed to be contacted for future research studies. Participants will provide written consent before study participation. Up to 200 healthy adults, 18-49 years old, will be screened for participation. Eligible participants will take part in the study over 5 months. Enrolled participants will be admitted to Emory University Hospital during which time they will receive the influenza virus in the form of a spray in the nose or exposure to infected participants followed by an 8-12 day inpatient stay for observation. Follow-up outpatient visits will take place at the Hope Clinic of the Emory Vaccine Center. Participants will receive compensation (pro-rated for all visits completed) for their time and effort. There will be no costs to participants as a result of being in the study. Read Less