View clinical trials related to Influenza, Human.
Filter by:An open-label, dose-ranging influenza challenge study in healthy adult volunteers to determine the optimal infection dose and safety of a recombinant H3N2 (A/Texas/ A/Texas/71/2017 (H3N2, clade 3C3a) influenza strain. The goal of this study is to find a challenge virus dose that is safe and can achieve a symptomatic influenza Attack Rate (AR) that will be sufficiently high for utilization in future vaccine or intervention studies. The optimal dose of the three considered is broadly defined as the minimum challenge virus dose that elicits the highest AR without meeting safety-stopping criteria. Additionally, viral recovery, clinical symptoms, and immune responses over the post-challenge period will be described by challenge dose group. This study will last for up to 1 year depending upon the number of challenge cohorts enrolled given the adaptive dose-escalation design. The populations are healthy males and non-pregnant, non-breastfeeding females aged = 18 and < 46 years of age with a serum HAI antibody titer of </=1:40 against influenza A/Texas/71/2017 (H3N2), clade 3C3a. The study will enroll and challenge up to 106 (plus 8 shams) healthy adult volunteers with the H3N2 (A/Texas/71/2017 (H3N2), clade 3C3a) influenza virus challenge strain. The primary objectives are: 1) To determine the optimal infectious dose of a recombinant influenza virus (A/Texas/71/2017 (H3N2), clade 3C3a) to be used as a clinical challenge strain in future vaccine efficacy or intervention studies as assessed by viral shedding and clinical symptoms. 2) To describe viral detection by quantitative and qualitative Reverse Transcription - Polymerase Chain Reaction (RT-PCR) from study subjects at baseline and post-challenge. 3) To document clinical symptoms from self-reported surveys and standardized symptom scales at baseline and post-challenge.
The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65 years of age and older having received their second dose of the 2-dose schedule of Moderna COVID-19 vaccine at least 5 months before enrollment in the study.
Background: The influenza (flu) virus infects millions around the world every year. Children are at increased risk of complications from the flu. The flu vaccine protects against influenza, but the vaccine can be improved. Researchers want to learn more about children s mucosal and systemic immunity after flu vaccination. This could help to develop more effective flu vaccines in the future. Objective: To learn what happens in kids immune systems after receiving a flu vaccine. Eligibility: Children ages 2-17 who have received a flu vaccine in the past and plan to get the current seasonal flu vaccine given by injection. Design: All study visits will take place at home and communication with the study team will be done via phone or videoconference. Participants will review medical history and flu vaccination history with the study team. Participants will get the flu vaccine at their local doctor s office or pharmacy. They will not be given the vaccine in this study. Participants will complete an electronic survey to give details about the date and type of flu vaccine received. Participants will collect nasal and fingerstick samples at home. They will collect 4 nasal samples and 3 fingerstick samples over 6 months: once before they get the flu vaccine and 2-3 times after they get the vaccine. They will use collection kits that include instructions, sample collection supplies, and shipping materials. They will ship all samples back to NIH with all costs covered by NIH. Participation will last for 6 months. Compensation is provided.
The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine.
Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.
To explore the different clinical and CT features distinguishing COVID-19 from H1N1 influenza pneumonia.
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.
This study is an open-label, single-center, randomized phase IV clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of the SARS-CoV-2 Inactivated Vaccine (Vero cell) with Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years
The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions. Innate immunity can adapt and respond more efficiently to secondary exposures, thanks to epigenetic and metabolic reprogramming, namely "trained immunity". ABBC1 is a combination of beta-1,3/1,6-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for training immunity. ABBC1 includes repurposed synergistic yeast-based ingredients: a unique ß-1,3/1,6-glucan complex and a consortium of probiotic Saccharomyces cerevisiae, rich in Selenium and Zinc. ABBC1 induces trained immunity due to its specific chemical and tridimensional structure: its ß-glucan complex interacts with specific receptors in immune cells, provoking a release of cytokines and priming phagocytosis. Simultaneous activation of these pathways activates innate immunity and counteracts cytokine storm. ABBC1 provides highly bioavailable selenium and zinc, micronutrients with a critical role in an optimal immune responsiveness to allergy, infection, and vaccines. ABBC1 possesses proven microbiome modulating properties, which revert in immune training. Due to its high tolerance, safety and immediate availability, ABBC1 is an ideal candidate for complementary management of geriatric patients with seasonal influenza viruses or COVID-19, or to improve the immune response in the general population receiving the influenza or Covid-19 vaccines. The absence of drug interactions in ABBC1 allows a dosage that is fully compatible with the medication prescribed for all types of patients, including the elderly who are frequently polymedicated, and allows adding an additional therapeutic tool in the fight against the pandemic. This study assesses the benefits of a nutritional supplementation with ABBC1 in volunteers receiving the influenza vaccine during autumn 2020 and the Covid-10 vaccine during winter 2021.
Subjects will be recruited and divided into 3 groups: Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd dose: PPV23 only. Blood samples will be collected 3 times: before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination. The immunogenicity and safety of both experimental and control groups will be analyzed.