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155 active trials for Influenza

Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine

Background: Influenza (flu) is a virus that infects people of all ages. Some people may have mild flu symptoms. Others may get very sick and even die from the flu. Flu vaccines help protect people against the flu, but if the flu strains in the vaccine are not a good match with the strains circulating in the community, the vaccine is not as effective. Researchers want to make flu vaccines that protect against changing flu strains. Objective: To test if a new flu vaccine is safe and if it creates an immune response. Eligibility: Healthy adults ages 18-55 who do not smoke and have not received a flu vaccine in the 8 weeks prior or a COVID-19 vaccine in the 4 weeks prior to enrollment. Design: Participants will be screened on a separate protocol. Participants will have 11 visits over 7 months. They will get a combination of study vaccine and/or placebo, both as a shot in the arm and as a spray into the nose, at 2 visits. For 7 days after getting the vaccines, they will take their temperature and complete online surveys at home to record any symptoms. At each visit, participants will have a physical exam and medical history. They will give blood and urine samples. They will have nasal testing. For this, a thin absorptive strip will be inserted into their nostril for 1 minute to collect mucus. At some visits, the inside of their nose will be wiped with a small brush to collect cells. For this, their nostril will be numbed to make it more comfortable. Some blood and nasal samples will be used for genetic testing. Participants who get flu-like symptoms during the study will be asked to collect nasal samples at home and send these samples back to NIH to test if they actually have the flu.

Bethesda, MarylandStart: September 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.

Bethesda, MarylandStart: September 2021
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.

Bethesda, MarylandStart: July 2011
Natural History of Systemic and Nasal Mucosal Immunity After Influenza Vaccination in a Pediatric Population

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.

Bethesda, MarylandStart: September 2021
Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine

This is a Phase 1b, randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled study of a targeted 220 children, ages 6 months to 17 years, inclusive. This clinical trial is designed to assess the safety and immunogenicity of of one and two doses of Sing2016 M2SR H3N2 influenza vaccine (manufactured by FluGen) administered intranasally in seven cohorts of children. The first two groups to be vaccinated will be Cohorts 1 and 2. Cohort 1 consists of 45 children 9-17 years old. Thirty of them will receive one dose of the vaccine at a dose of 10^9 TCID50, and 15 will receive one dose of placebo. Cohort 2 comprises 45 children 2-8 years old. Thirty of them will receive one dose of the vaccine at a dose of 10^8 TCID50 and 15 will receive one dose of placebo. Sites will enroll participants into Cohorts 1 and 2 simultaneously. Once 25 or more participants in each of the first 2 cohorts (Cohorts 1 and 2) have completed Day 8, the Safety Review Committee (SRC) will evaluate if any halting rules are met and if it is deemed safe to proceed to enrollment of the next cohort. Cohort 3 consists of 25 children 2-8 years old. Fifteen of them will receive one dose of vaccine at 10^9 TCID50 and 10 will receive one dose of placebo. Once all 25 participants in Cohort 3 have completed Day 8 of follow-up, similar to Cohorts 1 and 2, the SRC will review to ensure no halting rules are met and if no rules are met, progression to Cohort 4 can begin. Cohort 4 consists of 45 children 2-8 years old, thirty of them will receive two doses of vaccine at 10^9 TCID50 and 15 will receive two doses of placebo, with a 28-day interval between the first and second doses. Once 25 or more participants in Cohort 4 have completed Day 36 of follow-up, once again the SRC will review to ensure no halting rules are met. If progression is allowed, Cohort 5 will begin. Enrollment within the cohort will not halt during the SRC review of the lead-in group of eight children. In Cohorts 5, 6, and 7, each will enroll 6- to 23-month-olds who are influenza-naïve (defined as children without receipt of influenza vaccine and without previous documented influenza infection). Cohort 5 consists of 8 children who will be randomized to receive two doses of 10^7 TCID50 Sing2016 M2SR (n=6) or two doses of placebo (n=2). A safety assessment will be conducted once all 8 have completed Day 8 to determine progression to Cohort 6. Cohort 6 will consist of 26 children. A lead-in group of 8 children will be randomly assigned to receive either two doses of 10^8 TCID50 of the Sing2016 M2SR (n=6) or two doses of placebo (n=2). Once the first 8 children have completed Day 8, the SRC will review the safety and determine if Cohort 7 may begin enrollment. The additional 18 children in Cohort 6 may continue to enroll during the SRC review. Overall, they will be assigned randomly to two doses of 10^8 TCID50 of the Sing2016 M2SR (n=12) or two doses of placebo (n=6). Cohort 7 will be the final cohort. Twenty-six children will be randomly allocated to receive two doses of either 10^9 TCID50 Sing2016 M2SR (n=18) or placebo (n=8). This cohort does not have a "lead-in" group since data from such a group are not needed to allow the enrollment in a subsequent cohort. However, the study-wide and individual halting rules still apply. For all cohorts, a minimally acceptable pre-vaccination blood volume is set at one 5-mL tube of blood (Serum Separator Tube (SST) for serum), regardless of age. Should the site not be able to collect that blood before the first vaccination, the child will not be permitted to continue. After the administration of the above noted vaccine doses, safety will be assessed by the evaluation of reactogenicity from Days 1-8 for participants in Cohorts 1-3, who are receiving a single dose of vaccine or placebo, and from Days 1-8 and approximately Days 29-36 for participants in Cohorts 4, 5, 6, and 7, who are receiving 2 doses of vaccine or placebo. Study duration will be approximately 22 months with subject participation duration approximately three months. The primary study objective is to assess the safety and tolerability of one and two administrations of the Sing2016 M2SR H3N2 influenza vaccine at 10^7, 10^8, or 10^9 TCID50 delivered intranasally to healthy participants, 6 months to 17 years of age.

Durham, North CarolinaStart: August 2021
Influenza Challenge Study to Determine the Optimal Infection Dose and Safety of a Recombinant H3N2 (A/Texas/71/2017 (H3N2, Clade 3C3a) Influenza Strain

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 7.5 months 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 dose1 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.

Durham, North CarolinaStart: August 2021