66 Clinical Trials for Various Conditions
Background: - Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop flu symptoms. Objective: - To see if the drug CR6261 reduces flu disease in people treated with this drug versus a placebo. Eligibility: - Healthy nonsmokers ages 18 45. Design: * Participants will be screened under a separate protocol. * Participants must use contraception or abstinence for several weeks before and after the study. They must have no alcohol for 1 day before each visit. Any medicine must be approved by the study doctor until after follow-up. * Participants will stay in a hospital isolation unit for at least 10 days. * They will have: * Medical history * Physical exam * Blood and urine tests * Heart and lung test * Tests for drugs and alcohol * Throughout their stay, participants will: * Be closely watched by a medical team * Have nasal washes and swabs several times a day * Participants will have the flu virus sprayed in each nostril. * The next day, participants will get either study drug or placebo through a soft plastic tube placed in a vein by needle. It will take 2 hours. They will not know which they get. * Participants can go home after 10 days if they test negative for the flu 2 days in a row. * Participants will have daily questionnaires at home and 2 follow-up visits over 2 months.
Immunosuppressed patients are at increased risk for complications of influenza infection, including secondary pneumonia and are recommended for annual influenza vaccination. Thus, the appearance of a novel subtype of influenza A virus designated as 2009 swine H1N1 virus has added an extra layer of complexity in the immunization regimen in this population. In general, susceptibility to swine H1N1 infection among young population is higher as young adults and children completely lack protective titers. According to the Center for Disease Control (CDC), 70 percent of people hospitalized with H1N1 have been "high risk" cases, including persons 65 years of age or older, or people with compromised immune systems as observed during HIV infection. This has prompted CDC to include HIV infected children to be one of the five groups to be vaccinated with the new H1N1 vaccine (National Center for Immunization). Currently no information exists about the nature of the immune response to the vaccine against H1N1 swine-origin influenza virus (S-OIV) in HIV infected children. It is unknown whether HIV impairs the immunogenicity of the vaccine predisposing this population to infection with S-OIV. Thus, a pilot proposal is being undertaken to study the mechanism of H1N1 vaccine protection in HIV infected children, by investigating the correlation of infection status with seroresponse, duration of response and development of influenza-like illness following vaccine. Additionally we will establish whether we can identify immune signatures by characteristic gene expression patterns correlating with the vaccine immunogenicity that can be predictive of efficacy for "good" and "suboptimal" vaccination regimen. Data generated will be used to initiate a comprehensive study on the immunogenicity of the influenza vaccines in HIV-infected children and youth, which is critically important to address the health care needs of this vulnerable population.
Background: - A challenge study exposes a person to a disease and allows researchers to study the disease through the body's healing process. An influenza challenge study that looks at different amounts of the flu virus can provide more information on the smallest amount needed to cause an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy volunteers to see how the body responds to the virus. Objectives: * To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate flu infection in a healthy adult. * To study how the body s immune system responds to the virus. Eligibility: * Healthy volunteers at least 18 years of age. * Participants must be willing to remain in isolation for a minimum of 9 days. Design: * Participants will be admitted to a hospital inpatient isolation unit. They will be screened with a physical exam and medical history. They will also have heart and lung function tests. Blood, urine, and nasal swab/wash samples will be collected. * Participants will receive a single nasal spray of the flu virus. They will stay on the inpatient unit for at least 9 days. * Participants will be monitored for the length of their stay. They will have frequent blood tests and other procedures as needed. * Participants will be allowed to go home once they have had two negative tests for the virus. The tests will be given on two consecutive days....
The purpose of this research study is to evaluate the immune response to the H1N1 influenza or "flu" vaccine. The "immune response" is how your body recognizes and defends itself against bacteria, viruses, and substances that may be harmful to the body. HIV-1 infected children typically respond more poorly to vaccines compared to uninfected, healthy children and so this study hopes to learn whether or not the body will successfully produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1 flu virus. There is no information yet on the safety or immune response to this vaccine in children infected with HIV.
A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or licensed inactivated A/California/07/09 influenza vaccine (IIV) or IIV followed by LAIV separated by 28 days. Children with prior vaccination or natural infection with novel H1N1 influenza will be excluded. Randomization will be stratified by pre-existing HAI titers to the previous winter's seasonal H1N1 A/Brisbane/57/07 reference virus.
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.
Unlike most influenza viruses, the 2009 H1N1 virus has affected people between 5 and 40 years old more often than people 60 years old or older. It may be that older people have had greater exposure to previous strains of H1N1 influenza, and this previous exposure protects them from infection. This study will examine how older people respond to a version of the H1N1 virus vaccine that includes a live, noninfectious version of the virus.
The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.
This is study where medical record information will be collected as well as collection of excess biological samples.
The purpose of this research is to determine the effectiveness of the novel H1Nl influenza (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons. The administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care.
This is a study of a reverse-engineered, Good Manufacturing Practice (GMP) grade, antiviral-sensitive, influenza A/Bethesda/MM2/H1N1 virus (A/California/04/2009/H1N1-like) infection to assess the effect of pre-existing immunity on clinical and immunological responses. Up to 80 healthy adult subjects will undergo intranasal inoculation with A/Bethesda/MM2/H1N1 virus, and their clinical manifestations, viral shedding and immunological responses will be characterized. The Primary Objective for this study is to evaluate the association of symptomatic Reverse Transcription-Polymerase Chain Reaction (RT-PCR)-positive influenza virus infection post-challenge and pre-existing Hemagglutinin Inhibition Test (HAI) antibody titers.
The purpose of this study is to evaluate the immune response produced by a seasonal live attenuated influenza vaccine (LAIV) when compared to placebo. The initial vaccination will be followed 2 months later by an inpatient trial evaluating safety, infectivity, clinical response, and viral shedding after exposure to the wild-type A/California/2009-like influenza challenge virus.
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.
The purpose of this study is to evaluate specific approaches used to prevent/reduce influenza transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic, including assessing infection control strategies used by SCI staff and guidance provided by local infection control units. Due to the rapid spread of and uncertainties about the H1N1 virus, we will evaluate patient's beliefs, behaviors, and information seeking strategies (e.g., social media). These findings will lend to the understanding of ways to handle emergent issues, such as the H1N1 pandemic, in special populations.
Background: - Seasonal influenza is a major health problem whose impact is typically reduced by vaccination. The H1N1 (swine flu) influenza virus is an emerging pathogen that has the potential to cause devastating illness and even death in the coming months. Currently, there are limited data on the cellular and molecular immune responses in adult recipients of either the seasonal or the H1N1 influenza vaccines. Objectives: - To obtain blood and nasal wash samples and perform laboratory studies to characterize the immune response in healthy adult volunteers at baseline and after immunization with the seasonal or H1N1 influenza vaccines. Eligibility: - Adult employees at least 18 years of age of the NIH Clinical Center who are deemed healthy by a brief medical history and physical examination and routine blood testing. Design: * Before the start of the influenza season, volunteers will receive either the seasonal influenza vaccine or the H1N1 vaccine when it becomes available. If the H1N1 vaccine is available at the start of the season, volunteers will receive both the seasonal vaccine and the H1N1 vaccine. * Blood will be drawn over an 8-week period. Volunteers must not eat anything for 8 hours prior to the blood draw. The sequence of the blood draws is as follows: 2 weeks before vaccination; right before vaccination; and 1, 7, 14, 28, and 60 days after vaccination. * Two to four nasal washings will be collected by a nurse before volunteers receive the vaccination(s) and 28 days after the vaccination. * Prevaccine and postvaccine blood and nasal wash samples will be compared to determine volunteers immune responses. * Research samples will be stored indefinitely and will be used strictly for laboratory experiments.
The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults
This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.
The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their standard of care will be asked to donate blood samples for immunologic studies. These studies will determine whether participants were able to produce the appropriate antibodies to the vaccine and possibly identify predictors of vaccine responsiveness. Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be compromised in HIV infected patients.
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.
The purpose of this study is to describe the immune response to a novel H1N1 influenza vaccination in healthy adults, and to understand the factors that allow healthy adults to respond to a single dose of vaccine even if they have never previously experience novel H1N1 disease or vaccination.
The purpose of this research study is to collect information on problems that patients with the novel H1N1 influenza and/or the seasonal influenza experience. Novel H1N1 flu is also called the swine flu. Seasonal influenza is also called the regular flu. The purpose of this study is to collect information from patients who are infected with either the novel H1N1 or the seasonal flu and to determine what makes patients critically ill with these infections. The goal is to develop a registry that will aid investigators in determining specific markers that lead to development of severe illness in these infections.
This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Background: * The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is conducting research investigating how the swine flu (H1N1) vaccine affects the immune system. The exposure to the new swine flu vaccine gives us a rare opportunity to learn about how the human immune system responds to a new vaccine. * Researchers are interested in collecting blood samples from individuals who have received the vaccine. Participants will be selected from a group of healthy volunteers who will be receiving the H1N1 vaccine because it is mandatory for their work at the National Institutes of Health. This protocol will be one of the first studies to characterize the human innate immune response to H1N1 vaccine. Objectives: - To collect blood samples for research purposes before and after participants receive a standard non-research vaccination against swine flu (H1N1). Eligibility: * Healthy individuals 18 years of age and older who are employees of the National Institutes of Health. * Individuals who have had confirmed cases of influenza in the past year are not eligible to participate. Design: * Participants will be admitted for a 36-hour inpatient stay, during which blood samples will be taken frequently. Participants will have a standard intravenous catheter (similar to the one used for intravenous infusions) put in place to avoid multiple needle sticks. * Participants will be assigned into one of two groups; the two groups differ in the timing of blood draws but not in the overall amount of blood drawn. * Group 1: Blood samples 30 minutes before and immediately before vaccination. Additional samples will be taken 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, and 36 hours after vaccination. * Group 2: Blood samples 30 minutes before and immediately before vaccination. Additional samples will be taken over the following 36 hours, with exact timing to be determined based on the findings from group 1. * All participants will provide blood samples 7 days after being released from the inpatient stay. * Because of the amount of blood being drawn for research, participants should not donate blood or take part in any other protocols that collect blood while participating in this study.
Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.
The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in pregnant women and to determine how their body reacts to different strengths of the vaccine. Two strengths of the H1N1 influenza vaccine will be tested. Since it is not known if the response to the vaccine in pregnant women is the same or different than in non-pregnant women, the study also includes a group of women who are not pregnant for comparison. Participants include 200 pregnant women and 100 non-pregnant women ages 18-39. Study procedures include physical exams, several blood samples and maintaining a memory aid to document daily temperature and side effects for 8 days following vaccination. Participants will be involved in study related procedures for about 6 months.
The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot in persons infected with human immunodeficiency virus (HIV). This study will also compare how the CD4 count (cells that help fight disease) affects the body's response to the H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3 weeks apart. The results of this study will help researchers find out if the different strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take part in this study. Study procedures include: blood sampling, physical exams, and use of memory aids to record temperature, medications and symptoms. The length of patient participation is about 7 months.
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza vaccine in pregnant women infected with HIV.
The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.
The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older. This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.