62 Clinical Trials for Various Conditions
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.
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.
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.
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 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.
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 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 safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
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.
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 assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in people with asthma. The study will enroll 350, and possibly up to 400 healthy adults ages 12 and older with mild, moderate, or severe asthma. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine given as two 15 mcg injections. Both groups will receive vaccine injections on days 0 and 21. Study procedures include: medical history, physical exam, spirometry, maintaining a memory aid and, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's response to the H1N1 flu shot. In this study, 3 strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2 strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250 individuals greater than or equal to age 65. Study procedures include: physical exam, blood samples, completing a memory aid to record vaccine side effects, medications and daily oral temperature. Participants will be involved in study related procedures for up to 13 months.
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults
The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine. Up to 650 healthy volunteers from three age groups (greater than or equal to 6 months to less than 36 months, greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate. Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups. Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants will receive vaccine injections on Days 0 and 21 in the arm or thigh muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200 will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0 and 21 in the arm muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200 will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 micrograms (mcg) of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0 and 21 in the arm muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
The purpose of this study is to determine the pharmacokinetics (PK) of the anti-flu medication, Tamiflu during pregnancy and to determine to what extent pregnancy may affect the currently recommended dosage of this medication.
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.
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 purpose of this study is to evaluate the body's immune response at different time points to an FDA-approved seasonal influenza vaccine. By better understanding the way the immune system responds to the influenza vaccine, the investigators can design more effective vaccines against influenza.
Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).
This is a single center, randomized, partially-blinded, Phase II, small, targeted, prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18 to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v virus vaccine. The primary objectives are (1) assessing the serum anti-HA hemagglutination-inhibition (HAI) response to influenza A/H7N9 antigen (with and without adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9 vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one month after the study vaccination with A/H3N2v), and (2) identifying differentially expressed genes in human immune cells on Days 2, 4, and 29 (following the first study vaccination with A/H7N9 vaccine with or without AS03) and on Days 30, 32, and 36 (following the second study vaccination with A/H7N9 vaccine with or without AS03), compared to baseline assessments performed prior to each study vaccination (Days -7, 1, and 29).
To assess the efficacy and safety of oral rosuvastatin in patients with suspected or confirmed influenza who require intensive care unit (ICU) admission due to respiratory distress.
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after a single injection. * To describe the safety of the candidate vaccines after a single injection.
This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years) adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza trivalent inactivated vaccine (TIV) as the booster injection, as compared to placebo prime followed by the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe for human administration and that the DNA vaccine prime-TIV boost schedule will elicit a better immune response than the seasonal TIV alone.