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Virus Diseases clinical trials

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NCT ID: NCT00129766 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

Start date: November 2004
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

NCT ID: NCT00111878 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate MEDI-534 in Healthy Adults

Start date: April 2005
Phase: Phase 1
Study type: Observational

The primary objective of this study is to describe the safety and tolerability of a single dose of MEDI-534 when administered to healthy adult volunteers.

NCT ID: NCT00110279 Completed - Influenza Clinical Trials

Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study A)

Start date: June 2005
Phase: Phase 1
Study type: Interventional

Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults. Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide variety of birds and mammals. The direct transmission of avian influenza viruses from birds to humans has recently become a major health concern in Asia and other parts of the world, raising concern of a possible influenza pandemic in humans. This vaccine will evaluate the safety, infectivity and immunogenicity of Live Influenza A vaccine H9N2 (6-2) AA ca reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a cold-adapted, live attenuated virus vaccine administered intranasally for the protection of humans against pandemic influenza viruses of the H9N2 subtype.

NCT ID: NCT00070785 Completed - Clinical trials for Epstein-Barr Virus Infections

Protein Studies of the Epstein-Barr Virus in Ethnically Diverse Populations

Start date: October 6, 2003
Phase: N/A
Study type: Observational

This study will evaluate the ability of people of different ethnic backgrounds to develop immune responses against the Epstein-Barr virus (EBV). A common virus, EBV is present in 90 percent of healthy people and usually does not cause problems. Most people are infected in childhood, have no symptoms, and are unaware of their infection. People infected as adolescents or adults may develop infectious mononucleosis, which usually resolves completely. However, in immune suppressed people, like those who have had a transplant, EBV can cause fatal cancers. It can also cause certain cancers such as Burkitt's lymphoma, Hodgkin's lymphoma, and nasopharyngeal carcinoma in people who are not immune suppressed. Nasopharyngeal carcinoma is 100 times more common in people of Asian origin (particularly southern Chinese) compared with Caucasians. This difference may be the result of genetic, rather than environmental, factors. This study will examine whether the same proteins produced by EBV in the cancer cells react differently in people of different ethnic background in a way that could explain the differences in predisposition for this disease. Healthy normal volunteers 18 years of age and older of Caucasian or Chinese ancestry may be eligible for this study. Candidates of Chinese ancestry must be born in China (including Taiwan, Hong Kong, and Singapore, or be first generation offspring of parents born in these places). Participants will have a blood sample drawn and will undergo lymphapheresis - a procedure for collecting large numbers of white blood cells called lymphocytes. The blood sample is tested for blood counts and HLA type, a genetic marker of the immune system. HLA molecules help determine the way the body's immune cells respond to virus. HLA typing is similar to blood typing. Usually done to match stem cell or organ transplants, HLA testing may also be used to try to identify factors associated with an increased risk of certain diseases or conditions. HLA type is strongly associated with ethnic background. For lymphapheresis, blood is collected through a needle in an arm vein, similar to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm. The procedure takes 2 to 3 hours. The collected white cells are used for research for this study, including the ability to react to EBV proteins, and are then destroyed.

NCT ID: NCT00069303 Completed - Encephalitis Clinical Trials

Natural History of West Nile Virus Infection

Start date: September 16, 2003
Phase: N/A
Study type: Observational

This study will examine how West Nile virus (WNV) infection affects the body. Some people infected with WNV have no symptoms. In others, symptoms may vary from fever and headache to a polio-like syndrome with paralysis, to coma and brain changes like those of a stroke. Many patients recover with no lasting effects, while a few can have long-lasting neurological damage or may die. This study will collect clinical, laboratory, diagnostic, and radiographic information on people thought to have WNV to better understand the disease. Patients 18 years of age and older diagnosed with or suspected of having West Nile virus infection may be eligible for this study. Patients will be hospitalized until they are well enough to go home and will undergo the following tests and procedures: - Medical history and physical examination: A thorough history and physical examination will be done on the first day of the study. Then, brief physical exams, including measures of blood pressure, heart rate, breathing rate, and temperature, will be done during each day of hospitalization and at every follow-up clinic visit (at 2 weeks and at 1, 3, and 6 months). - Blood tests: Blood samples will be collected on the first day of the study, at day 7, at hospital discharge, and at follow-up visits to determine if virus remains in the blood and how it is affecting the body. - Magnetic resonance imaging (MRI): MRI scans will be done within 72 hours of beginning the study and 1 month after that. This test uses a strong magnetic field and radio waves to produce images of the brain that might show abnormalities in the brains of patients with WNV and reveal whether the abnormalities can predict how an individual will recover. For the procedure, the patient lies on a table that is moved into the narrow tunnel-like scanner. During the procedure, a contrast agent that brightens the images is injected through a catheter placed in an arm vein. - Neurological examination and neurological function tests: Participants will be tested to see if the West Nile virus has affected their thinking and ability to perform normal daily activities. These tests will be done at the start of the study, on days 3 and 7 (also days 2, 4, 5, and 6 if patients are still in the hospital), at discharge, and at follow-up visits. The tests involve answering a number of questions and performing simple tasks, such as squeezing a hand or lifting a foot. - Patients who develop weakness in their arms or legs will also have the following studies: 1. Electromyography (EMG) to study the electrical activity of the muscle. For this test, needles are placed into a muscle to record the electrical activity at that site. 2. Nerve conduction studies to measure how well the nerves are working. A small charge of electricity is delivered to a nerve in the affected limb, triggering a muscle to tighten or bend. Small wire electrodes are attached to the skin to measure the time is takes for the nerve to move the electrical current from one part of the limb to another. 3. Spinal MRI to see if the virus is affecting the spinal cord. Results of other tests done by the patient's local doctor (such as lumbar puncture, electroencephalogram, x-rays, etc.) will be requested. If a lumbar puncture is done, a small amount of cerebrospinal fluid will be requested for testing for WNV.

NCT ID: NCT00058812 Completed - Clinical trials for Epstein-Barr Virus Infections

Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients Who Have Had Donor Marrow Grafts

ETNA
Start date: May 1993
Phase: Phase 1
Study type: Interventional

Patients have a type of blood cell cancer or other blood problem that is very hard to cure with standard treatments and s/he will receive a bone marrow transplant. If the patient does not have a brother or sister whose marrow is a "perfect match", this bone marrow will come from a donor whose marrow is the best match available. This person may be a close relative or an unrelated person whose bone marrow best "matches" the patient's, and who agrees to donate marrow. In normal people, the Epstein-Barr (EB) virus infection causes a flu like illness and usually gets better when the immune system controls the infection. The virus, however, remains hidden in the body for life. After a transplant, while the new immune system is growing back, the EB virus can come out and infect cells and cause them to grow in an uncontrolled manner. Patients can develop fevers, swollen lymph nodes and damage to other organs such as kidneys and lungs. This infection acts like a cancer because the cells infected with EB virus grow very quickly and there is no known effective treatment. This sort of infection will occur in between 10-30% of patients receiving a transplant from a donor who is not a perfect match, and has been fatal in nearly all these cases. This infection occurs because the immune system cannot control the growth of the cells. We want to see if we can prevent it from happening or treat it by giving the patient a kind of white blood cell called T cells that we have grown from the marrow donor. These cells have been trained to attack EB virus infected cells. We will grow these T cells from blood taken from the donor at the time of bone marrow harvest. These T cells will be stimulated with the donor's EB virus-infected cells which have been treated with radiation so they cannot grow. After mixing these cells together we will be able to grow special T cells from the donor that can attack EB virus infected cells. We will then collect the T cells and make sure they can kill the virus infected cells. These EBV specific T cells are an investigational product not approved by the Food and Drug Administration.

NCT ID: NCT00058604 Completed - Clinical trials for Lymphoproliferative Disorders

Prevention and Treatment of Epstein-Barr Virus (EBV) Lymphoma Following a Solid Organ Transplant Using EBV Specific Cytotoxic T Lymphocytes (CTLs).

EUCLID
Start date: January 2001
Phase: Phase 1
Study type: Interventional

Patients who may have been infected with EBV (Epstein-Barr Virus) before or after the time of their transplant have a higher risk of developing Lymphoproliferative Disease (LPD) or may already have a form of this disease. This research study uses Epstein Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). These cells have been trained to attack and kill (cytotoxic) EB virus infected cells. We make these cells from the patients blood by first growing an EBV infected B cell line by infecting the blood with an EBV virus called B-95. We then treat these EBV infected B cells with radiation so they cannot grow and use them to stimulate T cells. This stimulation will train the T cells to kill EBV infected cells. We will then test the T cells to make sure they kill the EBV infected cells. The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help prevent or cure EBV related cancers in solid organ transplant patients

NCT ID: NCT00058591 Completed - Clinical trials for Epstein-Barr Virus Infections

Treating Severe Chronic Epstein-Barr Virus (EBV) Infection With EBV Specific Cytotoxic T Lymphocytes (CTLs)

SCAEBV
Start date: January 2000
Phase: Phase 1
Study type: Interventional

Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor). The reasons for the body's inability to control the EBV infection are still unknown and no effective treatment is currently available. This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient. The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help the body fight off the SCAEBV infection.

NCT ID: NCT00054041 Completed - Cervical Cancer Clinical Trials

Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Start date: June 2004
Phase: Phase 2
Study type: Interventional

Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

NCT ID: NCT00047814 Completed - Hepatitis C Clinical Trials

Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Start date: October 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4 weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during therapy and for four weeks following therapy.