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Virus Diseases clinical trials

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NCT ID: NCT01062321 Completed - Pregnancy Clinical Trials

Role of Cytokines in Hepatitis E Virus Infection During Pregnancy

Start date: August 2009
Phase: N/A
Study type: Observational

Hepatitis E virus is a public health problem in several countries of the world where safe drinking water is a problem. HEV is an exclusive cause of epidemic hepatitis in general population. HEV infection occurs most frequently in rainy season. The disease affects mainly young adults in the age of 15-40 years.HEV viral infection is of particular concern in pregnancy. It is a potential disaster for mother and child. HEV infection during pregnancy is fulminant and fatal especially if it occurs in third trimester. The mortality in the second trimester is around 20% and reaches upto 45% in the third trimester.

NCT ID: NCT01058239 Completed - Clinical trials for Solid Organ Transplant

Bortezomib Plus Rituximab for EBV+ PTLD

Start date: November 2011
Phase: Phase 2
Study type: Interventional

Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma that occurs in patients with weakened immune systems due to immunosuppressive medications taken after organ or stem cell transplantation. This is usually related to a virus called Epstein-Barr (EPV). Rituximab is a type of drug called an "antibody" that specifically destroys both normal and cancerous B-cells, and is commonly used for PTLD. Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) to treat multiple myeloma and a B-cell non-Hodgkin lymphoma called Mantle Cell Lymphoma, and shows significant activity in lymphoma cells caused by EBV. In this research study, we hope to learn if the addition of bortezomib to rituximab treatment can increase the rate of complete remissions and cures of PTLD after organ or stem cell transplant.

NCT ID: NCT01032408 Completed - Clinical trials for H1N1 Influenza Virus

Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With HIV-1 Infection

Start date: April 2010
Phase: Phase 3
Study type: Interventional

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects. Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

NCT ID: NCT01030562 Completed - Clinical trials for Papilloma Viral Infection

Immunogenicity of Off-Schedule Dosing of HPV Vaccine

Start date: June 2, 2010
Phase:
Study type: Observational

The purpose of this study is to gain a better understanding of the body's response to a human papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The study will also determine factors related to adolescents not following vaccination schedules. The HPV vaccine requires 3 doses (shots). Girls sometimes receive the 3 shots at the recommended time and sometimes girls receive the shots at non-recommended times. This study will evaluate if getting the shots at non-recommended times affects the level of protection provided by the vaccine. Participants will include about 1400 girls 9-17 years old receiving a third dose of HPV vaccine from their primary care clinician. The parent/legal guardian of each subject may answer a questionnaire related to the vaccine schedule. Study procedures include: medical history, questionnaires and blood draws. Participants will be involved in the study for about 6 months from time of enrollment.

NCT ID: NCT01021397 Completed - Virus Diseases Clinical Trials

Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children

Start date: November 2009
Phase: Phase 1
Study type: Interventional

Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The primary purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.

NCT ID: NCT01006629 Completed - Clinical trials for Congenital Heart Disease

Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.

NCT ID: NCT00997607 Completed - Ebola Virus Disease Clinical Trials

Evaluating an Ebola and a Marburg Vaccine in Uganda

Start date: February 2010
Phase: Phase 1
Study type: Interventional

This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if they are safe, if they have side effects, and if they create an immune response in people who receive them.

NCT ID: NCT00985582 Completed - Clinical trials for Influenza A Virus Infection

Antiviral Therapy for Influenza A H1N1

SEA032
Start date: September 2009
Phase: N/A
Study type: Observational

The aims of this study are to characterise the clinical efficacy and virological clearance dynamics of orally administered oseltamivir in patients with influenza caused by novel influenza A(H1N1). This research will also contribute to enhancing research capacity in affected countries. The objectives are to assess the: - viral replication levels over time in affected patients - antiviral efficacy of oral oseltamivir - patterns and compartments of viral shedding, tissue distribution - innate inflammatory response and relation to viral replication - kinetics of antibody response - antiviral sensitivity of influenza viruses at baseline and during oseltamivir treatment using in vitro and molecular methods - pharmacokinetic characteristics of oseltamivir and oseltamivir carboxylate - all cause in hospital mortality - clinical and radiological features, disease course and outcome - length of stay in hospital - risk factors associated with development of severe disease and death

NCT ID: NCT00984945 Completed - Clinical trials for Respiratory Tract Infections

Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The primary objective is to assess the safety and tolerability of two consecutive doses of plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21 days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined with Alhydrogel®.

NCT ID: NCT00984451 Completed - Clinical trials for Influenza A Virus Infection

A Pilot Study for Collection of Anti-Influenza A Immune Plasma

Start date: September 2009
Phase:
Study type: Observational

Background: - The influenza A virus can cause infections that lead to fever, cough, muscle aches, diarrhea, and headaches, and can even be fatal in some people. Seasonal influenza kills an estimated 36,000 people in the United States each year. In addition, more than 200,000 people are hospitalized for flu-related complications. Influenza A has a substantial health effect on every age group. - Currently, treatments are available for influenza A, but there is concern that the rate of complications or even death from this infection is still high despite treatment, and that over time this virus may become resistant to these treatments. Researchers are interested in developing a possible new treatment that uses antibodies against influenza A virus. Objectives: - To collect plasma (the liquid component of blood containing antibodies) from people who have high levels of antibodies against the influenza A virus because they either have been previously infected with the virus or have been vaccinated against the infection. Eligibility: - Healthy male volunteers between 18 and 60 years of age who are eligible to donate blood. - Individuals must have previously either recovered from influenza infection or have been vaccinated against the infection, and may be subject to other restrictions on participating in National Institutes of Health research studies. Design: - Volunteers will undergo apheresis, an outpatient procedure in which researchers will collect plasma containing antibodies against the influenza virus by drawing blood into a special machine that separates blood cells from the liquid portion under sterile conditions and then returns the blood cells to the donor. - Volunteers will be screened with blood tests to ensure that they are eligible to participate and donate blood. - Volunteers are asked to undergo at least 3 sessions of apheresis; if willing, they can volunteer to participate in up to 20 sessions. - After plasma is collected, it will be tested to ensure that it can be used to safely develop treatments for patients who have influenza A infection.