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Virus Diseases clinical trials

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NCT ID: NCT00551629 Completed - Clinical trials for Bacterial Infections; Virus Diseases

A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)

Start date: May 2001
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4 different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 4 formulations of HR5I administered as a primary series at 2, 3, and 4 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.

NCT ID: NCT00533182 Completed - Clinical trials for Respiratory Infections

Influenza in People With Normal and Weakened Immune Systems

Start date: January 3, 2008
Phase:
Study type: Observational

This study will evaluate how the immune system responds to influenza infection and compare how the infection differs in patients with a weakened immune system versus those with a healthy immune system. Patients at the NIH Clinical Center who are older than 2 years of age and who are diagnosed with influenza A or B may be eligible for this study. Patients with healthy immune systems and weakened immune systems are included. Participants answer questions about how they are feeling and have a physical examination to evaluate their symptoms. Blood and nasal fluid are collected on the first day and then every other day for a total of 8 days. Nasal fluid is collected by either inserting a small tube in the nose and washing the nose with salt water and collecting the fluid obtained, or by rubbing the inside of the nose with a swab. Physical examinations are repeated on the days that blood and nasal fluid are collected.

NCT ID: NCT00516035 Completed - Influenza Clinical Trials

Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults

Start date: September 2007
Phase: Phase 1
Study type: Interventional

Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains infecting people is important. The purpose of this study is to determine the safety of and immune response to a new AI vaccine in healthy adults against the H7N3 strain of avian influenza.

NCT ID: NCT00504907 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Safety Study of Oral BTA9881 to Treat RSV Infection

Start date: July 2007
Phase: Phase 1
Study type: Interventional

This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I clinical trial to determine the safety and tolerability of BTA9881 administered orally to healthy subjects

NCT ID: NCT00502086 Completed - Cirrhosis Clinical Trials

Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.

Start date: May 2005
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison with placebo, during 96 weeks of treatment.

NCT ID: NCT00496821 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus

Start date: July 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability and efficacy of intranasal ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers experimentally inoculated with RSV

NCT ID: NCT00493285 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age

CP149
Start date: July 2007
Phase: Phase 1
Study type: Interventional

The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.

NCT ID: NCT00491985 Completed - Influenza Clinical Trials

Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

Start date: June 2007
Phase: Phase 2
Study type: Interventional

This is an open, randomized, multicenter clinical trial. Objectives: - To describe the safety profiles during the 21 days following each primary and booster injection. - To describe the immune response 21 days after each primary and booster injection of each formulation. - To describe the antibody persistence after the first vaccination

NCT ID: NCT00489931 Completed - Influenza A Virus Clinical Trials

Phase I Open-Label Study of Recombinant DNA Plasmid Vaccine, VRC-AVIDNA036-00-VP, Encoding for Influenza Virus H5 Hemagglutinin Protein Given Intradermally

Start date: June 18, 2007
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and effectiveness of a vaccine to prevent avian influenza (bird flu). About 25 to 50 million cases of influenza occur a year in the U.S., leading to 150,000 hospitalizations and 30,000 to 40,000 deaths. Globally, a pandemic influenza may be 1 billion flu cases, with 3 to 5 million cases of severe illness and up to half a million deaths annually. There is potential threat of a pandemic from emerging virus strains for which the population has little or no preexisting immunity. Avian influenza A (H5N1) viruses causing serious disease have emerged recently, affecting domestic and wild bird populations. Patients ages 18 to 60 who are in good health and not pregnant or breast feeding may be eligible for this study. The study will be done at the NIH Clinical Center by staff of the Vaccine Research Center. It will last about 32 weeks for each person. A traditional needle or a needle-free device called Biojector 2000 will be used. Intramuscular (in the muscle) and subcutaneous (in fat below the skin) delivery of vaccine via Biojector is cleared for use by the Food and Drug Administration and is not considered investigational. Intradermal (in the skin) delivery of vaccine by Biojector in this study is deemed investigational but has been evaluated in humans before, and found safe and well tolerated in other trials. There will be about 10 clinic visits in this study, and it is important to stay on schedule. Visits are about 2 hours, though on injection days, visits are about 4 hours. Injections are given on day 0 and at weeks 4 and 8. The vaccine is given by injections in the skin on the upper arms. Clinic staff will observe patients for 30 minutes after each vaccination. One to 2 days after the first injection, there will be a clinic visit. One to 3 days after the second and third injections, patients need to telephone clinic staff to report on how they are doing. Patients will complete a diary card at home, recording temperature and symptoms, and looking at the injection site daily for 5 days. Patients should report any side effects to one of the study physicians or nurses as soon as possible. They will return to the clinic 2 weeks after each injection. A needle-free system uses the pressure of carbon dioxide, instead of a needle, to inject the vaccine into the skin. Discomfort can result from either the needle-free device or the needle. There may be stinging, pain, soreness, swelling, bruising, or a small cut in the skin.

NCT ID: NCT00488046 Completed - Influenza Clinical Trials

Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults

Start date: June 2007
Phase: Phase 1
Study type: Interventional

Over the past decade, avian influenza (AI) has become a major health concern. The development of a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults.