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Virus Diseases clinical trials

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NCT ID: NCT00981513 Completed - Clinical trials for Acute Respiratory Infection

Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

Start date: September 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.

NCT ID: NCT00980447 Completed - Influenza Clinical Trials

Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

Start date: October 2009
Phase: Phase 2
Study type: Interventional

UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults. Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.

NCT ID: NCT00975572 Completed - Influenza Clinical Trials

Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Population Aged 3 Years and Older

Start date: July 2009
Phase: Phase 2
Study type: Interventional

The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine with and without adjuvant when administered at the 7.5,15 or 30 mcg dose. The primary immunogenicity objective is to assess the antibody response following each dose of split- virion inactivated A(H1N1) vaccine with and without adjuvant. Participants will include up to 2200 healthy persons age 3 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, aged 3 years and older. Subjects will be stratified by elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years), elders and adolescents will be randomized into 5 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), children will be randomized into 4 dose groups (adjuvanted H1N1 vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), adults will be randomized into 6 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose or placebo), 110 subjects per dose and age stratum will be to receive intramuscular influenza H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses), serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after second vaccination), and reactogenicity to the vaccine for 8 days (Day 0-7) following each vaccination. Immunogenicity testing will be hemagglutination inhibiting (HAI) on serum obtained on the day 21 of each vaccination (prior to vaccination), on Day 21 after first vaccination, and 21 days following the second vaccination (Day 42).

NCT ID: NCT00973284 Completed - Clinical trials for Acute Gastroenteritis

Norwalk Vaccine Study

Start date: August 4, 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.

NCT ID: NCT00963248 Completed - Clinical trials for Epstein-Barr Virus Infections

EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients

Start date: July 2003
Phase: N/A
Study type: Observational

Question: In which stage of an EBV-infection is a selective reduction of immunosuppressive medication reasonable to minimize the risk for PTLD, without putting the transplant recipient at risk of acute rejection episodes due to under immunosuppression? Aim of study: Identification of patients at high-risk for PTLD.

NCT ID: NCT00949572 Completed - Clinical trials for Sexually Transmitted Diseases, Viral

Measuring Responses to Sublingual Antigens

Start date: September 2009
Phase: N/A
Study type: Interventional

This study is a preliminary investigation of immune responses, in the blood and in cervical & vaginal secretions, to proteins ("antigens") taken up across the undersurface of the tongue.

NCT ID: NCT00948220 Completed - Clinical trials for Hepatitis C, Chronic

Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C

Start date: July 2003
Phase: Phase 4
Study type: Interventional

One single study has suggested that bone mineral density (BMD) is reduced in patients with non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard interferon and ribavirin may further decrease BMD. The aim of this study is to systematically investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.

NCT ID: NCT00921934 Completed - Herpes Zoster Clinical Trials

Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles

168
Start date: April 2009
Phase: N/A
Study type: Observational

Chronic viral infections induce oxidative stress that can cause a number of concomitant diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient treatment of oxidative stress may be of benefit for the patient to prevent further diseases. Shingles (herpes zoster infection) have been successfully treated with antioxidative substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may be mitigated or even fully avoided.

NCT ID: NCT00921726 Completed - Influenza Clinical Trials

Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults

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

Due in part to widespread availability of oseltamivir and clinical experience using oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become resistant to it. Other reliable methods of treating H5N1 must be identified in case of a pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The primary purpose of this study is to evaluate the interaction between oral oseltamivir and intravenous zanamivir administered as either a continuous or intermittent infusion in healthy adults.

NCT ID: NCT00888446 Completed - HIV Infections Clinical Trials

Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid

TGC14F
Start date: October 2005
Phase: Phase 2
Study type: Interventional

This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study volunteers will receive two intramuscular injections of tgAAC09 or placebo at Months 0 and 6 (groups A, C, E and G) or at Months 0 and 12 (groups B, D and F) and be followed for a total of 18 months following the first injection with the exception of group G in which volunteers will be followed for 12 months after the first injection (6 months after the second injection). This study will explore whether boosting is possible, and compare a shorter and more practical six-month time interval with a twelve-month time interval.