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Virus Diseases clinical trials

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NCT ID: NCT01991561 Completed - Clinical trials for Respiratory Tract Infections

Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.

Start date: June 2013
Phase: Phase 2
Study type: Interventional

A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in healthy adults 18-60 years of age.

NCT ID: NCT01984983 Completed - Clinical trials for Venezuelan Equine Encephalitis Virus Infection

Study of a DNA-based Venezuelan Equine Encephalitis Virus DNA Vaccine Administered by Electroporation in Healthy Volunteers

Start date: December 2013
Phase: Phase 1
Study type: Interventional

The Phase I study will assess the basic safety, tolerability, and immunogenicity of a DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will comprise evaluation of intradermal or intramuscular administration by electroporation. Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0 mg/ml) for each route of administration. Electroporation will be administered using the TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional group of subjects will serve as a placebo control, receiving injections of saline with electroporation. The overall goal of this study will be to determine if further human clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection of dose and route of administration for future studies.

NCT ID: NCT01964755 Terminated - Clinical trials for Post-Transplant Lymphoproliferative Disease

Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

Start date: April 21, 2009
Phase: Phase 2
Study type: Interventional

By combining a variety of agents that potentiate Zidovudine (ZDV), the investigators hope to induce remission in this generally fatal disease. Most therapies for aggressive B cell lymphomas are based upon intensive chemotherapeutic regimens, expensive modalities (bone marrow transplant, Rituximab), or experimental approaches (gene therapy, cytotoxic T cell infusion) that are difficult to implement in heavily pre-treated patients. Therapy for relapsed aggressive B cell lymphomas is very poor. Even curable lymphomas such as Burkitt Lymphoma (BL) and Hodgkin lymphoma are extremely difficult to treat in relapse and/or after stem cell transplant failure. The investigators propose a novel therapeutic approach that exploits the presence of Epstein-Barr virus (EBV) in lymphomas; antiviral mediated suppression of NF-kB and disruption of viral latency.

NCT ID: NCT01960686 Completed - Clinical trials for Respiratory Syncytial Virus Infections

RSV F Dose-Ranging Study in Women

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.

NCT ID: NCT01957878 Completed - Clinical trials for HUMAN PAPILLOMA VIRUS

Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL

RHEIA-VAC
Start date: December 2013
Phase: Phase 2
Study type: Interventional

Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential. This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream). ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant. The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.

NCT ID: NCT01939197 Completed - Chronic Hepatitis C Clinical Trials

A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection

TURQUOISE-I
Start date: August 30, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment.

NCT ID: NCT01924117 Completed - Clinical trials for Intraepithelial Neoplasia

Genotypification and Predisposing Factors in Human Papilloma Virus Infection

HPV
Start date: February 2011
Phase: N/A
Study type: Interventional

Objective: Determine the genotypes and risk factors associated with human papilloma virus infection in Mexican women. Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital "Mónica Pretelini" and the Medical Research Center (CICMED), who were asked to complete a risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).

NCT ID: NCT01922648 Completed - Clinical trials for Respiratory Syncytial Virus Infections

RSV Observational Study 2

Start date: June 2013
Phase:
Study type: Observational

Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single most important cause of severe respiratory illness in infants and young children, and severe RSV infection early in life is associated with an increased risk of later developing asthma. RSV also causes severe disease in elderly and immune-compromised adults, and the amount of RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in the secretions of the upper respiratory tract of infected individuals and by contact with contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and neonatal wards, are not uncommon. Infection by RSV does not develop a natural long-lasting protection against re-infection (like, for example, measles does). In the USA nearly all children by 24 months of age have been infected at least once with RSV, and about half will have experienced two infections. There is no effective anti-viral drug to treat an infection and the only way of managing cases of severe infection is through supporting organs, such as the lungs, to withstand and recover from the illness. There remains a real need to develop an effective vaccine to prevent severe infections caused by RSV. A better understanding of the way the immune system responds to RSV in children would aid the development of such a vaccine. The purpose of this study is to increase our understanding of how the immune system responds to RSV. Only limited data is available on some important components of the immune response and this study is designed to measure these in more detail. This is done using a single blood sample. A total of 35 children are anticipated to be recruited to this study, at ages when we expect to see differences in the immune response to RSV; - 5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV - 20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one single RSV season in the winter of 2011/12 - 10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons

NCT ID: NCT01917461 Completed - Gastroenteritis Clinical Trials

Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections

CURIOSITY
Start date: September 2010
Phase: N/A
Study type: Observational

This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh cohort of patients. A collection of clinical, radiological and laboratory data will be gathered in order to establish a final diagnosis. Blood samples will be analyzed and the levels of approximately 700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements respectively. A final diagnosis will be determined based on a majority decision of a panel of three or more independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers and combined sets of biomarkers for differentiating between distinct groups of patients will be evaluated.

NCT ID: NCT01915394 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)

TurkNICU-RSV
Start date: September 2013
Phase: N/A
Study type: Observational

The principle purpose of this multicenter trial is to determine the definition, timing and the percentage of nosocomial RSV epidemics throughout Turkey. In addition, secondary purpose of the trial is to determine the prevention strategies of further spread of Respiratory Syncytial Virus (RSV) in the neonatal intensive care unit (NICU).