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Virus Diseases clinical trials

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NCT ID: NCT01909843 Completed - Clinical trials for Respiratory Syncytial Virus Infection

ALX-0171 Safety Study in Adults With Hyperresponsive Airways

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

This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with hyperresponsive airways. This phase I study is an exploratory study and serves to evaluate the occurrence and reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label trial with a sequential administration regimen of placebo and verum in all planned study subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (= formulation buffer) followed by escalating doses of ALX-0171 verum. Eventually a second administration of ALX-0171 placebo may take place at the end of the study (as defined per protocol).

NCT ID: NCT01906164 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers

Start date: May 31, 2013
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.

NCT ID: NCT01892358 Completed - HIV Clinical Trials

Preventing Bacterial and Viral Infections Among Injection Drug Users

Start date: September 2013
Phase: N/A
Study type: Interventional

We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.

NCT ID: NCT01883180 Completed - Clinical trials for Hematopoietic Stem Cell Transplantation

ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

Start date: June 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the incidences of GVHD and viral infections in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. Our first objective was to investigate the optimal dose of ATG for aGVHD and second object was to evaluate the effect of different dose of ATG on post-transplant viral infection.

NCT ID: NCT01869634 Completed - Clinical trials for Human Immunodeficiency Virus Infection

Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART

Start date: June 2013
Phase: Phase 4
Study type: Interventional

Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.

NCT ID: NCT01862874 Completed - Condyloma Acuminata Clinical Trials

Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

Start date: June 27, 2013
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.

NCT ID: NCT01854697 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before

MALACHITE 1
Start date: March 2013
Phase: Phase 3
Study type: Interventional

This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.

NCT ID: NCT01852266 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

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

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.

NCT ID: NCT01842997 Completed - Influenza Clinical Trials

Safety of H1N1 Influenza Vaccination in Pregnant Women

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

Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in population in China. However, there was little epidemiological evidence of safety when vaccinated in healthy pregnant women. The main objective of this study is to assess the safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women. And participants were included up to 226 healthy pregnant women aged 18 -35 years old who have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups: vaccinated group(122) and unvaccinated group(104). Subjects in the vaccinated group were administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated; and protective effect was observed for six months.

NCT ID: NCT01839188 Completed - Clinical trials for Bacterial Infections

Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)

Start date: May 1, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age Primary objectives - To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule - To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule Secondary objectives - To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule - To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine - To describe the safety profile after each dose of study vaccines administered