Active clinical trials for "Communicable Diseases"

This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The study will also help to define the optimal dose in this population, establish potential competitive advantages, and support the design of future studies.

This multicentre, parallel group, block randomised clinical trial aims to investigate the post booster antibody response in UK infants given a reduced priming schedule of meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. It will provide information about how best to include the meningococcal B vaccine (likely to be introduced late 2015) into the routine immunisation schedule. The UK Department of Health provides a routine vaccination schedule for children in the UK and are advised by the Joint Committee on Vaccination and Immunisation (JCVI). The Department of Health have announced that the meningococcal B vaccine (Bexsero) be introduced to the routine schedule as a 2+1 schedule. Cost effectiveness could also be improved by removing the current MenC conjugate vaccine dose given at 3 months of age. There is no published immunogenicity data for Bexsero when given at 2, 4 and 12 months of age (2+1 schedule) and with concomitant Infanrix/IPV/Hib which has now replaced Pediacel in the infant programme. This change to the schedule would result in three injections at 2, 4 and 12 months, and given previous reluctance among parents for three injections at one visit, an option to reduce PCV13 to a 1+1 schedule (priming dose at 3 months and booster at 12 months) will be assessed in this study.

The aim of this prospective, randomized study is to assess a subject's immunological status against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT technique confirming previous results and establishing their statistical validity in order to determine whether this test could be used routinely in clinical practice to assess the risk of developing hCMV infection after renal transplantation and, ultimately, identify the most effective individual antiviral therapeutic strategy against hCMV.

Urinary tract infections (UTIs) are the most common bacterial infections in women, with about 50% of women experiencing at least one UTI in their lifetime. The main pharmacological treatments of cystitis usually involve the use of antibiotics, in particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase inhibitors.

Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.

Primary Efficacy Objective -To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a sustained viral response (SVR), i.e. HCV RNA below the lower limit of quantification [LLOQ] for 12 weeks (SVR12) after completion of the study treatment course Secondary Objectives To assess the efficacy of elbasvir/grazoprevir in suppressing HCV viremia in treatment-naïve GT4 CHC patients at each scheduled visit and clinically meaningful endpoints (Week 2, 8 and 12 [End of Treatment - EOT]) and 24 (SVR12) To assess the safety and tolerability of a 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC. To assess liver fibrosis by non-invasive evaluation of liver stiffness (Fibroscan®) in the same patients before treatment and EOT and SVR12 Clinical hypotheses. Primary Efficacy Hypothesis - A 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC infection will result in an HCV RNA below the LLOQ in 95% of patients within 2 weeks of treatment, and at least 95% will have an SVR12. Secondary hypotheses A 12-week treatment course with elbasvir/grazoprevir in ESRD GT4 treatment-naïve patients will result in undetectable viremia in 95% patients at Week 2, 4, 8 and 12 (EOT) and 24 (SVR12) Treatment will be safe and well-tolerated in these patients, as determined by the type and number of adverse events identified through laboratory testing, vital signs and physical examinations. In these patients with liver fibrosis before treatment, the liver fibrosis as assessed by non-invasive evaluation of liver stiffness (Fibroscan®) will improve by EOT and SVR12

The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT). The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.

There is a theoretical possibility of a complete suppression of HIV viral replication, subject to the use of highly active associations of more than 25 antiretroviral drugs currently available and good treatment adherence. But a key question remains: whether it can persist viral replication low noise HAART, since several arguments suggest a subclinical escape of the virus to HAART at least in some individuals. The technique proposed in this research consists of the detection and quantification of the linear viral cDNA intra cytoplasmic, as persistent novo infection marker in order to highlight the subclinical replication active in treatment of HIV-1 and consider an optimized therapeutic management of patients. Main objective : Comparing the frequency of patients infected with HIV and treated effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker novo persistent, among patients with a therapeutic regimen contains or not the viral integrase inhibitor raltegravir. Secondary objectives To evaluate the frequency of patients infected with HIV and treated effectively with the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood Evaluate the causes of persistent infection in de novo virological responders to treatment with ART: presence of the HIV genome encoding strains resistant to treatment ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir , pretreatment level of plasma HIV RNA, total duration of ART Assess the impact of persistent novo infection virological responders: cell activation CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T naïve / memory cells cells, the presence of transient increase viremia, residual viremia levels Identify virological responders may benefit from treatment intensification

Infections at the site of surgical incisions (SSIs) are the most common infection among surgical patients. Although all patients undergoing surgical procedures are at risk for developing SSIs, colorectal surgery has had consistently had high rates of SSIs, ranging from 3-45%. These infections can increase the length of hospital stay, and increase the rate of readmissions and costs. Further research is needed to study the effects of mupirocin in general surgery. A recent study compared colorectal SSI rates between mupirocin and standard gauze surgical dressings. The results of this show that mupirocin has the greatest effect on reducing SSI rate when compared to standard gauze dressings. However, these studies have not been performed in the United States and have only been studied on a very specific patient population. The purpose of this study is to assess the rate of infections at the surgical incision after colorectal surgery when a mupirocin dressing is placed versus a standard gauze dressing without mupirocin.

This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.