The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule

<p>Abstract</p> <p>Background</p> <p>Combination vaccines improve coverage, compliance and effectively introduce new antigens to mass vaccination programmes. This was a phase III, observer-blind, randomized study of GSK Biologicals diphtheria-tetanus-whole cell pertussis vaccine combined with hepatitis B and <it>Haemophilus influenzae </it>type b vaccines, containing a reduced amount of polyribosyl-ribitol-phosphate (PRP) and a DTPw component manufactured at a different site (DTPw-HBV/Hib_2.5[Kft]). The primary aim of this study was to demonstrate that DTPw-HBV/Hib_2.5[Kft] was not inferior to the licensed DTPw-HBV/Hib (<it>Tritanrix</it>(tm)-HepB/<it>Hiberix</it>(tm)) vaccine or the DTPw-HBV/Hib_2.5vaccine, also containing a reduced amount of PRP, with respect to the immune response to the PRP antigen, when administered to healthy infants, according to the Expanded Programme for Immunization (EPI) schedule at 6, 10 and 14 weeks of age.</p> <p>Methods</p> <p>299 healthy infants were randomised to receive either DTPw-HBV/Hib_2.5[Kft] DTPw-HBV/Hib_2.5or DTPw-HBV/Hib according to the 6-10-14 week EPI schedule. Blood samples were analysed prior to the first dose of study vaccine and one month after the third vaccine dose for the analysis of immune responses. Solicited local and general symptoms such as pain, redness and swelling at the injection site and drowsiness and fever, unsolicited symptoms (defined as any additional adverse event) and serious adverse events (SAEs) were recorded up to 20 weeks of age.</p> <p>Results</p> <p>One month after the third vaccine dose, 100% of subjects receiving DTPw-HBV/Hib_2.5[Kft] or DTPw-HBV/Hib and 98.8% of subjects receiving DTPw-HBV/Hib_2.5vaccine had seroprotective levels of anti-PRP antibodies (defined as anti-PRP antibody concentration ≥0.15 μg/ml). Seroprotective antibody concentrations were attained in over 98.9% of subjects for diphtheria, tetanus and hepatitis B. The vaccine response rate to pertussis antigen was at least 97.8% in each group. Overall, the DTPw-HBV/Hib_2.5[Kft] vaccine was well tolerated in healthy infants; no SAEs were reported in any group.</p> <p>Conclusions</p> <p>The DTPw-HBV/Hib_2.5[Kft] vaccine was immunogenic and well-tolerated when administered according to the EPI schedule to Indian infants.</p> <p>Trial registration</p> <p><url>http://www.clinicaltrials.gov</url> NCT00473668</p

Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Diphtheria-tetanus-whole-cell pertussis (DTPw)-based combination vaccines are an attractive option to rapidly achieve high coverage and protection against other important pathogens, such as hepatitis B virus (HBV) and <it>Haemophilus influenzae </it>type B (Hib). To ensure adequate antigen supply, GlaxoSmithKline Biologicals has introduced a new DTPw antigen source and developed a new DTPw-HBV/Hib combination vaccine containing a reduced amount of Hib polyribosylribitol phosphate (PRP). This study was undertaken to compare the immunogenicity and reactogenicity of this new DTPw-HBV/Hib vaccine with a licensed DTPw-HBV/Hib vaccine (<it>Tritanrix</it>™-HBV/Hib).</p> <p>Methods</p> <p>This was a randomized, partially-blind, multicenter study in three countries in Latin America (Argentina, Chile and Nicaragua). Healthy children received either the new DTPw-HBV/Hib vaccine (1 of 3 lots; n = 439; double-blind) or Tritanrix™-HBV/Hib (n = 146; single-blind) co-administered with oral poliovirus vaccine (OPV) at 2, 4 and 6 months, with a booster dose at 18-24 months.</p> <p>Results</p> <p>One month after the end of the 3-dose primary vaccination course, the new DTPw-HBV/Hib vaccine was non-inferior to Tritanrix™-HBV/Hib in terms of seroprotection/vaccine response rates for all component antigens; ≥97.3% and ≥93.9% of subjects in the two groups, respectively, had seroprotective levels of antibodies against diphtheria, tetanus, hepatitis B and Hib and a vaccine response to the pertussis component. Persistence of antibodies against all vaccine antigens was comparable between groups, with marked increases in all antibody concentrations after booster administration in both groups. Both vaccines were generally well-tolerated as primary and booster doses.</p> <p>Conclusions</p> <p>Results confirm the suitability of this new DTPw-HBV/Hib vaccine comprising antigens from a new source and a reduced PRP content for inclusion into routine childhood vaccination programs.</p> <p>Trial registration</p> <p><url>http://www.clinicaltrials.gov</url> NCT00332566</p

Traumatic bone cyst of the mandible of possible iatrogenic origin: a case report and brief review of the literature

The traumatic bone cyst (TBC) is an uncommon nonepithelial lined cavity of the jaws. The lesion is mainly diagnosed in young patients most frequently during the second decade of life. The majority of TBCs are located in the mandibular body between the canine and the third molar. Clinically, the lesion is asymptomatic in the majority of cases and is often accidentally discovered on routine radiological examination usually as an unilocular radiolucent area with a "scalloping effect". The definite diagnosis of traumatic cyst is invariably achieved at surgery. Since material for histologic examination may be scant or non-existent, it is very often difficult for a definite histologic diagnosis to be achieved. We present a well documented radiographically and histopathologically atypical case of TBC involving the ramus of the mandible, which is also of possible iatrogenic origin. The literature is briefly reviewed

Search for new phenomena in final states with an energetic jet and large missing transverse momentum in pp collisions at √ s = 8 TeV with the ATLAS detector

Results of a search for new phenomena in final states with an energetic jet and large missing transverse momentum are reported. The search uses 20.3 fb−1 of √ s = 8 TeV data collected in 2012 with the ATLAS detector at the LHC. Events are required to have at least one jet with pT > 120 GeV and no leptons. Nine signal regions are considered with increasing missing transverse momentum requirements between Emiss T > 150 GeV and Emiss T > 700 GeV. Good agreement is observed between the number of events in data and Standard Model expectations. The results are translated into exclusion limits on models with either large extra spatial dimensions, pair production of weakly interacting dark matter candidates, or production of very light gravitinos in a gauge-mediated supersymmetric model. In addition, limits on the production of an invisibly decaying Higgs-like boson leading to similar topologies in the final state are presente

Maternal experiences of ethnic discrimination and subsequent birth outcomes in Aotearoa New Zealand

Background Interpersonal discrimination experience has been associated with adverse birth outcomes. Limited research has evaluated this relationship within multicultural contexts outside the United States where the nature and salience of discrimination experiences may differ. Such research is important in order to help identify protective and risk factors that may mediate the relationship between discrimination experience and adverse birth outcomes. Methods Evaluated the relationship between perceived discrimination, as measured in pregnancy, with birth weight and gestation length among Māori, Pacific, and Asian women from Aotearoa New Zealand (N = 1653). Results Thirty percent of the sample reported some type of unfair treatment that they attributed to their ethnicity. For Māori women specifically, unfair treatment at work (β = − 243 g) and in acquiring housing (β = − 146 g) were associated with lower birth weight when compared to Māori women not experiencing these types of discrimination, while an ethnically motivated physical attack (β = − 1.06 week), and unfair treatment in the workplace (β = − 0.95 week), in the criminal justice system (β = − 0.55 week), or in banking (β = − 0.73 week) were associated with significantly shorter gestation. Conclusions Despite a high prevalence of discrimination experience among women from all ethnic groups, discrimination experience was a strong predictor of lower birth weight and shorter gestation length among indigenous Māori women only. Additional research is needed to better understand the risk and protective factors that may moderate the relationship between discrimination experience and adverse birth outcomes among women from different ethnic groups

The Transcriptome of the Nosocomial Pathogen Enterococcus faecalis V583 Reveals Adaptive Responses to Growth in Blood

gains access to the bloodstream and establishes a persistent infection is not well understood.. infections

Single-cell analysis tools for drug discovery and development

The genetic, functional or compositional heterogeneity of healthy and diseased tissues presents major challenges in drug discovery and development. Such heterogeneity hinders the design of accurate disease models and can confound the interpretation of biomarker levels and of patient responses to specific therapies. The complex nature of virtually all tissues has motivated the development of tools for single-cell genomic, transcriptomic and multiplex proteomic analyses. Here, we review these tools and assess their advantages and limitations. Emerging applications of single cell analysis tools in drug discovery and development, particularly in the field of oncology, are discussed

Search for High-Mass Resonances Decaying to τν in pp Collisions at √s=13 TeV with the ATLAS Detector

A search for high-mass resonances decaying to τν using proton-proton collisions at √s=13 TeV produced by the Large Hadron Collider is presented. Only τ-lepton decays with hadrons in the final state are considered. The data were recorded with the ATLAS detector and correspond to an integrated luminosity of 36.1 fb−1. No statistically significant excess above the standard model expectation is observed; model-independent upper limits are set on the visible τν production cross section. Heavy W′ bosons with masses less than 3.7 TeV in the sequential standard model and masses less than 2.2–3.8 TeV depending on the coupling in the nonuniversal G(221) model are excluded at the 95% credibility level

Combined measurement of differential and total cross sections in the H → γγ and the H → ZZ* → 4ℓ decay channels at s=13 TeV with the ATLAS detector

A combined measurement of differential and inclusive total cross sections of Higgs boson production is performed using 36.1 fb−1 of 13 TeV proton–proton collision data produced by the LHC and recorded by the ATLAS detector in 2015 and 2016. Cross sections are obtained from measured H→γγ and H→ZZ*(→4ℓ event yields, which are combined taking into account detector efficiencies, resolution, acceptances and branching fractions. The total Higgs boson production cross section is measured to be 57.0−5.9 +6.0 (stat.) −3.3 +4.0 (syst.) pb, in agreement with the Standard Model prediction. Differential cross-section measurements are presented for the Higgs boson transverse momentum distribution, Higgs boson rapidity, number of jets produced together with the Higgs boson, and the transverse momentum of the leading jet. The results from the two decay channels are found to be compatible, and their combination agrees with the Standard Model predictions

Operation and performance of the ATLAS Tile Calorimeter in Run 1

The Tile Calorimeter is the hadron calorimeter covering the central region of the ATLAS experiment at the Large Hadron Collider. Approximately 10,000 photomultipliers collect light from scintillating tiles acting as the active material sandwiched between slabs of steel absorber. This paper gives an overview of the calorimeter’s performance during the years 2008–2012 using cosmic-ray muon events and proton–proton collision data at centre-of-mass energies of 7 and 8TeV with a total integrated luminosity of nearly 30 fb−1. The signal reconstruction methods, calibration systems as well as the detector operation status are presented. The energy and time calibration methods performed excellently, resulting in good stability of the calorimeter response under varying conditions during the LHC Run 1. Finally, the Tile Calorimeter response to isolated muons and hadrons as well as to jets from proton–proton collisions is presented. The results demonstrate excellent performance in accord with specifications mentioned in the Technical Design Report