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Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III, randomized, observer-blind, multicenter, parallel-group study.
Togashi, T, Mitsuya, N, Kogawara, O, Sumino, S, Takanami, Y, Sugizaki, K
Vaccine. 2016;(38):4635-4641
Abstract
BACKGROUND Broad use of monovalent Haemophilus influenzae type b (Hib) conjugate vaccines based on the capsular polysaccharide polyribosyl-ribitol phosphate (PRP), has significantly reduced invasive Hib disease burden in children worldwide, particularly in children aged <1year. In Japan, PRP conjugated to tetanus toxoid (PRP-T) vaccine has been widely used since the initiation of public funding programs followed by a routine vaccination designation in 2013. METHODS We compared the immunogenicity and safety of PRP conjugated to a non-toxic diphtheria toxin mutant (PRP-CRM197) vaccine with the PRP-T vaccine when administered subcutaneously to healthy Japanese children in a phase III study. Additionally, we evaluated the immunogenicity and safety profiles of a diphtheria-tetanus acellular pertussis (DTaP) combination vaccine when concomitantly administered with either PRP-CRM197 or PRP-T vaccines. The primary endpoint was the "long-term seroprotection rate", defined as the group proportion with anti-PRP antibody titers ⩾1.0μg/mL, after the primary series. RESULTS Long-term seroprotection rates were 99.3% in the PRP-CRM197 group and 95.6% in the PRP-T group. The intergroup difference (PRP-CRM197 group - PRP-T group) was 3.7% (95% confidence interval: 0.099-7.336), demonstrating that PRP-CRM197 vaccine was non-inferior to PRP-T vaccine (p<0.0001). Furthermore, the "short-term seroprotection rate" (anti-PRP antibody titer ⩾0.15μg/mL) before booster vaccination was higher in the PRP-CRM197 group than in PRP-T. Concomitant administration of PRP-CRM197 vaccine with DTaP vaccine showed no differences in terms of immunogenicity compared with concomitant vaccination with PRP-T vaccine and DTaP vaccine. Although CRM197 vaccine had higher local reactogenicity, overall, both Hib vaccines had acceptable safety and tolerability profiles. CONCLUSION The immunogenicity of PRP-CRM197 vaccine administered subcutaneously as a three-dose primary series in children followed by a booster vaccination 1year after the primary series induced protective levels of Hib antibodies with no safety or tolerability concerns. CLINICAL TRIAL REGISTRY Registered on ClinicalTrials.gov: NCT01379846.
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Prolonged carriage and potential onward transmission of carbapenemase-producing Enterobacteriaceae in Dutch travelers.
van Hattem, JM, Arcilla, MS, Bootsma, MC, van Genderen, PJ, Goorhuis, A, Grobusch, MP, Molhoek, N, Oude Lashof, AM, Schultsz, C, Stobberingh, EE, et al
Future microbiology. 2016;:857-64
Abstract
AIM: The aim was to study acquisition and persistence of carbapenemase-producing Enterobacteriaceae (CPE) among travelers. MATERIALS & METHODS Stools from 2001 travelers and 215 nontraveling household members, collected before and immediately post-travel as well as 1, 3, 6 and 12 months upon return, were screened for CPE. RESULTS Five travelers, all visiting Asia outside the Indian subcontinent, acquired CPE. One traveler persistently carried the same OXA-244 CPE up to 6 months post-travel. Three months after travel, her co-traveling spouse also became positive for this OXA-244 CPE strain, suggesting clonal transmission within this household. CONCLUSION Acquisition of CPE is not restricted to travelers to the Indian subcontinent and/or to travelers seeking healthcare during travel and can persist up to at least 6 months post-travel.
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Prospective analysis of the association of infection with CagA bearing strains of Helicobacter pylori and coronary heart disease.
Singh, RK, McMahon, AD, Patel, H, Packard, CJ, Rathbone, BJ, Samani, NJ
Heart (British Cardiac Society). 2002;(1):43-6
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Abstract
OBJECTIVE To see whether it was possible to replicate in a prospective study the association recently reported between infection with the more virulent (type 1) cytotoxin associated gene A (CagA) antigen carrying strains of Helicobacter pylori and increased risk of coronary heart disease. DESIGN AND SETTING Nested case-control study in a clinical outcomes trial. SUBJECTS Participants in the West of Scotland coronary prevention study. METHODS H pylori CagA serological status was determined in plasma samples of 201 subjects (cases) who subsequently had a coronary event during follow up and in 414 subjects (controls) matched for age and smoking who remained event-free, using a semiquantitative commercial enzyme linked immunosorbent assay (ELISA) kit against the p120 antigen of CagA. RESULTS 105 (52%) in the case group and 176 (43%) in the control group were seropositive (odds ratio (OR) 1.49, 95% confidence interval (CI) 1.06 to 2.10, p = 0.022). The association remained significant after adjustment for blood pressure, body mass index, plasma concentrations of low density lipoprotein and high density lipoprotein cholesterol, history of hypertension and diabetes, statin treatment, and socioeconomic status (OR 1.51, 95% CI 1.06 to 2.16, p = 0.023). Baseline inflammatory markers (white cell count, C reactive protein, fibrinogen) were not significantly increased in either H pylori CagA positive cases or controls. CONCLUSIONS The findings provide support from a prospective study for the hypothesis that there is an association between infection with CagA bearing strains of H pylori and coronary heart disease. The mechanism(s) underlying the association remain to be elucidated.