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[EN] Trial Design: An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. Inclusion Criteria: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)- classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking. Results: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate 0.5 ml doses of Fendrix , administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first dose of Fendrix. 57.14% (12 out 21) had a positive response to second dose of Fendrix . 22.22% (2 out 9) had a positive response to third dose of Fendrix and 42.96% (3 out 7) had a positive response to last dose of Fendrix. Overall, 94.02% (64 out 67) of participants had a positive response to Fendrix . No serious adverse event occurred. Conclusions: The use of Fendrix , is a viable vaccine alternative for NHS workers classified as ‘‘nonresponders”. Revaccination of healthy non-responders with Fendrix, resulted in very high proportions of responders without adverse events. Trial registration: The trial was registered in the Spanish National Trial Register (REEC), ClinicalTrials.gov and inclusion has been stopped (identifier NCT03410953; EudraCT-number 2016-004991-23). Funding: GRS 1360/A/16: Call for aid for the financing of research projects in biomedicine, health management and socio-health care to be developed in the centres of the Regional Health Management of Autonomous Community of Castile-Leon. In addition, this work has been supported by the Spanish Platform for Clinical Research and Clinical Trials, SCReN (Spanish Clinical Research Network), funded by the Subdirectorate General for Research Evaluation and Promotion of the Carlos III Health Institute (ISCIII), through the project PT13/0002/0039 and project PT17/0017/0023 integrated in the State Plan for R&D&I 2013–2016 and co-financed by and the European Regional Development Fund (ERDF).

Twin and family studies have demonstrated that a large part of a population's variance in bone mineral density (BMD) is attributable to genetic factors. A polymorphism in the collagen type I alpha1 (COLIA1) gene has recently been associated with low bone mass and fracture incidence. We analyzed the relationship between COLIA1 gene polymorphism, lumbar spine and hip BMD, and fracture prevalence in a population of 319 postmenopausal women classified by WHO standards, including 98 nonosteoporotic women (NOPW) and 221 osteoporotic postmenopausal women (OPW), divided into 139 osteoporotic women without fracture (OPWnF) and 82 osteoporotic women with fracture (OPWwF). The COLIA1 genotype was assessed by polymerase chain reaction and BalI endonuclease digestion. Genotype frequencies for the total group were 49.2% GG homozygotes, 39.5% GT heterozygotes, and 11.3% TT homozygotes. We found significant differences in the percentage of homozygous TT between NOPW and OPW (6.1% and 13.6%, respectively). Significantly, the occurrence of genotype TT in OPWnF was 6.2%, and 28% in OPWwF. We observed no associations between the COLIA1 genotype and lumbar spine and hip BMD. The prevalence of fractures varied significantly by genotype: GG, 26.1%; GT, 15.9%; and TT, 58.3%. Logistic regression analysis of fracture prevalence showed that, for prevalent fractures, the women with the TT genotype had a 5.9-fold increased risk when compared with the other genotypes (GG + GT). When prevalence was adjusted for age, body mass index, and BMD, the fracture risk was 4.8 for the TT group vs. the genotype GG, whereas it was 0.6 for the GT genotype. In conclusion, we found the COLIA1 Sp1 TT genotype to be associated with an increased fracture risk in postmenopausal women. Interestingly, this genotype-dependent risk could not be explained completely by BMD differences.

In this study, we have analyzed the direct effect of ultrahigh molecular weight polyethylene (polyethylene) on the osteoblastic cell growth in primary cultures. The cells were cultured from human bone samples obtained during reconstructive joint surgery. When cell cultures reached confluence (4-6 weeks) they were separated into three subcultures. One subculture was without particle addition (plain culture). In the other two subcultures, polyethylene or alumina was added. Two different sizes of particles were used,80 and160 microm. The subcultures were incubated until confluence. Proliferation of each subculture was measured by cell counts after 3, 6, 9 and 13 days, and the area under the curve (AUC) was calculated. Polyethylene particles of160 microm induced a decrease in growth, whereas alumina of the same size did not. Polyethylene and alumina particles of80 microm induced an inhibition in the osteoblastic cell growth;80 microm polyethylene induced a higher inhibition than alumina of the same particle size. In conclusion, we have observed a direct effect of polyethylene on osteoblastic cell growth. This study shows that polyethylene may decrease the growth rate of human osteoblastic cells in primary cultures. Smaller particles produce a more marked reduction.