"Back Health 24/7/365"-A Novel, Comprehensive "One Size Fits All" Workplace Health Promotion Intervention for Occupational Back Health among Hospital Employees.

BACKGROUND: Projects for workplace health promotion (WHP) for back pain traditionally focus exclusively on work-related but not on leisure-time stress on the spine. We developed a comprehensive WHP project on the back health of hospital workers regardless of the physical characteristics of their work and compared its effects on sedentary and physically active hospital workers. METHODS: Study assessments were carried out before and six months after participation in the WHP intervention. The primary outcome parameter was back pain (Oswestry Disability Index, ODI). Anxiety (Generalized Anxiety Disorder-7), work ability (Work Ability Index), depression (Patient Health Questionnaire-9), stress (Perceived Stress Scale-10), and quality of life (Short Form-36) were assessed via questionnaires as secondary outcome parameters. Physical performance was measured via the 30 seconds Sit-to-Stand test (30secSTS). RESULTS: Sixty-eight healthcare workers with non-specific back pain were included in the evaluation study of the WHP project "Back Health 24/7/365". After six months, back pain, physical performance, and self-perceived physical functioning (SF-36 Physical Functioning subscale) improved significantly in both groups. Not a single parameter showed an interaction effect with the group allocation. CONCLUSIONS: A comprehensive WHP-intervention showed significant positive effects on hospital workers regardless of the physical characteristics of their work.

A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results.

Background: Toxic shock syndrome toxin-1 (TSST-1) is a superantigen produced by Staphylococcus aureus that causes the life-threatening toxic shock syndrome. The development of a safe and immunogenic vaccine against TSST-1 remains an unmet medical need. We investigated the safety, tolerability and immunogenicity of a recombinant TSST-1 variant vaccine (rTSST-1v) after 1-3 injections in healthy volunteers. Methods: In this randomised, double-blind, adjuvant-controlled, parallel-group, phase 2 trial, healthy adults aged 18-64 were randomly allocated to undergo 1-3 injections of either 10 or 100 µg rTSST-1v or Al(OH)3. The primary endpoint was safety and tolerability of rTSST-1v in the intention-to-treat population. The per-protocol population was used for the immunogenicity analysis. The trial is registered with EudraCT#: 2015-003714-24; ClinicalTrials.gov#: NCT02814708. Findings: Between April and November 2017,140 subjects were enrolled and 126 completed the trial. rTSST-1v showed a good safety and tolerability profile. A total of 855 systemic adverse events occurred, 280 of which were suspected related adverse events, without dose dependency. Two participants were discontinued early because of allergic reactions. Seroconversion occurred in >81% of subjects within 3 months of the first immunisation which was sustained until 18 months after the third immunisation in over 70% of subjects in the pooled low-dose group and in over 85% in the pooled high-dose group. Interpretation: rTSST-1v in cumulative doses of up to 300 µg was safe, well-tolerated and highly immunogenic. Two immunisations with 100 µg rTSST-1v provided the most persistent immune response and may be evaluated in future trials. Funding: Biomedizinische Forschung & Bio-Produkte AG funded this study.