2 research outputs found
Yearly licensing studies from 1997 to 2007 of the inactivated whole virus seasonal influenza vaccine fluval--a useful approach to pandemic vaccine development even in less well developed countries?
OBJECTIVE: Seasonal vaccination has been consistently shown to significantly reduce morbidity and mortality because of influenza epidemics, even in healthy, working adults. Here we report the results of the yearly licensing studies of the past 11 influenza seasons (1997-2007) with a trivalent, inactivated whole virus vaccine with an aluminum phosphate adjuvant system. METHODS: Sixty healthy volunteers per age group (18-60 years and 60 years and older) were enrolled to receive vaccination each year, thus, a total of 1080 subjects were studied. Serum antibody titers were measured by hemagglutination inhibition (HI). RESULTS: The vaccine met the criteria for licensing each year, meaning seroprotection (achievement of an HI titer of >1:40 in >70% of subjects); seroconversion, i.e. a >4-fold increase in HI antibody titer, or reaching a titer of >1:40, in >40% of subjects; and an increase in geometric mean titers by >2.5-fold. Side effects were rare and mild. The same method was used to produce a pre-pandemic vaccine against influenza A (H5N1), which has been shown to be safe and immunogenic in humans. CONCLUSIONS: We conclude that the method presented is safe, effective and may serve as a useful approach to seasonal and pandemic vaccine production even in less well-developed countries by means of technological transfer
Echocardiographic findings in patients with Williams-Beuren syndrome.
BACKGROUND: Williams-Beuren syndrome is a multisystem developmental disorder
caused by a microdeletion at chromosome 7q11.23. In its classic form it includes
dysmorphic facial features, joint contractures, retardation of growth and mental
development, gregarious personality, visuospatial cognitive deficits,
hypercalcemia, primary or secondary hypertension and cardiovascular disorders.
AIM: Clinical diagnosis of Williams-Beuren syndrome can be a challenge in young
patients if none of the characteristic cardiovascular features, i.e.
supravalvular aortic stenosis or pulmonary artery stenosis, are present. Our aim
was to demonstrate the changes in cardiovascular lesions during the postnatal
development of Williams-Beuren patients and to follow all cardiovascular findings
beyond the most common ones. METHODS: The cardiovascular status of 29 patients
with Williams-Beuren syndrome (mean age 12.8 years) was recorded in correlation
with age. RESULTS: Cardiovascular diagnoses changed in the majority (72.4%) of
patients. Interestingly, 44.8% of the patients had periods with no reported
cardiovascular disease. Furthermore, 65.5% of the patients experienced periods
when none of the typical cardiovascular lesions, i.e. diffuse or localized
supravalvular aortic stenosis and/or pulmonary artery stenosis, were detected.
Spontaneous regression and progression of both supravalvular aortic stenosis and
pulmonary artery stenosis were observed. An unexpectedly high frequency (41%) of
mitral valve disorders was found. CONCLUSIONS: Our study showed that temporary
absence of and changes in cardiovascular findings are frequent in Williams-Beuren
syndrome. These results could contribute to the refinement of diagnostic criteria
and recommendations for cardiovascular follow-up of patients with this syndrome