Lancet
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Randomized Controlled Trial Clinical Trial
Safety of and immunological response to a recombinant vaccinia virus vaccine expressing HIV envelope glycoprotein.
In a randomised phase I trial of a recombinant vaccina virus vaccine expressing the gp160 envelope gene of the human immunodeficiency virus (HIVAC-1e) 35 healthy, HIV-seronegative males, 31 of whom had a history of smallpox immunisation and 4 of whom were vaccinia naive, were vaccinated and then boosted 8 weeks later with HIVAC-1e or standard NY strain vaccinia virus. The frequency, duration, and titre of virus isolation from the vaccination site and occurrence of local side-effects were similar between the two groups of vaccinees. Vaccinia-naive (vac-n) subjects shed virus from the vaccination site for longer and at a higher titre than did vaccinia-primed (vac-p) individuals (19 vs 7 days and 10(7) vs 10(5) pfu/ml, respectively). ⋯ The 2 vaccinia-naive subjects vaccinated with HIVAC-1e showed strong T-cell responses to homologous and heterologous strains of whole virus and to recombinant gp160 protein that remained detectable for over a year; antibodies to HIV envelope also developed in both. Recombinant vaccinia virus vaccines induce T-cell priming to the foreign gene products in most individuals. If used as the sole immunising agent they will be most efficacious in vaccinia-naive individuals.
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Pulmonary alveolar proteinosis (PAP), a disease characterised by accumulation of surfactant in alveoli, is diagnosed on the basis of invasive biopsy procedures. We have measured apoprotein A (SP-A) concentrations in sputum to see if this is useful for the diagnosis of PAP. Sputum samples from three patients with PAP and twenty patients with other pulmonary disease were assayed using monoclonal antibodies to SP-A. SP-A concentrations were 400 times higher in patients with PAP than in the controls, suggestions that this measurement is useful for the diagnosis of PAP especially where lung biopsy is contraindicated.
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To investigate whether the Glasgow Coma Scale (GCS) can be used reliably and accurately by inexperienced observers, ratings made by observers grouped by level of experience were examined for within-group interobserver disagreements and for discrepancies with scores given by an expert. The GCS was used accurately by experienced and highly trained users, but inexperienced users made consistent errors. ⋯ The findings support the continued use of the GCS by appropriately qualified personnel, but call into question much of the conventional wisdom about its reliability when used by untrained or inexperienced staff. The findings also suggest that interobserver comparisons are insufficient for establishing the viability of the GCS.