Immunogenicity and safety of the combined vaccine for measles, mumps, and rubella isolated or combined with the varicella component administered at 3-month intervals: randomised study

BACKGROUND Field testing required to license the combined measles, mumps, and rubella (MMR) vaccine must take into account the current recommendation of the vaccine in Brazil: first dose at 12 months and second dose at 15 months of age in combination with a varicella vaccine. OBJECTIVES This study aimed to evaluate the clinical consistency, immunogenicity, and reactogenicity of three batches of MMR vaccine prepared with active pharmaceutical ingredients (API) from Bio-Manguinhos, Fiocruz (MMR-Bio), and compare it to a vaccine (MMR produced by GlaxoSmithKline) with different API. METHODS This was a phase III, randomised, double-blind, non-inferiority study of the MMR-Bio administered in infants immunised at health care units in Pará, Brazil, from February 2015 to January 2016. Antibody levels were titrated by immunoenzymatic assays. Adverse events were recorded in diaries. FINDINGS Seropositivity levels after MMR-Bio were 97.6% for measles, 84.7% for mumps, and 98.0% for rubella. After the MMRV vaccine, seroconversion rates and GMT increased substantially for mumps. In contrast, approximately 35% of the children had no detectable antibodies to varicella. Systemic adverse events were more frequent than local events. CONCLUSION The demonstration of batch consistency and non-inferiority of the Bio-MMR vaccine completed the technology transfer. This is a significant technological achievement with implications for immunisation programs.

Exercícios de trato vocal semiocluído: revisão de literatura / Semioccluded vocal tract exercises: literature review

Este trabalho tem como tema os exercícios de trato vocal semiocluído (ETVSO) e procura sintetizar e organizar, por meio de revisão de literatura, informações sobre noções físicas e de anatomofisiologia subjacentes aos ETVSO e seus diferentes tipos, com descrição, aplicabilidades clínicas, restrições, tempo de realização, efeitos e eficácia. Os ETVSO são realizados com alguma oclusão no trato vocal que modifica a impedância acústica e gera ressonância retroflexa, afastando as pregas vocais na vibração, reduzindo os riscos de trauma e equilibrando as pressões sub e supraglótica, com economia vocal; tipos: vibração de lábios e de língua, sons fricativos, /b/ prolongado, humming, firmeza glótica, constrição labial e fonação em tubos; são utilizados em distúrbios vocais, incluindo a hipernasalidade, no aquecimento e aperfeiçoamento vocal; a fonação com tubo imerso a 15cm em água somente deve ser utilizada em disfonias hipocinéticas; não há definição científica quanto ao tempo de execução; os efeitos positivos gerados são a melhora da propriocepção, dos aspectos vocais perceptivo-auditivos e acústicos e mudanças no trato vocal; os estudos realizados com ressonância magnética e tomografia computadorizada verificaram modificações no trato vocal após a técnica de fonação em tubos, tais como área central mais alargada, firme fechamento do esfíncter velofaríngeo, diminuição da região do esfíncter velofaríngeo, epiglote em posição vertical, língua mais elevada posteriormente, expansão das áreas transversais da orofaringe e da cavidade oral; não foram encontrados estudos sobre eficácia dos ETVSO.

This study has as its theme the exercise with semi-occluded vocal tract (SOVTE) and tries to summarize and to organize, through review of literature, information about physical and anatomophysiology notions underlying SOVTE and its different types, through description, clinical applicability, restrictions, time of performance, effects and effectiveness. The SOVTE is performed with vocal tract occlusion which modifies the acoustic impedance and generates retroflex resonance, which repels the vocal folds during vibration, reduces the risks of trauma and balances sub- and supraglottic pressure, with vocal economy; types: tongue and lips vibration; fricative sounds, prolonged /b/, humming, glottic firmness, lips constriction and tube-phonation; they are used in vocal disorders, including hipernasality, in warming and improving vocal practice; phonation in immerse tube with 15cm water should only be used in cases of hypokinetic dysphonia; there is no scientific definition regarding the runtime; the generated positive effects are the improvement of proprioception, of vocal perceptive-auditory and acoustic aspects, and of vocal tract changes; studies performed with magnetic resonance imaging and computed tomography verified vocal tract modifications after the tube-phonation technique, such as more extensive central area, firm closure of the velopharyngeal sphincter, decreased velopharyngeal sphincter area, vertical epiglottis, posterior tongue elevation, expansion of the cross-sectional oropharynx and oral cavity areas; studies about the effectiveness of SOVTE were not found.