2 research outputs found
Rotaviruses as a cause of nosocomial, infantile diarrhoea in Northern Brazil: Pilot study
Faecal samples were obtained from 190 children, aged 0 to 5 years,
admitted to a public hospital in Belem, Para,Brazil. These patients
were placed in a pediatric ward with 40 beds distributed in six rooms.
Cases were classified into three groups: (a) nosocomial: children who
developed gastroenteritis 72 hr or later after admission; (b)
community-acquired: patients admitted either with diarrhoea or who had
diarrhoea within 72 hr following admission; (c) non-diarrhoeic: those
children who had no diarrhoea three days before and three days after
collection of formed faecal sample. Specimens were routinely processed
for the presence of rotaviruses, bacteria and parasites. Rotaviruses
were detected through enzyme-linked immunosorbent assay (ELISA)and
subsequently serotyped/electrophoretyped. Rotaviruseswere the most
prevalent enteropathogens among nosocomial cases, accounting for 39%
(9/23) of diarrhoeal episodes; on the other hand, rotaviruses occurred
in 8.3% (11/133) and 9% (3/34) of community-acquired and non-diarrhoeic
categories, respectively. Mixed infections involving rotavirus and
Giardia intestinalis and rotavirus plus G. intestinalis and Entamoeba
histolytica were detected in frequencies of 8.6 and 4.3%, respectively,
in the nosocomial group. The absence of bacterial pathogens in this
category, and the unusual low prevalence of these agents in the other
two groups may reflect the early and routine administration of
antibiotics following admission to this hospital. Rotavirus serotype 2
prevailed over the other types, accounting for 77.8% of isolates from
nosocomial diarrhoeal episodes. In addition, at least five different
genomic profiles could be observed, of which one displayed anunusual
five-segment first RNA cluster. Dehydration was recordedin all cases of
hospital-acquired, rotavirus-associated diarrhoea, whereas in only 57%
of nosocomial cases ofother aetiology. It was also noted that
nosocomial, rotavirus-associated diarrhoeal episodes occur earlier (7
days), following admission, if compared with those hospital-acquired
cases of other aetiology (14 days)
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