Our results show that internationally recommended MDR-TB treatment regimens were infrequently used and that ART use and viral suppression was well below the target of 90%, reflecting the challenging patient population and the environment in which health care is provided. Urgent improvement of management of patients with TB/HIV in EE, in particular for those with MDR-TB, is needed and includes widespread access to rapid TB diagnostics, better access to and use of second-line TB drugs, timely ART initiation with viral load monitoring, and integration of TB/HIV care.
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.
We evaluate the performance of a point-of-care immunochromatographic test DPP® Syphilis Screen & Confirm Bio-Manguinhos Assay in the whole blood, sera, and plasma of patients with acquired syphilis in. The population was composed by adults stratified in three groups: HIV (N= 174), pregnant women (N= 170) and neither pregnant nor HIV infected (N=149). The results from the dual test were compared to the combination of TPHA+/VDRL≥1:8. The results of sensitivity in people infected with HIV were 100% in whole blood, sera, and plasma, and the specificity ranged from 91.9- 93.1%. The results of sensitivity in pregnant women were 100% in whole blood, sera, and plasma, and the specificity ranged from98.2-99.4%. The results of sensitivity in people neither pregnant nor HIV infected were 80% in whole blood and 100% in sera and plasma. The specificity in whole blood, sera, and plasma, ranged from 96.5- 97.2%. The DPP® Syphilis Screen & Confirm Bio-Manguinhos Assay showed good performance in detecting treponemal and nontreponemal antibodies in whole blood, serum and plasma, although the study has showed syphilis prevalences lower than previously estimated, affecting the positive predictive value calculation. These results indicate that the dual test could be used as an alternative in the diagnosis of syphilis.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.