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Safety and immunogenicity of a prototype recombinant alpha-like protein subunit vaccine (GBS-NN) against Group B Streptococcus in a randomised placebo-controlled double-blind phase 1 trial in healthy adult women by Per Fischer; Andrzej Pawlowski; Duojia Cao; David Bell; Geoff Kitson; Michael Darsley; Bengt Johansson-Lindbom is a Medicine article available to read on EtoBox.

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## Background: Group b streptococcus (gbs) is the leading cause of life-threatening infections in new-borns and may cause invasive disease, stillbirth and preterm delivery during pregnancy. while no licensed vaccine exists, maternal immunization might protect against neonatal disease and adverse pregnancy outcomes. we assessed the safety and immunogenicity of a prototype vaccine consisting of the fused n-terminal domains of the alphac and rib surface proteins of gbs (gbs-nn). ## Methods: Gbs-nn was tested in a randomised, double-blind, placebo-controlled, parallel group, phase i study, in healthy non-pregnant women. a dose-escalation phase, with two doses, four weeks apart, of 10, 50 or 250 μg, administered with or without aluminium hydroxide, was initially assessed (n = 60). this was followed by a dose-confirmation study, where one dose of 100 μg adjuvanted gbs-nn was compared with two doses of either 50 or 100 μg adjuvanted gbs-nn, again administered with four weeks interval between the doses (n = 180). safety and immunogenicity were monitored for one year. ## Results: Gbs-nn was well tolerated with some, mostly mild, injection site reactions observed. adjuvant significantly incr

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Author

Per Fischer; Andrzej Pawlowski; Duojia Cao; David Bell; Geoff Kitson; Michael Darsley; Bengt Johansson-Lindbom

Publisher

Elsevier BV

Published

2021

Language

EN

Field

Medicine (Health Sciences)