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Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial

Gonzalez-Miro, Majela LU ; Pawlowski, Andrzej LU ; Lehtonen, Janne LU ; Cao, Duojia LU ; Larsson, Sara LU orcid ; Darsley, Michael ; Kitson, Geoff ; Fischer, Per B. and Johansson-Lindbom, Bengt LU (2023) In iScience 26(3).
Abstract

Group B streptococcus (GBS) is a leading cause of life-threatening neonatal infections and subsets of adverse pregnancy outcomes. Essentially all GBS strains possess one allele of the alpha-like protein (Alp) family. A maternal GBS vaccine, consisting of the fused N-terminal domains of the Alps αC and Rib (GBS-NN), was recently demonstrated to be safe and immunogenic in healthy adult women. To enhance antibody responses to all clinically relevant Alps, a second-generation vaccine has been developed (AlpN), also containing the N-terminal domain of Alp1 and the one shared by Alp2 and Alp3. In this study, the safety and immunogenicity of AlpN is assessed in a randomized, double-blind, placebo-controlled, and parallel-group phase I study,... (More)

Group B streptococcus (GBS) is a leading cause of life-threatening neonatal infections and subsets of adverse pregnancy outcomes. Essentially all GBS strains possess one allele of the alpha-like protein (Alp) family. A maternal GBS vaccine, consisting of the fused N-terminal domains of the Alps αC and Rib (GBS-NN), was recently demonstrated to be safe and immunogenic in healthy adult women. To enhance antibody responses to all clinically relevant Alps, a second-generation vaccine has been developed (AlpN), also containing the N-terminal domain of Alp1 and the one shared by Alp2 and Alp3. In this study, the safety and immunogenicity of AlpN is assessed in a randomized, double-blind, placebo-controlled, and parallel-group phase I study, involving 60 healthy non-pregnant women. AlpN is well tolerated and elicits similarly robust and persistent antibody responses against all four Alp-N-terminal domains, resulting in enhanced opsonophagocytic killing of all Alp serotypes covered by the vaccine.

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author
; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Bacteriology, Immunology, Microbiology
in
iScience
volume
26
issue
3
article number
106261
publisher
Elsevier
external identifiers
  • scopus:85150866956
  • pmid:36915681
ISSN
2589-0042
DOI
10.1016/j.isci.2023.106261
language
English
LU publication?
yes
id
3ca5de13-49ee-4295-92bf-452b2bc5107c
date added to LUP
2023-05-23 10:57:50
date last changed
2025-10-20 09:33:36
@article{3ca5de13-49ee-4295-92bf-452b2bc5107c,
  abstract     = {{<p>Group B streptococcus (GBS) is a leading cause of life-threatening neonatal infections and subsets of adverse pregnancy outcomes. Essentially all GBS strains possess one allele of the alpha-like protein (Alp) family. A maternal GBS vaccine, consisting of the fused N-terminal domains of the Alps αC and Rib (GBS-NN), was recently demonstrated to be safe and immunogenic in healthy adult women. To enhance antibody responses to all clinically relevant Alps, a second-generation vaccine has been developed (AlpN), also containing the N-terminal domain of Alp1 and the one shared by Alp2 and Alp3. In this study, the safety and immunogenicity of AlpN is assessed in a randomized, double-blind, placebo-controlled, and parallel-group phase I study, involving 60 healthy non-pregnant women. AlpN is well tolerated and elicits similarly robust and persistent antibody responses against all four Alp-N-terminal domains, resulting in enhanced opsonophagocytic killing of all Alp serotypes covered by the vaccine.</p>}},
  author       = {{Gonzalez-Miro, Majela and Pawlowski, Andrzej and Lehtonen, Janne and Cao, Duojia and Larsson, Sara and Darsley, Michael and Kitson, Geoff and Fischer, Per B. and Johansson-Lindbom, Bengt}},
  issn         = {{2589-0042}},
  keywords     = {{Bacteriology; Immunology; Microbiology}},
  language     = {{eng}},
  number       = {{3}},
  publisher    = {{Elsevier}},
  series       = {{iScience}},
  title        = {{Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial}},
  url          = {{http://dx.doi.org/10.1016/j.isci.2023.106261}},
  doi          = {{10.1016/j.isci.2023.106261}},
  volume       = {{26}},
  year         = {{2023}},
}