Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial
(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
- Gonzalez-Miro, Majela LU ; Pawlowski, Andrzej LU ; Lehtonen, Janne LU ; Cao, Duojia LU ; Larsson, Sara LU ; Darsley, Michael ; Kitson, Geoff ; Fischer, Per B. and Johansson-Lindbom, Bengt LU
- organization
- publishing date
- 2023
- 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
- 2024-10-06 15:24:17
@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}}, }