Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial
Summary: 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...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-03-01
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| Series: | iScience |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589004223003383 |
| _version_ | 1811155469180338176 |
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| author | Majela Gonzalez-Miro Andrzej Pawlowski Janne Lehtonen Duojia Cao Sara Larsson Michael Darsley Geoff Kitson Per B. Fischer Bengt Johansson-Lindbom |
| author_facet | Majela Gonzalez-Miro Andrzej Pawlowski Janne Lehtonen Duojia Cao Sara Larsson Michael Darsley Geoff Kitson Per B. Fischer Bengt Johansson-Lindbom |
| author_sort | Majela Gonzalez-Miro |
| collection | DOAJ |
| description | Summary: 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. |
| first_indexed | 2024-04-10T04:34:39Z |
| format | Article |
| id | doaj.art-1443ab166a6e426da5ab679b8a8cbc05 |
| institution | Directory Open Access Journal |
| issn | 2589-0042 |
| language | English |
| last_indexed | 2024-04-10T04:34:39Z |
| publishDate | 2023-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | iScience |
| spelling | doaj.art-1443ab166a6e426da5ab679b8a8cbc052023-03-10T04:35:49ZengElsevieriScience2589-00422023-03-01263106261Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trialMajela Gonzalez-Miro0Andrzej Pawlowski1Janne Lehtonen2Duojia Cao3Sara Larsson4Michael Darsley5Geoff Kitson6Per B. Fischer7Bengt Johansson-Lindbom8Immunology Section, Lund University, BMC D14, Lund, SwedenImmunology Section, Lund University, BMC D14, Lund, SwedenMinervax A/S, Ole Maaløes Vej 3, 2200 Copenhagen N, DenmarkImmunology Section, Lund University, BMC D14, Lund, SwedenImmunology Section, Lund University, BMC D14, Lund, SwedenMinervax A/S, Ole Maaløes Vej 3, 2200 Copenhagen N, DenmarkMinervax A/S, Ole Maaløes Vej 3, 2200 Copenhagen N, DenmarkMinervax A/S, Ole Maaløes Vej 3, 2200 Copenhagen N, DenmarkImmunology Section, Lund University, BMC D14, Lund, Sweden; Minervax A/S, Ole Maaløes Vej 3, 2200 Copenhagen N, Denmark; Corresponding authorSummary: 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.http://www.sciencedirect.com/science/article/pii/S2589004223003383ImmunologyMicrobiologyBacteriology |
| spellingShingle | Majela Gonzalez-Miro Andrzej Pawlowski Janne Lehtonen Duojia Cao Sara Larsson Michael Darsley Geoff Kitson Per B. Fischer Bengt Johansson-Lindbom Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial iScience Immunology Microbiology Bacteriology |
| title | Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial |
| title_full | Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial |
| title_fullStr | Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial |
| title_full_unstemmed | Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial |
| title_short | Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial |
| title_sort | safety and immunogenicity of the group b streptococcus vaccine alpn in a placebo controlled double blind phase 1 trial |
| topic | Immunology Microbiology Bacteriology |
| url | http://www.sciencedirect.com/science/article/pii/S2589004223003383 |
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