Clinical and regulatory development strategies for GBS vaccines intended for maternal immunisation in low- and middle-income countries Article Swipe
Kirsty Le Doaré
,
Virginia Benassi
,
Marco Cavaleri
,
Godwin Enwere
,
Birgitte Giersing
,
David Goldblatt
,
Paul T. Heath
,
Joachim Hombach
,
Richard Isbrucker
,
Kostas Karampatsas
,
Shabir A. Madhi
,
Annelies Wilder Smith
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1016/j.vaccine.2025.127131
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1016/j.vaccine.2025.127131
Group B Streptococcus (GBS) is a leading cause of infant mortality, particularly in low- and middle-income countries (LMICs). Several maternal GBS vaccine candidates, aimed at protecting infants, are progressing through clinical trials. The World Health Organisation (WHO) aims to ensure equitable access to safe, effective, and affordable vaccines of assured quality in LMICs, by facilitating regulatory pathways. An alternate approval pathway, based on safety and an immunological endpoint thought to predict clinical benefit (commonly referred to as serological threshold of risk reduction [SToRR]), is being considered for GBS maternal vaccines. Since this approach is new to many LMICs regulators and policymakers, WHO organized consultative meetings at national, regional, and global levels to discuss the feasibility and potential challenges of approving a GBS vaccine based on safety and immunogenicity data alone. These consultations focused on evidence supporting SToRR, their use as endpoints to infer protection, and post-licensure requirements. The aim of the consultations was to reduce the delay between vaccine development, licensure, policy recommendations and use in high-burden LMICs.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1016/j.vaccine.2025.127131
- OA Status
- hybrid
- Cited By
- 4
- References
- 35
- Related Works
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- OpenAlex ID
- https://openalex.org/W4410343518
All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W4410343518Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1016/j.vaccine.2025.127131Digital Object Identifier
- Title
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Clinical and regulatory development strategies for GBS vaccines intended for maternal immunisation in low- and middle-income countriesWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-05-13Full publication date if available
- Authors
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Kirsty Le Doaré, Virginia Benassi, Marco Cavaleri, Godwin Enwere, Birgitte Giersing, David Goldblatt, Paul T. Heath, Joachim Hombach, Richard Isbrucker, Kostas Karampatsas, Shabir A. Madhi, Annelies Wilder SmithList of authors in order
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https://doi.org/10.1016/j.vaccine.2025.127131Publisher landing page
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YesWhether a free full text is available
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hybridOpen access status per OpenAlex
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https://doi.org/10.1016/j.vaccine.2025.127131Direct OA link when available
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Low and middle income countries, Medicine, Pregnancy, Environmental health, Immunology, Developing country, Economic growth, Biology, Economics, GeneticsTop concepts (fields/topics) attached by OpenAlex
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4Total citation count in OpenAlex
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2025: 4Per-year citation counts (last 5 years)
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35Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.maternal | 19, 88 |
| abstract_inverted_index.meetings | 104 |
| abstract_inverted_index.pathway, | 60 |
| abstract_inverted_index.referred | 74 |
| abstract_inverted_index.vaccines | 47 |
| abstract_inverted_index.(commonly | 73 |
| abstract_inverted_index.[SToRR]), | 82 |
| abstract_inverted_index.alternate | 58 |
| abstract_inverted_index.approving | 119 |
| abstract_inverted_index.countries | 16 |
| abstract_inverted_index.endpoints | 140 |
| abstract_inverted_index.equitable | 40 |
| abstract_inverted_index.national, | 106 |
| abstract_inverted_index.organized | 102 |
| abstract_inverted_index.pathways. | 56 |
| abstract_inverted_index.potential | 116 |
| abstract_inverted_index.reduction | 81 |
| abstract_inverted_index.regional, | 107 |
| abstract_inverted_index.threshold | 78 |
| abstract_inverted_index.vaccines. | 89 |
| abstract_inverted_index.affordable | 46 |
| abstract_inverted_index.challenges | 117 |
| abstract_inverted_index.considered | 85 |
| abstract_inverted_index.effective, | 44 |
| abstract_inverted_index.licensure, | 160 |
| abstract_inverted_index.mortality, | 10 |
| abstract_inverted_index.protecting | 25 |
| abstract_inverted_index.regulators | 98 |
| abstract_inverted_index.regulatory | 55 |
| abstract_inverted_index.supporting | 135 |
| abstract_inverted_index.candidates, | 22 |
| abstract_inverted_index.feasibility | 114 |
| abstract_inverted_index.high-burden | 166 |
| abstract_inverted_index.progressing | 28 |
| abstract_inverted_index.protection, | 143 |
| abstract_inverted_index.serological | 77 |
| abstract_inverted_index.Organisation | 35 |
| abstract_inverted_index.consultative | 103 |
| abstract_inverted_index.development, | 159 |
| abstract_inverted_index.facilitating | 54 |
| abstract_inverted_index.particularly | 11 |
| abstract_inverted_index.Streptococcus | 2 |
| abstract_inverted_index.consultations | 131, 151 |
| abstract_inverted_index.immunological | 66 |
| abstract_inverted_index.middle-income | 15 |
| abstract_inverted_index.policymakers, | 100 |
| abstract_inverted_index.requirements. | 146 |
| abstract_inverted_index.immunogenicity | 127 |
| abstract_inverted_index.post-licensure | 145 |
| abstract_inverted_index.recommendations | 162 |
| cited_by_percentile_year.max | 98 |
| cited_by_percentile_year.min | 97 |
| countries_distinct_count | 6 |
| institutions_distinct_count | 12 |
| citation_normalized_percentile.value | 0.97462222 |
| citation_normalized_percentile.is_in_top_1_percent | True |
| citation_normalized_percentile.is_in_top_10_percent | True |