---
title: "Safety and Immunogenicity of the GBS-AlpN Vaccine in Adults 55–75: Phase 1 Randomised Trial"
id: "pubmed-42759245"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42759245"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42759245/"
doi: "10.1016/j.vaccine.2026.129133"
published_at: "2026-10-24T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Safety and Immunogenicity of the GBS-AlpN Vaccine in Adults 55–75: Phase 1 Randomised Trial
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42759245
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42759245/)
- **DOI:** [10.1016/j.vaccine.2026.129133](https://doi.org/10.1016%2Fj.vaccine.2026.129133)
- **Published At:** 2026-10-24T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- The trial assessed an adjuvanted **Group B Streptococcus** candidate vaccine (GBS-AlpN) in older adults aged 55–75. 60 healthy participants and 30 with obesity and/or type 2 diabetes (O/D) were enrolled. - Participants received three intramuscular administrations on Day 1, Week 4 and Week 24; the source reported allocation ratios (48:12 and 24:6) but did not report antigen dose amounts in the abstract. - Solicited local and systemic adverse events (AEs), unsolicited AEs and serious adverse events (SAEs) were collected; most solicited AEs were mild and observed in 53 healthy and 26 O/D participants. - Seven SAEs were recorded; study authors reported all were unrelated to vaccination (three in placebo, four in active groups). - At least one unsolicited AE was reported by 43 healthy and 22 O/D participants; none of the severe unsolicited AEs were attributed to the vaccine per the abstract. - Immunogenicity measured as geometric mean concentrations (GMCs) to four AlpN antigens (Alp1N, Alp2/3N, RibN, AlpCN) and seroconversion; by Day 57 all but three vaccine recipients had seroconverted for all four antigens. - Antibody responses were described as robust and durable, already evident after the second dose, with comparable responses between healthy and O/D subgroups. - The trial supports further clinical investigation to define an optimal vaccination strategy for older, vulnerable adults; the abstract does not provide detailed antigen dosing, exact GMC values, p-values, or long-term follow-up beyond the reported schedule. - Conflict of interest disclosures include multiple authors with employment, equity or consulting relationships with the sponsor, MinervaX; several authors reported institutional support or pending patents related to the investigational vaccine.
## Clinical Analysis & Structured Key Points
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Epub 2026 Sep 18. # A randomised, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability and immunogenicity of three doses of an adjuvanted group B Streptococcus vaccine in older adults aged 55 to 75 [Lidia Oostvogels](https://pubmed.ncbi.nlm.nih.gov/?term=Oostvogels+L&cauthor_id=42759245)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-1 "MinervaX, Copenhagen, Denmark. Electronic address: lio@minervax.com."), [Azhar Alhatemi](https://pubmed.ncbi.nlm.nih.gov/?term=Alhatemi+A&cauthor_id=42759245)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-2 "Ghent University Hospital, Ghent, Belgium."), [Simon De Gussem](https://pubmed.ncbi.nlm.nih.gov/?term=De+Gussem+S&cauthor_id=42759245)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-2 "Ghent University Hospital, Ghent, Belgium."), [Ebbe Englev](https://pubmed.ncbi.nlm.nih.gov/?term=Englev+E&cauthor_id=42759245)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-3 "MinervaX, Copenhagen, Denmark."), [Per B Fischer](https://pubmed.ncbi.nlm.nih.gov/?term=Fischer+PB&cauthor_id=42759245)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-3 "MinervaX, Copenhagen, Denmark."), [Bart Jacobs](https://pubmed.ncbi.nlm.nih.gov/?term=Jacobs+B&cauthor_id=42759245)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-2 "Ghent University Hospital, Ghent, Belgium."), [Bengt Johansson-Lindbom](https://pubmed.ncbi.nlm.nih.gov/?term=Johansson-Lindbom+B&cauthor_id=42759245)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-3 "MinervaX, Copenhagen, Denmark."), [Geoff Kitson](https://pubmed.ncbi.nlm.nih.gov/?term=Kitson+G&cauthor_id=42759245)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-4 "Kagulex Consulting Ltd, Horsham, UK."), [Gwenn Waerlop](https://pubmed.ncbi.nlm.nih.gov/?term=Waerlop+G&cauthor_id=42759245)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-5 "Centre for Vaccinology \(CEVAC\), Ghent University, Ghent, Belgium."), [Isabel Leroux-Roels](https://pubmed.ncbi.nlm.nih.gov/?term=Leroux-Roels+I&cauthor_id=42759245)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#full-view-affiliation-6 "Ghent University Hospital, Ghent, Belgium; Centre for Vaccinology \(CEVAC\), Ghent University, Ghent, Belgium.") Affiliations Expand ### Affiliations * 1 MinervaX, Copenhagen, Denmark. Electronic address: lio@minervax.com. * 2 Ghent University Hospital, Ghent, Belgium. * 3 MinervaX, Copenhagen, Denmark. * 4 Kagulex Consulting Ltd, Horsham, UK. * 5 Centre for Vaccinology (CEVAC), Ghent University, Ghent, Belgium. * 6 Ghent University Hospital, Ghent, Belgium; Centre for Vaccinology (CEVAC), Ghent University, Ghent, Belgium. * PMID: **42759245** * DOI: [ 10.1016/j.vaccine.2026.129133 ](https://doi.org/10.1016/j.vaccine.2026.129133) Free article Item in Clipboard Clinical Trial # A randomised, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability and immunogenicity of three doses of an adjuvanted group B Streptococcus vaccine in older adults aged 55 to 75 Lidia Oostvogels et al. Vaccine. 2026. Free article Show details Display options Display options Format Abstract PubMed PMID Vaccine Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Vaccine%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Vaccine%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42759245/) . 2026 Oct 24:92:129133. doi: 10.1016/j.vaccine.2026.129133. Epub 2026 Sep 18. ### Authors [Lidia Oostvogels](https://pubmed.ncbi.nlm.nih.gov/?term=Oostvogels+L&cauthor_id=42759245)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-1 "MinervaX, Copenhagen, Denmark. Electronic address: lio@minervax.com."), [Azhar Alhatemi](https://pubmed.ncbi.nlm.nih.gov/?term=Alhatemi+A&cauthor_id=42759245)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-2 "Ghent University Hospital, Ghent, Belgium."), [Simon De Gussem](https://pubmed.ncbi.nlm.nih.gov/?term=De+Gussem+S&cauthor_id=42759245)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-2 "Ghent University Hospital, Ghent, Belgium."), [Ebbe Englev](https://pubmed.ncbi.nlm.nih.gov/?term=Englev+E&cauthor_id=42759245)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-3 "MinervaX, Copenhagen, Denmark."), [Per B Fischer](https://pubmed.ncbi.nlm.nih.gov/?term=Fischer+PB&cauthor_id=42759245)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-3 "MinervaX, Copenhagen, Denmark."), [Bart Jacobs](https://pubmed.ncbi.nlm.nih.gov/?term=Jacobs+B&cauthor_id=42759245)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-2 "Ghent University Hospital, Ghent, Belgium."), [Bengt Johansson-Lindbom](https://pubmed.ncbi.nlm.nih.gov/?term=Johansson-Lindbom+B&cauthor_id=42759245)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-3 "MinervaX, Copenhagen, Denmark."), [Geoff Kitson](https://pubmed.ncbi.nlm.nih.gov/?term=Kitson+G&cauthor_id=42759245)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-4 "Kagulex Consulting Ltd, Horsham, UK."), [Gwenn Waerlop](https://pubmed.ncbi.nlm.nih.gov/?term=Waerlop+G&cauthor_id=42759245)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-5 "Centre for Vaccinology \(CEVAC\), Ghent University, Ghent, Belgium."), [Isabel Leroux-Roels](https://pubmed.ncbi.nlm.nih.gov/?term=Leroux-Roels+I&cauthor_id=42759245)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42759245/#short-view-affiliation-6 "Ghent University Hospital, Ghent, Belgium; Centre for Vaccinology \(CEVAC\), Ghent University, Ghent, Belgium.") ### Affiliations * 1 MinervaX, Copenhagen, Denmark. Electronic address: lio@minervax.com. * 2 Ghent University Hospital, Ghent, Belgium. * 3 MinervaX, Copenhagen, Denmark. * 4 Kagulex Consulting Ltd, Horsham, UK. * 5 Centre for Vaccinology (CEVAC), Ghent University, Ghent, Belgium. * 6 Ghent University Hospital, Ghent, Belgium; Centre for Vaccinology (CEVAC), Ghent University, Ghent, Belgium. * PMID: **42759245** * DOI: [ 10.1016/j.vaccine.2026.129133 ](https://doi.org/10.1016/j.vaccine.2026.129133) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID Linked Discoveries ## Abstract Group B Streptococcus (GBS) disease is an increasing medical burden in adults. The present phase 1 trial evaluated an adjuvanted GBS vaccine (GBS-AlpN) containing N-terminal domains of four alpha-like proteins (AlpNs) (Alp1N, Alp2/3 N, RibN and AlpCN) in 60 healthy adults and 30 with obesity and/or type 2 diabetes (O/D) aged 55 to 75 years of age. Participants received three intramuscular doses of GBS-AlpN or placebo (48:12 and 24:6) on Day 1, Week 4 and Week 24. Solicited local and systemic adverse events (AEs), unsolicited AEs, and serious AEs (SAEs) were collected. Geometric mean concentrations of antibodies to the four AlpN antigens, and seroconversion were determined. The median age was between 65 and 66 years with more females in the healthy groups and more males in the O/D groups. Mainly mild solicited local and systemic AEs were reported for 53 healthy and 26 O/D participants. Seven SAEs, all unrelated, were reported (three in the placebo group and four in the active groups). At least 1 unsolicited AE was reported by 43 healthy and 22 O/D participants. None of the severe unsolicited AEs were related. By Day 57 all participants except three, who received GBS-AlpN had seroconverted for all four AlpNs. The vaccine elicited robust and durable antibody responses, already after the second dose, with comparable results between subgroups. These findings support further clinical investigation for the optimal vaccination strategy to protect vulnerable older adults against GBS disease. **Keywords:** Adverse events; Group B streptococcal vaccines; Immunogenicity; Older adults; Randomised clinical trial. Copyright © 2026 MinervaX Asp. Published by Elsevier Ltd.. All rights reserved. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declaration of competing interest All authors report writing assistance provided by MinervaX ApS. Isabel Leroux-Roels reports institutional financial support. Geoff Kitson reports consultancy fees from MinervaX ApS. Lidia Oostvogels reports a relationship with MinervaX ApS that includes: employment, equity or stocks, and non-financial support. Ebbe Englev reports a relationship with MinervaX ApS that includes: employment and equity or stocks. Per Fischer reports a relationship with MinervaX ApS that includes: employment and equity or stocks. Bengt Johansson-Lindbom reports a relationship with MinervaX ApS that includes: employment and equity or stocks. Geoff Kitson reports a relationship with MinervaX ApS that includes: consulting or advisory. Bengt Johansson-Lindbom has patents pending to Assignee. Per B. Fischer has patents pending to Assignee. PBF is the CEO of MinervaX ApS, who is the sponsor of the study, and holds company shares. IL-R reports institutional research grants from Minervax, GSK, CSL Seqirus, Moderna, LiteVax, Osivax, Sumitomo Pharma, J&J, Virometix AG and AstriVax Therapeutics for the conduct of clinical vaccine trials; institutional lecture fees by GSK, MSD and CSL Seqirus; and institutional financial compensation for the participation in Data Safety Monitoring and Advisory Boards by JnJ, MSD, CSL Seqirus and Viatris. ## Similar articles * [ Immunogenicity and safety of a group B Streptococcus vaccine (GBS-AlpN) in pregnant women and their infants: a phase 2, multicentre, observer-blind, randomised, placebo-controlled study. ](https://pubmed.ncbi.nlm.nih.gov/41386262/) Heath PT, Zuma-Gwala N, Helmig RB, Horne E, Kjærbye-Thygesen A, Crusell MKW, Nchabeleng M, Strehlau R, Khalil MR, Jones CE, Biccler J, Dimsits J, Johansson-Lindbom B, Fischer PB, Oostvogels L, Madhi SA; MVX0004 study group.Heath PT, et al.Lancet Infect Dis. 2026 May;26(5):486-496. doi: 10.1016/S1473-3099(25)00659-0. Epub 2025 Dec 9.Lancet Infect Dis. 2026.PMID: 41386262Clinical Trial. * [ Safety and immunogenicity of a booster dose of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 2, open-label extension of a phase 1/2 randomised controlled trial. ](https://pubmed.ncbi.nlm.nih.gov/40523378/) Jongihlati B, Segall N, Block SL, Absalon J, Perez J, Munson S, Sanchez-Pearson Y, Simon R, Silmon de Monerri NC, Radley D, McLaughlin LC, Gaylord M, Gruber WC, Jansen KU, Scott DA, Anderson AS.Jongihlati B, et al.Lancet Infect Dis. 2025 Oct;25(10):1138-1148. doi: 10.1016/S1473-3099(25)00216-6. Epub 2025 Jun 13.Lancet Infect Dis. 2025.PMID: 40523378Clinical Trial. * [ Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. ](https://pubmed.ncbi.nlm.nih.gov/27139805/) Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Meulen AS, Baker S, Dull PM, Narasimhan V, Slobod K.Madhi SA, et al.Lancet Infect Dis. 2016 Aug;16(8):923-34. doi: 10.1016/S1473-3099(16)00152-3. Epub 2016 Apr 29.Lancet Infect Dis. 2016.PMID: 27139805Clinical Trial. * [ Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial. ](https://pubmed.ncbi.nlm.nih.gov/32891191/) Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, Peterson J, Watson WJ, Gruber WC, Jansen KU, Peng Y, Munson S, Pavliakova D, Scott DA, Anderson AS.Absalon J, et al.Lancet Infect Dis. 2021 Feb;21(2):263-274. doi: 10.1016/S1473-3099(20)30478-3. Epub 2020 Sep 3.Lancet Infect Dis. 2021.PMID: 32891191Free PMC article.Clinical Trial. * [ Safety and immunogenicity of a single booster dose of the group B streptococcus AlpN candidate vaccine (GBS-AlpN) in previously vaccinated healthy women compared with a single dose in previously unvaccinated women. ](https://pubmed.ncbi.nlm.nih.gov/41046840/) Johansson-Lindbom B, Kitson G, Oostvogels L, Darsley M, Fischer PB.Johansson-Lindbom B, et al.Vaccine. 2025 Oct 24;65:127820. doi: 10.1016/j.vaccine.2025.127820. 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