Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial.
Breast milk sIgA
Group B streptococcus
Immunogenicity
Maternal immunization
Safety
Journal
Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899
Informations de publication
Date de publication:
14 10 2020
14 10 2020
Historique:
received:
04
06
2020
revised:
18
08
2020
accepted:
20
08
2020
pubmed:
5
9
2020
medline:
28
4
2021
entrez:
5
9
2020
Statut:
ppublish
Résumé
This study evaluated the safety and immunogenicity of an investigational trivalent group B streptococcus (GBS) vaccine in US pregnant women, transplacental serotype-specific antibody transfer and persistence in infants, and serotype-specific antibodies in breast milk. This randomized, observer-blind, placebo-controlled trial administered one dose of trivalent GBS vaccine (n = 49) or placebo (n = 26) to healthy pregnant 18-40-year-old women at 24 Baseline characteristics were similar between groups. Serious adverse events were reported for 16% of GBS-vaccinated women and 15% of their infants, and 15% of placebo recipients and 12% of their infants; none were fatal or deemed vaccine-related. Serotype-specific IgG geometric mean concentrations (GMCs) were 13-23-fold higher in vaccine vs placebo recipients on day 31 and persisted until postpartum day 90. Median antibody concentrations were substantially higher in women with detectable pre-vaccination antibody concentrations. Antibody transfer ratios in the vaccine group were 0.62-0.82. Infant IgG GMCs and breast milk sIgA GMCs were higher in the vaccine vs the placebo group at all timepoints. Maternal immunization with the trivalent GBS vaccine in US women had a favorable safety profile, elicited antibodies that were transplacentally transferred and persisted in infants for a minimum of 3 months. Clinicaltrials.gov, NCT02046148.
Sections du résumé
BACKGROUND
This study evaluated the safety and immunogenicity of an investigational trivalent group B streptococcus (GBS) vaccine in US pregnant women, transplacental serotype-specific antibody transfer and persistence in infants, and serotype-specific antibodies in breast milk.
METHODS
This randomized, observer-blind, placebo-controlled trial administered one dose of trivalent GBS vaccine (n = 49) or placebo (n = 26) to healthy pregnant 18-40-year-old women at 24
RESULTS
Baseline characteristics were similar between groups. Serious adverse events were reported for 16% of GBS-vaccinated women and 15% of their infants, and 15% of placebo recipients and 12% of their infants; none were fatal or deemed vaccine-related. Serotype-specific IgG geometric mean concentrations (GMCs) were 13-23-fold higher in vaccine vs placebo recipients on day 31 and persisted until postpartum day 90. Median antibody concentrations were substantially higher in women with detectable pre-vaccination antibody concentrations. Antibody transfer ratios in the vaccine group were 0.62-0.82. Infant IgG GMCs and breast milk sIgA GMCs were higher in the vaccine vs the placebo group at all timepoints.
CONCLUSIONS
Maternal immunization with the trivalent GBS vaccine in US women had a favorable safety profile, elicited antibodies that were transplacentally transferred and persisted in infants for a minimum of 3 months.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov, NCT02046148.
Identifiants
pubmed: 32883555
pii: S0264-410X(20)31108-7
doi: 10.1016/j.vaccine.2020.08.056
pii:
doi:
Substances chimiques
Streptococcal Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT02046148']
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
6930-6940Informations de copyright
Copyright © 2020 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Z Bebia, M Lattanzi, O Henry, A Karsten, I Margarit, G Buffi and L Grassano are employees of the GSK group of companies. M Lattanzi, O Henry, A Karsten and I Margarit hold shares in the GSK group of companies. A Dreisbach was an employee of the GSK group of companies. GK Swamy, KM Edwards and JD Campbell report funding from the GSK group of companies for the work under consideration. TD Metz reports that her institution received funding from the GSK group of companies for the work under consideration. Outside the submitted work, GK Swamy is an advisor and chair of IDMCs for the GSK group of companies for RSV vaccine trials in pregnant women and chair of IDMCs for Pfizer for GBS vaccine trials in pregnant and nonpregnant women. Outside the submitted work, KM Edwards is an advisor to Bionet, X4 Pharmaceuticals, Merck, and IBM, and is on DSMBs for Moderna, Roche, Sanofi Pasteur and Sequiras. KM Edwards also reports grants from the CDC and the NIH. RH Beigi and DE Soper report no potential conflicts.