Safety and immunogenicity of a second dose of an investigational maternal trivalent Group B streptococcus vaccine in non-pregnant women 4-6 years after a first dose: results from a phase 2 trial

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Geert Leroux-RoelsOuzama Henry

Abstract

Maternal immunization against Group B streptococcus (GBS) could protect infants from invasive GBS disease. Additional doses in subsequent pregnancies may be needed. This study evaluated the safety and immunogenicity of a second dose of an investigational trivalent CRM197-glycoconjugate GBS vaccine (targeting serotypes Ia/Ib/III), administered to non-pregnant women 4-6 years post-dose 1. Healthy women either previously vaccinated with one dose of trivalent GBS vaccine 4-6 years before enrollment (n=53) or never GBS-vaccinated (n=27) received a single trivalent GBS vaccine injection. Adverse events (AEs) were recorded. Serotype-specific (Ia/Ib/III) anti-GBS antibodies were measured by multiplex immunoassay pre-vaccination and 30/60 days post-vaccination. AEs were reported with similar rates after a first or second dose. No serious AEs were reported. 92%-98% of previously GBS-vaccinated women had anti-GBS concentrations exceeding an arbitrary threshold of 8 µg/mL for each serotype 60 days post-dose 2, versus 36%-56% post-dose 1 in previously non-GBS-vaccinated women. 90%-98% of previously GBS-vaccinated women with undetectable baseline (pre-dose 1) anti-GBS levels reached this threshold post-dose 2. For each serotype, anti-GBS geo...Continue Reading

References

May 9, 2008·Vaccine·Viola SchultzeRenald Hennig
Jun 8, 2013·Obstetrics and Gynecology·Alison Gemmill, Laura Duberstein Lindberg
Oct 18, 2013·The Journal of Infectious Diseases·Carol J BakerRichard Platt
Sep 25, 2015·BJOG : an International Journal of Obstetrics and Gynaecology·L E MigniniK S Khan
Mar 2, 2016·Current Opinion in Infectious Diseases·Ziyaad DangorShabir A Madhi
Aug 22, 2017·Vaccine· World Health Organization
Oct 14, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Shabir A MadhiKaren Slobod
Nov 9, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Anna C SealeShabir A Madhi
Nov 9, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Kirsty Le DoareUNKNOWN GBS Intrapartum Antibiotic Investigator Group
Nov 9, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Lola MadridUNKNOWN Infant GBS Disease Investigator Group
Nov 9, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Neal J RussellUNKNOWN GBS Maternal Colonization Investigator Group
Nov 9, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Fiorella Bianchi-JassirCraig E Rubens
Nov 9, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Anna C SealeJoy E Lawn

❮ Previous
Next ❯

Citations

Aug 9, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Morven S Edwards, Carol J Baker

❮ Previous
Next ❯

Methods Mentioned

BETA
enzyme-linked immunosorbent assay
blood draw

Clinical Trials Mentioned

NCT01150123

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.