Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.

Summary

Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus. Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the first dose.

Timeline

Start

2015-05

Primary completion

2017-04-12

Completion

2017-04-21

Publications

• Pawlowski A, Lannergard J, Gonzalez-Miro M, Cao D, Larsson S, Persson JJ, Kitson G, Darsley M, Rom AL, Hedegaard M, Fischer PB, Johansson-Lindbom B. A group B Streptococcus alpha-like protein subunit vaccine induces functionally active antibodies in humans targeting homotypic and heterotypic strains. Cell Rep Med. 2022 Feb 15;3(2):100511. doi: 10.1016/j.xcrm.2022.100511. eCollection 2022 Feb 15.
• Fischer P, Pawlowski A, Cao D, Bell D, Kitson G, Darsley M, Johansson-Lindbom B. Safety and immunogenicity of a prototype recombinant alpha-like protein subunit vaccine (GBS-NN) against Group B Streptococcus in a randomised placebo-controlled double-blind phase 1 trial in healthy adult women. Vaccine. 2021 Jul 22;39(32):4489-4499. doi: 10.1016/j.vaccine.2021.06.046. Epub 2021 Jun 30.

Drugs

Indications