Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women

Summary

This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; three groups of 60 participants will receive will receive two doses of GBS-NN/NN2 vaccine and one dose of placebo (saline); one group of 60 participants will receive one dose of GBS-NN/NN2 vaccine and two doses of placebo (saline), and one group of 30 participants will receive three doses of placebo (saline).

Timeline

Start

2022-02-17

Primary completion

2023-04-26

Completion

2023-10-18

Publications

• Heath PT, Zuma-Gwala N, Helmig RB, Horne E, Kjaerbye-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. 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. Lancet Infect Dis. 2026 May;26(5):486-496. doi: 10.1016/S1473-3099(25)00659-0. Epub 2025 Dec 9.

Drugs

Indications