Immunogenicity and safety of GBS-NN/NN2 vaccine in pregnant women
Research type
Research Study
Full title
A multicentre, multinational, parallel group, observer-blind, randomised, placebo-controlled study on the Group B Streptococcus vaccine (GBS-NN/NN2), investigating the immunogenicity and safety of four vaccination regimens in pregnant woman, assessing IgG specific to AlpN proteins in cord blood and maternal blood, and the safety profile in mother and infant up to 6 months post-delivery
IRAS ID
301103
Contact name
Birgit Thierry-Carstensen
Contact email
Sponsor organisation
MinervaX Aps
Eudract number
2021-003214-40
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
MVX0004 is a phase II multicentre, multinational, placebo-controlled study and the 50 µg GBS-NN/NN2 vaccine or placebo will be administered to healthy pregnant women who are above the legal age of consent at the time of sceening and carrying a normal singleton pregnancy.
The Group B Streptococcus vaccine (GBS-NN/NN2), is being developed for vaccination of pregnant women with the aim of passive immunisation of their babies with the antibodies generated by the mother, to provide protection of the baby against invasive Group B Streptococcus (GBS) disease during the first three months of life.
The overall purpose of the study is to investigate four vaccination regimens, to determine if the different regimens affect the concentrations of IgG antibodies, against the four AlpN proteins, in maternal and cord blood. The different regimens will assess whether administering doses at 22- and 26-weeks gestational age (GA), 22- and 30-weeks GA, 26- and 30-weeks GA and a single dose at 26 weeks GA affect the IgG concentration in maternal and cord blood. The study will also assess the safety and tolerability of the GBS-NN/NN2 vaccine in the mother and evaluate developmental milestones in the baby up to 6 months post-delivery.
There will be five treatment groups; three groups of 60 subjects to receive two doses of GBS-NN/NN2 and one of placebo (saline), one group of 60 subjects to receive one dose of GBS-NN/NN2, and one group of 30 subjects to receive one dose of placebo (saline). Each dose of 0.5 mL GBS-NN/NN2 contains 50 µg of GBS-NN and 50 µg of GBS-NN2 and 0.5 mg of aluminium, for all vaccination regimens and groups, and will be given by intramuscular injection.The Placebo will be 0.9 % saline sterile solution for injection.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0209
Date of REC Opinion
9 Dec 2021
REC opinion
Further Information Favourable Opinion