Group B Streptococcus Vaccine Study
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 women, assessing IgG specific to AlpN proteins in cord blood, and the safety profile in mother and infant up to six months post-delivery.
Rationale
MVX0004 is a phase II placebo-controlled study. The 50 μg GBS-NN/NN2 vaccine will be administered to healthy pregnant women. The study will be conducted in compliance with ICH GCP E6 (R2) and applicable regulatory requirements. The overall purpose of the study is to determine how four investigated vaccination regimens affect the concentrations of IgG antibodies, against the four AlpN proteins, in cord blood, namely, the vaccination regimens of; two doses at 22- and 26-weeks GA, 22- and 30-weeks GA, 26- and 30-weeks GA, and a single dose at 26 weeks GA, all doses administered by intramuscular injection.
Investigators
- Dr Elizea Horne, Principal Investigator
- Dr Faeezah Patel, Sub-Investigator
- Mrinmayee Dhar, Sub-Investigator
- Muneerah Khan, Sub-Investigator
- Muneerah Khan, Sub-Investigator
- Jeanne Coetzee, Sub-Investigator
- Tiffany Seef, Clinical Associate
- Othusitse Segalo, Clinical Associate
Latest Update
March 2024
For more about Group B Streptococcus vaccine study please email rhicomms@wrhi.ac.za
