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Wits RHI

MVX008 Study

Vaccine Preventable Diseases

The MVX008 Study is a Phase 3 follow-up trial assessing the long-term immunogenicity of the Group B Streptococcus (GBS) vaccine (GBS NN/NN2) previously administered to pregnant women between 21–24 weeks gestation. The Wits RHI site is participating in the HIV-negative cohort of the study. This study will also offer a booster dose to women who become pregnant again during the follow-up period, with comprehensive evaluations of safety, reactogenicity, and immunogenicity.

Primary Objective

To assess the persistence of immune response to the GBS vaccine (GBS NN/NN2) in women who received it during pregnancy and to evaluate the response to a booster dose in subsequent pregnancies.

Rationale

Group B Streptococcus is a leading cause of neonatal infections. The GBS NN/NN2 vaccine is being developed to protect newborns by enhancing maternal immunity during pregnancy. This follow-up study is critical in understanding the duration of vaccine-induced protection and the potential need for booster immunization in future pregnancies.

Study Population

Women who previously received the GBS vaccine between 21–24 weeks of pregnancy and were HIV-negative at the time of vaccination.

Investigators

  • Dr Elizea Horne, Principal Investigator 

Latest Update

March 2025

For more details about MVX008, please email rhicomms@wrhi.ac.za.