Description: Study to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine.
Description: Safety and immunogenicity Phase II study in 270 healthy pregnant women in Denmark and United Kingdom. Study is conducted under an IND.
Description: Safety and immunogenicity Phase II study in 200 pregnant women in South Africa and Uganda. Study supported by European Developing Countries Trial Partnership.
Description: Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants.
Description: Assessing the immunogenicity of a single-dose of GBS-NN & GBS-NN2 in vaccine naïve subjects and subjects previously receiving 2 doses of the vaccine as part of MVX002.
Description: Safety and dose-finding Phase I study testing dual-component GBS-NN & GBS-NN2 vaccine composition covering 99.3% of clinical GBS isolates.
Description: Safety, dose-escalation and dose-confirmation Phase I study testing single-component GBS-NN vaccine composition.
Description: Association of infant Rib and Alp1 surface protein N-terminal domain immunoglobulin G and invasive Group B Streptococcal disease in young infants.
MinervaX understands the intent of expanded access programs but, at this time, we can best advance the development of our promising vaccine against GBS by enrolling patients in clinical trials, which are designed to provide the data to facilitate regulatory approval and marketing of the vaccine; thus, allowing access for the broader patient community. Our priority is to demonstrate the safety and effectiveness of GBS-NN/NN2 Vaccine, in an appropriately designed and robust clinical trial program.
MinervaX is currently unable to offer expanded access for GBS-NN/NN2 Vaccine and we believe that participation in one of our clinical trials is the most appropriate way to access our investigational vaccine.
MinervaX’s vaccine is currently in clinical studies. It has not been approved for use by any regulatory agency. The details provided in this section are for informational purposes only.