ADVANCING OUR SCIENCE
Clinical Trials
We are committed to developing safe and effective vaccines that address global unmet medical needs. Learn more about our active and completed clinical studies for our GBS vaccine here.
Ongoing trials
MVX007 Phase I
A Follow up Study of Group B Streptococcus Vaccine (GBS-NN/NN2 Vaccine) in Healthy Volunteers
Description: Study to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine.
Countries: Countries: UK
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Completed trials
MVX0004 Phase II
Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women
Description: Safety and immunogenicity Phase II study in 270 healthy pregnant women in Denmark and United Kingdom. Study is conducted under an IND.
Countries: UK, Denmark and South Africa
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MVX0005 Phase II
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
Description: Safety and immunogenicity Phase II study in 200 pregnant women in South Africa and Uganda. Study supported by European Developing Countries Trial Partnership.
Countries: South Africa and Uganda
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MVX0006 Phase I
Immunogenicity and Safety of GBS-NN/NN2 in Older Adults
Description: Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants.
Countries: Belgium
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MVX0003 Phase I
Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine
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.
Countries: UK
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MVX0002 Phase I
Group B Streptococcus Vaccine in Healthy Females
Description: Safety and dose-finding Phase I study testing dual-component GBS-NN & GBS-NN2 vaccine composition covering 99.3% of clinical GBS isolates.
Countries: UK
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MVX13211 Phase I
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age
Description: Safety, dose-escalation and dose-confirmation Phase I study testing single-component GBS-NN vaccine composition.
Countries: UK
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Related Publications:
Other
Correlates of Protection
Description: Association of infant Rib and Alp1 surface protein N-terminal domain immunoglobulin G and invasive Group B Streptococcal disease in young infants.
Related Publications:
STATEMENT
Statement on Early Access Policy
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.
