PATH Inventprise Inc. Phase 1/2 Group B Streptococcus Investigational Vaccine Clinical Trial

Brief description of study

The purpose of this study is to gain understanding of the safety, tolerability, and immunogenicity of a new Group B streptococcus (GBS) investigational vaccine (IVT GBS-06) among women of childbearing age. Group B streptococcus (GBS) is a bacterium that can cause severe bacterial infections. About 1 in 5 women carry this bacterium, which can be transferred to their baby, resulting in a life-threatening infection and potentially invasive diseases such as sepsis, pneumonia, and meningitis. It is important to prevent GBS-related infections for those in vulnerable groups, especially among infants born to women carrying this bacterium.

There will be 4 study groups. If you are eligible and agree to participate, you will be randomly assigned to 1 of 4 groups:

  • Groups 1, 2, and 3 will receive a single injection of the IVT-GBS 06 investigational vaccine candidate (75% chance)
  • Group 4 will receive the placebo injection (25% chance)
If you decide to participate in this study, you would be asked to complete a minimum of 7 in-person study visits over a period of approximately 7 months. You may be reimbursed $110 per each in-person study visit completed.


Clinical Study Identifier: s23-01638


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