Study of 4 regimens of Group B Streptococcus vaccine (GBS-NN/NN2) in pregnant women

Status: Closed to Recruitment 

Population: Maternal 

Disease group: GBS 

Funder: MinervaX 

Sponsor: MinervaX 

Principal Investigator: Professor Paul Heath  

Study Aims

Group B Streptococcus (GBS) is a type of bacteria that many people carry in their bodies. GBS generally lives in the body of healthy adults without causing harm, but it can cause severe, potentially fatal infections in babies such as meningitis (infection of the lining covering the brain and spinal cord) and pneumonia (lung infection). GBS in pregnant people can also lead to poor growth of the baby in the womb, early delivery of the baby, miscarriage, or stillbirth. 

We are researching the Minervax GBS vaccine (called GBS-NN/NN2) to see if this provides an effective level of antibodies to infants to best protect them from GBS. This will help provide key data and vital information as no GBS vaccine is currently available for clinical use.  

We are inviting pregnant people who do not have any complications in their pregnancy to take part in this study. In this study, participants will be assigned randomly (by chance, like flipping a coin) to 1 of 5 groups and receive 3 injections, 4 weeks apart. Participants will receive either the GBS vaccine or a Placebo so researchers can tell if the effects seen in the study are a result of the vaccine or not. 

What does participating in the study involve?  

Participation includes: 

  • Study visits throughout pregnancy and up to 6 months after delivery 
  • A 24-hour phone line to the study team
  • Travel reimbursement for study visits
  • Completion of an e-diary to record any symptoms following vaccination 

There will be eight routine study visits in pregnancy and participants will be followed up until 6 months after their baby’s birth. Blood samples will be taken from participants throughout the study and a baby blood sample will be taken when babies are 1 and 3 months old.  

For more information on taking part in the study please contact: MVX0004trial@sgul.ac.uk  

Read more about the study in the SGUL press release: https://www.stgeorges.nhs.uk/newsitem/local-mums-invited-to-support-group-b-strep-vaccine-study-to-help-protect-new-born-babies/