Pregnancy vaccine trial launched to investigate protection against Group B Streptococcus

Pregnant women and birthing people are taking part in a new study at University Hospital Southampton to see if a vaccine can help protect against Group B Streptococcus.

Group B strep is a common type of bacteria that is found in around one in five pregnant women.

Most people will not realise they have it, however it can cause complications during pregnancy and serious illness in babies.

Despite being a leading cause of life-threatening infections in the first months of life, there is not yet a licensed vaccine for Group B strep around the world.

Participants are supporting these efforts by joining the Pfizer sponsored BEATRIX vaccine study at the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility at Southampton General Hospital.

Professor Chrissie Jones, Southampton study lead, said: “There is a need to assess the safety and efficacy of a Group B Strep vaccine which has the potential to transform the way we protect newborn babies, both here in the UK and around the world. Group B Strep remains a serious infection in early life – one that can be life-threatening and may lead to long-term health problems for infants who survive.“

A successful vaccine would represent a breakthrough in preventing these severe infections. We are now inviting pregnant women and birthing people from the Southampton area to take part in this important study and help us evaluate this potentially promising new vaccine.”

During pregnancy and birth, Group B strep increases the risk of complications, including preterm delivery, low birth weight and miscarriage. If it spreads to the newborn during labour, it can make them very ill.

After giving birth, women with Group B strep are more at risk of developing sepsis, as well as infections of the womb and surrounding area.

The international study is investigating a vaccine designed to help protect against serious disease caused by the most common types of Group B strep bacteria.

It is hoped that the vaccine will protect both the pregnant mother and her baby.

The intention is that the antibodies produced by the woman will pass through the placenta, protecting the baby both during pregnancy and for the first few months of their life.

The study is taking place at approximately 183 research sites in about 18 countries. Overall, around 6,000 pregnant women and their babies will take part.

To take part, participants will need to be 24 to 36 weeks pregnant on the day of the planned study vaccination and expecting a healthy baby.

Participants are randomly assigned to either receive the study vaccine or a placebo (saltwater). This will be given by injection into the upper arm at the first study visit.

Mothers will stay in the study for 6 months after they give birth, and their babies will stay in the study until they are about 12 months old. Their health will be closely monitored during the study.

For more information, please call the study team on 02381206856 or email reprohealthresearcht@uhs.nhs.uk.