New study to test vaccine for Group B strep in babies

Southampton researchers are leading a new study to test a new vaccine that would protect babies from potentially life-threatening Group B streptococcus.

The clinical trial, which being carried out in both Southampton and London, is investigating the best time to offer the vaccine to guard against the common bacterial infection.

Group B streptococcus, also known as Group B strep, affects two to four in 10 women. It is usually harmless in adults but can be very dangerous to unborn and newborn babies.

It is responsible for nearly half of all life-threatening infections in newborns during the first three months of life. It also sometimes causes miscarriages, premature births and stillbirths.

It usually lives in the lower intestine (rectum) or vagina, and can infect babies during pregnancy and birth. It is not routinely tested for in pregnancy in the UK but may be found during tests carried out for another reason, such as a urine test or vaginal swab. In November, the World Health Organization reported the urgent need for a global vaccine against Group B strep.

The hope is that the vaccine, which is being developed by Danish company MinervaX, will protect a baby during pregnancy and birth.

Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases and Immunology within the Faculty of Medicine, will lead the Southampton part of the study.

She said: “A safe and effective Group B Strep vaccine would be a game-changer for newborn infants, both in the UK and globally. This is a significant infection in newborn babies, that can be life-threatening and can also cause long-term problems in those babies who recover from the infection.

“A vaccine against Group B Strep would be a massive step forward in our ability to protect newborn infants from serious infection. We are inviting pregnant women from the Southampton area to help us test this vaccine.”

The MinervaX vaccine has already been given to non-pregnant women in a previous UK study, with no safety concerns.

It has been shown to induce a strong immune response – a sign it is effective – even in people with low levels of pre-existing immunity to the bacteria.

Pregnant women in South Africa, Uganda and Denmark have taken part in studies of this vaccine. All babies in the South African study have been born, with no serious side effects reported.

Women who are pregnant without complications can take part in the study, which is being held in the NIHR Southampton Clinical Research Facility.

Participants will start the study at about 20 weeks of pregnancy and be followed through six months after delivery. There are 12 hospital visits in total including a screening visit. Volunteers can be reimbursed for travel costs.

For more information on the study, please contact reprohealthresearcht@uhs.nhs.uk.