iGBS feasibility study
Research type
Research Study
Full title
Feasibility study for the development of a sero-correlate of protection against invasive Group B Streptococcus disease (iGBS)
IRAS ID
246149
Contact name
Paul Heath
Contact email
Sponsor organisation
St George's, University of London and St George's University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Research summary
Group B Streptococcus (GBS) is a bacterium (germ) that can cause serious infections such as meningitis, blood poisoning and pneumonia in newborns. Infection during the first 6 days of life may be prevented by antibiotics given to the mother during labour, but will offer no protection for infections occurring later. A vaccine against GBS has been developed and is currently being tested. If effective this could be offered to pregnant women to protect their babies from this devastating disease. However, we do not know what level of antibody is needed to protect infants against GBS. We need to collect comprehensive information about the amount of antibody that protects infants from GBS in order to facilitate the development and licensure of a vaccine to give to pregnant women. To do this requires a very large study and this feasibility study aims to understand how many women we could recruit and follow up and whether we are able to collect and process large numbers of blood samples in a timely manner.In this study we will obtain a blood sample from the mother and/or umbilical cord at delivery at one of 5 hospitals. Participants will be pregnant women of at least 18 years of age. In 2 of the 5 hospitals we will also obtain a swab from the vagina/rectum from women after 35 weeks of pregnancy to assess the presence of GBS carriage. For these participants, if the swab comes back as GBS positive, we will invite them to participate in the infant blood sample collection sub-study, in which a blood sample will be obtained from the newborn at 1, 2 or 3 months of age. Participants at all hospitals will also be invited to participate in a 90 day follow-up telephone call to assess whether the newborn has developed GBS disease.
Summary of reseults
We have verified the feasibility of collecting and processing rectovaginal swabs and blood samples in pregnant women, as well as cord sera and samples from infants with invasive group B streptococcal disease (iGBS) and healthy infants exposed to GBS. We have made recommendations for the recruitment of cases and controls within the iGBS3 study, that is now underway. We estimated a colonisation rate of 17% in the participating sites. The half-life of antibodies against GBS in healthy infants was 4 weeks. These results provide a basis for future studies in the UK and other settings to facilitate the licensure of a GBS vaccine.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0147
Date of REC Opinion
15 Jun 2018
REC opinion
Further Information Favourable Opinion