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Developing a serocorrelate of protection against invasive group B streptococcus disease in pregnant women: a feasibility study.

Carreras-Abad, C; Cochet, M; Hall, T; Ramkhelawon, L; Khalil, A; Peregrine, E; Vinayakarao, L; Sivarajan, S; Hamid, R; Planche, T; et al. Carreras-Abad, C; Cochet, M; Hall, T; Ramkhelawon, L; Khalil, A; Peregrine, E; Vinayakarao, L; Sivarajan, S; Hamid, R; Planche, T; Sheridan, E; Winchester, S; Plumb, J; Djennad, A; Andrews, N; Le Doare, K; Heath, P (2019) Developing a serocorrelate of protection against invasive group B streptococcus disease in pregnant women: a feasibility study. Health Technol Assess, 23 (67). pp. 1-40. ISSN 2046-4924 https://doi.org/10.3310/hta23670
SGUL Authors: Le Doare, Kirsty Heath, Paul Trafford Khalil, Asma

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Abstract

BACKGROUND: Group B streptococcus is the leading cause of infection in infants. Currently, intrapartum antibiotic prophylaxis is the major strategy to prevent invasive group B streptococcus disease. However, intrapartum antibiotic prophylaxis does not prevent maternal sepsis, premature births, stillbirths or late-onset disease. Maternal vaccination may offer an alternative strategy. Multivalent polysaccharide protein conjugate vaccine development is under way and a serocorrelate of protection is needed to expedite vaccine licensure. OBJECTIVES: The ultimate aim of this work is to determine the correlate of protection against the major group B streptococcus disease-causing serotypes in infants in the UK. The aim of this feasibility study is to test key operational aspects of the study design. DESIGN: Prospective cohort study of pregnant women and their infants in a 6-month period (1 July to 31 December 2018). SETTING: Five secondary and tertiary hospitals from London and South England. National iGBS disease surveillance was conducted in all trusts in England and Wales. PARTICIPANTS: Pregnant women aged ≥ 18 years who were delivering at one of the selected hospitals and who provided consent during the study period. There were no exclusion criteria. INTERVENTIONS: No interventions were performed. MAIN OUTCOME MEASURES: (1) To test the feasibility of collecting serum at delivery from a large cohort of pregnant women. (2) To test the key operational aspects for a proposed large serocorrelates study. (3) To test the feasibility of collecting samples from those with invasive group B streptococcus. RESULTS: A total of 1823 women were recruited during the study period. Overall, 85% of serum samples were collected at three sites collecting only cord blood. At the two sites collecting maternal, cord and infant blood samples, the collection rate was 60%. A total of 614 women were screened for group B streptococcus with a colonisation rate of 22% (serotype distribution: 30% III, 25% Ia, 16% II, 14% Ib, 14% V and 1% IV). A blood sample was collected from 34 infants who were born to colonised women. Maternal and infant blood and the bacterial isolates for 15 newborns who developed invasive group B streptococcal disease during the study period were collected (serotype distribution: 29% III, 29% II, 21% Ia, 7% Ib, 7% IV and 7% V). LIMITATIONS: Recruitment and sample collection were dependent on the presence of research midwives rather than the whole clinical team. In addition, individualised consent limited the number of women who could be approached each day, and site set-up for the national surveillance study and the limited time period of this feasibility study limited recruitment of all eligible participants. CONCLUSIONS: We have verified the feasibility of collecting and processing rectovaginal swabs and blood samples in pregnant women, as well as samples from those with invasive group B streptococcal disease. We have made recommendations for the recruitment of cases within the proposed GBS3 study and for controls both within GBS3 and as an extension of this feasibility study. FUTURE WORK: A large case-control study comparing specific immunoglobulin G levels in mothers whose infants develop invasive group B streptococcal disease with those in colonised mothers whose infants do not develop invasive group B streptococcal disease is recommended. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49326091; IRAS project identification number 246149/REC reference number 18/WM/0147. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 67. See the NIHR Journals Library website for further project information.

Item Type: Article
Additional Information: © Queen’s Printer and Controller of HMSO 2019. This work was produced by Carreras-Abad et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Keywords: GROUP B STREPTOCOCCUS, IMMUNISATION, INFANT, MENINGITIS, NEWBORN, SEPSIS, STREPTOCOCCUS AGALACTIAE, 1117 Public Health and Health Services, 0807 Library and Information Studies, 0806 Information Systems, Health Policy & Services
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: Health Technol Assess
ISSN: 2046-4924
Language: eng
Dates:
DateEvent
December 2019Published
August 2019Accepted
Publisher License: Publisher's own licence
Projects:
Project IDFunderFunder ID
17/153/01Health Technology Assessment programmehttp://dx.doi.org/10.13039/501100000664
PubMed ID: 31855555
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/111517
Publisher's version: https://doi.org/10.3310/hta23670

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