Kyohere Mary, Davies Hannah Georgia, Musoke Philippa, Nakimuli Annettee, Tusubira Valerie, Tasimwa Hannington Baluku, Nsimire Juliet Sendagala, Heath Paul, Cose Stephen, Baker Carol, Le Doare Kirsty, Sekikubo Musa
Makerere University - Johns Hopkins University (MUJHU) Research Collaboration, Kampala, Uganda.
Paediatric Infection and Immunology Institute of Infection and Immunity, St George's, University of London, London, SW170RE, UK.
Gates Open Res. 2020 Nov 13;4:155. doi: 10.12688/gatesopenres.13183.2. eCollection 2020.
: Group B (GBS) is a major contributor to the high burden of neonatal and young infant infectious disease in resource- limited settings. As disease protection during the first six months of life is provided via placental transfer of maternal antibodies, a maternal GBS vaccine may provide an effective strategy to reduce infectious death and disability. An efficacy study may be difficult because of the large sample size required and alternative approaches such as serocorrelates of protection based on natural antibody concentration are being considered. Such studies would need to be undertaken in high burden settings such as Uganda. We therefore aim to evaluate the feasibility and acceptability of a GBS sero-epidemiology study in Kampala, Uganda. : This is a prospective cohort and nested case-control study, conducted across two-centres with two entry points. A) consecutive women and their infants at birth, with collection of maternal swab, cord and maternal blood, and follow up by telephone until the infant is 3 months old; B) any infant under 3 months of age, presenting with signs of sepsis to any of the paediatric units, with collection of blood culture, cerebrospinal fluid and nasopharyngeal swabs. Any infants identified as having GBS disease (defined as GBS isolated from a normally sterile site) will be recruited and followed up for two years to assess their neurodevelopment. A nested qualitative study will investigate stakeholder (pregnant women and their families, healthcare workers and community leaders) opinions of sampling for such a study and understanding and potential uptake of vaccines in pregnancy. : The primary aim is to determine anti-GBS antibody concentration in infants with GBS disease compared to healthy controls. Secondary outcomes include stillbirth and all-cause infection and acceptance of sample methods and vaccination. The findings will inform scalability and sustainability of the programme in Uganda.
在资源有限的环境中，B组链球菌（GBS）是导致新生儿和幼儿传染病负担沉重的主要因素。由于生命最初六个月的疾病保护是通过母体抗体的胎盘转移来提供的，因此母体GBS疫苗可能是减少感染性死亡和残疾的有效策略。由于所需样本量较大，进行疗效研究可能会很困难，目前正在考虑采用替代方法，例如基于天然抗体浓度的保护血清学关联指标。此类研究需要在乌干达等高负担环境中开展。因此，我们旨在评估在乌干达坎帕拉进行GBS血清流行病学研究的可行性和可接受性。 这是一项前瞻性队列研究和嵌套病例对照研究，在两个中心设有两个入组点。A）连续招募分娩时的妇女及其婴儿，采集母体拭子、脐带和母体血液，并通过电话随访至婴儿3个月大；B）任何3个月以下出现败血症体征的婴儿，到任何儿科病房就诊，采集血培养、脑脊液和鼻咽拭子。任何被确定患有GBS疾病（定义为从通常无菌部位分离出GBS）的婴儿都将被招募并随访两年，以评估其神经发育情况。一项嵌套的定性研究将调查利益相关者（孕妇及其家人、医护人员和社区领袖）对该研究采样的看法，以及对孕期疫苗的理解和潜在接受情况。 主要目的是确定患有GBS疾病的婴儿与健康对照相比的抗GBS抗体浓度。次要结果包括死产、全因感染以及样本采集方法和疫苗接种的可接受性。研究结果将为该项目在乌干达的可扩展性和可持续性提供依据。
