Abstract:
Invasive non-typhoidal Salmonella (iNTS) disease is an under-recognized high-burden disease causing major health and socioeconomic issues in sub-Saharan Africa (sSA), predominantly among immune-naïve infants and young children, including those with recognized comorbidities such as HIV infection. iNTS disease is primarily caused by Salmonella enterica serovar Typhimurium sequence type (ST) 313 and \'African-restricted clades\' of Salmonella Enteritidis ST11 that have emerged across the African continent as a series of epidemics associated with acquisition of new antimicrobial resistance. Due to genotypes with a high prevalence of antimicrobial resistance and scarcity of therapeutic options, these NTS serovars are designated by the World Health Organization as a priority pathogen for research and development of interventions, including vaccines, to address and reduce NTS associated bacteremia and meningitis in sSA. Novel and traditional vaccine technologies are being applied to develop vaccines against iNTS disease, and the results of the first clinical trials in the infant target population should become available in the near future. The \"Vaccine Value Profile\" (VVP) addresses information related predominantly to invasive disease caused by Salmonella Enteritidis and Salmonella Typhimurium prevalent in sSA. Information is included on stand-alone iNTS disease candidate vaccines and candidate vaccines targeting iNTS disease combined with another invasive serotype, Salmonella Typhi, that is also common across sSA. Out of scope for the first version of this VVP is a wider discussion on either diarrheagenic NTS disease (dNTS) also associated with Salmonella Enteritidis and Salmonella Typhimurium or the development of a multivalent Salmonella vaccines targeting key serovars for use globally. This VVP for vaccines to prevent iNTS disease is intended to provide a high-level, holistic assessment of the information and data that are currently available to inform the potential public health, economic, and societal value of pipeline vaccines and vaccine-like products. Future versions of this VVP will be updated to reflect ongoing activities such as vaccine development strategies and a \"Full Vaccine Value Assessment\" that will inform the value proposition of an iNTS disease vaccine. This VVP was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships, and multi-lateral organizations, and in collaboration with stakeholders from the World Health Organization African Region. All contributors have extensive expertise on various elements of the iNTS disease VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using only existing and publicly available information.
摘要:
侵袭性非伤寒沙门氏菌(iNTS)是一种未被认可的高负担疾病,在撒哈拉以南非洲(sSA)引起重大的健康和社会经济问题。主要是免疫幼稚的婴儿和幼儿,包括那些公认的合并症,如艾滋病毒感染。iNTS病主要是由肠道沙门氏菌血清型鼠伤寒沙门氏菌序列型(ST)313和肠炎沙门氏菌ST11的非洲限制性进化枝引起的,它们是在非洲大陆出现的一系列与获得新的抗菌素耐药性相关的流行病。由于基因型具有高流行的抗菌素耐药性和治疗选择的稀缺性,这些NTS血清型被世界卫生组织指定为研究和开发干预措施的优先病原体,包括疫苗,解决和减少sSA中NTS相关的菌血症和脑膜炎。新的和传统的疫苗技术正在被用于开发针对iNTS疾病的疫苗,在婴儿目标人群中进行的首次临床试验的结果将在不久的将来获得。“疫苗价值概况”(VVP)主要涉及由肠炎沙门氏菌和sSA中流行的鼠伤寒沙门氏菌引起的侵袭性疾病。信息包括独立的iNTS疾病候选疫苗和针对iNTS疾病的候选疫苗结合另一种侵入性血清型,伤寒沙门氏菌,这在整个sSA中也很常见。本VVP第一版的范围之外是关于腹泻性NTS病(dNTS)也与肠炎沙门氏菌和鼠伤寒沙门氏菌相关的更广泛的讨论,或者针对全球使用的关键血清变型的多价沙门氏菌疫苗的开发。此VVP用于预防iNTS疾病的疫苗旨在提供高水平的,全面评估目前可用于潜在公共卫生的信息和数据,经济,以及管道疫苗和疫苗类产品的社会价值。该VVP的未来版本将进行更新,以反映正在进行的活动,例如疫苗开发策略和“全面疫苗价值评估”,这将为iNTS疾病疫苗的价值主张提供信息。这个VVP是由学术界的主题专家工作组开发的,非营利组织,公私伙伴关系,和多边组织,并与世界卫生组织非洲区域的利益攸关方合作。所有贡献者都对iNTS疾病VVP的各种要素具有广泛的专业知识,并共同旨在确定当前的研究和知识差距。VVP是仅使用现有的和公开的信息开发的。