Vaccine value profile for invasive non-typhoidal Salmonella disease

• Published in: Vaccine Vol. 42; no. 19; pp. S101 - S124
• Main Authors: Martin, Laura B., Tack, Bieke, Marchello, Christian S., Sikorski, Michael J., Owusu-Dabo, Ellis, Nyirenda, Tonney, Mogasale, Vittal, Crump, John A.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 25.07.2024; Elsevier Limited
• Subjects: Africa South of the Sahara - epidemiology; Allergy and Immunology; antibiotic resistance; Antimicrobial agents; Antimicrobial resistance; Bacteremia; Clinical trials; Combined vaccines; Comorbidity; Development strategies; Disease prevention; Drug resistance; Epidemiology; Fever; Genotypes; HIV; HIV infections; Human immunodeficiency virus; Humans; Illnesses; Infants; Infections; iNTS; Invasive non-typhoidal Salmonella; Malaria; Malnutrition; Meningitis; Nonprofit organizations; Organizations; Pathogens; Population-based studies; Public health; Public private partnerships; Quality control; R&D; Research & development; research and development; Risk factors; Salmonella; Salmonella Enteritidis; Salmonella enteritidis - genetics; Salmonella enteritidis - immunology; Salmonella enteritidis - pathogenicity; Salmonella Infections - epidemiology; Salmonella Infections - immunology; Salmonella Infections - microbiology; Salmonella Infections - prevention & control; Salmonella Typhi; Salmonella Typhimurium; Salmonella typhimurium - genetics; Salmonella typhimurium - immunology; Salmonella typhimurium - pathogenicity; Salmonella Vaccines - administration & dosage; Salmonella Vaccines - immunology; serotypes; social benefit; stakeholders; Sub-Saharan Africa; Surveillance; therapeutics; Tropical diseases; Typhoid; Vaccine; Vaccine development; Vaccine value profile; Vaccines; Virulence; World Health Organization; Africa South of the Sahara; Zambia; Nigeria; Kenya; Africa; Sub-Saharan Africa; sSA; VIS; AVAREF; PDVAC; SAGE; NARMS; DT; VVP; QC; FERG; TSCV; Pf; WaSH; Tfh; SETA; UN; MDR; Th17; CMI; WHO; IL; IM; AMR; MIC; GMP; IV; STm; UNICEF; US CDC; EU; R&D; NITAG; IVB; MAPS; Vaccine value profile; STy; IVI; ELISA; IgA; PPC; DCVMN; ECBI; RITAG; TCV; dNTS; IgG; NTS; Invasive non-typhoidal Salmonella; CFR; IgM; LPS; C3; GLASS; SBA; DALY; IHME; TPP; CHIM; LANT; FVVA; GMMA; SEn; PTRS; ST; HIC; OR; PAHO RF; CI; Treg; XDR; Vaccine; COPS; CD4; HIV; iNTS; CD8; LMIC; iTPP; VAF; NRA; EPI; PO; Full value of vaccine assessment; National regulatory authority; Global Anti-Microbial Resistance and Use Surveillance System of WHO; Intramuscular administration; Per os, oral administration; T-follicular helper cell; Multiple antigen presenting system; High-income country; United States Centers for Disease Control and Prevention; World Health Organization; Case fatality ratio; Minimum inhibitory concentration; Human immunodeficiency virus; United Nations Children's Fund (originally known as the United Nations International Children's Emergency Fund); Core O-polysaccharide of LPS; Intervention target product profile; Cell-mediated immunity; Serum bactericidal activity; Non-typhoidal Salmonella; Preferred product characteristics; Water, sanitation and hygiene; International Vaccine Institute, (Seoul,South Korea); Controlled human infection model; Expanded Programme on Immunization; European Union; Sequnce type; Intravenous administration; United Nations; Vaccine investment strategy, Gavi; Diarrheagenic non-typhoidal Salmonella; Generalized modules for membrane antigens; Salmonella enterica serovar Typhimurium, Salmonella Typhimurium; Lipopolysaccharide; Pan American Health Organization revolving fund; Salmonella enterica serovar Enteritidis, Salmonella Enteritidis; Trivalent Salmonella conjugate vaccine; Typhoid conjugate vaccine ( Salmonella Typhi Vi-polysaccharide conjugated to a carrier protein); Product Development for Vaccines Advisory Committeeof WHO; Cluster of differentiation 4; National Antimicrobial Resistance Monitoring System of U.S. Food and Drug Administration; Quality control; Regulatory T cell; African Vaccine Regulatory Forum; Cluster of differentiation 8; Disability-adjusted life years; Developing Countries Vaccine Manufacturers Network; Immunoglobulin M; Good manufacturing practice; Extensive drug resistance; Immunoglobulin G; Interleukin; Vaccine value profile, developed by WHO; Live attenuated non-transmissible; Immunoglobulin A; Plasmodium falciparum, P. falciparum; Research and development; National Immunization Technical Advisory Groups of WHO; sub-Saharan Africa; Regional Immunization Technical Advisory Group of WHO; Target product profile; Foodborne Disease Burden Epidemiology Research Group of WHO; Salmonella enterica serovar Typhi, Salmonella Typhi; Enzyme-linked immunosorbent assay; Probability of technical and regulatory success; Diphtheria toxoid; Institute of Health Metrics and Evaluation, University of Washington; Low- and middle-income country; Strategic Advisory Group of Experts on Immunization of WHO; Multidrug resistant; Complement component 3; T-helper 17 cell; Confidence interval; Severe typhoid in Africa program; Immunization, Vaccines and Biologicals department of WHO; Odds ratio; Antimicrobial resistance; Value attribution framework, developed by WHO; Expert Committee on Biological Standarization
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2024.04.045

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.