Vaccine value profile for invasive non-typhoidal Salmonella disease

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. iNT...

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Published inVaccine 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
LanguageEnglish
Published Netherlands Elsevier Ltd 25.07.2024
Elsevier Limited
Subjects
HIV
R&D
sSA
VIS
DT
VVP
QC
Pf
Tfh
UN
MDR
CMI
WHO
IL
IM
AMR
MIC
GMP
IV
STm
EU
R&D
IVB
STy
IVI
IgA
PPC
TCV
IgG
NTS
CFR
IgM
LPS
C3
SBA
TPP
SEn
ST
HIC
OR
CI
XDR
CD4
HIV
CD8
VAF
NRA
EPI
PO
Online AccessGet full text
ISSN0264-410X
1873-2518
1873-2518
DOI10.1016/j.vaccine.2024.04.045

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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.
AbstractList 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.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.
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.
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.
AbstractInvasive 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.
Author Owusu-Dabo, Ellis
Marchello, Christian S.
Sikorski, Michael J.
Crump, John A.
Martin, Laura B.
Mogasale, Vittal
Tack, Bieke
Nyirenda, Tonney
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– sequence: 6
  givenname: Tonney
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  givenname: Vittal
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/39003017$$D View this record in MEDLINE/PubMed
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CitedBy_id crossref_primary_10_12677_acm_2025_151220
crossref_primary_10_1016_j_vaccine_2025_126913
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ContentType Journal Article
Copyright 2024
Copyright © 2024. Published by Elsevier Ltd.
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DOI 10.1016/j.vaccine.2024.04.045
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Pharmacy, Therapeutics, & Pharmacology
Public Health
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Journal Article
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Sun Feb 23 10:19:35 EST 2025
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IsDoiOpenAccess true
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Issue 19
Keywords 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
Language English
License Copyright © 2024. Published by Elsevier Ltd.
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SSID ssj0005319
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Snippet Invasive non-typhoidal Salmonella (iNTS) disease is an under-recognized high-burden disease causing major health and socioeconomic issues in sub-Saharan Africa...
AbstractInvasive non-typhoidal Salmonella (iNTS) disease is an under-recognized high-burden disease causing major health and socioeconomic issues in...
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elsevier
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SubjectTerms 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
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Title Vaccine value profile for invasive non-typhoidal Salmonella disease
URI https://www.clinicalkey.com/#!/content/1-s2.0-S0264410X24004705
https://www.clinicalkey.es/playcontent/1-s2.0-S0264410X24004705
https://dx.doi.org/10.1016/j.vaccine.2024.04.045
https://www.ncbi.nlm.nih.gov/pubmed/39003017
https://www.proquest.com/docview/3079783218
https://www.proquest.com/docview/3079956125
https://www.proquest.com/docview/3153681450
Volume 42
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