TY - JOUR
T1 - Vaccine value profile for enterotoxigenic Escherichia coli (ETEC)
AU - Khalil, Ibrahim
AU - Anderson, John D.
AU - Bagamian, Karoun H.
AU - Baqar, Shahida
AU - Giersing, Birgitte
AU - Hausdorff, William P.
AU - Marshall, Caroline
AU - Porter, Chad K.
AU - Walker, Richard I.
AU - Bourgeois, A. Louis
N1 - Funding Information:
This work was supported by the World Health Organization (WHO), Bill & Melinda Gates Foundation grant: INV-005318. Under the grant conditions of the Foundation, a Creative Commons Attribution 4.0 Generic License has already been assigned to the Author Accepted Manuscript version that might arise from this sumission.
Funding Information:
This supplement was sponsored by the World Health Organization’s Immunization, Vaccines, and Biologicals unit. The authors alone are responsible for the views expressed in each article and they do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated.
Publisher Copyright:
© 2023 The Authors
PY - 2023
Y1 - 2023
N2 - Enterotoxigenic Escherichia coli (ETEC) is one of the leading bacterial causes of diarrhoea, especially among children in low-resource settings, and travellers and military personnel from high-income countries. WHO's primary strategic goal for ETEC vaccine development is to develop a safe, effective, and affordable ETEC vaccine that reduces mortality and morbidity due to moderate-to-severe diarrhoeal disease in infants and children under 5 years of age in LMICs, as well as the long-term negative health impact on infant physical and cognitive development resulting from infection with this enteric pathogen. An effective ETEC vaccine will also likely reduce the need for antibiotic treatment and help limit the further emergence of antimicrobial resistance bacterial pathogens. The lead ETEC vaccine candidate, ETVAX, has shown field efficacy in travellers and has moved into field efficacy testing in LMIC infants and children. A Phase 3 efficacy study in LMIC infants is projected to start in 2024 and plans for a Phase 3 trial in travellers are under discussion with the U.S. FDA. Licensing for both travel and LMIC indications is projected to be feasible in the next 5–8 years. Given increasing recognition of its negative impact on child health and development in LMICs and predominance as the leading etiology of travellers’ diarrhoea (TD), a standalone vaccine for ETEC is more cost-effective than vaccines targeting other TD pathogens, and a viable commercial market also exists. In contrast, combination of an ETEC vaccine with other vaccines for childhood pathogens in LMICs would maximize protection in a more cost-effective manner than a series of stand-alone vaccines. This ‘Vaccine Value Profile’ (VVP) for ETEC is intended to provide a high-level, holistic assessment of available data to inform the potential public health, economic and societal value of pipeline vaccines and vaccine-like products. This VVP was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships, and multi-lateral organizations. All contributors have extensive expertise on various elements of the ETEC VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using only existing and publicly available information.
AB - Enterotoxigenic Escherichia coli (ETEC) is one of the leading bacterial causes of diarrhoea, especially among children in low-resource settings, and travellers and military personnel from high-income countries. WHO's primary strategic goal for ETEC vaccine development is to develop a safe, effective, and affordable ETEC vaccine that reduces mortality and morbidity due to moderate-to-severe diarrhoeal disease in infants and children under 5 years of age in LMICs, as well as the long-term negative health impact on infant physical and cognitive development resulting from infection with this enteric pathogen. An effective ETEC vaccine will also likely reduce the need for antibiotic treatment and help limit the further emergence of antimicrobial resistance bacterial pathogens. The lead ETEC vaccine candidate, ETVAX, has shown field efficacy in travellers and has moved into field efficacy testing in LMIC infants and children. A Phase 3 efficacy study in LMIC infants is projected to start in 2024 and plans for a Phase 3 trial in travellers are under discussion with the U.S. FDA. Licensing for both travel and LMIC indications is projected to be feasible in the next 5–8 years. Given increasing recognition of its negative impact on child health and development in LMICs and predominance as the leading etiology of travellers’ diarrhoea (TD), a standalone vaccine for ETEC is more cost-effective than vaccines targeting other TD pathogens, and a viable commercial market also exists. In contrast, combination of an ETEC vaccine with other vaccines for childhood pathogens in LMICs would maximize protection in a more cost-effective manner than a series of stand-alone vaccines. This ‘Vaccine Value Profile’ (VVP) for ETEC is intended to provide a high-level, holistic assessment of available data to inform the potential public health, economic and societal value of pipeline vaccines and vaccine-like products. This VVP was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships, and multi-lateral organizations. All contributors have extensive expertise on various elements of the ETEC VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using only existing and publicly available information.
KW - Clinical development
KW - Clinical research
KW - Epidemiology
KW - ETEC
KW - LMIC
KW - Vaccine
KW - Vaccine Value
UR - http://www.scopus.com/inward/record.url?scp=85174692332&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2023.02.011
DO - 10.1016/j.vaccine.2023.02.011
M3 - Article
AN - SCOPUS:85174692332
SN - 0264-410X
JO - Vaccine
JF - Vaccine
ER -