Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates

Autores
Bardach, Ariel Esteban; Berrueta, Amanda Mabel; Ciapponi, Agustín; Sambade, Juan M.; Castellana, Noelia; Ballivian Cuellar, Jamile Rusbania; Brizuela, Nicolás Martín; Caravario, Julieta; Comande, Daniel; Couto, Esteban Manuel; Mazzoni, Agustina; Ortega, Vanesa; Parker, Edward P. K.; Salva, Florencia; Stegelmann, Katharina; Schieffelin, John S.; Xiong, Xu; Stergachis, Andy; Munoz, Flor M.; Buekens, Pierre
Año de publicación
2025
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
AbstractBackgroundLassa fever (LF) is an acute viral hemorrhagic illness endemic in West Africa, representing significant public health challenges, particularly for pregnant persons and children who experience higher morbidity and mortality. Although several vaccine candidates are being developed, no LF vaccine has been licensed yet.MethodsWe conducted a living systematic review (LSR) of the literature to evaluate the safety, efficacy, effectiveness, and immunogenicity of LF vaccines. We performed biweekly searches in major biomedical databases, trial registries, preprint servers, and other sources. Eligible studies included preclinical studies, clinical trials, and observational studies published from January 2014 to April 2025. Reviewer pairs screened studies extracted data (REDCap), and assessed risk of bias independently. Data synthesis involved random-effects pairwise and proportion meta-analyses (R software), with GRADE assessment of evidence certainty. PROSPERO registries: (CRD42024514513; CRD42024516754).ResultsSearches retrieved 1423 records, including 51 studies, 2 clinical trials in adults involving 88 vaccinated persons, and 49 preclinical studies of 30 vaccine candidates. Trials evaluated Recombinant Measles-Vectored (MV-LASV) and Recombinant Vesicular Stomatitis Virus-based (rVSVΔG-LASV-GPC) LF vaccine candidates. No published clinical trials were found to evaluate LF vaccines in special populations such as pregnant persons, infants, children, or adolescents. Although injection site reactogenicity was reported, no vaccine-related serious adverse events (SAEs) were reported in study participants. Immunogenicity was robust in adults, with vaccines achieving around 95% seroconversion at 30 days. Preclinical data evaluated nine different platforms. Findings are disseminated via an interactive online dashboard (https://safeinpregnancy.org/living-systematic-review-lassa/).ConclusionCurrently, two LF vaccine candidates that have advanced to clinical trials exhibit high immunogenicity, but the safety profile in healthy adults is still limited. Clinical evidence in pregnant persons, infants, children, and adolescents is absent. Vaccine platforms of interest have been identified in preclinical studies, providing information on those that could advance to clinical studies.
Fil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Berrueta, Amanda Mabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Sambade, Juan M.. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Castellana, Noelia. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Ballivian Cuellar, Jamile Rusbania. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Brizuela, Nicolás Martín. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Caravario, Julieta. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Comande, Daniel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Couto, Esteban Manuel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Ortega, Vanesa. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Parker, Edward P. K.. The London School of Economics and Political Science; Reino Unido
Fil: Salva, Florencia. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Stegelmann, Katharina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Schieffelin, John S.. University of Tulane; Estados Unidos
Fil: Xiong, Xu. University of Tulane; Estados Unidos
Fil: Stergachis, Andy. University of Washington; Estados Unidos
Fil: Munoz, Flor M.. No especifíca;
Fil: Buekens, Pierre. University of Tulane; Estados Unidos
Materia
vaccines
lassa
systematic review
meta-analyses
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/291226

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network_name_str CONICET Digital (CONICET)
spelling Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidatesBardach, Ariel EstebanBerrueta, Amanda MabelCiapponi, AgustínSambade, Juan M.Castellana, NoeliaBallivian Cuellar, Jamile RusbaniaBrizuela, Nicolás MartínCaravario, JulietaComande, DanielCouto, Esteban ManuelMazzoni, AgustinaOrtega, VanesaParker, Edward P. K.Salva, FlorenciaStegelmann, KatharinaSchieffelin, John S.Xiong, XuStergachis, AndyMunoz, Flor M.Buekens, Pierrevaccineslassasystematic reviewmeta-analyseshttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3AbstractBackgroundLassa fever (LF) is an acute viral hemorrhagic illness endemic in West Africa, representing significant public health challenges, particularly for pregnant persons and children who experience higher morbidity and mortality. Although several vaccine candidates are being developed, no LF vaccine has been licensed yet.MethodsWe conducted a living systematic review (LSR) of the literature to evaluate the safety, efficacy, effectiveness, and immunogenicity of LF vaccines. We performed biweekly searches in major biomedical databases, trial registries, preprint servers, and other sources. Eligible studies included preclinical studies, clinical trials, and observational studies published from January 2014 to April 2025. Reviewer pairs screened studies extracted data (REDCap), and assessed risk of bias independently. Data synthesis involved random-effects pairwise and proportion meta-analyses (R software), with GRADE assessment of evidence certainty. PROSPERO registries: (CRD42024514513; CRD42024516754).ResultsSearches retrieved 1423 records, including 51 studies, 2 clinical trials in adults involving 88 vaccinated persons, and 49 preclinical studies of 30 vaccine candidates. Trials evaluated Recombinant Measles-Vectored (MV-LASV) and Recombinant Vesicular Stomatitis Virus-based (rVSVΔG-LASV-GPC) LF vaccine candidates. No published clinical trials were found to evaluate LF vaccines in special populations such as pregnant persons, infants, children, or adolescents. Although injection site reactogenicity was reported, no vaccine-related serious adverse events (SAEs) were reported in study participants. Immunogenicity was robust in adults, with vaccines achieving around 95% seroconversion at 30 days. Preclinical data evaluated nine different platforms. Findings are disseminated via an interactive online dashboard (https://safeinpregnancy.org/living-systematic-review-lassa/).ConclusionCurrently, two LF vaccine candidates that have advanced to clinical trials exhibit high immunogenicity, but the safety profile in healthy adults is still limited. Clinical evidence in pregnant persons, infants, children, and adolescents is absent. Vaccine platforms of interest have been identified in preclinical studies, providing information on those that could advance to clinical studies.Fil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Berrueta, Amanda Mabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Sambade, Juan M.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Castellana, Noelia. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Ballivian Cuellar, Jamile Rusbania. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Brizuela, Nicolás Martín. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Caravario, Julieta. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Comande, Daniel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Couto, Esteban Manuel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Ortega, Vanesa. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Parker, Edward P. K.. The London School of Economics and Political Science; Reino UnidoFil: Salva, Florencia. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Stegelmann, Katharina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Schieffelin, John S.. University of Tulane; Estados UnidosFil: Xiong, Xu. University of Tulane; Estados UnidosFil: Stergachis, Andy. University of Washington; Estados UnidosFil: Munoz, Flor M.. No especifíca;Fil: Buekens, Pierre. University of Tulane; Estados UnidosPublic Library of Science2025-12info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/291226Bardach, Ariel Esteban; Berrueta, Amanda Mabel; Ciapponi, Agustín; Sambade, Juan M.; Castellana, Noelia; et al.; Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates; Public Library of Science; Plos One; 20; 12; 12-2025; 1-161932-6203CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://dx.plos.org/10.1371/journal.pone.0338128info:eu-repo/semantics/altIdentifier/doi/10.1371/journal.pone.0338128info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2026-08-25T14:37:54Zoai:ri.conicet.gov.ar:11336/291226instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982026-08-25 14:37:55.255CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates
title Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates
spellingShingle Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates
Bardach, Ariel Esteban
vaccines
lassa
systematic review
meta-analyses
title_short Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates
title_full Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates
title_fullStr Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates
title_full_unstemmed Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates
title_sort Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates
dc.creator.none.fl_str_mv Bardach, Ariel Esteban
Berrueta, Amanda Mabel
Ciapponi, Agustín
Sambade, Juan M.
Castellana, Noelia
Ballivian Cuellar, Jamile Rusbania
Brizuela, Nicolás Martín
Caravario, Julieta
Comande, Daniel
Couto, Esteban Manuel
Mazzoni, Agustina
Ortega, Vanesa
Parker, Edward P. K.
Salva, Florencia
Stegelmann, Katharina
Schieffelin, John S.
Xiong, Xu
Stergachis, Andy
Munoz, Flor M.
Buekens, Pierre
author Bardach, Ariel Esteban
author_facet Bardach, Ariel Esteban
Berrueta, Amanda Mabel
Ciapponi, Agustín
Sambade, Juan M.
Castellana, Noelia
Ballivian Cuellar, Jamile Rusbania
Brizuela, Nicolás Martín
Caravario, Julieta
Comande, Daniel
Couto, Esteban Manuel
Mazzoni, Agustina
Ortega, Vanesa
Parker, Edward P. K.
Salva, Florencia
Stegelmann, Katharina
Schieffelin, John S.
Xiong, Xu
Stergachis, Andy
Munoz, Flor M.
Buekens, Pierre
author_role author
author2 Berrueta, Amanda Mabel
Ciapponi, Agustín
Sambade, Juan M.
Castellana, Noelia
Ballivian Cuellar, Jamile Rusbania
Brizuela, Nicolás Martín
Caravario, Julieta
Comande, Daniel
Couto, Esteban Manuel
Mazzoni, Agustina
Ortega, Vanesa
Parker, Edward P. K.
Salva, Florencia
Stegelmann, Katharina
Schieffelin, John S.
Xiong, Xu
Stergachis, Andy
Munoz, Flor M.
Buekens, Pierre
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv vaccines
lassa
systematic review
meta-analyses
topic vaccines
lassa
systematic review
meta-analyses
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv AbstractBackgroundLassa fever (LF) is an acute viral hemorrhagic illness endemic in West Africa, representing significant public health challenges, particularly for pregnant persons and children who experience higher morbidity and mortality. Although several vaccine candidates are being developed, no LF vaccine has been licensed yet.MethodsWe conducted a living systematic review (LSR) of the literature to evaluate the safety, efficacy, effectiveness, and immunogenicity of LF vaccines. We performed biweekly searches in major biomedical databases, trial registries, preprint servers, and other sources. Eligible studies included preclinical studies, clinical trials, and observational studies published from January 2014 to April 2025. Reviewer pairs screened studies extracted data (REDCap), and assessed risk of bias independently. Data synthesis involved random-effects pairwise and proportion meta-analyses (R software), with GRADE assessment of evidence certainty. PROSPERO registries: (CRD42024514513; CRD42024516754).ResultsSearches retrieved 1423 records, including 51 studies, 2 clinical trials in adults involving 88 vaccinated persons, and 49 preclinical studies of 30 vaccine candidates. Trials evaluated Recombinant Measles-Vectored (MV-LASV) and Recombinant Vesicular Stomatitis Virus-based (rVSVΔG-LASV-GPC) LF vaccine candidates. No published clinical trials were found to evaluate LF vaccines in special populations such as pregnant persons, infants, children, or adolescents. Although injection site reactogenicity was reported, no vaccine-related serious adverse events (SAEs) were reported in study participants. Immunogenicity was robust in adults, with vaccines achieving around 95% seroconversion at 30 days. Preclinical data evaluated nine different platforms. Findings are disseminated via an interactive online dashboard (https://safeinpregnancy.org/living-systematic-review-lassa/).ConclusionCurrently, two LF vaccine candidates that have advanced to clinical trials exhibit high immunogenicity, but the safety profile in healthy adults is still limited. Clinical evidence in pregnant persons, infants, children, and adolescents is absent. Vaccine platforms of interest have been identified in preclinical studies, providing information on those that could advance to clinical studies.
Fil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Berrueta, Amanda Mabel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Sambade, Juan M.. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Castellana, Noelia. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Ballivian Cuellar, Jamile Rusbania. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Brizuela, Nicolás Martín. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Caravario, Julieta. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Comande, Daniel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Couto, Esteban Manuel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Ortega, Vanesa. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Parker, Edward P. K.. The London School of Economics and Political Science; Reino Unido
Fil: Salva, Florencia. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Stegelmann, Katharina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Schieffelin, John S.. University of Tulane; Estados Unidos
Fil: Xiong, Xu. University of Tulane; Estados Unidos
Fil: Stergachis, Andy. University of Washington; Estados Unidos
Fil: Munoz, Flor M.. No especifíca;
Fil: Buekens, Pierre. University of Tulane; Estados Unidos
description AbstractBackgroundLassa fever (LF) is an acute viral hemorrhagic illness endemic in West Africa, representing significant public health challenges, particularly for pregnant persons and children who experience higher morbidity and mortality. Although several vaccine candidates are being developed, no LF vaccine has been licensed yet.MethodsWe conducted a living systematic review (LSR) of the literature to evaluate the safety, efficacy, effectiveness, and immunogenicity of LF vaccines. We performed biweekly searches in major biomedical databases, trial registries, preprint servers, and other sources. Eligible studies included preclinical studies, clinical trials, and observational studies published from January 2014 to April 2025. Reviewer pairs screened studies extracted data (REDCap), and assessed risk of bias independently. Data synthesis involved random-effects pairwise and proportion meta-analyses (R software), with GRADE assessment of evidence certainty. PROSPERO registries: (CRD42024514513; CRD42024516754).ResultsSearches retrieved 1423 records, including 51 studies, 2 clinical trials in adults involving 88 vaccinated persons, and 49 preclinical studies of 30 vaccine candidates. Trials evaluated Recombinant Measles-Vectored (MV-LASV) and Recombinant Vesicular Stomatitis Virus-based (rVSVΔG-LASV-GPC) LF vaccine candidates. No published clinical trials were found to evaluate LF vaccines in special populations such as pregnant persons, infants, children, or adolescents. Although injection site reactogenicity was reported, no vaccine-related serious adverse events (SAEs) were reported in study participants. Immunogenicity was robust in adults, with vaccines achieving around 95% seroconversion at 30 days. Preclinical data evaluated nine different platforms. Findings are disseminated via an interactive online dashboard (https://safeinpregnancy.org/living-systematic-review-lassa/).ConclusionCurrently, two LF vaccine candidates that have advanced to clinical trials exhibit high immunogenicity, but the safety profile in healthy adults is still limited. Clinical evidence in pregnant persons, infants, children, and adolescents is absent. Vaccine platforms of interest have been identified in preclinical studies, providing information on those that could advance to clinical studies.
publishDate 2025
dc.date.none.fl_str_mv 2025-12
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/291226
Bardach, Ariel Esteban; Berrueta, Amanda Mabel; Ciapponi, Agustín; Sambade, Juan M.; Castellana, Noelia; et al.; Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates; Public Library of Science; Plos One; 20; 12; 12-2025; 1-16
1932-6203
CONICET Digital
CONICET
url http://hdl.handle.net/11336/291226
identifier_str_mv Bardach, Ariel Esteban; Berrueta, Amanda Mabel; Ciapponi, Agustín; Sambade, Juan M.; Castellana, Noelia; et al.; Efficacy, safety, and immunogenicity of Lassa fever vaccines: A living systematic review and landscape analysis of vaccine candidates; Public Library of Science; Plos One; 20; 12; 12-2025; 1-16
1932-6203
CONICET Digital
CONICET
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