Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial

Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We condu...
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Autor*in:	Katia Abarca [verfasserIn] Emma Rey-Jurado [verfasserIn] Natalia Muñoz-Durango [verfasserIn] Yaneisi Vázquez [verfasserIn] Jorge A. Soto [verfasserIn] Nicolás M.S. Gálvez [verfasserIn] Javier Valdés-Ferrada [verfasserIn] Carolina Iturriaga [verfasserIn] Marcela Urzúa [verfasserIn] Arturo Borzutzky [verfasserIn] Jaime Cerda [verfasserIn] Luis Villarroel [verfasserIn] Victoria Madrid [verfasserIn] Pablo A. González [verfasserIn] José V. González-Aramundiz [verfasserIn] Susan M. Bueno [verfasserIn] Alexis M. Kalergis [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Schlagwörter:	Human respiratory syncytial virus BCG vaccine Phase I clinical trial Safety Transmissibility Immunogenicity

Übergeordnetes Werk:	In: EClinicalMedicine - Elsevier, 2018, 27(2020), Seite 100517-
Übergeordnetes Werk:	volume:27 ; year:2020 ; pages:100517-

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1016/j.eclinm.2020.100517

Katalog-ID:	DOAJ048220361

Internformat


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520			\|a Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098.
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650		4	\|a Immunogenicity
653		0	\|a Medicine (General)
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700	0		\|a Natalia Muñoz-Durango \|e verfasserin \|4 aut
700	0		\|a Yaneisi Vázquez \|e verfasserin \|4 aut
700	0		\|a Jorge A. Soto \|e verfasserin \|4 aut
700	0		\|a Nicolás M.S. Gálvez \|e verfasserin \|4 aut
700	0		\|a Javier Valdés-Ferrada \|e verfasserin \|4 aut
700	0		\|a Carolina Iturriaga \|e verfasserin \|4 aut
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700	0		\|a Arturo Borzutzky \|e verfasserin \|4 aut
700	0		\|a Jaime Cerda \|e verfasserin \|4 aut
700	0		\|a Luis Villarroel \|e verfasserin \|4 aut
700	0		\|a Victoria Madrid \|e verfasserin \|4 aut
700	0		\|a Pablo A. González \|e verfasserin \|4 aut
700	0		\|a José V. González-Aramundiz \|e verfasserin \|4 aut
700	0		\|a Susan M. Bueno \|e verfasserin \|4 aut
700	0		\|a Alexis M. Kalergis \|e verfasserin \|4 aut
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allfields	10.1016/j.eclinm.2020.100517 doi (DE-627)DOAJ048220361 (DE-599)DOAJ137eebfd82344a5b8e4a0a28a136c4d8 DE-627 ger DE-627 rakwb eng R5-920 Katia Abarca verfasserin aut Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098. Human respiratory syncytial virus BCG vaccine Phase I clinical trial Safety Transmissibility Immunogenicity Medicine (General) Emma Rey-Jurado verfasserin aut Natalia Muñoz-Durango verfasserin aut Yaneisi Vázquez verfasserin aut Jorge A. Soto verfasserin aut Nicolás M.S. Gálvez verfasserin aut Javier Valdés-Ferrada verfasserin aut Carolina Iturriaga verfasserin aut Marcela Urzúa verfasserin aut Arturo Borzutzky verfasserin aut Jaime Cerda verfasserin aut Luis Villarroel verfasserin aut Victoria Madrid verfasserin aut Pablo A. González verfasserin aut José V. González-Aramundiz verfasserin aut Susan M. Bueno verfasserin aut Alexis M. Kalergis verfasserin aut In EClinicalMedicine Elsevier, 2018 27(2020), Seite 100517- (DE-627)1035271834 25895370 nnns volume:27 year:2020 pages:100517- https://doi.org/10.1016/j.eclinm.2020.100517 kostenfrei https://doaj.org/article/137eebfd82344a5b8e4a0a28a136c4d8 kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537020302613 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 27 2020 100517-
spelling	10.1016/j.eclinm.2020.100517 doi (DE-627)DOAJ048220361 (DE-599)DOAJ137eebfd82344a5b8e4a0a28a136c4d8 DE-627 ger DE-627 rakwb eng R5-920 Katia Abarca verfasserin aut Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098. Human respiratory syncytial virus BCG vaccine Phase I clinical trial Safety Transmissibility Immunogenicity Medicine (General) Emma Rey-Jurado verfasserin aut Natalia Muñoz-Durango verfasserin aut Yaneisi Vázquez verfasserin aut Jorge A. Soto verfasserin aut Nicolás M.S. Gálvez verfasserin aut Javier Valdés-Ferrada verfasserin aut Carolina Iturriaga verfasserin aut Marcela Urzúa verfasserin aut Arturo Borzutzky verfasserin aut Jaime Cerda verfasserin aut Luis Villarroel verfasserin aut Victoria Madrid verfasserin aut Pablo A. González verfasserin aut José V. González-Aramundiz verfasserin aut Susan M. Bueno verfasserin aut Alexis M. Kalergis verfasserin aut In EClinicalMedicine Elsevier, 2018 27(2020), Seite 100517- (DE-627)1035271834 25895370 nnns volume:27 year:2020 pages:100517- https://doi.org/10.1016/j.eclinm.2020.100517 kostenfrei https://doaj.org/article/137eebfd82344a5b8e4a0a28a136c4d8 kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537020302613 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 27 2020 100517-
allfields_unstemmed	10.1016/j.eclinm.2020.100517 doi (DE-627)DOAJ048220361 (DE-599)DOAJ137eebfd82344a5b8e4a0a28a136c4d8 DE-627 ger DE-627 rakwb eng R5-920 Katia Abarca verfasserin aut Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098. Human respiratory syncytial virus BCG vaccine Phase I clinical trial Safety Transmissibility Immunogenicity Medicine (General) Emma Rey-Jurado verfasserin aut Natalia Muñoz-Durango verfasserin aut Yaneisi Vázquez verfasserin aut Jorge A. Soto verfasserin aut Nicolás M.S. Gálvez verfasserin aut Javier Valdés-Ferrada verfasserin aut Carolina Iturriaga verfasserin aut Marcela Urzúa verfasserin aut Arturo Borzutzky verfasserin aut Jaime Cerda verfasserin aut Luis Villarroel verfasserin aut Victoria Madrid verfasserin aut Pablo A. González verfasserin aut José V. González-Aramundiz verfasserin aut Susan M. Bueno verfasserin aut Alexis M. Kalergis verfasserin aut In EClinicalMedicine Elsevier, 2018 27(2020), Seite 100517- (DE-627)1035271834 25895370 nnns volume:27 year:2020 pages:100517- https://doi.org/10.1016/j.eclinm.2020.100517 kostenfrei https://doaj.org/article/137eebfd82344a5b8e4a0a28a136c4d8 kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537020302613 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 27 2020 100517-
allfieldsGer	10.1016/j.eclinm.2020.100517 doi (DE-627)DOAJ048220361 (DE-599)DOAJ137eebfd82344a5b8e4a0a28a136c4d8 DE-627 ger DE-627 rakwb eng R5-920 Katia Abarca verfasserin aut Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098. Human respiratory syncytial virus BCG vaccine Phase I clinical trial Safety Transmissibility Immunogenicity Medicine (General) Emma Rey-Jurado verfasserin aut Natalia Muñoz-Durango verfasserin aut Yaneisi Vázquez verfasserin aut Jorge A. Soto verfasserin aut Nicolás M.S. Gálvez verfasserin aut Javier Valdés-Ferrada verfasserin aut Carolina Iturriaga verfasserin aut Marcela Urzúa verfasserin aut Arturo Borzutzky verfasserin aut Jaime Cerda verfasserin aut Luis Villarroel verfasserin aut Victoria Madrid verfasserin aut Pablo A. González verfasserin aut José V. González-Aramundiz verfasserin aut Susan M. Bueno verfasserin aut Alexis M. Kalergis verfasserin aut In EClinicalMedicine Elsevier, 2018 27(2020), Seite 100517- (DE-627)1035271834 25895370 nnns volume:27 year:2020 pages:100517- https://doi.org/10.1016/j.eclinm.2020.100517 kostenfrei https://doaj.org/article/137eebfd82344a5b8e4a0a28a136c4d8 kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537020302613 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 27 2020 100517-
allfieldsSound	10.1016/j.eclinm.2020.100517 doi (DE-627)DOAJ048220361 (DE-599)DOAJ137eebfd82344a5b8e4a0a28a136c4d8 DE-627 ger DE-627 rakwb eng R5-920 Katia Abarca verfasserin aut Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098. Human respiratory syncytial virus BCG vaccine Phase I clinical trial Safety Transmissibility Immunogenicity Medicine (General) Emma Rey-Jurado verfasserin aut Natalia Muñoz-Durango verfasserin aut Yaneisi Vázquez verfasserin aut Jorge A. Soto verfasserin aut Nicolás M.S. Gálvez verfasserin aut Javier Valdés-Ferrada verfasserin aut Carolina Iturriaga verfasserin aut Marcela Urzúa verfasserin aut Arturo Borzutzky verfasserin aut Jaime Cerda verfasserin aut Luis Villarroel verfasserin aut Victoria Madrid verfasserin aut Pablo A. González verfasserin aut José V. González-Aramundiz verfasserin aut Susan M. Bueno verfasserin aut Alexis M. Kalergis verfasserin aut In EClinicalMedicine Elsevier, 2018 27(2020), Seite 100517- (DE-627)1035271834 25895370 nnns volume:27 year:2020 pages:100517- https://doi.org/10.1016/j.eclinm.2020.100517 kostenfrei https://doaj.org/article/137eebfd82344a5b8e4a0a28a136c4d8 kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537020302613 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 27 2020 100517-
language	English
source	In EClinicalMedicine 27(2020), Seite 100517- volume:27 year:2020 pages:100517-
sourceStr	In EClinicalMedicine 27(2020), Seite 100517- volume:27 year:2020 pages:100517-
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Human respiratory syncytial virus BCG vaccine Phase I clinical trial Safety Transmissibility Immunogenicity Medicine (General)
isfreeaccess_bool	true
container_title	EClinicalMedicine
authorswithroles_txt_mv	Katia Abarca @@aut@@ Emma Rey-Jurado @@aut@@ Natalia Muñoz-Durango @@aut@@ Yaneisi Vázquez @@aut@@ Jorge A. Soto @@aut@@ Nicolás M.S. Gálvez @@aut@@ Javier Valdés-Ferrada @@aut@@ Carolina Iturriaga @@aut@@ Marcela Urzúa @@aut@@ Arturo Borzutzky @@aut@@ Jaime Cerda @@aut@@ Luis Villarroel @@aut@@ Victoria Madrid @@aut@@ Pablo A. González @@aut@@ José V. González-Aramundiz @@aut@@ Susan M. Bueno @@aut@@ Alexis M. Kalergis @@aut@@
publishDateDaySort_date	2020-01-01T00:00:00Z
hierarchy_top_id	1035271834
id	DOAJ048220361
language_de	englisch
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callnumber-first	R - Medicine
author	Katia Abarca
spellingShingle	Katia Abarca misc R5-920 misc Human respiratory syncytial virus misc BCG vaccine misc Phase I clinical trial misc Safety misc Transmissibility misc Immunogenicity misc Medicine (General) Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial
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topic_title	R5-920 Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial Human respiratory syncytial virus BCG vaccine Phase I clinical trial Safety Transmissibility Immunogenicity
topic	misc R5-920 misc Human respiratory syncytial virus misc BCG vaccine misc Phase I clinical trial misc Safety misc Transmissibility misc Immunogenicity misc Medicine (General)
topic_unstemmed	misc R5-920 misc Human respiratory syncytial virus misc BCG vaccine misc Phase I clinical trial misc Safety misc Transmissibility misc Immunogenicity misc Medicine (General)
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title	Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial
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title_full	Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial
author_sort	Katia Abarca
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author_browse	Katia Abarca Emma Rey-Jurado Natalia Muñoz-Durango Yaneisi Vázquez Jorge A. Soto Nicolás M.S. Gálvez Javier Valdés-Ferrada Carolina Iturriaga Marcela Urzúa Arturo Borzutzky Jaime Cerda Luis Villarroel Victoria Madrid Pablo A. González José V. González-Aramundiz Susan M. Bueno Alexis M. Kalergis
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title_sort	safety and immunogenicity evaluation of recombinant bcg vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase i clinical trial
callnumber	R5-920
title_auth	Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial
abstract	Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098.
abstractGer	Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098.
abstract_unstemmed	Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. Funding: This work was supported by Millennium Institute on Immunology and Immunotherapy from Chile (P09/016), FONDECYT 1190830, and FONDEF D11E1098.
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title_short	Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial
url	https://doi.org/10.1016/j.eclinm.2020.100517 https://doaj.org/article/137eebfd82344a5b8e4a0a28a136c4d8 http://www.sciencedirect.com/science/article/pii/S2589537020302613 https://doaj.org/toc/2589-5370
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up_date	2024-07-03T16:35:43.994Z
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ048220361</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230308133333.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230227s2020 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.eclinm.2020.100517</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ048220361</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJ137eebfd82344a5b8e4a0a28a136c4d8</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">R5-920</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Katia Abarca</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2020</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV). Once inclusion criteria were met, volunteers were enrolled in three cohorts in an open and successive design. Each cohort included six volunteers vaccinated with 5 × 103, 5 × 104, or 1 × 105 CFU, as well as two volunteers vaccinated with the full dose of the standard BCG vaccine. This clinical trial (clinicaltrials.gov NCT03213405) was conducted in Santiago, Chile. Findings: The rBCG-N-RSV vaccine was safe, well-tolerated, and no serious adverse events related to the vaccine were recorded. Serum IgG-antibodies directed against Mycobacterium and the N-protein of RSV increased after vaccination, which were capable of neutralizing RSV in vitro. Additionally, all volunteers displayed increased cellular response consisting of IFN-γ and IL-2 production against PPD and the N-protein, starting at day 14 and 30 post-vaccination respectively. Interpretation: The rBCG-N-hRSV vaccine had a good safety profile and induced specific cellular and humoral responses. 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Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial

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