Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study

Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Ilaria Galgani [verfasserIn] Margherita Annaratone [verfasserIn] Daniela Casula [verfasserIn] Gennaro Di Maro [verfasserIn] Michel Janssens [verfasserIn] Annaelisa Tasciotti [verfasserIn] Tino Schwarz [verfasserIn] Murdo Ferguson [verfasserIn] Ashwani Kumar Arora [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	Non-typeable Haemophilus influenzae Moraxella catarrhalis COPD Exacerbation Vaccination Immunogenicity

Übergeordnetes Werk:	In: Respiratory Research - BMC, 2003, 23(2022), 1, Seite 13
Übergeordnetes Werk:	volume:23 ; year:2022 ; number:1 ; pages:13

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/s12931-022-02019-4

Katalog-ID:	DOAJ041177363

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245	1	0	\|a Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study
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520			\|a Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018.
650		4	\|a Non-typeable Haemophilus influenzae
650		4	\|a Moraxella catarrhalis
650		4	\|a COPD
650		4	\|a Exacerbation
650		4	\|a Vaccination
650		4	\|a Immunogenicity
653		0	\|a Diseases of the respiratory system
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700	0		\|a Michel Janssens \|e verfasserin \|4 aut
700	0		\|a Annaelisa Tasciotti \|e verfasserin \|4 aut
700	0		\|a Tino Schwarz \|e verfasserin \|4 aut
700	0		\|a Murdo Ferguson \|e verfasserin \|4 aut
700	0		\|a Ashwani Kumar Arora \|e verfasserin \|4 aut
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allfields	10.1186/s12931-022-02019-4 doi (DE-627)DOAJ041177363 (DE-599)DOAJfc1514b4d48c4189934eed3b948d783f DE-627 ger DE-627 rakwb eng RC705-779 Ilaria Galgani verfasserin aut Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018. Non-typeable Haemophilus influenzae Moraxella catarrhalis COPD Exacerbation Vaccination Immunogenicity Diseases of the respiratory system Margherita Annaratone verfasserin aut Daniela Casula verfasserin aut Gennaro Di Maro verfasserin aut Michel Janssens verfasserin aut Annaelisa Tasciotti verfasserin aut Tino Schwarz verfasserin aut Murdo Ferguson verfasserin aut Ashwani Kumar Arora verfasserin aut In Respiratory Research BMC, 2003 23(2022), 1, Seite 13 (DE-627)326646485 (DE-600)2041675-1 1465993X nnns volume:23 year:2022 number:1 pages:13 https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/article/fc1514b4d48c4189934eed3b948d783f kostenfrei https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/toc/1465-993X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13
spelling	10.1186/s12931-022-02019-4 doi (DE-627)DOAJ041177363 (DE-599)DOAJfc1514b4d48c4189934eed3b948d783f DE-627 ger DE-627 rakwb eng RC705-779 Ilaria Galgani verfasserin aut Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018. Non-typeable Haemophilus influenzae Moraxella catarrhalis COPD Exacerbation Vaccination Immunogenicity Diseases of the respiratory system Margherita Annaratone verfasserin aut Daniela Casula verfasserin aut Gennaro Di Maro verfasserin aut Michel Janssens verfasserin aut Annaelisa Tasciotti verfasserin aut Tino Schwarz verfasserin aut Murdo Ferguson verfasserin aut Ashwani Kumar Arora verfasserin aut In Respiratory Research BMC, 2003 23(2022), 1, Seite 13 (DE-627)326646485 (DE-600)2041675-1 1465993X nnns volume:23 year:2022 number:1 pages:13 https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/article/fc1514b4d48c4189934eed3b948d783f kostenfrei https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/toc/1465-993X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13
allfields_unstemmed	10.1186/s12931-022-02019-4 doi (DE-627)DOAJ041177363 (DE-599)DOAJfc1514b4d48c4189934eed3b948d783f DE-627 ger DE-627 rakwb eng RC705-779 Ilaria Galgani verfasserin aut Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018. Non-typeable Haemophilus influenzae Moraxella catarrhalis COPD Exacerbation Vaccination Immunogenicity Diseases of the respiratory system Margherita Annaratone verfasserin aut Daniela Casula verfasserin aut Gennaro Di Maro verfasserin aut Michel Janssens verfasserin aut Annaelisa Tasciotti verfasserin aut Tino Schwarz verfasserin aut Murdo Ferguson verfasserin aut Ashwani Kumar Arora verfasserin aut In Respiratory Research BMC, 2003 23(2022), 1, Seite 13 (DE-627)326646485 (DE-600)2041675-1 1465993X nnns volume:23 year:2022 number:1 pages:13 https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/article/fc1514b4d48c4189934eed3b948d783f kostenfrei https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/toc/1465-993X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13
allfieldsGer	10.1186/s12931-022-02019-4 doi (DE-627)DOAJ041177363 (DE-599)DOAJfc1514b4d48c4189934eed3b948d783f DE-627 ger DE-627 rakwb eng RC705-779 Ilaria Galgani verfasserin aut Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018. Non-typeable Haemophilus influenzae Moraxella catarrhalis COPD Exacerbation Vaccination Immunogenicity Diseases of the respiratory system Margherita Annaratone verfasserin aut Daniela Casula verfasserin aut Gennaro Di Maro verfasserin aut Michel Janssens verfasserin aut Annaelisa Tasciotti verfasserin aut Tino Schwarz verfasserin aut Murdo Ferguson verfasserin aut Ashwani Kumar Arora verfasserin aut In Respiratory Research BMC, 2003 23(2022), 1, Seite 13 (DE-627)326646485 (DE-600)2041675-1 1465993X nnns volume:23 year:2022 number:1 pages:13 https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/article/fc1514b4d48c4189934eed3b948d783f kostenfrei https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/toc/1465-993X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13
allfieldsSound	10.1186/s12931-022-02019-4 doi (DE-627)DOAJ041177363 (DE-599)DOAJfc1514b4d48c4189934eed3b948d783f DE-627 ger DE-627 rakwb eng RC705-779 Ilaria Galgani verfasserin aut Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018. Non-typeable Haemophilus influenzae Moraxella catarrhalis COPD Exacerbation Vaccination Immunogenicity Diseases of the respiratory system Margherita Annaratone verfasserin aut Daniela Casula verfasserin aut Gennaro Di Maro verfasserin aut Michel Janssens verfasserin aut Annaelisa Tasciotti verfasserin aut Tino Schwarz verfasserin aut Murdo Ferguson verfasserin aut Ashwani Kumar Arora verfasserin aut In Respiratory Research BMC, 2003 23(2022), 1, Seite 13 (DE-627)326646485 (DE-600)2041675-1 1465993X nnns volume:23 year:2022 number:1 pages:13 https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/article/fc1514b4d48c4189934eed3b948d783f kostenfrei https://doi.org/10.1186/s12931-022-02019-4 kostenfrei https://doaj.org/toc/1465-993X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA 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_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 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_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 13
language	English
source	In Respiratory Research 23(2022), 1, Seite 13 volume:23 year:2022 number:1 pages:13
sourceStr	In Respiratory Research 23(2022), 1, Seite 13 volume:23 year:2022 number:1 pages:13
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Non-typeable Haemophilus influenzae Moraxella catarrhalis COPD Exacerbation Vaccination Immunogenicity Diseases of the respiratory system
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authorswithroles_txt_mv	Ilaria Galgani @@aut@@ Margherita Annaratone @@aut@@ Daniela Casula @@aut@@ Gennaro Di Maro @@aut@@ Michel Janssens @@aut@@ Annaelisa Tasciotti @@aut@@ Tino Schwarz @@aut@@ Murdo Ferguson @@aut@@ Ashwani Kumar Arora @@aut@@
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Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. 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callnumber-first	R - Medicine
author	Ilaria Galgani
spellingShingle	Ilaria Galgani misc RC705-779 misc Non-typeable Haemophilus influenzae misc Moraxella catarrhalis misc COPD misc Exacerbation misc Vaccination misc Immunogenicity misc Diseases of the respiratory system Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study
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topic_title	RC705-779 Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study Non-typeable Haemophilus influenzae Moraxella catarrhalis COPD Exacerbation Vaccination Immunogenicity
topic	misc RC705-779 misc Non-typeable Haemophilus influenzae misc Moraxella catarrhalis misc COPD misc Exacerbation misc Vaccination misc Immunogenicity misc Diseases of the respiratory system
topic_unstemmed	misc RC705-779 misc Non-typeable Haemophilus influenzae misc Moraxella catarrhalis misc COPD misc Exacerbation misc Vaccination misc Immunogenicity misc Diseases of the respiratory system
topic_browse	misc RC705-779 misc Non-typeable Haemophilus influenzae misc Moraxella catarrhalis misc COPD misc Exacerbation misc Vaccination misc Immunogenicity misc Diseases of the respiratory system
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title	Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study
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title_full	Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study
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author_browse	Ilaria Galgani Margherita Annaratone Daniela Casula Gennaro Di Maro Michel Janssens Annaelisa Tasciotti Tino Schwarz Murdo Ferguson Ashwani Kumar Arora
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title_sort	safety and immunogenicity of three doses of non-typeable haemophilus influenzae-moraxella catarrhalis (nthi-mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study
callnumber	RC705-779
title_auth	Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study
abstract	Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018.
abstractGer	Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018.
abstract_unstemmed	Abstract Background Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections are frequently associated with exacerbations of chronic obstructive pulmonary disease (COPD). Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018.
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container_issue	1
title_short	Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study
url	https://doi.org/10.1186/s12931-022-02019-4 https://doaj.org/article/fc1514b4d48c4189934eed3b948d783f https://doaj.org/toc/1465-993X
remote_bool	true
author2	Margherita Annaratone Daniela Casula Gennaro Di Maro Michel Janssens Annaelisa Tasciotti Tino Schwarz Murdo Ferguson Ashwani Kumar Arora
author2Str	Margherita Annaratone Daniela Casula Gennaro Di Maro Michel Janssens Annaelisa Tasciotti Tino Schwarz Murdo Ferguson Ashwani Kumar Arora
ppnlink	326646485
callnumber-subject	RC - Internal Medicine
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isOA_txt	true
hochschulschrift_bool	false
doi_str	10.1186/s12931-022-02019-4
callnumber-a	RC705-779
up_date	2024-07-03T18:50:02.002Z
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Results were reported with a two-dose (0–2 months) schedule of an investigational AS01E-adjuvanted NTHi-Mcat vaccine containing three surface proteins from NTHi and one from Mcat. We evaluated the safety and immunogenicity of three NTHi-Mcat vaccine doses administered in two different schedules to adults with a smoking history (≥ 10 pack-years), immunologically representing the COPD population. Methods In this 18-month, randomised (1:1), observer-blind study with 6-month open follow-up, 200 healthy adults aged 40–80 years received NTHi-Mcat vaccine at 0–2–6 months and placebo at 12 months (0–2–6 group), or vaccine at 0–2–12 months and placebo at 6 months (0–2–12 group). Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days, respectively, post-vaccination, and potential immune-mediated diseases (pIMDs) and serious AEs (SAEs) throughout the study. Immune responses were assessed. Results No safety concerns were identified with the third vaccine dose or overall. Most solicited AEs were mild/moderate. Unsolicited AEs were reported in 16%, 16.1% and 14.4% of participants in the 0–2–6 group post-dose 1, 2 and 3, respectively, and 20%, 20.4% and 9.7%, respectively, in the 0–2–12 group. In 24 months, SAEs were reported in 12 participants in the 0–2–6 group and 9 in the 0–2–12 group (18 events in each group). There were three deaths (unknown cause, 0–2–6 group; myocardial infarction, lung cancer in 0–2–12 group). pIMDs were reported in three participants in the 0–2–6 group (non-serious inflammatory bowel disease, gout, psoriasis) and three in the 0–2–12 group (serious ulcerative colitis, two with non-serious gout). The SAEs, deaths and pIMDs were considered not causally related to vaccination. Antigen-specific antibody concentrations were higher at 12 months post-dose 1 with the 0–2–6 schedule than with the 0–2–12 schedule and at 12 months post-dose 3 were similar between schedules, remaining higher than baseline. Conclusions No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0–2–6 months or 0–2–12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. 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Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study

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