Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial
A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines contain...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Ilaria Galgani [verfasserIn] Airi Põder [verfasserIn] Rain Jõgi [verfasserIn] Veli-Jukka Anttila [verfasserIn] Stefano Milleri [verfasserIn] Alberto M. Borobia [verfasserIn] Odile Launay [verfasserIn] Marco Testa [verfasserIn] Daniela Casula [verfasserIn] Luca Grassano [verfasserIn] Annaelisa Tasciotti [verfasserIn] Marie Dozot [verfasserIn] Ashwani K. Arora [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Schlagwörter: |
non-typable haemophilus influenzae |
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| Übergeordnetes Werk: |
In: Human Vaccines & Immunotherapeutics - Taylor & Francis Group, 2022, 19(2023), 1 |
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| Übergeordnetes Werk: |
volume:19 ; year:2023 ; number:1 |
| Links: |
Link aufrufen |
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| DOI / URN: |
10.1080/21645515.2023.2187194 |
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| Katalog-ID: |
DOAJ090686187 |
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| 245 | 1 | 0 | |a Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial |
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| 520 | |a A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines containing the same AS01-adjuvant system could lead to immune interference. We compared administration of NTHi-Mcat following AS01-adjuvanted recombinant zoster vaccine (RZV) versus NTHi-Mcat alone. This phase 2a, open-label trial (NCT03894969) randomized healthy current or former smokers (50–80 years) without COPD to administration of NTHi-Mcat at 1, 3 or 6 months after RZV or to NTHi-Mcat alone (2-dose for both vaccines). Primary outcome was non-inferiority of the humoral immune response to NTHi-Mcat administered 1 month after RZV versus NTHi-Mcat alone, evaluated by specific antibody geometric mean concentration (GMC) ratio with 95% confidence intervals (CIs). The per-protocol set included 411 participants. Primary objective was met; lower limit of the 95%CI for the GMC ratio above 0.667 for all four vaccine antigens, 1 month after the second NTHi-Mcat dose. NTHi-Mcat induced similar immune response regardless of whether administered alone or 1, 3 or 6 months following RZV. Safety and reactogenicity profiles were acceptable; adverse event frequency was similar among study groups. Injection site pain was the most common symptom. No new safety concerns were identified. The study demonstrated non-inferiority of the immune response elicited by NTHi-Mcat administered sequentially to RZV versus NTHi-Mcat alone, indicating no immune interference. Starting from 1 month, no specific interval is required between RZV and NTHi-Mcat containing the same AS01-adjuvant system components in different quantities. | ||
| 650 | 4 | |a non-typable haemophilus influenzae | |
| 650 | 4 | |a moraxella catarrhalis | |
| 650 | 4 | |a chronic obstructive pulmonary disease | |
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10.1080/21645515.2023.2187194 doi (DE-627)DOAJ090686187 (DE-599)DOAJa22f2fc2d4424a7484a23d2c14b24cde DE-627 ger DE-627 rakwb eng RC581-607 RM1-950 Ilaria Galgani verfasserin aut Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines containing the same AS01-adjuvant system could lead to immune interference. We compared administration of NTHi-Mcat following AS01-adjuvanted recombinant zoster vaccine (RZV) versus NTHi-Mcat alone. This phase 2a, open-label trial (NCT03894969) randomized healthy current or former smokers (50–80 years) without COPD to administration of NTHi-Mcat at 1, 3 or 6 months after RZV or to NTHi-Mcat alone (2-dose for both vaccines). Primary outcome was non-inferiority of the humoral immune response to NTHi-Mcat administered 1 month after RZV versus NTHi-Mcat alone, evaluated by specific antibody geometric mean concentration (GMC) ratio with 95% confidence intervals (CIs). The per-protocol set included 411 participants. Primary objective was met; lower limit of the 95%CI for the GMC ratio above 0.667 for all four vaccine antigens, 1 month after the second NTHi-Mcat dose. NTHi-Mcat induced similar immune response regardless of whether administered alone or 1, 3 or 6 months following RZV. Safety and reactogenicity profiles were acceptable; adverse event frequency was similar among study groups. Injection site pain was the most common symptom. No new safety concerns were identified. The study demonstrated non-inferiority of the immune response elicited by NTHi-Mcat administered sequentially to RZV versus NTHi-Mcat alone, indicating no immune interference. Starting from 1 month, no specific interval is required between RZV and NTHi-Mcat containing the same AS01-adjuvant system components in different quantities. non-typable haemophilus influenzae moraxella catarrhalis chronic obstructive pulmonary disease recombinant zoster vaccine non-inferiority immune response adjuvant system as01 Immunologic diseases. Allergy Therapeutics. Pharmacology Airi Põder verfasserin aut Rain Jõgi verfasserin aut Veli-Jukka Anttila verfasserin aut Stefano Milleri verfasserin aut Alberto M. Borobia verfasserin aut Odile Launay verfasserin aut Marco Testa verfasserin aut Daniela Casula verfasserin aut Luca Grassano verfasserin aut Annaelisa Tasciotti verfasserin aut Marie Dozot verfasserin aut Ashwani K. Arora verfasserin aut In Human Vaccines & Immunotherapeutics Taylor & Francis Group, 2022 19(2023), 1 (DE-627)718665929 (DE-600)2664177-X 2164554X nnns volume:19 year:2023 number:1 https://doi.org/10.1080/21645515.2023.2187194 kostenfrei https://doaj.org/article/a22f2fc2d4424a7484a23d2c14b24cde kostenfrei http://dx.doi.org/10.1080/21645515.2023.2187194 kostenfrei https://doaj.org/toc/2164-5515 Journal toc kostenfrei https://doaj.org/toc/2164-554X 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_70 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_2014 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 19 2023 1 |
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10.1080/21645515.2023.2187194 doi (DE-627)DOAJ090686187 (DE-599)DOAJa22f2fc2d4424a7484a23d2c14b24cde DE-627 ger DE-627 rakwb eng RC581-607 RM1-950 Ilaria Galgani verfasserin aut Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines containing the same AS01-adjuvant system could lead to immune interference. We compared administration of NTHi-Mcat following AS01-adjuvanted recombinant zoster vaccine (RZV) versus NTHi-Mcat alone. This phase 2a, open-label trial (NCT03894969) randomized healthy current or former smokers (50–80 years) without COPD to administration of NTHi-Mcat at 1, 3 or 6 months after RZV or to NTHi-Mcat alone (2-dose for both vaccines). Primary outcome was non-inferiority of the humoral immune response to NTHi-Mcat administered 1 month after RZV versus NTHi-Mcat alone, evaluated by specific antibody geometric mean concentration (GMC) ratio with 95% confidence intervals (CIs). The per-protocol set included 411 participants. Primary objective was met; lower limit of the 95%CI for the GMC ratio above 0.667 for all four vaccine antigens, 1 month after the second NTHi-Mcat dose. NTHi-Mcat induced similar immune response regardless of whether administered alone or 1, 3 or 6 months following RZV. Safety and reactogenicity profiles were acceptable; adverse event frequency was similar among study groups. Injection site pain was the most common symptom. No new safety concerns were identified. The study demonstrated non-inferiority of the immune response elicited by NTHi-Mcat administered sequentially to RZV versus NTHi-Mcat alone, indicating no immune interference. Starting from 1 month, no specific interval is required between RZV and NTHi-Mcat containing the same AS01-adjuvant system components in different quantities. non-typable haemophilus influenzae moraxella catarrhalis chronic obstructive pulmonary disease recombinant zoster vaccine non-inferiority immune response adjuvant system as01 Immunologic diseases. Allergy Therapeutics. Pharmacology Airi Põder verfasserin aut Rain Jõgi verfasserin aut Veli-Jukka Anttila verfasserin aut Stefano Milleri verfasserin aut Alberto M. Borobia verfasserin aut Odile Launay verfasserin aut Marco Testa verfasserin aut Daniela Casula verfasserin aut Luca Grassano verfasserin aut Annaelisa Tasciotti verfasserin aut Marie Dozot verfasserin aut Ashwani K. Arora verfasserin aut In Human Vaccines & Immunotherapeutics Taylor & Francis Group, 2022 19(2023), 1 (DE-627)718665929 (DE-600)2664177-X 2164554X nnns volume:19 year:2023 number:1 https://doi.org/10.1080/21645515.2023.2187194 kostenfrei https://doaj.org/article/a22f2fc2d4424a7484a23d2c14b24cde kostenfrei http://dx.doi.org/10.1080/21645515.2023.2187194 kostenfrei https://doaj.org/toc/2164-5515 Journal toc kostenfrei https://doaj.org/toc/2164-554X 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_70 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_2014 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 19 2023 1 |
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10.1080/21645515.2023.2187194 doi (DE-627)DOAJ090686187 (DE-599)DOAJa22f2fc2d4424a7484a23d2c14b24cde DE-627 ger DE-627 rakwb eng RC581-607 RM1-950 Ilaria Galgani verfasserin aut Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines containing the same AS01-adjuvant system could lead to immune interference. We compared administration of NTHi-Mcat following AS01-adjuvanted recombinant zoster vaccine (RZV) versus NTHi-Mcat alone. This phase 2a, open-label trial (NCT03894969) randomized healthy current or former smokers (50–80 years) without COPD to administration of NTHi-Mcat at 1, 3 or 6 months after RZV or to NTHi-Mcat alone (2-dose for both vaccines). Primary outcome was non-inferiority of the humoral immune response to NTHi-Mcat administered 1 month after RZV versus NTHi-Mcat alone, evaluated by specific antibody geometric mean concentration (GMC) ratio with 95% confidence intervals (CIs). The per-protocol set included 411 participants. Primary objective was met; lower limit of the 95%CI for the GMC ratio above 0.667 for all four vaccine antigens, 1 month after the second NTHi-Mcat dose. NTHi-Mcat induced similar immune response regardless of whether administered alone or 1, 3 or 6 months following RZV. Safety and reactogenicity profiles were acceptable; adverse event frequency was similar among study groups. Injection site pain was the most common symptom. No new safety concerns were identified. The study demonstrated non-inferiority of the immune response elicited by NTHi-Mcat administered sequentially to RZV versus NTHi-Mcat alone, indicating no immune interference. Starting from 1 month, no specific interval is required between RZV and NTHi-Mcat containing the same AS01-adjuvant system components in different quantities. non-typable haemophilus influenzae moraxella catarrhalis chronic obstructive pulmonary disease recombinant zoster vaccine non-inferiority immune response adjuvant system as01 Immunologic diseases. Allergy Therapeutics. Pharmacology Airi Põder verfasserin aut Rain Jõgi verfasserin aut Veli-Jukka Anttila verfasserin aut Stefano Milleri verfasserin aut Alberto M. Borobia verfasserin aut Odile Launay verfasserin aut Marco Testa verfasserin aut Daniela Casula verfasserin aut Luca Grassano verfasserin aut Annaelisa Tasciotti verfasserin aut Marie Dozot verfasserin aut Ashwani K. Arora verfasserin aut In Human Vaccines & Immunotherapeutics Taylor & Francis Group, 2022 19(2023), 1 (DE-627)718665929 (DE-600)2664177-X 2164554X nnns volume:19 year:2023 number:1 https://doi.org/10.1080/21645515.2023.2187194 kostenfrei https://doaj.org/article/a22f2fc2d4424a7484a23d2c14b24cde kostenfrei http://dx.doi.org/10.1080/21645515.2023.2187194 kostenfrei https://doaj.org/toc/2164-5515 Journal toc kostenfrei https://doaj.org/toc/2164-554X 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_70 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_2014 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 19 2023 1 |
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Ilaria Galgani @@aut@@ Airi Põder @@aut@@ Rain Jõgi @@aut@@ Veli-Jukka Anttila @@aut@@ Stefano Milleri @@aut@@ Alberto M. Borobia @@aut@@ Odile Launay @@aut@@ Marco Testa @@aut@@ Daniela Casula @@aut@@ Luca Grassano @@aut@@ Annaelisa Tasciotti @@aut@@ Marie Dozot @@aut@@ Ashwani K. Arora @@aut@@ |
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Ilaria Galgani |
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Ilaria Galgani misc RC581-607 misc RM1-950 misc non-typable haemophilus influenzae misc moraxella catarrhalis misc chronic obstructive pulmonary disease misc recombinant zoster vaccine misc non-inferiority misc immune response misc adjuvant system misc as01 misc Immunologic diseases. Allergy misc Therapeutics. Pharmacology Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial |
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RC581-607 RM1-950 Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial non-typable haemophilus influenzae moraxella catarrhalis chronic obstructive pulmonary disease recombinant zoster vaccine non-inferiority immune response adjuvant system as01 |
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misc RC581-607 misc RM1-950 misc non-typable haemophilus influenzae misc moraxella catarrhalis misc chronic obstructive pulmonary disease misc recombinant zoster vaccine misc non-inferiority misc immune response misc adjuvant system misc as01 misc Immunologic diseases. Allergy misc Therapeutics. Pharmacology |
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misc RC581-607 misc RM1-950 misc non-typable haemophilus influenzae misc moraxella catarrhalis misc chronic obstructive pulmonary disease misc recombinant zoster vaccine misc non-inferiority misc immune response misc adjuvant system misc as01 misc Immunologic diseases. Allergy misc Therapeutics. Pharmacology |
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Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial |
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Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial |
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Ilaria Galgani Airi Põder Rain Jõgi Veli-Jukka Anttila Stefano Milleri Alberto M. Borobia Odile Launay Marco Testa Daniela Casula Luca Grassano Annaelisa Tasciotti Marie Dozot Ashwani K. Arora |
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Ilaria Galgani |
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immunogenicity and safety of the non-typable haemophilus influenzae–moraxella catarrhalis (nthi-mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: results from a randomized, phase 2a, non-inferiority trial |
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Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial |
| abstract |
A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines containing the same AS01-adjuvant system could lead to immune interference. We compared administration of NTHi-Mcat following AS01-adjuvanted recombinant zoster vaccine (RZV) versus NTHi-Mcat alone. This phase 2a, open-label trial (NCT03894969) randomized healthy current or former smokers (50–80 years) without COPD to administration of NTHi-Mcat at 1, 3 or 6 months after RZV or to NTHi-Mcat alone (2-dose for both vaccines). Primary outcome was non-inferiority of the humoral immune response to NTHi-Mcat administered 1 month after RZV versus NTHi-Mcat alone, evaluated by specific antibody geometric mean concentration (GMC) ratio with 95% confidence intervals (CIs). The per-protocol set included 411 participants. Primary objective was met; lower limit of the 95%CI for the GMC ratio above 0.667 for all four vaccine antigens, 1 month after the second NTHi-Mcat dose. NTHi-Mcat induced similar immune response regardless of whether administered alone or 1, 3 or 6 months following RZV. Safety and reactogenicity profiles were acceptable; adverse event frequency was similar among study groups. Injection site pain was the most common symptom. No new safety concerns were identified. The study demonstrated non-inferiority of the immune response elicited by NTHi-Mcat administered sequentially to RZV versus NTHi-Mcat alone, indicating no immune interference. Starting from 1 month, no specific interval is required between RZV and NTHi-Mcat containing the same AS01-adjuvant system components in different quantities. |
| abstractGer |
A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines containing the same AS01-adjuvant system could lead to immune interference. We compared administration of NTHi-Mcat following AS01-adjuvanted recombinant zoster vaccine (RZV) versus NTHi-Mcat alone. This phase 2a, open-label trial (NCT03894969) randomized healthy current or former smokers (50–80 years) without COPD to administration of NTHi-Mcat at 1, 3 or 6 months after RZV or to NTHi-Mcat alone (2-dose for both vaccines). Primary outcome was non-inferiority of the humoral immune response to NTHi-Mcat administered 1 month after RZV versus NTHi-Mcat alone, evaluated by specific antibody geometric mean concentration (GMC) ratio with 95% confidence intervals (CIs). The per-protocol set included 411 participants. Primary objective was met; lower limit of the 95%CI for the GMC ratio above 0.667 for all four vaccine antigens, 1 month after the second NTHi-Mcat dose. NTHi-Mcat induced similar immune response regardless of whether administered alone or 1, 3 or 6 months following RZV. Safety and reactogenicity profiles were acceptable; adverse event frequency was similar among study groups. Injection site pain was the most common symptom. No new safety concerns were identified. The study demonstrated non-inferiority of the immune response elicited by NTHi-Mcat administered sequentially to RZV versus NTHi-Mcat alone, indicating no immune interference. Starting from 1 month, no specific interval is required between RZV and NTHi-Mcat containing the same AS01-adjuvant system components in different quantities. |
| abstract_unstemmed |
A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines containing the same AS01-adjuvant system could lead to immune interference. We compared administration of NTHi-Mcat following AS01-adjuvanted recombinant zoster vaccine (RZV) versus NTHi-Mcat alone. This phase 2a, open-label trial (NCT03894969) randomized healthy current or former smokers (50–80 years) without COPD to administration of NTHi-Mcat at 1, 3 or 6 months after RZV or to NTHi-Mcat alone (2-dose for both vaccines). Primary outcome was non-inferiority of the humoral immune response to NTHi-Mcat administered 1 month after RZV versus NTHi-Mcat alone, evaluated by specific antibody geometric mean concentration (GMC) ratio with 95% confidence intervals (CIs). The per-protocol set included 411 participants. Primary objective was met; lower limit of the 95%CI for the GMC ratio above 0.667 for all four vaccine antigens, 1 month after the second NTHi-Mcat dose. NTHi-Mcat induced similar immune response regardless of whether administered alone or 1, 3 or 6 months following RZV. Safety and reactogenicity profiles were acceptable; adverse event frequency was similar among study groups. Injection site pain was the most common symptom. No new safety concerns were identified. The study demonstrated non-inferiority of the immune response elicited by NTHi-Mcat administered sequentially to RZV versus NTHi-Mcat alone, indicating no immune interference. Starting from 1 month, no specific interval is required between RZV and NTHi-Mcat containing the same AS01-adjuvant system components in different quantities. |
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Immunogenicity and safety of the non-typable Haemophilus influenzae–Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial |
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Airi Põder Rain Jõgi Veli-Jukka Anttila Stefano Milleri Alberto M. Borobia Odile Launay Marco Testa Daniela Casula Luca Grassano Annaelisa Tasciotti Marie Dozot Ashwani K. Arora |
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