Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial

A multicomponent vaccine has been developed to reduce the frequency of acute exacerbations of COPD associated with non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections, containing NTHi (PD and PE-PilA) and Mcat (UspA2) surface proteins. In a randomised, observer-bli...

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Autores principales:	Philippe De Smedt, Geert Leroux-Roels, Corinne Vandermeulen, Annaelisa Tasciotti, Gennaro Di Maro, Marie Dozot, Daniela Casula, Margherita Annaratone, Daniele Riccucci, Ashwani Kumar Arora
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Acute exacerbation Antibody persistence Clinical trial COPD Haemophilus influenzae Moraxella catarrhalis Immunologic diseases. Allergy RC581-607
Acceso en línea:	https://doaj.org/article/378e0635c1c34397a8de8fc1124c2db9
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spelling	oai:doaj.org-article:378e0635c1c34397a8de8fc1124c2db92021-11-12T04:46:46ZLong-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial2590-136210.1016/j.jvacx.2021.100124https://doaj.org/article/378e0635c1c34397a8de8fc1124c2db92021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2590136221000413https://doaj.org/toc/2590-1362A multicomponent vaccine has been developed to reduce the frequency of acute exacerbations of COPD associated with non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections, containing NTHi (PD and PE-PilA) and Mcat (UspA2) surface proteins. In a randomised, observer-blind, placebo-controlled study with two steps (NCT02547974), the investigational vaccine had good immunogenicity and no safety concerns were identified. In step 2, 90 adults aged 50–71 years with smoking history received two doses 60 days apart of one of two AS01E-adjuvanted formulations containing 10 µg of each antigen (10–10-AS01) or 10 µg NTHi antigens and 3.3 µg UspA2 (10–3-AS01), or placebo. Long-term persistence of antigen-specific humoral antibodies was assessed in 81 participants during 3 years of follow-up after the initial 14-month study (NCT03201211).Antigen-specific antibody concentrations were measured in blood samples taken every 6 months. Safety monitoring evaluated serious adverse events (SAEs) and potential immune-mediated disease (pIMD).Immune responses against NTHi antigens persisted up to 4 years post-vaccination. For PD, PE and PilA, at each follow-up time point, adjusted antibody geometric mean concentrations (GMCs) were higher (non-overlapping 95% confidence intervals [CIs]) in the vaccine groups versus placebo and versus pre-vaccination. Antibody GMC point estimates were higher with 10–3-AS01 than with 10–10-AS01. For UspA2, 95% CIs included 1 for GMC ratios of 10–10-AS01 or 10–3-AS01 to placebo at each time point. During follow-up, SAEs were reported in nine (11.1%) participants, one of which was fatal (lung cancer, 607 days after second 10–10-AS01 dose). One non-serious pIMD, trigeminal neuralgia, was reported 771 days after second 10–3-AS01 dose. The SAEs and pIMD were considered not related to vaccination.Immune responses against NTHi antigens persisted for 4 years after two-dose vaccination with the investigational NTHi-Mcat vaccine. There was no persistent response against the Mcat antigen. No safety concerns were identified during the long-term follow-up.Philippe De SmedtGeert Leroux-RoelsCorinne VandermeulenAnnaelisa TasciottiGennaro Di MaroMarie DozotDaniela CasulaMargherita AnnaratoneDaniele RiccucciAshwani Kumar AroraElsevierarticleAcute exacerbationAntibody persistenceClinical trialCOPDHaemophilus influenzaeMoraxella catarrhalisImmunologic diseases. AllergyRC581-607ENVaccine: X, Vol 9, Iss , Pp 100124- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Acute exacerbation Antibody persistence Clinical trial COPD Haemophilus influenzae Moraxella catarrhalis Immunologic diseases. Allergy RC581-607
spellingShingle	Acute exacerbation Antibody persistence Clinical trial COPD Haemophilus influenzae Moraxella catarrhalis Immunologic diseases. Allergy RC581-607 Philippe De Smedt Geert Leroux-Roels Corinne Vandermeulen Annaelisa Tasciotti Gennaro Di Maro Marie Dozot Daniela Casula Margherita Annaratone Daniele Riccucci Ashwani Kumar Arora Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial
description	A multicomponent vaccine has been developed to reduce the frequency of acute exacerbations of COPD associated with non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) infections, containing NTHi (PD and PE-PilA) and Mcat (UspA2) surface proteins. In a randomised, observer-blind, placebo-controlled study with two steps (NCT02547974), the investigational vaccine had good immunogenicity and no safety concerns were identified. In step 2, 90 adults aged 50–71 years with smoking history received two doses 60 days apart of one of two AS01E-adjuvanted formulations containing 10 µg of each antigen (10–10-AS01) or 10 µg NTHi antigens and 3.3 µg UspA2 (10–3-AS01), or placebo. Long-term persistence of antigen-specific humoral antibodies was assessed in 81 participants during 3 years of follow-up after the initial 14-month study (NCT03201211).Antigen-specific antibody concentrations were measured in blood samples taken every 6 months. Safety monitoring evaluated serious adverse events (SAEs) and potential immune-mediated disease (pIMD).Immune responses against NTHi antigens persisted up to 4 years post-vaccination. For PD, PE and PilA, at each follow-up time point, adjusted antibody geometric mean concentrations (GMCs) were higher (non-overlapping 95% confidence intervals [CIs]) in the vaccine groups versus placebo and versus pre-vaccination. Antibody GMC point estimates were higher with 10–3-AS01 than with 10–10-AS01. For UspA2, 95% CIs included 1 for GMC ratios of 10–10-AS01 or 10–3-AS01 to placebo at each time point. During follow-up, SAEs were reported in nine (11.1%) participants, one of which was fatal (lung cancer, 607 days after second 10–10-AS01 dose). One non-serious pIMD, trigeminal neuralgia, was reported 771 days after second 10–3-AS01 dose. The SAEs and pIMD were considered not related to vaccination.Immune responses against NTHi antigens persisted for 4 years after two-dose vaccination with the investigational NTHi-Mcat vaccine. There was no persistent response against the Mcat antigen. No safety concerns were identified during the long-term follow-up.
format	article
author	Philippe De Smedt Geert Leroux-Roels Corinne Vandermeulen Annaelisa Tasciotti Gennaro Di Maro Marie Dozot Daniela Casula Margherita Annaratone Daniele Riccucci Ashwani Kumar Arora
author_facet	Philippe De Smedt Geert Leroux-Roels Corinne Vandermeulen Annaelisa Tasciotti Gennaro Di Maro Marie Dozot Daniela Casula Margherita Annaratone Daniele Riccucci Ashwani Kumar Arora
author_sort	Philippe De Smedt
title	Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial
title_short	Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial
title_full	Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial
title_fullStr	Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial
title_full_unstemmed	Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial
title_sort	long-term immunogenicity and safety of a non-typeable haemophilus influenzae-moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/378e0635c1c34397a8de8fc1124c2db9
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Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial

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