Non-typeable Haemophilus influenzae–Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Andreas, Stefan; Testa, Marco; Janssens, Wim; Kerwin, Edward; Papi, Alberto; Pek, Bonavuth; Saralaya, Dinesh; Watz, Henrik; Wilkinson, Tom; Maltais, François; Corhay, Jean-Louis; Janssens, E.; Leys, Mathias H; Ferguson, Murdo; FitzGerald, Mark; Mayers, Irvin; McNeil, Shelly; Bourdin, Arnaud; Boyer, Laurent; Couturaud, Francis; Dussart, Luc; Illies, Gabriele; Eich, Andreas; Ludwig-Sengpiel, Andrea; Blasi, Francesco; Centanni, Stefano; Pomari, Carlo; Echave-Sustaeta, José; Martínez, Eleuterio Llorca; Pérez, Silvia Narejos; Pascual-Guardia, Sergi; Vera, Mercè Pérez; Riera, Manuel Terns; Anderson, William C.; Choudhury, Gourab; DeSoyza, A; Boscia, Joseph; Chinsky, Kenneth; Dunn, Leonard; Erb, David; Fogarty, Charles; Downey, H. Jackson; Kunz, Craig; Poling, Terry L.; Sellman, Richard; Sigal, Barry; Southard, John; Spangenthal, Selwyn; Tannous, Ziad; Casula, D; Maro, Gennaro Di; Lattanzi, Maria; Moraschini, Luca; Schoonbroodt, Sonia; Tasciotti, Annaelisa; Arora, Ashwani Kumar

doi:10.1016/s2213-2600(21)00502-6

Cited by 26 publications

(23 citation statements)

References 30 publications

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“…The safety and reactogenicity profile of the NTHi-Mcat vaccine was consistent with previous studies. 5 , 6 , 15 , 16 Reactogenicity was similar in the study groups who received NTHi-Mcat after RZV and the group who received NTHi-Mcat vaccine alone and there were few severe reactogenicity events. Unsolicited AEs occurred with similar frequency in all study groups and were mainly mild or moderate in severity.…”

Section: Discussionmentioning

confidence: 76%

“…Similar robust humoral immune responses have been observed in previous studies of the vaccine when administered alone. 5 , 6 , 15 , 16 …”

Section: Discussionmentioning

confidence: 99%

“…The vaccine has been shown to be immunogenic and have an acceptable safety profile in phase 1 and 2 studies, but did not demonstrate efficacy against moderate and severe COPD exacerbations in a phase 2 study. 5 , 6 Development of the vaccine has been discontinued.…”

Section: Introductionmentioning

confidence: 99%

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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

Galgani¹,

Põder²,

Jõgi

et al. 2023

Human Vaccines & Immunotherapeutics

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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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Section: Discussionmentioning

confidence: 76%

“…Similar robust humoral immune responses have been observed in previous studies of the vaccine when administered alone. 5 , 6 , 15 , 16 …”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

Galgani¹,

Põder²,

Jõgi

et al. 2023

Human Vaccines & Immunotherapeutics

Self Cite

View full text Add to dashboard Cite

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“…The results of a phase 2b randomized clinical trial testing the efficacy of a non-typeable Haemophilus influenzae and Moraxella catarrhalis vaccine for the prevention of COPD exacerbations were recently published. 12 Unfortunately, this study was not positive.…”

mentioning

confidence: 78%

Role of Vaccines in COPD Patients

Jareño-Esteban

Miguel‐Díez

2022

Open Respiratory Archives

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“…A recent study investigated the efficacy of a vaccine targeted at non-typeable H. influenzae and M. catarrhalis in preventing AECOPD. 20 Our study will aid in determining which subgroups require vaccination against a particular pathogen.…”

Section: Discussionmentioning

confidence: 99%

The Relationship Between Comorbidities and Microbiologic Findings in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Seo¹,

Sim²,

Min³

et al. 2022

COPD

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Purpose Data regarding the relationship between microbiologic features and comorbidities in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) are limited. The aim of this study was to correlate microbiologic findings with comorbidities in patients with moderate to severe AECOPD. Patients and Methods This multicenter observational study included patients with AECOPD seen at 28 hospitals in South Korea between January 2015 and December 2018, and the data were retrospectively collected. Pathogens were examined in patients with either pulmonary or extrapulmonary comorbidities, and compared to those of patients without comorbidities. The relationship between pathogen type and the number of comorbidities was also evaluated. Results Bacterial infections (178 [37.2%] vs 203 [28.7%], p = 0.002) and co-infections with bacteria and viruses (65 [13.6%] vs 57 [8.1%], p = 0.002) were more prevalent in patients with pulmonary comorbidities. Bacterial pathogens (280 [34.7%] vs 101 [26.7%], p=0.006) were detected at a higher rate in patients with extrapulmonary comorbidities. Previous pulmonary tuberculosis (PTB), bronchiectasis, and diabetes mellitus were risk factors for bacterial infection, and congestive heart failure was a risk factor for bacterial and viral co-infection. As the number of comorbidities increased, the risk of bacterial infection increased considerably. Pseudomonas aeruginosa was more frequently identified in patients with previous PTB (57 [15.3%] vs 59 [7.4%], p < 0.001) and bronchiectasis (33 [19.6%] vs 83 [8.3%], p < 0.001). Conclusion AECOPD patients with comorbidities were more likely to experience infection-related exacerbations compared to those without comorbidities. As the overall number of comorbidities increased, the risk of bacterial infection increased significantly.

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Non-typeable Haemophilus influenzae–Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial

Abstract: HAL is a multi-disciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers.

Cited by 26 publications

References 30 publications

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

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

Role of Vaccines in COPD Patients

The Relationship Between Comorbidities and Microbiologic Findings in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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