| Title: |
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 |
| Authors: |
Galgani, Ilaria; Poder, Airi; Jogi, Rain; Anttila, Veli-Jukka; Milleri, Stefano; Borobia, Alberto M.; Launay, Odile; Testa, Marco; Casula, Daniela; Grassano, Luca; Tasciotti, Annaelisa; Dozot, Marie; Arora, Ashwani K. |
| Contributors: |
HUS Inflammation Center; Infektiosairauksien yksikkö |
| Publisher Information: |
Taylor and Francis Ltd. |
| Publication Year: |
2023 |
| Collection: |
Helsingfors Universitet: HELDA – Helsingin yliopiston digitaalinen arkisto |
| Subject Terms: |
As01; Moraxella catarrhalis; Adjuvant system; Chronic obstructive pulmonary disease; Immune response; Non-inferiority; non-typable Haemophilus influenzae; Recombinant zoster vaccine; Medical biotechnology; 11832 Microbiology and virology |
| Description: |
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. ; Peer reviewed |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
https://hdl.handle.net/10138/563521; 85151674950; 000959529200001 |
| Availability: |
https://hdl.handle.net/10138/563521 |
| Rights: |
cc_by_nc_nd ; info:eu-repo/semantics/openAccess ; openAccess |
| Accession Number: |
edsbas.E42AF6AF |
| Database: |
BASE |