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Lot-to-lot immunoge...
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Ferguson, MurdoColchester Research Group, Canada
(author)
Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults
- Article/chapterEnglish2024
Publisher, publication year, extent ...
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Elsevier,2024
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electronicrdacarrier
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LIBRIS-ID:oai:DiVA.org:bth-26212
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https://urn.kb.se/resolve?urn=urn:nbn:se:bth-26212URI
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https://doi.org/10.1016/j.jvacx.2024.100494DOI
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https://lup.lub.lu.se/record/29ffab4a-56ce-48de-bb98-8912cd79fa75URI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Background: Previous phase 3 studies showed that the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) is well tolerated and efficacious in preventing RSV-associated lower respiratory tract disease in adults ≥ 60 years of age. This study evaluated lot-to-lot immunogenicity consistency, reactogenicity, and safety of three RSVPreF3 OA lots. Methods: This phase 3, multicenter, double-blind study randomized (1:1:1) participants ≥ 60 years of age to receive one of three RSVPreF3 OA lots. Serum RSVPreF3-binding immunoglobulin G (IgG) concentration was assessed at baseline and 30 days post-vaccination. Lot-to-lot consistency was demonstrated if the two-sided 95 % confidence intervals (CIs) of the RSVPreF3-binding IgG geometric mean concentration (GMC) ratios between each lot pair at 30 days post-vaccination were within 0.67 and 1.50. Solicited adverse events (AEs) within four days, unsolicited AEs within 30 days, and serious AEs (SAEs) and potential immune-mediated diseases within six months post-vaccination were recorded. Results: A total of 757 participants received RSVPreF3 OA, of whom 708 were included in the per-protocol set (234, 237, and 237 participants for each lot). Lot-to-lot consistency was demonstrated: GMC ratios were 1.06 (95 % CI: 0.94–1.21), 0.92 (0.81–1.04), and 0.87 (0.77–0.99) between the lot pairs (lot 1/2; 1/3; 2/3). For the three lots, the RSVPreF3-binding IgG concentration increased 11.84-, 11.29-, and 12.46-fold post-vaccination compared to baseline. The reporting rates of solicited and unsolicited AEs, SAEs, and potential immune-mediated diseases were balanced between lots. Twenty-one participants reported SAEs; one of these–a case of atrial fibrillation–was considered by the investigator as vaccine-related. SAEs with a fatal outcome were reported for four participants, none of which were considered by the investigator as vaccine-related. Conclusion: This study demonstrated lot-to-lot immunogenicity consistency of three RSVPreF3 OA vaccine lots and indicated that the vaccine had an acceptable safety profile. ClinicalTrials.gov: NCT05059301. © 2024 GSK
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Murray, AlexanderPharmQuest, USA
(author)
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Pliamm, LewCanadian Phase Onward Inc, Canada
(author)
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Rombo, LarsUppsala University,Clinical Research Centre Sörmland
(author)
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Sanmartin Berglund, Johan,ProfessorBlekinge Institute of Technology,Lund University,Lunds universitet,Blekinge Tekniska Högskola,Institutionen för hälsa,Geriatrik,Forskargrupper vid Lunds universitet,Geriatric Medicine,Lund University Research Groups,Geriatrics(Swepub:lu)smi-jbe
(author)
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David, Marie-PierreGSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
(author)
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De Schrevel, NathalieGSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
(author)
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Maschino, FranckGSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
(author)
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Kotb, ShadyGSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
(author)
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Olivier, AurélieGSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
(author)
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Hulstrøm, VeronicaGSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
(author)
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Colchester Research Group, CanadaPharmQuest, USA
(creator_code:org_t)
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In:Vaccine: X: Elsevier182590-1362
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