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Lot-to-lot immunoge...
Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults
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Ferguson, Murdo (author)
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Murray, Alexander (author)
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Pliamm, Lew (author)
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- Rombo, Lars (author)
- Uppsala University
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- Sanmartin Berglund, Johan (author)
- Blekinge Institute of Technology,Lund University,Lunds universitet,Geriatrik,Forskargrupper vid Lunds universitet,Geriatric Medicine,Lund University Research Groups,Geriatrics
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- David, Marie Pierre (author)
- GlaxoSmithKline Pharmaceuticals SA
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- De Schrevel, Nathalie (author)
- GlaxoSmithKline Pharmaceuticals SA
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- Maschino, Franck (author)
- GlaxoSmithKline Pharmaceuticals SA
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- Kotb, Shady (author)
- GlaxoSmithKline Pharmaceuticals SA
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- Olivier, Aurélie (author)
- GlaxoSmithKline Pharmaceuticals SA
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- Hulstrøm, Veronica (author)
- GlaxoSmithKline Pharmaceuticals SA
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(creator_code:org_t)
- 2024
- 2024
- English.
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In: Vaccine: X. - 2590-1362. ; 18
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Abstract
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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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Immunogenicity
- Lot-to-lot consistency
- Older adults
- Prefusion F protein vaccine
- Respiratory syncytial virus
- Safety
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Ferguson, Murdo
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Murray, Alexande ...
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Pliamm, Lew
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Rombo, Lars
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Sanmartin Berglu ...
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David, Marie Pie ...
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show more...
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De Schrevel, Nat ...
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Maschino, Franck
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Kotb, Shady
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Olivier, Aurélie
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Hulstrøm, Veroni ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
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Vaccine: X
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Lund University