Sökning: WFRF:(Sanmartin Berglund Johan Professor) >
Lot-to-lot immunoge...
Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults
-
- Ferguson, Murdo (författare)
- Colchester Research Group, Canada
-
- Murray, Alexander (författare)
- PharmQuest, USA
-
- Pliamm, Lew (författare)
- Canadian Phase Onward Inc, Canada
-
visa fler...
-
- Rombo, Lars (författare)
- Uppsala University,Clinical Research Centre Sörmland
-
- Sanmartin Berglund, Johan, Professor (författare)
- Blekinge 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
-
- David, Marie-Pierre (författare)
- GSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
-
- De Schrevel, Nathalie (författare)
- GSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
-
- Maschino, Franck (författare)
- GSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
-
- Kotb, Shady (författare)
- GSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
-
- Olivier, Aurélie (författare)
- GSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
-
- Hulstrøm, Veronica (författare)
- GSK, Belgium,GlaxoSmithKline Pharmaceuticals SA
-
visa färre...
-
(creator_code:org_t)
- Elsevier, 2024
- 2024
- Engelska.
-
Ingår i: Vaccine: X. - : Elsevier. - 2590-1362. ; 18
- Relaterad länk:
-
https://doi.org/10.1...
-
visa fler...
-
https://bth.diva-por... (primary) (Raw object)
-
http://dx.doi.org/10... (free)
-
https://urn.kb.se/re...
-
https://doi.org/10.1...
-
https://lup.lub.lu.s...
-
visa färre...
Abstract
Ämnesord
Stäng
- 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
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Geriatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Geriatrics (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- Immunogenicity
- Lot-to-lot consistency
- Older adults
- Prefusion F protein vaccine
- Respiratory syncytial virus
- Safety
- immunoglobulin G
- respiratory syncytial virus prefusion F protein vaccine
- respiratory syncytial virus vaccine
- unclassified drug
- adult
- aged
- arthralgia
- Article
- atrial fibrillation
- confidence interval
- controlled study
- double blind procedure
- drug safety
- erythema
- fatigue
- female
- fever
- follow up
- headache
- human
- immunoglobulin blood level
- lot to lot immunogenicity
- male
- middle aged
- multicenter study
- myalgia
- pain
- phase 3 clinical trial
- randomized controlled trial
- respiratory syncytial virus infection
- swelling
- vaccination
- vaccine immunogenicity
- very elderly
- Immunogenicity
- Lot-to-lot consistency
- Older adults
- Prefusion F protein vaccine
- Respiratory syncytial virus
- Safety
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Ferguson, Murdo
-
Murray, Alexande ...
-
Pliamm, Lew
-
Rombo, Lars
-
Sanmartin Berglu ...
-
David, Marie-Pie ...
-
visa fler...
-
De Schrevel, Nat ...
-
Maschino, Franck
-
Kotb, Shady
-
Olivier, Aurélie
-
Hulstrøm, Veroni ...
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Hälsovetenskap
-
och Folkhälsovetensk ...
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Geriatrik
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Kardiologi
- Artiklar i publikationen
-
Vaccine: X
- Av lärosätet
-
Blekinge Tekniska Högskola
-
Lunds universitet