Efficacy, Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine in Adults Aged 60 Years and Older: Results From the ZOE-50 and ZOE-70 Efficacy Studies
Notice bibliographique
Résumé
Background. The recombinant herpes zoster (HZ) subunit vaccine candidate (HZ/su) had >90% efficacy (VE) against HZ in older adults in two phase 3 clinical trials (ZOE-50, ZOE-70 [NCT01165177, NCT01165229]). Here we report HZ/su VE against HZ and postherpetic neuralgia (PHN), immunogenicity and safety data in adults ≥60 years of age (YOA) from these studies (VE ≥60 YOA [ZOE-50], immunogenicity/safety 69–69 YOA [ZOE-50], immunogenicity/safety ≥70 YOA [pooled ZOE-50/70]). Methods. Subjects were randomized 1:1 to receive 2 intramuscular doses of HZ/su vaccine (containing 50 µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System) or placebo (saline solution) 2 months (M) apart. We report VE in reducing HZ and PHN compared to placebo, humoral immune responses (assessed by anti-gE ELISA prior to vaccination and 1, 12, 24 and 36 M post-dose 2 [subset of subjects]) and safety (solicited [diary card subset of subjects] and unsolicited adverse events [AEs] collected for 7 and 30 days after each dose, respectively; medically attended AEs [MAEs] for 6 M after dose 2; fatal events, serious AEs [SAEs] related to vaccination/study participation and potential immune-mediated diseases [pIMDs] until study end [all subjects]). Results. A total of 4490 subjects 60–69 YOA (HZ/su: 2244; control: 2246), 8122 ≥60 YOA (4053; 4069) (ZOE-50) and 17531 ≥70 YOA (8758; 8773) (pooled ZOE-50/70) were vaccinated. VE against HZ in ZOE-50 was 97.6% (95% confidence interval: 92.7–99.6) in adults ≥60 YOA. VE in 60–69 YOA was 97.4% (ZOE-50) and in ≥70 YOA, 91.3% (pooled ZOE-50/70). VE against PHN was 100.0% (55.2–100.0) in adults ≥60 YOA (ZOE-50) and 88.8% in ≥70 YOA (pooled ZOE-50/70) (Table 1). Highest vaccine response rates and geometric mean concentrations of anti-gE antibodies in the HZ/su group were observed 1M post-dose 2. Immune responses persisted for 36M post-vaccination (Figure 1). HZ/su vaccine was more reactogenic than placebo, but reactions were mostly mild or moderate and transient (Figure 2). SAEs, fatal cases and pIMDs were equally distributed between HZ/su group and placebo. Conclusion. In adults ≥60 YOA, HZ/su vaccine is efficacious against HZ and PHN, highly immunogenic and has a clinically acceptable safety profile. Funding. GlaxoSmithKline Biologicals SA. Disclosures. J. E. McElhaney, GSK group of companies: Scientific Advisor and Site PI for clinical trial, Institution received payments for enrollment in clinical trial and Speaker honorarium; H. Lal, GSK group of companies: Employee and Shareholder, Salary and stock; A. L. Cunningham, GSK group of companies: Board Member, My Institution received honorarium for an international advisory board meeting; M. J. Levin, GSK group of companies: Investigator and Scientific Advisor, Consulting fee and Grant recipient. Merck, Sharp & Dohme: Intellectual Property and Scientific Advisor, Consulting fee and patent royalty; R. Chlibek, GSK group of companies: Investigator, Research support; J. Diez-Domingo, SPMSD: Grant Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research grant and Speaker honorarium; H. J. Downey, GSK group of companies, Pfizer, Protein Science: Investigator, Grant recipient; O. Godeaux, GSK group of companies: Former Employee, Salary; I. Gorfinkel, GSK group of companies: Research Contractor, Research grant and Research support; T. Korhonen, University of Tampere, Finland: Employee and Investigator, Salary; S. McNeil, GSK group of companies: Grant Investigator, Collaborative Research Agreement, Grant recipient, Research grant and Research support. Pfizer: Grant Investigator, Collaborative Research Agreement, Grant recipient, Research grant and Research support; K. Pauksens, Akademiska sjukhuset, Uppsala University Hospital: Investigator, The institution received compensation to perform clinical trial; T. J. Avelino-Silva, GSK group of companies: Investigator, Research support; T. Vesikari, University of Tampere: Investigator and Scientific Advisor, Research support; A. Volpi, SanofiPasteur MSD Italy: Scientific Advisor, Salary; D. Watanabe, GSK group of companies: Consultant, Consulting fee; W. Yeo, University of Wollongong: Employee and Investigator, Research support and Salary; L. Campora, GSK group of companies: Employee, Salary; C. Vanden Abeele, GSK group of companies: Employee, Salary; L. Oostvogels, GSK group of companies: Employee, Salary; T. C. Heineman, GSK group of companies: Employee and Shareholder, Salary
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».