A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults

Summary

The purpose of this study was a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses in two subgroups of older adults.

Timeline

Start

2016-04-16

Primary completion

2023-06-28

Completion

2024-01-30

Publications

• Background Strezova A, Diez Domingo J, Cunningham AL, Eto T, Andrews C, Arns C, Choo EJ, Hui DSC, Icardi G, McNeil SA, Poder A, Kosina P, Rombo L, Schwarz TF, Tinoco JC, Yu CJ, Wang J, Soni J, Tsang M, Leon R, Mwakingwe-Omari A; Zoster-049 Study Group. Final analysis of the ZOE-LTFU trial to 11 years post-vaccination: efficacy of the adjuvanted recombinant zoster vaccine against herpes zoster and related complications. EClinicalMedicine. 2025 May 9;83:103241. doi: 10.1016/j.eclinm.2025.103241. eCollection 2025 May.
• Leon R, Diez-Domingo J, Andrews C, Arns da Cunha C, Choo EJ, Hui DSC, Cunningham AL, Eto T, Icardi G, McNeil SA, Poder A, Kosina P, Rombo L, Schwarz TF, Tinoco JC, Yu CJ, Wang J, Soni J, Tsang M, Strezova A, Salaun B, Mwakingwe-Omari A. Safety and Immunogenicity of 1 or 2 Additional Doses of the Adjuvanted Recombinant Zoster Vaccine Administered 5-6 Years After Primary Vaccination in Adults >/=50 Years. Open Forum Infect Dis. 2026 May 4;13(6):ofag282. doi: 10.1093/ofid/ofag282. eCollection 2026 Jun.
• Giannelos N, Curran D, Matthews S, Carrico J, Cunningham AL. The Potential Impact of Increased Recombinant Zoster Vaccine Uptake in Older Adults Worldwide. Infect Dis Ther. 2025 Jun;14(6):1327-1341. doi: 10.1007/s40121-025-01161-y. Epub 2025 May 21.
• Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu CJ, Andrews C, Beytout J, Caso C, Cheng HS, Cheong HJ, Choo EJ, Curiac D, Di Paolo E, Dionne M, Eckermann T, Esen M, Ferguson M, Ghesquiere W, Hwang SJ, Avelino-Silva TJ, Kosina P, Liu CS, Markkula J, Moeckesch B, Murta de Oliveira C, Park DW, Pauksens K, Pirrotta P, Plassmann G, Pretswell C, Rombo L, Salaun B, Sanmartin Berglund J, Schenkenberger I, Schwarz T, Shi M, Ukkonen B, Zahaf T, Zerbini C, Schuind A, Cunningham AL; Zoster-049 Study Group. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70. Clin Infect Dis. 2022 Apr 28;74(8):1459-1467. doi: 10.1093/cid/ciab629.

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