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. 2022 Oct 23;9(10):ofac485.
doi: 10.1093/ofid/ofac485. eCollection 2022 Oct.

Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination

Ana Strezova  1 , Javier Diez-Domingo  2 , Kamal Al Shawafi  3 , Juan Carlos Tinoco  4 , Meng Shi  5 , Paola Pirrotta  6 , Agnes Mwakingwe-Omari  5 ; Zoster-049 Study Group
Collaborators, Affiliations

Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination

Ana Strezova et al. Open Forum Infect Dis. .

Abstract

Approximately 10 years after vaccination with the recombinant zoster vaccine (RZV), an interim analysis of this follow-up study of the ZOE-50/70 trials demonstrated that efficacy against herpes zoster remained high. Moreover, the safety profile remained clinically acceptable, suggesting that the clinical benefit of the RZV in ≥50-year-olds is sustained up to 10 years.

Keywords: adjuvanted recombinant zoster vaccine; immune response persistence; long-term efficacy; long-term safety.

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Conflict of interest statement

Potential conflicts of interest. K.A.S. is a Modis employee, working on behalf of the GSK group of companies. A.M.O., M.S., A.S., and P.P. are employees of the GSK group of companies. P.P. and A.S. hold shares/stocks in the GSK group of companies as part of their employee remuneration. J.D.D. reports grants from the GSK group of companies, Sanofi, and MSD; consulting fees from Sanofi Pasteur and MSD paid to him and his institution; honoraria from the GSK group of companies and SEQIRUS (to him and his institution), outside the submitted work. J.C.T. reports grant/research support from the GSK group of companies. The authors have no other financial or nonfinancial interests to declare. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Persistence of humoral (A) and cell-mediated (B) immune responses to RZV up to the second interim analysis of ZOE-LTFU (ATP cohort for persistence). aPrevaccination values from all RZV recipients in the humoral immunogenicity/CMI subsets in ZOE-50 and ZOE-70 [6]. Year 5 data for CD4[2+] T-cell frequencies are not shown because only 3 participants had available results for this analysis. bAt the data lock point for the second interim analysis in ZOE-LTFU, data collection for year 10 was still incomplete. Abbreviations: ATP, according-to-protocol; CI, confidence interval; CMI, cell-mediated immunity; gE, glycoprotein E; GMC, geometric mean concentration; CD4[2+] T cells, CD4+ T cells expressing at least 2 of 4 assessed activation markers (interferon-γ, interleukin-2, tumor necrosis factor–α, and CD40 ligand) per 106 CD4+ T cells; Q1 and Q3, first and third quartiles, respectively; mIU/mL, milli-International Units per milliliter; N, number of participants with available results; RZV, adjuvanted recombinant zoster vaccine; ZOE-LTFU, long-term follow-up study of ZOE-50/70.
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References

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