Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine: Persistence and Anamnestic Response to Additional Doses Administered 10 Years After Primary Vaccination

Abstract

<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>The adjuvanted recombinant zoster vaccine (RZV) is highly immunogenic and efficacious in adults ≥50 years of age. We evaluated (1) long-term immunogenicity of an initial 2-dose RZV schedule, by following up adults vaccinated at ≥60 years of age and by modeling, and (2) immunogenicity of 2 additional doses administered 10 years after initial vaccination.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Persistence of humoral and cell-mediated immune (CMI) responses to 2 initial RZV doses was assessed through 10 years after initial vaccination, and modeled through 20 years using a Piecewise, Power law and Fraser model. The immunogenicity and safety of 2 additional RZV doses were also evaluated.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Seventy adults were enrolled. Ten years after initial vaccination, humoral and CMI responses were approximately 6-fold and 3.5-fold, respectively, above those before the initial vaccination levels. Predicted immune persistence through 20 years after initial vaccination was similar across the 3 models. Sixty-two participants (mean age [standard deviation], 82.6 [4.4] years) received ≥1 additional RZV dose. Strong anamnestic humoral and CMI responses were elicited by 1 additional dose, without further increases after a second additional dose.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Immune responses to an initial 2-dose RZV course persisted for many years in older adults. Strong anamnestic immune responses can be induced by additional dosing 10 years after the initial 2-dose course.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trials Registration</jats:title> <jats:p>NCT02735915.</jats:p> </jats:sec>

Early examination of real-world uptake and second-dose completion of recombinant zoster vaccine in the United States from October 2017 to September 2019

“…15 RZV should be administered as two doses, separated by two to six months in order to achieve optimal immunogenicity and efficacy as demonstrated in two large phase III studies and post-marketing studies. [16][17][18][19] Post-hoc analyses of limited phase III data showed reduced vaccine efficacy in subjects receiving only one RZV dose, i.e., 90.8% and 69.5% in adults ≥50 years and ≥70 years, respectively, compared with estimated vaccine efficacies of 97.2% and 91.3% in these age groups. 18,20 In a post-marketing phase III study, the humoral immune response of two RZV doses given six and 12 months apart was compared to RZV doses given two months apart.…”

Recombinant adjuvanted zoster vaccine and reduced risk of COVID-19 diagnosis and hospitalization in older adults

“…[9] It is possible that the AS01 adjuvant used in RZV, which activates innate immune responses including monocytes and the IFN-response pathways, may be associated with the reduced risk of COVID-19 diagnosis and hospitalization observed in this study. [10,11,31] Influenza and other vaccines may also induce similar trained immunity against SARS-CoV-2 infection, although the duration may be variable. [9,25,[32][33][34] Additional research is needed to elucidate immunologic mechanisms for our findings and to explore implications such as trained immunitybased vaccines that might mitigate serious infections in future pandemics until specific vaccines become available.…”

“…[5][6][7][8][9] Recombinant adjuvanted zoster vaccine (RZV) is the first approved and widely used vaccine with the novel AS01 adjuvant, which elicits an innate immune response and robust cellular and humoral responses. [10,11] We hypothesized that RZV could induce trained immunity that might reduce SARS-CoV-2 infections in older adults, who are at high risk of severe disease and poor outcomes following SARS-CoV-2 infection. [12] .…”

Zosterimpfung unter Biologikatherapie

“…Die Wirksamkeit des Impfstoffes wurde in entsprechend großen Zulassungsstudien für Patienten über 50 Jahre beziehungsweise über 70 Jahre überzeugend nachgewiesen [ 7 , 8 ] und hält bei Patienten aller Altersgruppen über fünf Jahre an [ 8 ]. Mathematische Modellierungen zeigen eine potenzielle Impfantwort noch nach bis zu 20 Jahren [ 14 ]. Als besonders verdienstvoll sind Studien zu bewerten, die einen guten Impfschutz bei älteren, gebrechlichen Patienten zeigten [ 15 ].…”