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


Journal

The Journal of infectious diseases
ISSN: 1537-6613
Titre abrégé: J Infect Dis
Pays: United States
ID NLM: 0413675

Informations de publication

Date de publication:
15 12 2021
Historique:
received: 26 03 2020
accepted: 10 06 2020
pubmed: 6 6 2020
medline: 12 1 2022
entrez: 6 6 2020
Statut: ppublish

Résumé

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. 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. 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. 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. NCT02735915.

Sections du résumé

BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
CLINICAL TRIALS REGISTRATION
NCT02735915.

Identifiants

pubmed: 32502272
pii: 5851921
doi: 10.1093/infdis/jiaa300
pmc: PMC8672743
doi:

Substances chimiques

Adjuvants, Immunologic 0
Herpes Zoster Vaccine 0
Vaccines, Synthetic 0

Banques de données

ClinicalTrials.gov
['NCT02735915']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2025-2034

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

Références

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pubmed: 25916341
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pubmed: 23999562
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pubmed: 29461919
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pubmed: 19217149
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Auteurs

Andrew Hastie (A)

GSK, Rockville, Maryland, USA.

Grégory Catteau (G)

GSK, Wavre, Belgium.

Adaora Enemuo (A)

GSK, Rockville, Maryland, USA.

Tomas Mrkvan (T)

GSK, Wavre, Belgium.

Bruno Salaun (B)

GSK, Rixensart, Belgium.

Stephanie Volpe (S)

GSK, Wavre, Belgium.

Jan Smetana (J)

Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic.

Lars Rombo (L)

Centre for Clinical Research, Eskilstuna, Sweden.
Uppsala University, Sweden.

Tino Schwarz (T)

Klinikum Wuerzburg Mitte, Standort Juliusspital, Wuerzburg, Germany.

Karlis Pauksens (K)

Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.

Caroline Hervé (C)

UCB Pharma, Braine-L'Alleud, Belgium.

Adriana Bastidas (A)

Mithra Pharmaceuticals, Flémalle, Belgium.

Anne Schuind (A)

GSK, Rockville, Maryland, USA.

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Classifications MeSH