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Record W3186328747 · doi:10.1093/cid/ciab629

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

2021· article· en· W3186328747 on OpenAlexaff
Céline Boutry, Andrew Hastie, Javier Díez‐Domingo, Juan Carlos Tinoco, Chong‐Jen Yu, Charles P. Andrews, Jean Beytout, Covadonga Caso, Huey‐Shinn Cheng, Hee Jin Cheong, Eun Ju Choo, Dan Curiac, Emmanuel Di Paolo, Marc Dionne, Tamara Eckermann, Meral Esen, Murdo Ferguson, Wayne Ghesquière, Shinn‐Jang Hwang, Thiago Junqueira Avelino‐Silva, Pavel Kosina, Chiu-Shong Liu, Jukka Markkula, Beate Moeckesch, Cláudia Murta de Oliveira, Dae Won Park, Karlis Pauksens, Paola Pirrotta, Georg Plassmann, Carol Pretswell, Lars Rombo, Bruno Salaun, Johan Berglund, Isabelle Schenkenberger, Tino F. Schwarz, Meng Shi, Benita Ukkonen, Toufik Zahaf, Cristiano A. F. Zerbini, Anne Schuind, Anthony L. Cunningham, Michael A. Adams, Anitta Ahonen, Eugene Athan, Jose-Fernando Barba-Gómez, Piero Barbanti, Elisabeth Barberan, Alain Baty, Niklas Bengtsson, Juergen Berger-Roscher, Katarina Berndtsson Blom, Loïc Boucher, Alain Boye, François Brault, Laurie Breger, Carles Brotons Cuixart, Christine Cerna, Clóvis Cunha, Benoit Daguzan, Antje Dahmen, Susan Datta, Maria Giuseppina Desole, Petr Dítě, Jan Dutz, John Earl, William Ellison, Jurij Eremenko, Takashi Eto, Xavier Farrés Fabré, Cecil Farrington, Pierre André Ferrand, Matthew Finneran, David Francyk, Marshall Freedman, George Freeman, Péter Gál, Jean-Sebastien Gauthier, Beatrice Gerlach, Iris Gorfinkel, Christine Grigat, Josef Großkopf, Mónika Inés Hamann, Pascal Hanrion, Paul Hartley, Ken Heaton, Agnes Himpel-Boenninghoff, Thomas Horacek, David S.C. Hui, Yieng Huong, Giancarlo Icardi, Gabriele Illies, Junya Irimajiri, Alen Jambrecina, Hyo Youl Kim, Christiane Klein, Uwe Kleinecke, Hans-Joachim Koenig, Satu Kokko, Pekka Koskinen, Maximilian Kropp, Rie Kuroki, Outi Laajalahti, Pierre Lachance, Jacob Lee, Jin Soo Lee, Peter Levins, Robert Lipetz, Bo Liu, Martin Lundvall, Mary Beth Manning, Frederick N. Martin, Pyrene Martínez Piera, Damien McNally, Shelly McNeil, Guglielmo Migliorino, Stephan Morscher, Michael Mueller, Abul Kashem Munir, Kenjiro Nakamura, Silvia Narejos Pérez, Yuji Naritomi, Patrice Nault, José Luiz Costa Neto, Concepción Núñez López, Åke Olsson, Pauliina Paavola, Janice Patrick, Mercè Pérez Vera, Airi Põder, Terry L. Poling, Samir Purnell-Mullick, George Raad, T. Michael Redmond, Philippe Remaud, Ernie Riffer, P. C. Robert, Alex Rodríguez Badia, María Luisa Rodríguez de la Pinta, Robert Rosen, Shari E. Rozen, Dominique Saillard, Joachim Sauter, Axel Schaefer, Schmidt Juergen, Bernhard Schmitt, Schubert Christian, Ilkka Seppä, Edmund Kwok Yiu Sha, Gerald Shockey, Sylvia Shoffner, Elina Sirnela-Rif, Tommaso Staniscia, Hirohiko Sueki, Suzuki Shin, Denis Taminau, Guy Tellier, Manuel Terns Riera, Azhar Toma, Nicole Toursarkissian, M. Turner, Anna Vilella Morató, Juergen Wachter, Brian Webster, Karl Wilhelm, Jonathan Wilson, Wilfred Yeo, Irina Zahharova

Bibliographic record

VenueClinical Infectious Diseases · 2021
Typearticle
Languageen
FieldMedicine
TopicHerpesvirus Infections and Treatments
Canadian institutionsIsland HealthUniversité Laval
FundersEuropean and Developing Countries Clinical Trials PartnershipElse Kröner-Fresenius-StiftungDeutsche ForschungsgemeinschaftDeutsches Zentrum für InfektionsforschungBiogenSanofiPfizer
KeywordsMedicineVaccinationInterim analysisVaccine efficacyConfidence intervalImmune systemImmunologyClinical trialInternal medicine

Abstract

fetched live from OpenAlex

BACKGROUND: This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age ≥50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after ≥2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. METHODS: Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing ≥2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. RESULTS: Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. CONCLUSIONS: Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination. Clinical Trials Registration. NCT02723773.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.011
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.563
Threshold uncertainty score0.997

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0030.011
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.165
GPT teacher head0.482
Teacher spread0.317 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations93
Published2021
Admission routes1
Has abstractyes

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