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First-in-Human Phase I Clinical Trial of an SFV-Based RNA Replicon Cancer Vaccine against HPV-Induced Cancers.
Komdeur, Fenne L; Singh, Amrita; van de Wall, Stephanie; Meulenberg, Janneke J M; Boerma, Annemarie; Hoogeboom, Baukje Nynke; Paijens, Sterre T; Oyarce, Cesar; de Bruyn, Marco; Schuuring, Ed; Regts, Joke; Marra, Ruben; Werner, Naomi; Sluis, Jessica; van der Zee, Ate G J; Wilschut, Jan C; Allersma, Derk P; van Zanten, Coba J; Kosterink, Jos G W; Jorritsma-Smit, Annelies; Yigit, Refika; Nijman, Hans W; Daemen, Toos.
Afiliación
  • Komdeur FL; Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Singh A; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • van de Wall S; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Meulenberg JJM; ViciniVax BV, Meditech Center, Groningen, the Netherlands.
  • Boerma A; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Hoogeboom BN; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Paijens ST; Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Oyarce C; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • de Bruyn M; Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Schuuring E; Department of Pathology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Regts J; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Marra R; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Werner N; Department of Pathology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Sluis J; Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • van der Zee AGJ; Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Wilschut JC; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Allersma DP; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • van Zanten CJ; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Kosterink JGW; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Jorritsma-Smit A; Department of Pathology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Yigit R; Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Nijman HW; Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  • Daemen T; Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: c.a.h.h.daemen@umcg.nl.
Mol Ther ; 29(2): 611-625, 2021 02 03.
Article en En | MEDLINE | ID: mdl-33160073
ABSTRACT
A first-in-human phase I trial of Vvax001, an alphavirus-based therapeutic cancer vaccine against human papillomavirus (HPV)-induced cancers was performed assessing immunological activity, safety, and tolerability. Vvax001 consists of replication-incompetent Semliki Forest virus replicon particles encoding HPV16-derived antigens E6 and E7. Twelve participants with a history of cervical intraepithelial neoplasia were included. Four cohorts of three participants were treated per dose level, ranging from 5 × 105 to 2.5 × 108 infectious particles per immunization. The participants received three immunizations with a 3-week interval. For immune monitoring, blood was drawn before immunization and 1 week after the second and third immunization. Immunization with Vvax001 was safe and well tolerated, with only mild injection site reactions, and resulted in both CD4+ and CD8+ T cell responses against E6 and E7 antigens. Even the lowest dose of 5 × 105 infectious particles elicited E6/E7-specific interferon (IFN)-γ responses in all three participants in this cohort. Overall, immunization resulted in positive vaccine-induced immune responses in 12 of 12 participants in one or more assays performed. In conclusion, Vvax001 was safe and induced immune responses in all participants. These data strongly support further clinical evaluation of Vvax001 as a therapeutic vaccine in patients with HPV-related malignancies.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Virus de los Bosques Semliki / Vacunas contra el Cáncer / Infecciones por Papillomavirus / Vacunas contra Papillomavirus / Vectores Genéticos / Neoplasias Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Mol Ther Asunto de la revista: BIOLOGIA MOLECULAR / TERAPEUTICA Año: 2021 Tipo del documento: Article País de afiliación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Virus de los Bosques Semliki / Vacunas contra el Cáncer / Infecciones por Papillomavirus / Vacunas contra Papillomavirus / Vectores Genéticos / Neoplasias Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Mol Ther Asunto de la revista: BIOLOGIA MOLECULAR / TERAPEUTICA Año: 2021 Tipo del documento: Article País de afiliación: Países Bajos