Design of a randomized, placebo-controlled study evaluating efficacy and safety of a cancer preventative vaccine in dogs.

Canine Frameshift peptides Neoantigens Neoplasms Vaccination

Journal

Veterinary immunology and immunopathology
ISSN: 1873-2534
Titre abrégé: Vet Immunol Immunopathol
Pays: Netherlands
ID NLM: 8002006

Informations de publication

Date de publication:
29 Nov 2023
Historique:
received: 20 06 2023
revised: 06 11 2023
accepted: 24 11 2023
medline: 7 12 2023
pubmed: 7 12 2023
entrez: 6 12 2023
Statut: aheadofprint

Résumé

Preventative anti-cancer vaccination strategies have long been hampered by the challenge of targeting the diverse array of potential tumor antigens, with successes to date limited to cancers with viral etiologies. Identification and vaccination against frameshift neoantigens conserved across multiple species and tumor histologies is a potential cancer preventative strategy currently being investigated. Companion dogs spontaneously develop cancers at a similar incidence to those in people and are a complementary comparative patient population for the development of novel anti-cancer therapeutics. In addition to an intact immune system with tumors that arise in an autochthonous tumor microenvironment, dogs also have a shorter lifespan and temporally compressed tumor natural history as compared to humans, which allows for more rapid evaluation of safety, immunogenicity, and efficacy of cancer vaccination strategies. Here we describe the study protocol for the Vaccination Against Canine Cancer Study (VACCS), the largest interventional cancer clinical trial conducted in companion dogs to date. In addition to safety and immunogenicity, the primary endpoint of VACCS is the cumulative incidence (CI) of dogs developing malignant neoplasia of any type at the end of the study period. Secondary endpoints include changes in incidence of specific tumor types, survival times following neoplasia diagnosis, and all-cause mortality.

Identifiants

DOI: 10.1016/j.vetimm.2023.110691 PMID: 38056066
pubmed: 38056066
pii: S0165-2427(23)00145-9
doi: 10.1016/j.vetimm.2023.110691
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

110691

Informations de copyright

Copyright © 2023. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest SAJ, KFS and DHT are shareholders in Calviri Inc., which is commercializing the described frameshift vaccination technology. JLW is currently an employee of Antech Diagnostics, however this organization did not participate in funding this work. JHB, DMV, JE, JRB, LS, RLP, SA, AJ, DB, JR, IM, IDK, MKH, RH, and BMS declare they have no competing interests.

Auteurs

Jenna H Burton (JH)

Flint Animal Cancer Center, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, 300 W. Drake Road, Fort Collins, CO 80523, United States.

Stephen Albert Johnston (SA)

Calviri, Inc., Phoenix Bioscience Core, 850 North 5th Street, Phoenix, AZ 85004, United States; Center for Innovations in Medicine, Biodesign Institute, Arizona State University, 727 E. Tyler Street, Tempe, AZ 85281, United States.

David M Vail (DM)

Carbone Cancer Center, University of Wisconsin-Madison, 600 Highland Ave, Madison, WI 53705, United States; Department of Medical Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI 53706, United States.

Jens C Eickhoff (JC)

Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin-Madison, 610 Walnut Street, Madison, WI 53726, United States.

Kathryn F Sykes (KF)

Calviri, Inc., Phoenix Bioscience Core, 850 North 5th Street, Phoenix, AZ 85004, United States.

Justin R Brown (JR)

Calviri, Inc., Phoenix Bioscience Core, 850 North 5th Street, Phoenix, AZ 85004, United States.

Luhui Shen (L)

Calviri, Inc., Phoenix Bioscience Core, 850 North 5th Street, Phoenix, AZ 85004, United States.

Ana Gervassi (A)

Calviri, Inc., Phoenix Bioscience Core, 850 North 5th Street, Phoenix, AZ 85004, United States.

Rodney L Page (RL)

Flint Animal Cancer Center, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, 300 W. Drake Road, Fort Collins, CO 80523, United States.

Jennifer L Willcox (JL)

Department of Surgical and Radiological Sciences, School of Veterinary Medicine, University of California, One Shields Avenue, Davis, CA 95616, United States.

Sami Al-Nadaf (S)

Department of Surgical and Radiological Sciences, School of Veterinary Medicine, University of California, One Shields Avenue, Davis, CA 95616, United States.

Amanda L Willis (AL)

Flint Animal Cancer Center, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, 300 W. Drake Road, Fort Collins, CO 80523, United States.

Danielle Biggs (D)

Flint Animal Cancer Center, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, 300 W. Drake Road, Fort Collins, CO 80523, United States.

Jessica Ralston (J)

Flint Animal Cancer Center, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, 300 W. Drake Road, Fort Collins, CO 80523, United States.

Irene Mok (I)

Flint Animal Cancer Center, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, 300 W. Drake Road, Fort Collins, CO 80523, United States.

Ilene D Kurzman (ID)

Department of Medical Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI 53706, United States.

Michael K Huelsmeyer (MK)

Department of Medical Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI 53706, United States.

Rubi Hayim (R)

Department of Medical Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI 53706, United States.

Brittany M Smith (BM)

Veterinary Center for Clinical Trials, School of Veterinary Medicine, University of California, One Shields Avenue, Davis, CA 95616, United States.

Douglas H Thamm (DH)

Flint Animal Cancer Center, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, 300 W. Drake Road, Fort Collins, CO 80523, United States. Electronic address: dthamm@colostate.edu.

Classifications MeSH