Field safety study of VANGUARD®crLyme: A vaccine for the prevention of Lyme disease in dogs.
Borrelia
Borreliella
C6
Chimeritope
Ixodes
Lyme disease
Ticks
Vaccine
Journal
Vaccine: X
ISSN: 2590-1362
Titre abrégé: Vaccine X
Pays: England
ID NLM: 101748769
Informations de publication
Date de publication:
11 Dec 2020
11 Dec 2020
Historique:
received:
28
08
2020
revised:
17
10
2020
accepted:
19
10
2020
entrez:
18
12
2020
pubmed:
19
12
2020
medline:
19
12
2020
Statut:
epublish
Résumé
Here we report the results of a large-scale pre-license safety study in which two serials of VANGUARD®crLyme, a vaccine for canine Lyme disease, were tested in its target population (dogs) under the conditions of its intended use. Six-hundred and twenty dogs, from three distinct geographic regions of the United States were enrolled in this study with each receiving two doses of vaccine by subcutaneous injection 3 to 4 weeks apart. Approximately one-third of the dogs were of minimum age (≤8 weeks of age) to meet regulatory requirements. Safety was evaluated by observation of local and systemic reactions for at least 10 days after each vaccination. Abnormal health events (AHEs) occurred at low frequencies and no serious AHEs were observed. The results demonstrated that VANGUARD®crLyme is safe for use in healthy dogs 8 weeks of age or older.
Identifiants
pubmed: 33336186
doi: 10.1016/j.jvacx.2020.100080
pii: S2590-1362(20)30027-9
pmc: PMC7733143
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100080Informations de copyright
© 2020 The Author(s).
Déclaration de conflit d'intérêts
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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