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Safety, efficacy and immunogenicity of a recombinant Osp subunit canine Lyme disease vaccine
Open accessAbstract
A subunit canine Lyme disease vaccine formulated with recombinant lipidated Osp A and OspB and saponin QS21 was assessed for safety, protective efficacy, and immunogenicity. Ten normal beagles were subcutaneously vaccinated twice at age 12 and 16 weeks, respectively. Three months after the second vaccination, the vaccinates and another 10 nonvaccinated control beagles were challenged by feeding ticks on each dog for 5 days using eight field-collected adult female and six adult male Ixodes scapularis infected with Lyme disease spirochetes per dog. Adverse reactions associated with the vaccinations were limited to injection site swellings which occurred within the first 48 h and resolved within a week. The local reaction was independent of vaccination times and tick challenge. On the basis of typical clinical signs, xenodiagnosis, and diagnostic immunoblotting, all 10 controls were infected; five developed lameness and three of them experienced at least two to three episodes of limping during a 10-month monitoring period. In contrast, eight of ten vaccinates were protected and two infected vaccinates, as judged by xenodiagnosis, were asymptomatic. None of the protected vaccinates developed antibodies to diagnostic spirochetal antigens other than OspA and OspB. In contrast, most controls produced antibodies to borrelial antigens, but not to OspA and OspB. Antibody production in vaccinates receiving a third vaccination 10 months postchallenge was greatly boosted; the geometric mean antibody titer was significantly higher (P < 0.0001) than that tested prechallenge. Thus, the subunit canine Lyme disease vaccine was safe and protective and elicited immunological memory. Vaccinated dogs were serologically distinguishable from those naturally exposed.
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Three of the studies reporting adverse events noted mild swelling and reddening at the injection site.
“Three of these studies noted mild swelling and reddening at the injection site.1, 30, 32”
From Efficacy of Borrelia burgdorferi vaccine in dogs in North America: A systematic review and meta-analysis (2019) · cites this paper as [32]
The Vaccine safety section reports slight swelling at the injection sites of vaccinated dogs, supporting that part of the claim. It does not report reddening; it describes the swelling as occurring without heat or tenderness. No page number is available in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOne study reported that 8 of 10 dogs had a slight swelling at the injection site at the 1st vaccination and 3 of the 10 dogs had a similar reaction at the 2nd vaccination.
“One of these studies reported that 8 of 10 dogs had a slight swelling at the injection site at the 1st vaccination and 3 of the 10 dogs had a similar reaction at the 2nd vaccination.32”
From Efficacy of Borrelia burgdorferi vaccine in dogs in North America: A systematic review and meta-analysis (2019) · cites this paper as [32]
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“reaction at the 2nd vaccination.(32) One observational study reported that 38 of 1969 dogs (1.”
Background
Metadata
- Authors
- Ma, J., Hine, P. M., Clough, E. R., Fish, D., Coughlin, R. T., Beltz, G. A., & Shew, M. G.
- Affiliations
- Mallinckrodt (United States) (US)
- Yale University (US)
- Corresponding author
- Ma, Jianneng
- ORCID
- Fish, Durland
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 1996-10
- Volume
- 14
- Issue
- 14
- Pages
- 1366-1374
- ISSN
- 0264-410X (ISSN-L)
- OpenAlex
- W2011484134
- Cited by
- 21
- References
- 62
- Citations by year
- 2025: 1 · 2021: 1 · 2018: 1 · 2017: 1 · 2013: 2
- FWCI
- 1.19
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Vaccine (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Parasitology › Vector-borne infectious diseases
- Health Sciences › Medicine › Infectious Diseases › Brucella: diagnosis, epidemiology, treatment
- Life Sciences › Immunology and Microbiology › Microbiology › Microbial infections and disease research
- Keywords
- subunit vaccine, OspA, OspB, Ixodes scapularis, Borrelia burgdorferi, vaccine safety, vaccine efficacy, immunogenicity, xenodiagnosis, antibody response, immunological memory, serological cross-reactivity, dogs
- MeSH terms
- Animals, Antibodies, Bacterial, Antigens, Bacterial, Bacterial Outer Membrane Proteins, Dogs, Enzyme-Linked Immunosorbent Assay, Immune Sera, Lyme Disease, Vaccines, Synthetic, Borrelia burgdorferi Group
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