Efficacy and safety field trials of a recombinant DNA vaccine against feline leukemia virus infection

Nancy Clark From the Department of Medicine, School of Veterinary Medicine, Tufts University, North Grafton, MA 01536 (Clark, Cotter), and Cambridge Biotech Corporation, 365 Plantation St, Worcester, MA 01605 (Kushner, Barren, Kensil), and Pitman-Moore, 421 East Hawley St, Mundelein, IL 60060 (Salsbury).

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N.N. Kushner From the Department of Medicine, School of Veterinary Medicine, Tufts University, North Grafton, MA 01536 (Clark, Cotter), and Cambridge Biotech Corporation, 365 Plantation St, Worcester, MA 01605 (Kushner, Barren, Kensil), and Pitman-Moore, 421 East Hawley St, Mundelein, IL 60060 (Salsbury).

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C.B. Barrett From the Department of Medicine, School of Veterinary Medicine, Tufts University, North Grafton, MA 01536 (Clark, Cotter), and Cambridge Biotech Corporation, 365 Plantation St, Worcester, MA 01605 (Kushner, Barren, Kensil), and Pitman-Moore, 421 East Hawley St, Mundelein, IL 60060 (Salsbury).

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Charlotte R. Kensil From the Department of Medicine, School of Veterinary Medicine, Tufts University, North Grafton, MA 01536 (Clark, Cotter), and Cambridge Biotech Corporation, 365 Plantation St, Worcester, MA 01605 (Kushner, Barren, Kensil), and Pitman-Moore, 421 East Hawley St, Mundelein, IL 60060 (Salsbury).

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D. Salsbury From the Department of Medicine, School of Veterinary Medicine, Tufts University, North Grafton, MA 01536 (Clark, Cotter), and Cambridge Biotech Corporation, 365 Plantation St, Worcester, MA 01605 (Kushner, Barren, Kensil), and Pitman-Moore, 421 East Hawley St, Mundelein, IL 60060 (Salsbury).

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Susan Cotter From the Department of Medicine, School of Veterinary Medicine, Tufts University, North Grafton, MA 01536 (Clark, Cotter), and Cambridge Biotech Corporation, 365 Plantation St, Worcester, MA 01605 (Kushner, Barren, Kensil), and Pitman-Moore, 421 East Hawley St, Mundelein, IL 60060 (Salsbury).

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Summary

A new recombinant gp70 vaccine was found to be safe and effective for prevention of infection by FeLV. The vaccine incorporates a unique purified saponin adjuvant with the recombinant antigen. Serious systemic reactions were not observed during the efficacy trial. Local reactions were transient and mild. More than 2,000 doses were administered to a cross section of household cats in a field safety trial. Only 1 cat had hypersensitivity reaction, which resolved. Among veterinarians who used the vaccine and the cat owners, the vaccine was judged satisfactory and safe.

After rigorous intraperitoneal challenge exposure without use of immunosuppressants, 100% of the controls in the efficacy trial became infected, 70% of which remained persistently infected with FeLV. Among vaccinates, 45% were never viremic and 40% cleared transient infection within 12 weeks after challenge exposure. Of the 20 vaccinated cats, 3 were persistently infected. Overall, 85% of cats vaccinated with this recombinant dna FeLV vaccine resisted persistent FeLV infection after stringent challenge exposure, which translates to preventable fraction of 78.6%.

Summary

A new recombinant gp70 vaccine was found to be safe and effective for prevention of infection by FeLV. The vaccine incorporates a unique purified saponin adjuvant with the recombinant antigen. Serious systemic reactions were not observed during the efficacy trial. Local reactions were transient and mild. More than 2,000 doses were administered to a cross section of household cats in a field safety trial. Only 1 cat had hypersensitivity reaction, which resolved. Among veterinarians who used the vaccine and the cat owners, the vaccine was judged satisfactory and safe.

After rigorous intraperitoneal challenge exposure without use of immunosuppressants, 100% of the controls in the efficacy trial became infected, 70% of which remained persistently infected with FeLV. Among vaccinates, 45% were never viremic and 40% cleared transient infection within 12 weeks after challenge exposure. Of the 20 vaccinated cats, 3 were persistently infected. Overall, 85% of cats vaccinated with this recombinant dna FeLV vaccine resisted persistent FeLV infection after stringent challenge exposure, which translates to preventable fraction of 78.6%.

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