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Parvovirus Vaccine (Canine). Secutive Days Postchallenge

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Parvovirus Vaccine (Canine). Secutive Days Postchallenge Animal and Plant Health Inspection Service, USDA § 113.317 vaccine is administered and individ- virus infection; or, if less than 19 of 20 ually tested on susceptible cell cul- vaccinates show serum neutralization tures for the presence of canine titers of 1:4 or greater; or, if there is parainfluenza virus. Blood samples not a significant reduction in virus iso- shall also be drawn and individual lation rate in vaccinates when com- serum samples tested for neutralizing pared with controls, the Master Seed is antibody. Dogs shall be considered sus- unsatisfactory. ceptible if all swabs are negative for (5) An Outline of Production change virus isolation and if all serums are shall be made before authority for use negative for canine parainfluenza anti- of a new lot of Master Seed shall be body at a 1:2 final dilution in a con- granted by Animal and Plant Health stant virus-varying serum neutraliza- Inspection Service. tion test using 50 to 300 TCID50 of ca- (c) Test requirements for release. Each nine parainfluenza virus. serial and subserial shall meet the ap- (2) A geometric mean titer of vaccine plicable general requirements pre- produced at the highest passage from scribed in § 113.300 and the require- the Master Seed shall be established ments in this paragraph. Any serial or before the immunogenicity test is con- subserial found unsatisfactory by a ducted. The 20 dogs used as vaccinates prescribed test shall not be released. shall be administered a predetermined (1) Virus titer requirements. Final con- quantity of vaccine virus. Five rep- tainer samples of completed product licate virus titrations shall be con- shall be tested for virus titer using the ducted on a sample of the vaccine virus titration method used in paragraph dilution used to confirm the dosage ad- (b)(2) of this section. To be eligible for ministered. If two doses are used, five release, each serial and each subserial replicate confirming titrations shall be shall have a virus titer sufficiently conducted on each dose. greater than the titer of vaccine virus (3) Three to 4 weeks after the final used in the immunogenicity test pre- dose of vaccine, all dogs shall be bled scribed in paragraph (b) of this section for serum antibodies and nasal swabs to assure that, when tested at any time shall be collected for canine within the expiration period, each se- parainfluenza virus isolation. On the rial and subserial shall have a virus same day, all vaccinates and controls titer at least 100.7 greater than that shall be challenged with canine used in the immunogenicity test but 2.5 parainfluenza virus furnished or ap- not less than 10 TCID50 per dose. proved by Animal and Plant Health In- (2) [Reserved] spection Service. [50 FR 436, Jan. 4, 1985. Redesignated at 55 (4) The rectal temperature of each FR 35562, Aug. 31, 1990, as amended at 56 FR dog shall be taken and the presence of 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, respiratory or other clinical signs of 2007] canine parainfluenza virus infection noted and recorded each day for 14 con- § 113.317 Parvovirus Vaccine (Canine). secutive days postchallenge. Nasal Parvovirus Vaccine recommended for swabs shall be collected from each dog use in dogs shall be prepared from each day for at least 10 consecutive virus-bearing cell culture fluids. Only days postchallenge. Individual swabs Master Seed which has been estab- shall be tested for virus isolation by lished as pure, safe, and immunogenic culture in canine parainfluenza virus shall be used for preparing seeds for susceptible cells for at least 7 days. Re- vaccine production. All serials of vac- sults shall be evaluated according to cine shall be prepared from the first the following criteria: through the fifth passage from the (i) If five of five controls have not re- Master Seed. mained seronegative at a final serum (a) The Master Seed shall meet the dilution of 1:2 during the prechallenge applicable general requirements pre- period, the test is inconclusive and scribed in § 113.300 and the require- may be repeated. ments in this section. (ii) If more than one vaccinate shows (b) The Master Seed shall be tested febrile response, respiratory or other for reversion to virulence in dogs using clinical signs of canine parainfluenza a method acceptable to Animal and 769 VerDate Nov<24>2008 12:41 Mar 16, 2010 Jkt 220028 PO 00000 Frm 00779 Fmt 8010 Sfmt 8010 Y:\SGML\220028.XXX 220028 cprice-sewell on DSK89S0YB1PROD with CFR § 113.318 9 CFR Ch. I (1–1–10 Edition) Plant Health Inspection Service. If a controls do not show at least three of significant increase in virulence is seen the four criteria of infection during the within five backpassages, the Master observation period, the test is incon- Seed is unsatisfactory. clusive and may be repeated. (c) Each lot of Master Seed shall be (ii) If at least 19 of the 20 vaccinates tested for immunogenicity. The se- do not survive the observation period lected virus dose shall be established as without showing more than one cri- follows: terion of infection described in para- (1) Twenty-five canine parvovirus graph (c)(3)(i), of this section, the Mas- susceptible dogs (20 vaccinates and 5 ter Seed is unsatisfactory. controls) shall be used as test animals. (4) An Outline of Production change Blood samples drawn from each dog shall be made before authority for use shall be individually tested for neutral- of a new lot of Master Seed shall be izing antibody against canine granted by Animal and Plant Health parvovirus to determine susceptibility. Inspection Service. Dogs shall be considered susceptible if (d) Each there is no neutralization at a 1:2 final Test requirements for release. serum dilution in a constant virus- serial and subserial shall meet the ap- varying serum neutralization test in plicable general requirements pre- scribed in § 113.300 and the require- cell culture using 50 to 300 TCID50 of canine parvovirus. ments in this paragraph. Any serial or (2) A geometric mean titer of the vac- subserial found unsatisfactory by a cine produced at the highest passage prescribed test shall not be released. from the Master Seed shall be estab- (1) Virus titer requirements. Final con- lished before the immunogenicity test tainer samples of completed product is conducted. The 20 dogs used as vac- shall be tested for virus titer using the cinates shall be administered a pre- titration method used in paragraph determined quantity of vaccine virus (c)(2) of this section. To be eligible for by the method recommended on the release, each serial and each subserial label. To confirm the dosage calcula- shall have a virus titer sufficiently tions, five replicate virus titrations greater than the titer of vaccine used shall be conducted on a sample of the in the immunogenicity test in para- vaccine virus dilution used. If two graph (c) of this section to assure that, doses are used, five replicate con- when tested at any time within the ex- firming titrations shall be conducted piration period, each serial and sub- on each dose. serial shall have a virus titer of 100.7 (3) Fourteen days or more after the greater than that used in the final dose of vaccine the vaccinates and immunogenicity test, but not less than 2.5 the controls shall be challenged with 10 ID50 per dose. virulent canine parvovirus furnished or approved by Animal and Plant Health [50 FR 436, Jan. 4, 1985. Redesignated at 55 Inspection Service and the dogs ob- FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, served each day for 14 days. Rectal 2007] temperature, blood lymphocyte count, and feces for viral detection shall be § 113.318 Pseudorabies Vaccine. taken from each dog each day for at least 10 days postchallenge and the Pseudorabies Vaccine shall be pre- presence or absence of clinical signs pared from virus-bearing cell culture noted and recorded each day. fluids. Only Master Seed which has (i) The immunogenicity of the Mas- been established as pure, safe, and ter Seed shall be evaluated on the fol- immunogenic shall be used for pre- lowing criteria of infection: tempera- paring seeds for vaccine production. All ture ≥103.4 ° F; lymphopenia of ≥50 per- serials of vaccine shall be prepared cent of prechallenge normal; clinical from the first through the fifth passage signs such as diarrhea, mucus in feces, from the Master Seed. or blood in feces; and viral (a) The Master Seed shall meet the hemagglutinins at a level of ≥1:64 in a applicable general requirements pre- 1:5 dilution of feces or a test of equal scribed in § 113.300 and the require- sensitivity. If at least 80 percent of the ments in this section. 770 VerDate Nov<24>2008 12:41 Mar 16, 2010 Jkt 220028 PO 00000 Frm 00780 Fmt 8010 Sfmt 8010 Y:\SGML\220028.XXX 220028 cprice-sewell on DSK89S0YB1PROD with CFR.
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