KRISHI: Technology Repository

General Part-1

Technology Code:-	:	201720796439297
Organization Details...
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Details of Inventors..
Principal Inventor	:	Dr. Kalaiyarasu, S
Principal Inventor Designation:	:	Senior Scientist
Principal Inventor Email	:	kalaiyarasu.s@icar.gov.in
Principal Inventor Address	:	ICAR-National Institute of High Security Animal Diseases, Hathai Kheda Road, Anand Nagar, Bhopal � 462022, Madhya Pradesh.
Co-Inventor Name	:	Dr. N. Mishra, Dr. S.B. Sudhakar, Late Dr. Richa Sood
Co-Inventor Email	:	Niranjan.mishra1@icar.gov.in,SB.Sudhakar@icar.gov.in
Technology Name	:	Inactivated Bovine Viral Diarrhea Virus (BVDV-1) Vaccine for cattle
Technology Details..
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Complete Details of Technology:	:
Bovine viral diarrhea (BVD) is an economically important viral disease of cattle and prevalent worldwide including India. BVD is caused by three bovine pestiviruses, bovine viral diarrhea virus 1 (BVDV-1), BVDV-2 and HoBi-like pestivirus (HoBiPeV), which belong to the genus Pestivirus in the family Flaviviridae. The main losses of BVD include reproductive disease, severe respiratory disease, gastroenteritis and mucosal disease with high fatalities in cattle. BVD is widely prevalent in India, causing production losses in both large and small holder dairies. In India, successful isolation of BVDV-1 from cattle was first reported in 2004, followed by BVDV-2 in 2011 and HoBiPeV in 2014. Studies in Indian cattle have shown that BVDV-1 is predominantly prevalent, while BVDV-2 and HoBiPeV occurs sporadically. Although, India is the leading milk producing country in the world, reproductive failure/disease in dairy cows still remains a major cause of low average animal productivity. As BVDV is one of the major causes of reproductive disease in cattle, vaccination against BVD is advocated as it enhances herd level immunity, reduces clinical disease, prevents fetal infection and generation of PI calf. However, BVD vaccine is not available in India so far. To prevent BVDV infection in cattle, ICAR-NIHSAD has developed an inactivated BVDV whole virus vaccine using a BVDV-1 field isolate from India. The vaccine was prepared by propagating the BVDV in suitable cell lines followed by inactivation and emulsion preparation with water-in-oil adjuvant. The vaccine has passed the sterility test and showed no adverse effects in guinea pigs when tested for safety by injecting 1.0 ml vaccine by intramuscular route followed by booster on 28th day. To evaluate vaccine safety, immunogenicity and efficacy in experimental cattle, BVDV vaccine was inoculated in 9-12 months cattle calves intramuscularly with 5ml/dose followed by booster on 28th day of primary dose. The vaccine was found to be safe, immunogenic, potent and efficacious in preventing clinical disease upon challenge. It provides protective immunity up to 12 months following vaccination and booster and covers divergent strains of BVDV-1 circulating in India, besides providing partial protection against BVDV-2 and HoBiPeV. Fetal protective antibody titre was persisted for 5 months post vaccination. Vaccine safety and immunogenicity trial in field cattle also showed promising results up to the assessed period of 6 months following the booster vaccination. Vaccine is stable at 4�C for 8 months as assessed by immunogenicity in guinea pigs.
Brief Description of Technology Including Salient Features:
BVDV-1 isolate was selected for development of vaccine, based on genetic and antigenic characterization data and its sterility and purity were confirmed. Freeness from adventitious bovine viruses was ensured by molecular testing. Growth kinetics and inactivation kinetics were studied to select optimum conditions for laboratory scale propagation and inactivation. Seed stock of BVDV-1 vaccine virus with a titre of 106.0 TCID50/ml was prepared, aliquoted and preserved at -80�C until use. For assessment of safety, immunogenicity and efficacy of BVDV (BVDV-1) vaccine, emulsion (water-in-oil emulsion) was prepared using inactivated BVDV-1 vaccine virus and adjuvant in a selected ratio. Vaccine safety and immunogenicity was initially assessed by inoculating 1 ml dose of vaccine intramuscularly in guinea pigs. Evaluation of BVDV (BVDV-1) vaccine safety, immunogenicity and efficacy in experimental cattle was conducted as per the CPCSEA approved protocol. Following challenge with BVDV-1 clinical signs like ocular discharge, nasal discharge and diarrhea were noticed in control animals whereas BVDV-1 vaccinated calves appeared healthy during the study period. The protective antibody response (VN antibody titre) following vaccination was measured up to one year post primary vaccination by virus neutralization test (VNT). It provides protective immunity against BVDV-1 that persisted up to 12 months following vaccination and booster (at 28dpv), while fetal protective antibody titre persisted for 5 months post vaccination. Safety and immunogenicity of ICAR-NIHSAD BVDV (BVDV-1) vaccine was assessed in field cattle (n=116). The animals were inoculated with different doses of vaccine and protective antibody response (VN antibody titre) was measured upto 6 months post booster vaccination. Vaccine Stability: The vaccine was found to be stable for up to 8 months (study period) at 4�C.
Benefits/Utility	:
This is the first indigenously developed BVD vaccine in India, intended for prevention and control of BVDV infection and in reducing losses associated with clinical disease in cattle, so as to achieve the goal of one calf per breeding cow each year for the dairy farmers and industry. Vaccination against BVD along with farm biosecurity will help in BVD control thereby protecting the dairy cattle farmers and industry from economic losses. As the inactivated BVDV vaccine developed by ICAR-NIHSAD is based on the genetic and antigenic characterization of locally circulating BVDV strains of all three bovine pestivirus species over 20 years, it will provide a better antigenic coverage and clinical protection against BVDV-1 infection and cross-protection against BVDV-2 and HoBiPeV strains circulating in India. Besides, the BVD vaccine strain replacement period will be longer, which is a benefit to both the dairy farmers and animal vaccine industry.
Precaution With The Technology	:	The vaccine should be stored at 4�C in the refrigerator.
How To Use	:
Vaccination schedule, route and storage conditions are provided along with the kit.
TargetUsers/Stake holders	:	Dairy farmers/entrepreneurs/dairy industry
Technology Contact..
Name	:	Director
Email	:	director.nihsad@icar.gov.in
Phone Number	:	0755-2759204
Fax Number	:	0755-2758842
Address	:	ICAR-National Institute of High Security Animal Diseases,Anand Nagar, Bhopal-462021.,Bhopal-462022
Alternate Contact..
Name	:	Dr. Kalaiyarasu, S
Email	:	Kalaiyarasu.s@icar.gov.in
Phone No	:	07552754675
Keyword for Technology	:	Bovine Viral Diarrhea Virus, Cattle, Vaccine

Technology Development Details Part-2

Project Details (Through which technology was developed)	:	1. IXX13759 (2017-2020)-Selection of BVDV vaccine candidate strain(s) and characterization of master seed virus stock(s). 2. 49/CI/IPP/PME/Ins-solo/20-21/05 (2020-2024)-Studies on safety, efficacy and immunogenicity of BVDV vaccine candidate(s) in cattle
Time of Initiation Technology Development	:	6-2017
Time of Completion Technology Development	:	3-2024
Technology Validated by	:	Within ICAR
Technology Validation Details..
Subject Matter Division	:	{{smdOb.smdName}}
Organization Name(if within ICAR)	:	ICAR-National Institute of High Security Animal Diseases,Bhopal
Organization Name(if outside ICAR,Please enter)	:
Year of Validation(YYYY)	:	9-2022
Year of Release/Adoption(YYYY)	:	3-2024
Release Reference Number	:	Yet to be given
Statutory Approval Status	:	Not yet applied
Through Technology Transfer	:	YES

Applies To(Regional Differentiation)Inform Part-3

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