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The current state of vaccines used in the field for foot and mouth disease virus in China
Expert Rev. Vaccines 10(1), 13–15 (2011)
Author for correspondence: State Key Laboratory of Veterinary Etiological Biology, Key Laboratory of Grazing Animal Diseases of Ministry of Agriculture, Lanzhou Veterinary Research Institute, Chinese Academy of Agriculture Sciences, 1 Xujiaping, Lanzhou, 730046 China Tel.: +86 931 834 2685 Fax: +86 931 834 0977 firstname.lastname@example.org
“Foot and mouth disease is the most important disease of the Office International des Epizooties list A due to its effect on trade. The highly infectious nature of the disease, combined with its ability to cause persistent infections and to exist as multiple types and variants, makes foot and mouth disease difficult to control.”
Foot and mouth disease (FMD) is the highly contagious disease of livestock that causes severe economic loss in susceptible cloven-hoofed animals such as cattle, swine, sheep and goats. FMD virus (FMDV) is a member of genus Aphthovirus of the family Picornaviridae. Seven immuno logically distinct serotypes (A, O, C, Asia 1, SAT I, SAT II and SAT III) have been identified  . Viral infection or immunization with one serotype does not confer protection against the other serotypes  . In recent years, three serotypes of FMDV have caused epidemics in China. In March 2005, FMDV serotype Asia 1 was found in Hong Kong. Subsequently, this type of the virus was reported in mainland China in April 2005  . In 2009, type A FMDV caused outbreaks of FMD in cattle in Wuhan, Hubei Province, Shanghai and Beijing. In early 2010, a type O FMDV outbreak was recorded in Shenzhen, Guangzhou Province. So far, outbreaks of FMD O have been reported in several provinces and autonomous regions of China, which suggests that the virus might have crossed China. Foot and mouth disease is the most important disease of the Office International des Epizooties (OIE) list A due to its effect on trade. The highly infectious nature of the disease, combined with its ability to cause persistent infections and to exist as multiple types and variants, makes FMD difficult to control  . The Chinese government undertook vaccination of livestock by preventive vaccination programs, supplemented by the slaughter of infected animals and susceptible in-contact animals. The types of FMDV vaccines that have been developed in China include: inactivated vaccine; synthesized peptide vaccine; recombinant adenovirus, pseudorabies or fowlpox-vectored vaccine; empty capsid-like particles produced from recombinant baculoviruses; DNA vaccines; and oral vaccine produced from transgenic plants [5–12] . Among these, the inactivated vaccine and synthesized peptide vaccine are currently available for use in governmentapproved disease control programs in China, and the vaccine composed of inactivated antigen and empty capsid-like particles produced from recombinant silkworm baculovirus are used in eight provinces and autonomous regions of China. Other vaccines are still under evaluation in the laboratory or field to establish their safety and efficacy.
State Key Laboratory of Veterinary Etiological Biology, Key Laboratory of Animal Virology of Ministry of Agriculture, Lanzhou Veterinary Research Institute, Chinese Academy of Agriculture Sciences, 1 Xujiaping, Lanzhou, 730046 China
The inactivated vaccine is produced by infecting baby hamster kidney (BHK)-21 cells with virulent FMDV, followed by
Keywords : China • empty capsid vaccine • foot and mouth disease virus • inactivated vaccine
• safety • synthesized peptide vaccine • vaccination
© 2011 Expert Reviews Ltd
As a result. It has been proven that the virus involved in FMD outbreaks was sometimes closely related to virus strains used in vaccine manufacturing plants. immunological and virological data documenting the efficacy of these vaccines are required by the Veterinary Bureau at the Ministry of Agriculture. The vaccines can be monovalent or multivalent. has a unique consensus sequence to confront the hypervariability of serotype O viruses and a promiscuous artificial Th site. This interesting finding requires further investigation. Of note. including viruses of different serotypes of FMDV. thereby decreasing the possible selection of antigenic variants from the quasispecies. (2011) . “The complete control and eradication of foot and mouth disease virus can only ultimately be achieved by a combination of vaccination. but whether the synthesized peptide vaccine could overcome the quasispecies problem still needs to be evaluated. the production of type O inactivated antigens still requires the use of live virus in the manufacturing process. Therefore. The type O and Asia 1 bivalent vaccine (empty capsid vaccine compound) consists not only of the pure empty capsid-like ������������������ particle component but also includes the type O inactivated antigen. First. Synthesized peptide vaccine The type O and Asia 1 bivalent vaccine (empty capsid vaccine compound) is composed of type O inactivated antigens and type Asia 1 empty capsid-like particles produced from recombinant silkworm baculoviruses. However. it has several potential disadvantages. The type O and Asia 1 bivalent vaccine (empty capsid vaccine compound) should be evaluated in the field based on Expert Rev. Vaccines 10(1). some of the antigenic sites on FMDV are discontinuous and involve different regions of a capsid protein or more than one protein. Clinical. the FMDV circulating in China in 2005 was genetically closely related to an Indian FMDV vaccine strain  . it is difficult to distinguish between vaccinated and field-infected animals by currently approved diagnostic tests  . The FMD outbreak in the UK in 2007 was caused by an FMDV 01 BFS67-like virus that only existed in FMD reference laboratories and pharmaceutical manufacturing plants. Only monovalent/multivalent vaccines for type O. This means that the safety of the compound vaccine is lower than that of the pure empty capsid vaccine. the FMD inactivated vaccine should be purified by industrial ultrafiltration and chromatography in order to remove unwanted cellular protein contaminants and viral NSP. It is the authors’ opinion that this compound vaccine needs to be replaced by pure empty capsid vaccine. 14 The vaccine is a fundamental component of strategies aimed at China’s control and eradication of FMD. Now the synthesized peptide vaccine’s market share is close to that of the inactivated vaccine. either because of the incomplete inactivation of FMDV in large-scale production or owing to the escape of the live virus from vaccine plants. they are noninfectious as they lack nucleic acid. the empty capsid-like particles of type O are more difficult to obtain by genetic engineering techniques as the viral capsid of type O is more acid-sensitive than other types of FMDV  . ����������������� Although the synthesized peptide vaccine is safer than the inactivated vaccine. Second.Editorial Li & Liu inactivation with binary ethyleneimine (BEI) and purification by ultrafiltration  . Currently. In addition to the aforementioned disadvantage. some measures need to be strengthened to ensure the quality and safety of the vaccine. a greater emphasis should be placed on quality assurance/quality control in order to reduce the risk of spreading viruses from manufacturing plants. the synthesized peptide vaccine is safer than the inactivated vaccine. However. depending on the manufacturer. the outbreak of type O FMDV seen in China in 2010 coincided with the widespread use of the synthesized peptide vaccine in the field. In addition. however. All companies in China producing FMDV-inactivated vaccines do so under strict biosecure conditions. The synthetic peptide vaccine has been designed with the B-cell sites spans the entire G–H loop domain and extensive flanking sequences. The company producing the vaccines follows the guidelines of the Veterinary Bureau at the Ministry of Agriculture for Veterinary Medicines Products. First. The safety is thus improved and the empty capsid vaccine is considered safer than the inactivated vaccine  . Conclusion The FMDV (type O) synthesized peptide vaccine for swine has been used in the field in China since 2007. Problems Type O & Asia-1 bivalent vaccine (empty capsid vaccine compound) Although the inactivated vaccine has been shown to be effective. the quasispecies nature of FMDV invites the selection of antigenic variants not targeted by the vaccine that could cause outbreaks in animals vaccinated with peptide vaccines  . Problems The synthesized peptide vaccine reduces the risk of outbreak from laboratories or vaccine-manufacturing plants because it does not use the virus in its manufacturing process. However. only a limited number of antigenic sites and T-cell epitopes of FMDV can be synthesized and consequently the vaccine is not able to induce significant protection. The inactivated vaccine remains the most widely used FMD vaccine in the world. it may lead to new outbreaks of FMD. It has shown good immunogenicity in swine but limited immunogenicity in cattle. the vaccine may also contain varying degrees of contaminating viral nonstructural proteins (NSPs). type A and type Asia 1 are now produced and used in China. As a new-generation vaccine. the diagnostic tests to distinguish virus-infected carrier animals from vaccinated animals are based on the detection of antibodies to viral NSPs. Second. Empty viral capsids are as immunogenic as the 140S virions. the empty capsid vaccine contains the entire repertoire of antigenic sites present on the 140S virion.” Compared with synthetic peptide vaccines. It was licensed for use in eight provinces and autonomous regions of China in 2008. extensive surveillance and an effective monitoring program.
Dis. In addition. De Clercq K. research concerning appropriate adjutants for vaccines to induce either a Th1 or a Th2 response is also required. newgeneration efficacious vaccines. 2003–2007. Vaccine 26. Although the control strategies that include culling FMD-infected animals and susceptible animals. Terry G. 14 Domingo E. Li X. Cao Y et al. Expert Rev. An approach to a FMD vaccine based on genetic engineered attenuated pseudorabies virus: one experiment using VP1 gene alone generates an antibody responds on FMD and pseudorabies in swine. B. Peng GQ. 227–238 (1975). Jin ML. A comparative chemical and serological study of the full and empty particles of foot-and mouth disease virus. Sun J et al. Virol. Chen H. Cao Y. Vet. immunological and virological data. Synthesis of empty capsid-like particles of Asia I foot-and-mouth disease virus in insect cells and their immunogenicity in guinea pigs. Mol. Grubman MJ. 1–7 (2008). After the outbreak in UK in 2001. Wang X et al.com 15 . van Vlijmen HW. Yin X. Rweyemamu MM. Karplus M. Gen. Liu R. Vet. FMD vaccines: reflections on quality aspects for applicability in European disease control policy. Financial & competing interests disclosure This work was supported by grants from National 863 Project of China (No. Valarcher J. Su BW. PLoS ONE 3. Moraes MP. Induction of a protective antibody response to FMDV in mice following oral immunization with transgenic Stylosanthes spp. 2714–2722 (2008). Li Z. In addition to the aforementioned vaccines. The effects of IL-6 and TNF. e2273 (2008). Wang JP. Zhu JB. Titration calculations of foot-and-mouth disease virus capsids and their stabilities as a function of pH. Escarmis C. Qian P. References 1 should be developed. Rowlands DJ. Infect. Zhang Z. Vaccine 22. 26. Vaccine 26. Acknowledgement The authors would like to thank Lauren Constable at Expert Reviews Ltd for her helpful comments. Stability and immunogenicity of empty particles of foot-and-mouth disease virus. Immunopathol. 1046–1051 (2009). Immune responses of swine inoculated with a recombinant fowlpox virus co-expressing P12A and 3C of FMDV and swine IL-18. J. 5111–5122 (2008). the animals vaccinated with the empty capsid vaccine can be distinguished from infected or convalescent carrier using currently approved diagnostic assays. the compound vaccine should be replaced by pure empty capsid vaccine. Baranowski E et al. The complete control and eradication of FMDV can only ultimately be achieved by a combination of vaccination. 137. Emerg. After successful assembly of the empty capsids of type O FMDV. Grubman MJ. 8 2 Lu Z. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Protection of guinea pigs and swine by a recombinant adenovirus expressing O serotype of foot-and-mouth disease virus whole capsid and 3C protease. Evolution of foot-and-mouth disease virus. Foot-and-mouth disease. 121. Microbiol. 17(6). Moreover. the FMD disease-free countries do not need to worry about the escape of infectious virus. 53. Liu X. Guo H. Baxt B. Induction of protective immunity in swine by immunization with live attenuated recombinant pseudorabies virus expressing the capsid precursor encoding regions of foot-and-mouth disease virus. Li XM. Biol. Grubman MJ. J. Recent outbreaks of foot-and-mouth disease type Asia 1 in China. Liu J. 2005DIB4J041). Schaefer M. Brum MCS. Dis. Vet. Transbound. Sangar DV. extensive surveillance and an effective monitoring program. Jin N. G48–G53 (2008). Curry S. 10–17 (2009).a as molecular adjuvants on immune responses to FMDV and maturation of dendritic cells by DNA vaccination. 2129–2136 (2004). 275. 295–308 (1998). 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Virus Res. 46–56 (2008).Vaccines for foot & mouth disease virus in China Editorial clinical. As the empty capsid vaccine lacks infectious viral nucleic acid. It is the authors’ opinion that the empty capsid vaccine should be used predominately in China’s FMD control policy in the future and that the empty capsid vaccine would also be greatly beneficial to control outbreaks of FMD in disease-free countries. China still faces challenges in its efforts to eliminate FMDV circulation in livestock. Pay TW. Transgenic Res. Lu Z. MacKay DK. Barnett PV. According to this recommendation. 55. Rapid protection of cattle from direct challenge with foot-and-mouth disease virus (FMDV) by a single inoculation with an adenovirus-vectored FMDV subunit vaccine. Immunol. Qian P. Multiple origins of foot-and-mouth disease virus serotype Asia 1 outbreaks. Moraes MP. Brown F. Peng M et al. Shen G et al. 205–209 (2005). J. Vaccine 22. 15 3 9 4 16 10 5 17 11 6 18 12 19 7 13 www. 59. some reports recommended the development of both improved vaccines and modern diagnostic methods to control FMD  . Chen HC. The vaccination strategy has been effective and has played an important role in the control of FMDV infection in China. Goris N. Emerg. 2006AA02Z440) and Chinese Funding for Social Public Interests (No. 17. but not vaccination. Clin. Brum MC. we believe the empty capsid vaccine would be greatly beneficial to control outbreaks of FMD in disease-free countries. allow the countries to resume FMD-free status quickly. Bao H. Virology 337. Yi Y.
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