LC16m8: An attenuated smallpox vaccine

Marennikova, 1969, Characteristics of virus strains for production of smallpox vaccines, 65 Kitamura, 1996, Effort to improve smallpox vaccine, Rinsho to Uirusu [Clin Virus], 24, 41 Hirayama, 1975, In search of attenuated vaccine. Clinical special edition: vaccination in future—everything about attenuated vaccine, Rinsho to Uirusu [Clin Virus], 3, 225 Yamaguchi, 1975, Vaccination research group research report: Ministry of Health and Welfare special research: postvaccination side effects and research regarding treatment of complications, Rinsho to Uirusu [Clin Virus], 3, 269 Kimura, 1996, Vaccination in Japan, Rinsho to Uirusu [Clin Virus], 24, 30 Meiser, 2003, Comparison of virus production in chicken embryo fibroblasts infected with the WR, IHD-J and MVA strains of vaccinia virus: IHD-J is most efficient in trans-Golgi network wrapping and extracellular enveloped virus release, J Gen Virol, 84, 1383, 10.1099/vir.0.19016-0 Hochstein-Mintzel, 1975, An attenuated strain of vaccinia virus (MVA). Successful intramuscular immunization against vaccinia and variola (author's translation), Zentralbl Bakteriol, 230, 283 McCurdy, 2004, Modified vaccinia Ankara: potential as an alternative smallpox vaccine, Clin Infect Dis, 38, 1749, 10.1086/421266 Meyer, 1991, Mapping of deletions in the genome of the highly attenuated vaccinia virus MVA and their influence on virulence, J Gen Virol, 72, 1031, 10.1099/0022-1317-72-5-1031 Blanchard, 1998, Modified vaccinia virus Ankara undergoes limited replication in human cells and lacks several immunomodulatory proteins: implications for use as a human vaccine, J Gen Virol, 79, 1159, 10.1099/0022-1317-79-5-1159 Hochstein-Mintzel, 1972, Virulence and immunogenicity of a modified vaccinia virus (MVA), Z Immun Exp Klin Immunol, 144, 140 Parker, 1941, Further studies of the infectious unit of vaccinia, J Exp Med, 74, 263, 10.1084/jem.74.3.263 Kempe, 1968, Smallpox vaccination of eczema patients with a strain of attenuated live vaccinia (CVI-78), Pediatrics, 42, 980, 10.1542/peds.42.6.980 Kempe, 1968, Smallpox vaccination of eczema patients with attenuated live vaccinia virus, Yale J Biol Med, 41, 1 Hashizume, 1972, Intracerebral inoculation of monkeys with several vaccinia strains: an approach to the comparison of different strains, 325 van der Noordaa, 1967, Primary vaccination with an attenuated strain of vaccinia virus, Arch Gesamte Virusforsch, 22, 210, 10.1007/BF01240515 Tint, 1973, The rationale for elective prevaccination with attenuated vaccinia (CVI-78) in preventing some vaccination complications, 281 Hashizume, 1975, Chiba Serum Institute. Special edition future of vaccination: everything about attenuated vaccines. Basics of new attenuated vaccine strain LC16m8, Clin Virus, 3, 229 Hashizume, 1985, Properties of attenuated mutant of vaccinia virus, LC16m8, derived from Lister strain KAKETSUKEN (Chiba Serum Institute) documents on file. Takeuchi, 1976, Results of experimental inoculation of attenuated LC16m8 reducing effect of LC16m8 strain pre-treatment, Shonika Shinryo [Pediatr Diagn], 39, 1208 Fenner, 1988 McClain, 1997, Immunologic responses to vaccinia vaccines administered by different parenteral routes, J Infect Dis, 175, 756, 10.1086/513968 Cockburn, 1957, Laboratory and vaccination studies with dried smallpox vaccines, Bull World Health Organ, 16, 63 Cross, 1958, Studies with dried and glycerinated smallpox vaccines of full and diminished potencies, Bull World Health Organ, 19, 123 Kaplan, 1965, Immunogenicity of ultraviolet-irradiated, non-infectious, vaccinia-virus vaccine in infants and young children, Lancet, 191, 573, 10.1016/S0140-6736(65)91146-3 Watanabe, 1989, Stability of recombinant vaccinia virus LC16mO or LC16m8: preserved laboratory attenuation markers and conserved expression of HBsAg gene, Vaccine, 7, 499, 10.1016/0264-410X(89)90272-7 Takahashi-Nishimaki, 1987, Genetic analysis of vaccinia virus Lister strain and its attenuated mutant LC16m8: production of intermediate variants by homologous recombination, J Gen Virol, 68, 2705, 10.1099/0022-1317-68-10-2705 Sugimoto, 1985, Gene structures of low-neurovirulent vaccinia virus LC16mO, LC16m8, and their Lister original (LO) strains, Microbiol Immunol, 29, 421, 10.1111/j.1348-0421.1985.tb00843.x Takahashi-Nishimaki, 1991, Regulation of plaque size and host range by a vaccinia virus gene related to complement system proteins, Virology, 181, 158, 10.1016/0042-6822(91)90480-Y Engelstad, 1992, A constitutively expressed vaccinia gene encodes a 42-kDa glycoprotein related to complement control factors that forms part of the extracellular virus envelope, Virology, 188, 801, 10.1016/0042-6822(92)90535-W Herrera, 1998, Functional analysis of vaccinia virus B5R protein: essential role in virus envelopment is independent of a large portion of the extracellular domain, J Virol, 72, 294, 10.1128/JVI.72.1.294-302.1998 Morikawa, 2005, An attenuated LC16m8 smallpox vaccine: analysis of full-genome sequence and induction of immune protection, J Virol, 79, 11873, 10.1128/JVI.79.18.11873-11891.2005 Smith, 2002, The formation and function of extracellular enveloped vaccinia virus, J Gen Virol, 83, 2915, 10.1099/0022-1317-83-12-2915 Payne, 1980, Significance of extracellular enveloped virus in the in vitro and in vivo dissemination of vaccinia, J Gen Virol, 50, 89, 10.1099/0022-1317-50-1-89 Bell, 2004, Antibodies against the extracellular enveloped virus B5R protein are mainly responsible for the EEV neutralizing capacity of vaccinia immune globulin, Virology, 325, 425, 10.1016/j.virol.2004.05.004 Galmiche, 1999, Neutralizing and protective antibodies directed against vaccinia virus envelope antigens, Virology, 254, 71, 10.1006/viro.1998.9516 Empig, 2006, Highly attenuated smallpox vaccine protects rabbits and mice against pathogenic orthopoxvirus challenge, Vaccine, 24, 3686, 10.1016/j.vaccine.2005.03.029 Hooper, 2004, Smallpox DNA vaccine protects nonhuman primates against lethal monkeypox, J Virol, 78, 4433, 10.1128/JVI.78.9.4433-4443.2004 Fogg, 2004, Protective immunity to vaccinia virus induced by vaccination with multiple recombinant outer membrane proteins of intracellular and extracellular virions, J Virol, 78, 10230, 10.1128/JVI.78.19.10230-10237.2004 Demkowicz, 1993, Vaccinia virus-specific CD8+ cytotoxic T lymphocytes in humans, J Virol, 67, 1538, 10.1128/JVI.67.3.1538-1544.1993 Kennedy, 2004, Induction of human T cell-mediated immune responses after primary and secondary smallpox vaccination, J Infect Dis, 190, 1286, 10.1086/423848 Crotty, 2003, Cutting edge: long-term B cell memory in humans after smallpox vaccination, J Immunol, 171, 4969, 10.4049/jimmunol.171.10.4969 Hammarlund, 2003, Duration of antiviral immunity after smallpox vaccination, Nat Med, 9, 1131, 10.1038/nm917 Rock, 2005, Differential regulation of granzyme and perforin in effector and memory T cells following smallpox immunization, J Immunol, 174, 3757, 10.4049/jimmunol.174.6.3757 Amara, 2004, Long-lived poxvirus immunity, robust CD4 help, and better persistence of CD4 than CD8 T cells, J Virol, 78, 3811, 10.1128/JVI.78.8.3811-3816.2004 Kidokoro, 2005, Genetically stable and fully effective smallpox vaccine strain constructed from highly attenuated vaccinia LC16m8, Proc Natl Acad Sci USA, 102, 4152, 10.1073/pnas.0406671102 Johnston, 2003, Poxvirus immunomodulatory strategies: current perspectives, J Virol, 77, 6093, 10.1128/JVI.77.11.6093-6100.2003 Johnston, 2004, Technical knockout: understanding poxvirus pathogenesis by selectively deleting viral immunomodulatory genes, Cell Microbiol, 6, 695, 10.1111/j.1462-5822.2004.00423.x Shchelkunov, 2003, Immunomodulatory proteins of orthopoxviruses, Mol Biol, 37, 37, 10.1023/A:1022324511384 Mackett, 1982, Vaccinia virus: a selectable eukaryotic cloning and expression vector, Proc Natl Acad Sci USA, 79, 7415, 10.1073/pnas.79.23.7415 Panicali, 1982, Construction of poxviruses as cloning vectors: insertion of the thymidine kinase gene from herpes simplex virus into the DNA of infectious vaccinia virus, Proc Natl Acad Sci USA, 79, 4927, 10.1073/pnas.79.16.4927 Sugimoto, 1994, Characteristics of an attenuated vaccinia virus strain, LC16mO, and its recombinant virus vaccines, Vaccine, 12, 675, 10.1016/0264-410X(94)90215-1 Kitabatake, 2005, Development of SARS vaccine using recombinant vaccinia virus derived from LC16m8. Abstract P65 Kidokoro, 2002, Large-scale preparation of biologically active measles virus haemagglutinin expressed by attenuated vaccinia virus vectors, Microb Infect, 4, 1035, 10.1016/S1286-4579(02)01627-1 Morita, 1987, Recombinant vaccinia virus LC16mO or LC16m8 that expresses hepatitis B surface antigen while preserving the attenuation of the parental virus strain, Vaccine, 5, 65, 10.1016/0264-410X(87)90012-0 Watanabe, 1989, Improved recombinant LC16mO or LC16m8 vaccinia virus successfully expressing hepatitis B surface antigen, Vaccine, 7, 53, 10.1016/0264-410X(89)90011-X Shida, 1988, Effects and virulences of recombinant vaccinia viruses derived from attenuated strains that express the human T-cell leukemia virus type 1 envelope gene, J Virol, 62, 4474, 10.1128/JVI.62.12.4474-4480.1988 Yasuda, 1990, Induction of protective immunity in animals vaccinated with recombinant vaccinia viruses that express PreM and E glycoproteins of Japanese encephalitis virus, J Virol, 64, 2788, 10.1128/JVI.64.6.2788-2795.1990 Ohishi, 1990, Induction of neutralizing antibodies against bovine leucosis virus in rabbits by vaccination with recombinant vaccinia virus expressing bovine leucosis virus envelope glycoprotein, Am J Vet Res, 51, 1170 Asano, 1991, Immunological and virological characterization of improved construction of recombinant vaccinia virus expressing rinderpest virus hemagglutinin, Arch Virol, 116, 81, 10.1007/BF01319233 Yamanouchi, 1993, Immunisation of cattle with a recombinant vaccinia vector expressing the haemagglutinin gene of rinderpest virus, Vet Rec, 132, 152, 10.1136/vr.132.7.152 Xuan, 1997, Analysis of canine herpesvirus gB, gC, and gD expressed by a recombinant vaccinia virus, Arch Virol, 142, 1003, 10.1007/s007050050135 Ohishi, 2000, Long-term protective immunity to rinderpest in cattle following a single vaccination with a recombinant vaccinia virus expressing the virus haemagglutinin protein, J Gen Virol, 81, 1439, 10.1099/0022-1317-81-6-1439 Cherry, 1978, Clinical and immunological study of percutaneous revaccination in children who originally received smallpox vaccine subcutaneously, J Clin Microbiol, 7, 158, 10.1128/jcm.7.2.158-164.1978 McIntosh, 1977, Standard percutaneous revaccination of children who receive primary percutaneous vaccination, J Infect Dis, 135, 155, 10.1093/infdis/135.1.155 Rosenthal, 2001, Developing new smallpox vaccines, Emerg Infect Dis, 7, 920, 10.3201/eid0706.010602 21 CFR Section 601.90: approval of biological products when human efficacy studies are not ethical or feasible. Bedson, 1963, Rabbit pox: an experimental study of the pathways of infection in rabbits, J Pathol Bacteriol, 85, 1, 10.1002/path.1700850102 Appleyard, 1971, An antigenic difference between intracellular and extracellular rabbitpox virus, J Gen Virol, 13, 9, 10.1099/0022-1317-13-1-9 Buller, 2004, Efficacy of oral active ether lipid analogs of cidofovir in a lethal mousepox model, Virology, 318, 474, 10.1016/j.virol.2003.11.015 Saijo, 2006, LC16m8, a highly attenuated vaccinia virus vaccine lacking expression of the membrane protein B5R, protects monkeys from monkeypox, J Virol, 80, 5179, 10.1128/JVI.02642-05 Horiuchi K, Otani S, Tsuchiya H, Tanaka Y, Miwa Y, Kubotani H, et al. Reintroduction of smallpox vaccine with attenuated vaccine LC16m8 timeline of arriving at manufacturing, clinical studies, and investigation of immunity; 2002. Kenner JK, Gurwith M, Luck A, Empig C, Greenberg RN, Edwards K, et al. Safety and immunogenicity of attenuated smallpox vaccine, LC16m8: results from a phase 2 study [poster 206E]. In: Proceedings of the 4th Annual American Society for Microbiology Biodefense Research Meeting; 2006 Feb 17; Washington, DC. Monath, 2004, ACAM 2000 clonal Vero cell culture vaccinia virus (New York City Board of Health Strain)—a second-generation smallpox vaccine for biological defense, Int J Inf Dis, 8, s31, 10.1016/j.ijid.2004.09.002 Murphy, 2005, Adventitious agents and smallpox vaccine in strategic national stockpile, CDC Emerg Infect Dis, 11 Lane, 1970, Deaths attributable to smallpox vaccination 1959 to 1966 and 1968, JAMA, 212, 441, 10.1001/jama.212.3.441 Arness, 2004, Myopericarditis following smallpox vaccination, Am J Epidemiol, 160, 642, 10.1093/aje/kwh269 Enserink, 2004, Smallpox vaccines: looking beyond the next generation, Science, 304, 809, 10.1126/science.304.5672.809a Dryvax [package insert]. Collegeville, PA: Wyeth Pharmaceuticals Inc.; 2004. Weltzin, 2003, Clonal vaccinia virus grown in cell culture as a new smallpox vaccine, Nat Med, 9, 1125, 10.1038/nm916 Greenberg, 2005, Safety and immunogenicity of new cell-cultured smallpox vaccine compared with calf-lymph derived vaccine: a blind, single-centre, randomised controlled trial, Lancet, 365, 398, 10.1016/S0140-6736(05)17827-1 Artenstein, 2005, A novel, cell culture-derived smallpox vaccine in vaccinia-naive adults, Vaccine, 23, 3301, 10.1016/j.vaccine.2005.01.079 Government urged to stockpile smallpox vaccine. The Daily Yomiuri. Tokyo:July 12, 2005. Wyatt, 2004, Highly attenuated smallpox vaccine protects mice with and without immune deficiencies against pathogenic vaccinia virus challenge, Proc Natl Acad Sci USA, 101, 4590, 10.1073/pnas.0401165101 Earl, 2004, Immunogenicity of a highly attenuated MVA smallpox vaccine and protection against monkeypox, Nature, 428, 182, 10.1038/nature02331 Slifka, 2005, The future of smallpox vaccination: is MVA the key?, Med Immunol, 4, 2, 10.1186/1476-9433-4-2 Engler, 2002, Smallpox vaccination: risk considerations for patients with atopic dermatitis, J Allergy Clin Immunol, 110, 357, 10.1067/mai.2002.128052 McCurdy, 2004, Modified vaccinia virus Ankara immunization protects against lethal challenge with recombinant vaccinia virus expressing murine interleukin-4, J Virol, 78, 12471, 10.1128/JVI.78.22.12471-12479.2004 Edghill-Smith, 2005, Smallpox vaccine does not protect macaques with AIDS from a lethal monkeypox virus challenge, J Infect Dis, 191, 372, 10.1086/427265 Stittelaar, 2005, Modified vaccinia virus Ankara protects macaques against respiratory challenge with monkeypox virus, J Virol, 79, 7845, 10.1128/JVI.79.12.7845-7851.2005 Tscharke, 2005, Identification of poxvirus CD8+ T cell determinants to enable rational design and characterization of smallpox vaccines, J Exp Med, 201, 95, 10.1084/jem.20041912 Mathew, 2005, Identification of murine poxvirus-specific CD8+ CTL epitopes with distinct functional profiles, J Immunol, 174, 2212, 10.4049/jimmunol.174.4.2212 Davies, 2005, Profiling the humoral immune response to infection by using proteome microarrays: high-throughput vaccine and diagnostic antigen discovery, Proc Natl Acad Sci USA, 102, 547, 10.1073/pnas.0408782102 Edghill-Smith, 2005, Smallpox vaccine-induced antibodies are necessary and sufficient for protection against monkeypox virus, Nat Med, 11, 740, 10.1038/nm1261 Cohen, 2001, Bioterrorism. smallpox vaccinations: how much protection remains?, Science, 294, 985, 10.1126/science.294.5544.985 Mack, 1972, Smallpox in Europe, 1950–1971, J Infect Dis, 125, 161, 10.1093/infdis/125.2.161 el-Ad, 1990, The persistence of neutralizing antibodies after revaccination against smallpox, J Infect Dis, 161, 446, 10.1093/infdis/161.3.446 Demkowicz, 1996, Human cytotoxic T-cell memory: long-lived responses to vaccinia virus, J Virol, 70, 2627, 10.1128/JVI.70.4.2627-2631.1996 Frelinger, 2002, Responses to smallpox vaccine, N Engl J Med, 347, 689, 10.1056/NEJM200208293470913 Hammarlund, 2005, Multiple diagnostic techniques identify previously vaccinated individuals with protective immunity against monkeypox, Nat Med, 11, 1005, 10.1038/nm1273