Repeated high-dose (5 × 10⁸ TCID₅₀) toxicity study of a third generation smallpox vaccine (IMVAMUNE) in New Zealand white rabbits

References

• Artenstein AW, Grabenstein JD. Smallpox vaccines for biodefense: need and feasibility. Expert Rev Vaccines 2008; 7:1225-37; PMID:18844596; http://dx.doi.org/10.1586/14760584.7.8.1225
   PubMed Web of Science ®Google Scholar
• Russell PK. Vaccines in civilian defense against bioterrorism. Emerg Infect Dis 1999; 5:531-3; PMID:10458959; http://dx.doi.org/10.3201/eid0504.990413
   PubMed Web of Science ®Google Scholar
• Henderson DA, Inglesby TV, Bartlett JG, Ascher MS, Eitzen E, Jahrling PB, Hauer J, Layton M, McDade J, Osterholm MT, et al. Smallpox as a biological weapon: medical and public health management. Working Group on Civilian Biodefense. Jama 1999; 281:2127-37; PMID:10367824; http://dx.doi.org/10.1001/jama.281.22.2127
   PubMed Web of Science ®Google Scholar
• Frey SE, Newman FK, Kennedy JS, Sobek V, Ennis FA, Hill H, Yan LK, Chaplin P, Vollmar J, Chaitman BR, et al. Clinical and immunologic responses to multiple doses of IMVAMUNE (Modified Vaccinia Ankara) followed by Dryvax challenge. Vaccine 2007; 25:8562-73; PMID:18036708; http://dx.doi.org/10.1016/j.vaccine.2007.10.017
   PubMed Web of Science ®Google Scholar
• Metzger W, Mordmueller BG. Vaccines for preventing smallpox. Cochrane Database Syst Rev 2007 Jul 18; (3):CD004913; PMID:17636779
   PubMedGoogle Scholar
• Lane JM, Ruben FL, Neff JM, Millar JD. Complications of smallpox vaccination, 1968: results of ten statewide surveys. J Infect Dis 1970; 122:303-9; PMID:4396189; http://dx.doi.org/10.1093/infdis/122.4.303
   PubMed Web of Science ®Google Scholar
• Thomas TN, Reef S, Neff L, Sniadack MM, Mootrey GT. A review of the smallpox vaccine adverse events active surveillance system. Clin Infect Dis 2008; 46 Suppl 3:S212-20; PMID:18284361; http://dx.doi.org/10.1086/524742
   PubMedGoogle Scholar
• Kemper AR, Davis MM, Freed GL. Expected adverse events in a mass smallpox vaccination campaign. Eff Clin Pract 2002; 5:84-90; PMID:11990216
   PubMedGoogle Scholar
• Earl PL, Americo JL, Wyatt LS, Eller LA, Whitbeck JC, Cohen GH, Eisenberg RJ, Hartmann CJ, Jackson DL, Kulesh DA, et al. Immunogenicity of a highly attenuated MVA smallpox vaccine and protection against monkeypox. Nature 2004; 428:182-5; PMID:15014500; http://dx.doi.org/10.1038/nature02331
   PubMed Web of Science ®Google Scholar
• Stickl H, Hochstein-Mintzel V, Mayr A, Huber HC, Schafer H, Holzner A. [MVA vaccination against smallpox: clinical tests with an attenuated live vaccinia virus strain (MVA) (author's transl)]. Dtsch Med Wochenschr 1974; 99:2386-92; PMID:4426258; http://dx.doi.org/10.1055/s-0028-1108143
   PubMed Web of Science ®Google Scholar
• Mayr A, Stickl H, Muller HK, Danner K, Singer H. [The smallpox vaccination strain MVA: marker, genetic structure, experience gained with the parenteral vaccination and behavior in organisms with a debilitated defence mechanism (author's transl)]. Zentralbl Bakteriol B 1978; 167:375-90; PMID:219640
   PubMedGoogle Scholar
• Kennedy JS, Greenberg RN. IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine. Exp Rev Vaccines 2009; 8:13-24; PMID:19093767; http://dx.doi.org/10.1586/14760584.8.1.13
   PubMed Web of Science ®Google Scholar
• Frey SE, Winokur PL, Salata RA, El-Kamary SS, Turley CB, Walter EB, Jr., Hay CM, Newman FK, Hill HR, Zhang Y, et al. Safety and immunogenicity of IMVAMUNE(R) smallpox vaccine using different strategies for a post event scenario. Vaccine 2013; 31:3025-33; PMID:23664987; http://dx.doi.org/10.1016/j.vaccine.2013.04.050
   PubMed Web of Science ®Google Scholar
• Vollmar J, Arndtz N, Eckl KM, Thomsen T, Petzold B, Mateo L, Schlereth B, Handley A, King L, Hulsemann V, et al. Safety and immunogenicity of IMVAMUNE, a promising candidate as a third generation smallpox vaccine. Vaccine 2006; 24:2065-70; PMID:16337719; http://dx.doi.org/10.1016/j.vaccine.2005.11.022
   PubMed Web of Science ®Google Scholar
• von Krempelhuber A, Vollmar J, Pokorny R, Rapp P, Wulff N, Petzold B, Handley A, Mateo L, Siersbol H, Kollaritsch H, et al. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE. Vaccine 2010; 28:1209-16; PMID:19944151; http://dx.doi.org/10.1016/j.vaccine.2009.11.030
   PubMed Web of Science ®Google Scholar
• Hatch GJ, Graham VA, Bewley KR, Tree JA, Dennis M, Taylor I, Funnell SG, Bate SR, Steeds K, Tipton T, et al. Assessment of the Protective Effect of Imvamune and Acam2000 Vaccines against Aerosolized Monkeypox Virus in Cynomolgus Macaques. J Virol 2013; 87:7805-15; PMID:23658452; http://dx.doi.org/10.1128/JVI.03481-12
   PubMed Web of Science ®Google Scholar
• Keckler MS, Carroll DS, Gallardo-Romero NF, Lash RR, Salzer JS, Weiss SL, Patel N, Clemmons CJ, Smith SK, Hutson CL, et al. Establishment of the black-tailed prairie dog (Cynomys ludovicianus) as a novel animal model for comparing smallpox vaccines administered preexposure in both high- and low-dose monkeypox virus challenges. J Virol 2011; 85:7683-98; PMID:21632764; http://dx.doi.org/10.1128/JVI.02174-10
   PubMed Web of Science ®Google Scholar
• Garza NL, Hatkin JM, Livingston V, Nichols DK, Chaplin PJ, Volkmann A, Fisher D, Nalca A. Evaluation of the efficacy of modified vaccinia Ankara (MVA)/IMVAMUNE against aerosolized rabbitpox virus in a rabbit model. Vaccine 2009; 27:5496-504; PMID:19632316; http://dx.doi.org/10.1016/j.vaccine.2009.06.105
   PubMed Web of Science ®Google Scholar
• Stabenow J, Buller RM, Schriewer J, West C, Sagartz JE, Parker S. A mouse model of lethal infection for evaluating prophylactics and therapeutics against Monkeypox virus. J Virol 2010; 84:3909-20; PMID:20130052; http://dx.doi.org/10.1128/JVI.02012-09
   PubMed Web of Science ®Google Scholar
• Townsend MB, Keckler MS, Patel N, Davies DH, Felgner P, Damon IK, Karem KL. Humoral immunity to smallpox vaccines and monkeypox virus challenge: proteomic assessment and clinical correlations. J Virol 2013; 87:900-11; PMID:23135728; http://dx.doi.org/10.1128/JVI.02089-12
   PubMed Web of Science ®Google Scholar
• Frey SE, Winokur PL, Hill H, Goll JB, Chaplin P, Belshe RB. Phase II randomized, double-blinded comparison of a single high dose (5×10(8) TCID50) of modified vaccinia Ankara compared to a standard dose (1×10(8) TCID50) in healthy vaccinia-naive individuals. Vaccine 2014; 32:2732-9; PMID:24607004; http://dx.doi.org/10.1016/j.vaccine.2014.02.043
   PubMed Web of Science ®Google Scholar
• Troy JD, Hill HR, Ewell MG, Frey SE. Sex difference in immune response to vaccination: A participant-level meta-analysis of randomized trials of IMVAMUNE((R)) smallpox vaccine. Vaccine 2015; 33:5425-31; PMID:26319063; http://dx.doi.org/10.1016/j.vaccine.2015.08.032
   PubMed Web of Science ®Google Scholar
• Draize JH, Woodard G, Calvery HO. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Therapies 1944; 82:377-90
   Web of Science ®Google Scholar
• Angervall L, Carlstrom E. Theoretical criteria for the use of relative organ weights and similar ratios in biology. J Theoret Biol 1963; 4:254-259; PMID:5875198
   PubMed Web of Science ®Google Scholar