ACAM2000™: The new smallpox vaccine for United States Strategic National Stockpile

Drug Design, Development and Therapy

Volumn 4, Issue , 2010, Pages 71-79

  Nalca, Aysegul ^a   Zumbrun, Elizabeth E ^a  

^a UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES   (United States)

Author keywords

Efficacy; Safety; Smallpox; Vaccine; Vaccinia; Variola

Indexed keywords

ANTIVIRUS AGENT; CIDOFOVIR; SMALLPOX VACCINE; TECOVIRIMAT; TROPONIN I;

ACUTE DISSEMINATED ENCEPHALOMYELITIS; ANTIBODY RESPONSE; CELLULAR IMMUNITY; CONGESTIVE CARDIOMYOPATHY; DOSE RESPONSE; DRUG ANTAGONISM; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG SCREENING; ECZEMA; ECZEMA VACCINATUM; ELECTROCARDIOGRAM; ENZYME BLOOD LEVEL; EYE DISEASE; HEART ARRHYTHMIA; HEART DISEASE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE PRURITUS; ISCHEMIC HEART DISEASE; LYMPH NODE PAIN; MYOCARDITIS; NEUROLOGIC DISEASE; NONHUMAN; PATIENT MONITORING; PERICARDITIS; RASH; REVIEW; SEROCONVERSION; SKIN DISEASE; SKIN MANIFESTATION; SMALLPOX; THORAX PAIN; UNITED STATES; URTICARIA; VACCINATION; VACCINATION REACTION; VACCINE PRODUCTION; VACCINIA; VACCINIA VIRUS; VIRAL EYE INFECTION; VIRUS VIRULENCE; ANIMAL; CLINICAL TRIAL; IMMUNOLOGY;

ANIMALS; CLINICAL TRIALS AS TOPIC; HUMANS; SMALLPOX; SMALLPOX VACCINE; UNITED STATES;

EID: 77957064170     PISSN: 11778881     EISSN: None     Source Type: Journal    
DOI: 10.2147/dddt.s3687     Document Type: Review

References (55)

1. Fenner F. World Health Organization. Smallpox and its eradication.Geneva: World Health Organization; 1988.
2. Schwartz B, Lebwohl M. Complications of the smallpox vaccine. IntJ Dermatol. 2005;44(4):289-292.
3. Henderson DA. Smallpox: The death of a disease. The inside story oferadicating a worldwide killer. Amherst: Prometheus Books; 2009.
4. Kretzschmar M, Wallinga J, Teunis P, Xing S, Mikolajczyk R. Frequencyof adverse events after vaccination with different vacciniastrains. PLoS Med. 2006;3(8):e272.
5. Acambis I. ACAM2000™ smallpox vaccine: Vaccines and Related BiologicalProducts Advisory Committee (VRBPAC). In: FDA C, ed; 2007.
6. Monath TP, Caldwell JR, Mundt W, et al. ACAM2000™ clonal Verocell culture vaccinia virus (New York City Board of Health strain)-asecond-generation smallpox vaccine for biological defense. Int J InfectDis. 2004;8 Suppl 2:S31-S44.
7. Marennikova SS CK, Maltseva NN, Shelukhina EM, Fedorov VV. Proceedings of: the symposium on smallpox. Yugoslavia Academy ofSciences and Arts. Zagreb, Yugoslavia. 2-3 September 1969.
8. Marennikova SS CK, Maltseva NN, Shelukhina EM, Fedorov VV. International symposium on smallpox vaccine 1972. Bilthoven,The Netherlands. Karger, Basel. October, 1973.
9. Handley L, Buller RM, Frey SE, Bellone C, Parker S. The newACAM2000™ vaccine and other therapies to control orthopoxvirus outbreaksand bioterror attacks. Expert Rev Vaccines. 2009;8(7):841-850.
10. Weltzin R, Liu J, Pugachev KV, et al. Clonal vaccinia virus grown in cellculture as a new smallpox vaccine. Nat Med. 2003;9(9):1125-1130.
11. Li G, Chen N, Feng Z, et al. Genomic sequence and analysis of avaccinia virus isolate from a patient with a smallpox vaccine-relatedcomplication. Virol J. 2006;3:88.
12. Symons JA, Alcami A, Smith GL. Vaccinia virus encodes a solubletype I interferon receptor of novel structure and broad species specificity. Cell. 1995;81(4):551-560.
13. Osborne JD, Da Silva M, Frace AM, et al. Genomic differences ofVaccinia virus clones from Dryvax® smallpox vaccine: The Dryvax®-like ACAM2000™ and the mouse neurovirulent Clone-3. Vaccine.2007;25(52):8807-8832.
14. Xiao Y, Aldaz-Carroll L, Ortiz AM, et al. A protein-based smallpox vaccineprotects mice from vaccinia and ectromelia virus challenges whengiven as a prime and single boost. Vaccine. 2007;25(7):1214-1224.
15. Chen Z, Earl P, Americo J, et al. Chimpanzee/human mAbs to vacciniavirus B5 protein neutralize vaccinia and smallpox virusesand protect mice against vaccinia virus. Proc Natl Acad Sci U S A.2006;103(6):1882-1887.
16. Hooper JW, Golden JW, Ferro AM, King AD. Smallpox DNA vaccinedelivered by novel skin electroporation device protects mice againstintranasal poxvirus challenge. Vaccine. 2007;25(10):1814-1823.
17. Thornburg NJ, Ray CA, Collier ML, Liao HX, Pickup DJ, Johnston RE. Vaccination with Venezuelan equine encephalitis replicons encodingcowpox virus structural proteins protects mice from intranasal cowpoxvirus challenge. Virology. 2007;362(2):441-452.
18. Edghill-Smith Y, Golding H, Manischewitz J, et al. Smallpox vaccineinducedantibodies are necessary and sufficient for protection againstmonkeypox virus. Nat Med. 2005;11(7):740-747.
19. Edghill-Smith Y, Bray M, Whitehouse CA, et al. Smallpox vaccinedoes not protect macaques with AIDS from a lethal monkeypox viruschallenge. J Infect Dis. 2005;191(3):372-381.
20. Nigam P, Earl PL, Americo JL, et al. DNA/MVA HIV-1/AIDS vaccineelicits long-lived vaccinia virus-specific immunity and confers protectionagainst a lethal monkeypox challenge. Virology. 2007;366(1):73-83.
21. Saijo M, Ami Y, Suzaki Y, et al. LC16m8, a highly attenuated vacciniavirus vaccine lacking expression of the membrane protein B5R, protectsmonkeys from monkeypox. J Virol. 2006;80(11):5179-5188.
22. Marriott KA, Parkinson CV, Morefield SI, Davenport R, Nichols R, Monath TP. Clonal vaccinia virus grown in cell culture fully protects monkeysfrom lethal monkeypox challenge. Vaccine. 2008;26(4):581-588.
23. Artenstein AW, Johnson C, Marbury TC, et al. A novel, cell culture-derived smallpox vaccine in vaccinia-naïve adults. Vaccine.2005;23(25):3301-3309.
24. Frey SE, Newman FK, Kennedy JS, et al. Comparison of the safetyand immunogenicity of ACAM1000, ACAM2000™ and Dryvax® inhealthy vaccinia-naïve adults. Vaccine. 2009;27(10):1637-1644.
25. Frey SE, Couch RB, Tacket CO, et al. Clinical responses to undiluted anddiluted smallpox vaccine. N Engl J Med. 2002;346(17):1265-1274.
26. Kennedy RB, Ovsyannikova IG, Jacobson RM, Poland GA. The immunology of smallpox vaccines. Curr Opin Immunol.2009;21(3):314-320.
27. Mack TM, Noble J Jr, Thomas DB. A prospective study of serumantibody and protection against smallpox. Am J Trop Med Hyg.1972;21(2):214-218.
28. Hopkins RJ, Lane JM. Clinical eff icacy of intramuscular vacciniaimmune globulin: A literature review. Clin Infect Dis.2004;39(6):819-826.
29. Acambis I. Package insert. ACAM2000™ smallpox (vaccinia) vaccine,live; 2008.
30. Lane JM, Ruben FL, Neff JM, Millar JD. Complications of smallpoxvaccination, 1968: Results of ten statewide surveys. J Infect Dis.1970;122(4):303-309.
31. Amanna IJ, Slifka MK, Crotty S. Immunity and immunological memoryfollowing smallpox vaccination. Immunol Rev. 2006;211:320-337.
32. Hammarlund E, Lewis MW, Hansen SG, et al. Duration of antiviralimmunity after smallpox vaccination. Nat Med. 2003;9(9):1131-1137.
33. Mortimer PP. Can postexposure vaccination against smallpox succeed? Clin Infect Dis. 2003;36(5):622-629.
34. Wollenberg A, Engler R. Smallpox, vaccination and adversereactions to smallpox vaccine. Curr Opin Allergy Clin Immunol.2004;4(4):271-275.
35. Aragon TJ, Ulrich S, Fernyak S, Rutherford GW. Risks of serious complicationsand death from smallpox vaccination: A systematic reviewof the United States experience, 1963-1968. BMC Public Health.2003;3:26.
36. Morgan J, Roper MH, Sperling L, et al. Myocarditis, pericarditis, anddilated cardiomyopathy after smallpox vaccination among civiliansin the United States, January-October 2003. Clin Infect Dis. 2008; 46Suppl 3:S242-S250.
37. Eckart RE, Scoville SL, Campbell CL, et al. Sudden death in youngadults: A 25-year review of autopsies in military recruits. Ann InternMed. 2004;141(11):829-834.
38. Webpage TMVAMH. Available at www.vaccines.mil. Accessed on4 December 2009.
39. Eckart RE, Shry EA, Atwood JE, et al. Smallpox vaccination and ischemiccoronary events in healthy adults. Vaccine. 2007;25(50):8359-8364.
40. Neff J, Modlin J, Birkhead GS, et al. Monitoring the safety of a smallpoxvaccination program in the United States: Report of the Joint SmallpoxVaccine Safety Working Group of the advisory committee on immunizationpractices and the Armed Forces Epidemiological Board. ClinInfect Dis. 2008;46 Suppl 3:S258-S270.
41. Van Dam CN, Syed S, Eron JJ, et al. Severe postvaccinia encephalitiswith acute disseminated encephalomyelitis: Recovery with earlyintravenous immunoglobulin, high-dose steroids, and vaccinia immunoglobulin. Clin Infect Dis. 2009;48(4):e47-e49.
42. Poland GA, Grabenstein JD, Neff JM. The US smallpox vaccinationprogram: A review of a large modern era smallpox vaccination implementationprogram. Vaccine. 2005;23(17-18):2078-2081.
43. Arness MK, Eckart RE, Love SS, et al. Myopericarditis followingsmallpox vaccination. Am J Epidemiol. 2004;160(7):642-651.
44. Swerdlow DL, Roper MH, Morgan J, et al. Ischemic cardiac eventsduring the Department of Health and Human Services Smallpox VaccinationProgram, 2003. Clin Infect Dis. 2008;46 Suppl 3:S234-S241.
45. Lane JM, Ruben FL, Neff JM, Millar JD. Complications of smallpoxvaccination, 1968. N Engl J Med. 1969;281(22):1201-1208.
46. Monath TP, Frey SE. Possible autoimmune reactions following smallpoxvaccination: The biologic false positive test for syphilis. Vaccine.2009;27(10):1645-1650.
47. Lynch FW, Kimball AC, Kernan PD. Serologic tests for syphilis followingsmallpox vaccination and including Reiter protein complementfixation technic. J Invest Dermatol. 1960;34:219-222.
48. Grossman LJ, Peery TM. Biologically false-positive serologictests for syphilis due to smallpox vaccination. Am J Clin Pathol.1969;51(3):375-378.
49. Harris EN, Pierangeli SS, Gharavi AE. Diagnosis of the antiphospholipidsyndrome: A proposal for use of laboratory tests. Lupus. 1998;7Suppl 2:S144-S148.
50. Jain D, Halushka MK. Cardiac pathology of systemic lupus erythematosus. J Clin Pathol. 2009;62(7):584-592.
51. von Landenberg P, Lehmann HW, Modrow S. Human parvovirusB19 infection and antiphospholipid antibodies. Autoimmun Rev.2007;6(5):278-285.
52. Leung WH, Wong KL, Lau CP, Wong CK, Liu HW. Association betweenantiphospholipid antibodies and cardiac abnormalities in patients withsystemic lupus erythematosus. Am J Med. 1990;89(4):411-419.
53. Woodruff JF. Viral myocarditis. A review. Am J Pathol. 1980;101(2):425-484.
54. Berhanu A, King DS, Mosier S, et al. ST-246 inhibits in vivo poxvirusdissemination, virus shedding, and systemic disease manifestation. Antimicrob Agents Chemother. 2009;53(12):4999-5009.
55. Wei H, Huang D, Fortman J, Wang R, Shao L, Chen ZW. Coadministrationof cidofovir and smallpox vaccine reduced vaccination side effectsbut interfered with vaccine-elicited immune responses and immunityto monkeypox. J Virol. 2009;83(2):1115-1125.