Prospective Surveillance for Cardiac Adverse Events in Healthy Adults Receiving Modified Vaccinia Ankara Vaccines: A Systematic Review

PLoS ONE

Volumn 8, Issue 1, 2013, Pages

  Elizaga, Marnie L ^a   Vasan, Sandhya ^b,g   Marovich, Mary A ^c   Sato, Alicia H ^a   Lawrence, Dale N ^d   Chaitman, Bernard R ^e   Frey, Sharon E ^e   Keefer, Michael C ^f  

^a Fred Hutchinson Cancer Research Center   (United States)

^b AARON DIAMOND AIDS RESEARCH CENTER   (United States)

^c WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

^d NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^e SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^g U S ARMY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TROPONIN; VACCINIA VACCINE;

ARTICLE; CARDIOVERSION; CREATINE KINASE BLOOD LEVEL; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ELECTROCARDIOGRAM; HEART DISEASE; HEART PALPITATION; HUMAN; MYOCARDITIS; PERICARDITIS; PHASE 1 CLINICAL TRIAL (TOPIC); QT INTERVAL; RADIOFREQUENCY ABLATION; SIDE EFFECT; SMALLPOX; ST SEGMENT; SUPRAVENTRICULAR TACHYCARDIA; SYSTEMATIC REVIEW; T WAVE; VACCINATION;

CLINICAL TRIALS, PHASE I AS TOPIC; EPIDEMIOLOGICAL MONITORING; HEART FAILURE; HUMANS; PROSPECTIVE STUDIES; SMALLPOX; SMALLPOX VACCINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VACCINATION; VACCINES, ATTENUATED; VACCINIA; VACCINIA VIRUS;

VARIOLA VIRUS;

EID: 84872578653     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0054407     Document Type: Article

References (40)

1. Mayr A, Hochstein-Mintzel V, Stickl H, (1975) Passage history, properties and use of the attenuated vaccinia virus strain Ankara. Infection 3: 6-14 (in German).
2. Stickl H, Hochstein-Mintzel V, Mayr A, Huber HC, Schafer H, et al. (1974) MVA vaccination against smallpox: clinical trials of an attenuated live vaccinia virus strain (MVA). Dtsch Med Wochenschr 99: 2386-92 (in German).
3. Mayr A, Danner K, (1978) Vaccination against pox diseases under immunosuppressive conditions. Dev Biol Stand 41: 225-34.
4. Fenner F, Henderson DA, Arita I, Jezek Z and Ladnyi ID (1988) History of International Public Health: smallpox and its eradication. Geneva: World Health Organization.
5. Neff JM, Lane JM, Pert JH, Moore R, Millar JD, et al. (1967) Complications of smallpox vaccination*, I. National survey in the United States, 1963. N Eng J Med 276(3): 125-32.
6. Morgan J, Roper MH, Sperling L, Schieber RA, Heffelfinger JD, et al. (2008) Myocarditis, pericarditis, and dilated cardiomyopathy after smallpox vaccination among civilians in the United States, January-October 2003. Clin Infect Dis 46: S242-50.
7. Mackett M, Smith GL, Moss B, (1982) Vaccinia virus: a selectable eukaryotic cloning and expression vector. Proc Natl Acad Sci USA 79: 7415-9.
8. Zagury D, Bernard J, Cheynier R, Desportes I, Leonard R, et al. (1988) A group specific anamnestic immune reaction against HIV-1 induced by a candidate vaccine against AIDS. Nature 332: 728-31.
9. Wallack MK, McNally K, Michaelides M, Bash J, Bartolucci A, et al. (1986) A phase I-II SECSG (Southeastern Cancer Study Group) pilot study of surgical adjuvant immunotherapy with vaccinia-melanoma oncolysates (VMO). Am Surg 52: 148-51.
10. McCurdy LH, Larkin BD, Martin JE, Graham BS, (2004) Modified vaccinia Ankara: potential as an alternative smallpox vaccine. Clin Infect Dis 38: 1749-53.
11. Frey SE, Newman FK, Kennedy JS, Sobek V, Ennis FA, et al. (2007) Clinical and immunologic responses to multiple doses of IMVAMUNE (modified vaccinia Ankara) followed by Dryvax challenge. Vaccine 25: 8562-73.
12. Mwau M, Cebere I, Sutton J, Chikoti P, Winstone N, et al. (2004) A human immunodediciency virus 1 (HIV-1) clade A vaccine in clinical trials: stimulation of HIV-specific T-cell responses by DNA and recombinant modified vaccinia virus Ankara (MVA) vaccines in humans. J Gen Virol 85: 911-19.
13. Bart PA, Goodall R, Barber T, Harari A, Guimaraes-Walker A, et al. (2008) EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium. Vaccine 26: 3153-61.
14. Pialoux G, Excler JL, Riviere Y, Gonzalez-Canali G, Feuillie V, et al. (1995) A prime-boost approach to HIV prevent vaccine using a recombinant canarypox virus expressing glycoprotein 160 (MN) followed by a recombinant glycoprotein 160 (MN/LAI). AIDS Res Hum Retroviruses 11: 373-81.
15. Moorthy VS, Imoukhuede EB, Keating S, Pinder M, Webster D, et al. (2004) Phase 1 evaluation of 3 highly immunogenic prime-boost regimens, including a 12-month reboosting vaccination, for malaria vaccination in Gambian men. J Infect Dis 189: 2213-9.
16. McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, et al. (2004) Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med 10: 1240-4.
17. Poland GA, Grabenstein JD, Neff JM, (2005) The US smallpox vaccination program: a review of a large modern era smallpox vaccination implementation program. Vaccine 23: 2078-81.
18. US Department of Defense, Smallpox Vaccination Program (2012) Available: http://www.smallpox.mil.Accessed 2012 Jun.
19. Casey CG, Iskander JK, Roper MH, Mast EE, Wen XJ, et al. (2005) Adverse events associated with smallpox vaccination in the United States, January-October 2003. JAMA 294: 2734-43.
20. Halsell JS, Riddle JR, Atwood JE, Gardner P, Shope R, et al. (2003) Myopericarditis following smallpox vaccination among vaccinia-naïve US military personnel. JAMA 289: 3283-9.
21. Eckart RE, Love SS, Atwood JE, Arness MK, Cassimatis DC, et al. (2004) Incidence and follow-up of inflammatory cardiac complications after smallpox vaccination. J Am Col Cardiol 44: 201-5.
22. CDC (2003) Cardiac adverse events following smallpox vaccination-United States, 2003. MMWR 52: 248-50.
23. Acambis Inc. (2007) ACAM2000 Smallpox vaccine: Vaccines and Related Biological Products Advisory Committee [VRBPAC] Briefing Document.
24. Cassimatis DC, Atwood JE, Engler RM, Linz PE, Grabenstein JD, et al. (2004) Smallpox vaccination and myopericarditis: a clinical review. J Am Coll Cardiol 43: 1503-10.
25. Carroll MW, Moss B, (1997) Host range and cytopathogenicity of the highly attenuated MVA strain of vaccinia virus: propagation and generation of recombinant viruses in a nonhuman mammalian cell line. Virology 238: 198-211.
26. Stittelaar KJ, Kuiken T, de Swart RL, van Amerongen G, Vos HW, et al. (2001) Safety of modified vaccinia virus Ankara (MVA) in immune-suppressed macaques. Vaccine 19: 3700-9.
27. Keefer MC, Frey SE, Elizaga M, Metch B, DeRosa SC, et al. (2011) A phase I trial of preventive HIV vaccination with heterologous poxviral-vectors containing matching HIV-1 inserts in healthy HIV-uninfected subjects. Vaccine 29: 1948-1958.
28. Goepfert PA, Elizaga ML, Sato A, Qin L, Cardinali M, et al. (2011) Phase I safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis 203: 610-9.
29. Gorse GJ, Newman MJ, deCamp A, Hay CM, DeRosa SC, et al. (2012) DNA and Modified Vaccinia Ankara (MVA) Human Immunodeficiency Virus Type 1(HIV-1) Vaccines Encoding Multiple Cytotoxic and Helper T-Lymphocyte Epitopes Are Safe But Weakly Immunogenic in HIV-1-Uninfected, Vaccinia-Naive Adults. Clin Vaccine Immunol.
30. Currier JR, Ngauy V, de Souza MS, Ratto-Kim S, Cox JH, et al. (2010) Phase I safety and immunogenicity evaluation of MVA-CMDR, a multigenic, recombinant modified vaccinia Ankara-HIV-1 vaccine candidate. PLoS One 5: e13983.
31. Vasan S, Schlesinger SJ, Chen Z, Hurley A, Lombardo A, et al. (2010) Phase I safety and immunogenicity evaluation of ADMVA, a multigenic, modified vaccinia Ankara-HIV-1 B'/C candidate vaccine. PLoS One 5: e8816.
32. CDC (2003) Update: Cardiac-related events during the civilian smallpox vaccination program - United States, 2003. MMWR 52: 492-6.
33. Sano J, Chaitman BR, Swindle J, Frey SE, (2009) Electrocardiography screening for cardiotoxicity after modified vaccinia Ankara vaccination. Am J Med 122: 79-84.
34. Fortescue EB, Shin AY, Greenes DS, Mannix RC, Agarwal S, et al. (2007) Cardiac troponin increases among runners in the Boston Marathon. Ann Emerg Med 49: 137-43.
35. Parrino J, McCurdy LH, Larkin BD, Gordon IJ, Rucker SE, et al. (2007) Safety, immunogenicity and efficacy of modified vaccinia Ankara (MVA) against Dryvax challenge in vaccinia-naïve and vaccinia-immune individuals. Vaccine 25: 1513-25.
36. McCormack S, Stohr W, Barber T, Bart P-A, Harari A, et al. (2008) EV02: A phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone. Vaccine 26: 3162-74.
37. Peters BS, Jaoko W, Vardas E, Panayotakopoulos G, Fast P, et al. (2007) Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: effects of dosage and route on safety and immunogenicity. Vaccine 25: 2120-7.
38. Guimaraes-Walker A, Mackie N, McCormack S, Hanke T, Schmidt C, et al. (2008) Lessons from IAVI-006, a phase I clinical trial to evaluate the safety and immunogenicity of the pTHr.HIVA DNA and MVA.HIVA vaccines in a prime-boost strategy to induce HIV-1 specific T-cell responses in healthy volunteers. Vaccine 26: 6671-7.
39. Jaoko W, Nakwagala FN, Anzala O, Manyonyi GO, Birungi J, et al. (2008) Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa. Vaccine 26: 2788-95.
40. Ramanathan VD, Kumar M, Mahalingam J, Sathyamoorthy P, Narayanan PR, et al. (2009) A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type-1 subtype C modified vaccinia Ankara virus vaccine candidate in Indian volunteers. AIDS Res Hum Retroviruses 25: 1107-16.