A novel, cell culture-derived smallpox vaccine in vaccinia-naive adults
| Autor: | Andrew W. Artenstein, Casey Johnson, John P. Balser, Thomas P. Monath, Michelle Currie, Richard A. Nichols, Thomas C. Marbury, Tracy Kemp, Paul S. Blum, Dennis Morrison |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male Adolescent Antibodies Viral complex mixtures Dryvax chemistry.chemical_compound Double-Blind Method Neutralization Tests medicine Vaccinia Smallpox Humans Pericarditis Adverse effect Smallpox vaccine Cells Cultured General Veterinary General Immunology and Microbiology business.industry Public Health Environmental and Occupational Health ACAM2000 medicine.disease Vaccination Infectious Diseases Treatment Outcome chemistry Immunology Molecular Medicine Bifurcated needle Female business Smallpox Vaccine |
| Zdroj: | Vaccine. 23(25) |
| ISSN: | 0264-410X |
| Popis: | Despite the eradication of smallpox as a naturally occurring disease, concern persists over its potential use as a bioterrorist agent. The development of a new-generation smallpox vaccine represents an important contribution to a cogent biodefense strategy. We conducted a phase 2 randomized, double-blind, controlled trial at four sites in the United States to determine whether a clonal smallpox vaccine manufactured in cell culture, ACAM2000, is equivalent to the standard calf-lymph vaccine, Dryvax, in terms of cutaneous response rate, antibody responses and safety. Subjects received either Dryvax or one of four dose levels of ACAM2000 administered percutaneously using a bifurcated needle. All subjects in the highest ACAM2000 dose group and the Dryvax group experienced a successful vaccination. Dilution doses of ACAM2000 were associated with success rates below the 90% threshold established for efficacy. There were no differences in the proportion of subjects who developed neutralizing antibody: 94% in the highest ACAM2000 dose group (95% CI, 84-99) and 96% in the Dryvax group (95% CI, 86-100). No significant differences were seen between the effective ACAM2000 and Dryvax groups regarding the occurrence of adverse events. One subject who received ACAM2000 developed myopericarditis. In healthy, primary vaccines ACAM2000 has a similar vaccination success rate, antibody response, and safety profile to Dryvax. |
| Databáze: | OpenAIRE |
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