Comparison of the safety and immunogenicity of ACAM1000, ACAM2000 and Dryvax in healthy vaccinia-naive adults.
Currently, more than half of the world's population has no immunity against smallpox variola major virus. This phase I double-blind, randomized trial was conducted to compare the safety and immunogenicity of two clonally derived, cell-culture manufactured vaccinia strains, ACAM1000 and ACAM2000, to the parent vaccine, Dryvax. Thirty vaccinia-naïve subjects were enrolled into each of three groups and vaccines were administered percutaneously using a bifurcated needle at a dose of 1.0x10(8)PFU/mL. All subjects had a primary skin reaction indicating a successful vaccination. The adverse events, 4-fold neutralizing antibody rise and T cell immune responses were similar between the groups.
Frey
Sharon E
SE
Division of Infectious Diseases and Immunology, Department of Internal Medicine, Saint Louis University School of Medicine, 1100 S. Grand Blvd - DRC-8th Floor, St. Louis, MO 63104, United States. freyse@slu.edu
Newman
Frances K
FK
Kennedy
Jeffrey S
JS
Ennis
Francis
F
Abate
Getahun
G
Hoft
Daniel F
DF
Monath
Thomas P
TP
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007156:Immunologic Memory; D008297:Male; D009500:Neutralization Tests; D012449:Safety; D012867:Skin / Q000473:pathology / Q000821:virology; D012900:Smallpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology* / Q000494:pharmacology*; D013601:T-Lymphocytes / Q000276:immunology; D014616:Vaccinia virus / Q000276:immunology* / Q000302:isolation & purification; D055815:Young Adult
D000914:Antibodies, Viral; C078786:DryVax vaccine; D012900:Smallpox Vaccine