Comparison of the immunogenicity and safety of two 17D yellow fever vaccines.
As part of the clinical validation process of a new working seed of a licensed yellow fever vaccine (new working seed PV26, Stamaril; Pasteur Mérieux Connaught, Lyon, France), the immunogenicity and safety of two batches of this vaccine (PM-YF) were compared with those of another commercially available vaccine (Arilvax; Evans Medical-Wellcome, Liverpool, United Kingdom) in 211 healthy adults. While the geometric mean titer values at days 10-14 and day 28 after vaccination were higher in the PM-YF group, the vaccines provided equivalent seroprotection (titers > or = 1/10) one month after a single vaccine dose (100% PM-YF versus 99% W-YF; P = 0.001, by one-sided equivalence test). Both vaccines were safe. There were no serious local or systemic reactions reported, nor any clinically significant hepatic function abnormalities associated with the use of either vaccine. These two 17D yellow fever vaccines from different European vaccine manufacturers were highly immunogenic and safe, and provided equivalent seroprotection.
Lang
J
J
Pasteur Mérieux Connaught, Lyon, France.
Zuckerman
J
J
Clarke
P
P
Barrett
P
P
Kirkpatrick
C
C
Blondeau
C
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D015203:Reproducibility of Results; D014611:Vaccination / Q000009:adverse effects / Q000592:standards; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology / Q000592:standards; D015004:Yellow Fever / Q000276:immunology / Q000517:prevention & control*; D015005:Yellow fever virus / Q000276:immunology*
D000914:Antibodies, Viral; D014765:Viral Vaccines