Safety and immunogenicity of a new influenza vaccine grown in mammalian cell culture.
In a phase I safety and immunogenicity study, 112 healthy adult volunteers were randomly allocated to receive a new bivalent (A/Texas/36/91[H1N1-like], B/Harbin/7/94) split virion influenza vaccine propagated in Madin-Darby Canine Kidney cell culture or an identical vaccine manufactured using currently licensed egg propagated virus technology. Soreness at the injection site was common but generally mild (75% of the cell culture-derived vaccine group and 62.5% of the egg-derived vaccine group; p = not significant). General reactions were less common; headache was the most frequently reported adverse effect (26.8 and 30.4%, respectively; p = not significant). Geometric mean haemagglutination inhibition titres post-immunization against the A/Texas strain were 1012 reciprocal dilution in the cell culture-derived vaccine group and 790 in the egg-derived vaccine group; against the B/Harbin strain titres were 420 and 447, respectively (all comparisons, p = not significant). It is concluded that the cell culture-derived split virion influenza vaccine is safe and immunogenic in healthy adult volunteers.
Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.
S A
SA
Halperin
A C
AC
Nestruck
B J
BJ
Eastwood
D000293:Adolescent; D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000096:biosynthesis; D002642:Chick Embryo; D002999:Clone Cells; D004285:Dogs; D004311:Double-Blind Method; D006801:Humans; D009980:Influenza A virus / Q000276:immunology*; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008875:Middle Aged
D000914:Antibodies, Viral; D007252:Influenza Vaccines