A placebo-controlled dose response study of the reactogenicity and immunogenicity of a live cold-recombinant influenza B virus vaccine in healthy volunteers.
A live cold-recombinant influenza B virus vaccine (RB77) was given intranasally in a placebo-controlled, double blind study to volunteers in dosages of 10(7.9) EID50/ml, 10(7.25) EID50/ml, 10(5.7) EID50/ml. The tolerability, safety, and immunogenicity of the vaccine were investigated. No revertant virus was found in nasal swabs taken after immunisation. Local reactions were mild and showed a significant increase over the placebo only in the highest dose group. Systemic reactions were not different from the placebo. A significant increase in haemagglutinin inhibition titre was found in the highest dose group against the immunising strain (RB77) and the two wild strains B/TEC and B/Sing.
Ganzinger
U
U
Sandoz Forschungsinstitut, Vienna, Austria.
Bachmayer
H
H
Liehl
E
E
Martindale
J J
JJ
Hamilton
F
F
Kuwert
E K
EK
D000281:Administration, Intranasal; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D002986:Clinical Trials as Topic; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000096:biosynthesis; D009981:Influenza B virus / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D011897:Random Allocation; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D007070:Immunoglobulin A; D014765:Viral Vaccines