A placebo-controlled dose response study of the reactogenicity and immunogenicity of a live cold-recombinant influenza B virus vaccine in healthy volunteers

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Abstract
A live cold‐recombinant influenza B virus vaccine (RB77) was given intranasally in a placebo‐controlled, double blind study to volunteers in dosages of 107.9 EID50/ml, 107.25 EID50/ml, 105.7 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.