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 v...

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Bibliographic Details
Published inJournal of medical virology Vol. 25; no. 2; p. 205
Main Authors Ganzinger, U, Bachmayer, H, Liehl, E, Martindale, J J, Hamilton, F, Kuwert, E K
Format Journal Article
LanguageEnglish
Published United States 01.06.1988
Subjects
Administration, Intranasal
Adult
Antibodies, Viral - biosynthesis
Clinical Trials as Topic
Dose-Response Relationship, Immunologic
Double-Blind Method
Female
Humans
Immunoglobulin A - biosynthesis
Influenza B virus - immunology
Influenza, Human - prevention & control
Male
Random Allocation
Viral Vaccines - administration & dosage
Viral Vaccines - adverse effects
Viral Vaccines - immunology
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Summary: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.
ISSN:0146-6615
DOI:10.1002/jmv.1890250211