A clinical trial with Alice/R-75 strain, live attenuated serum inhibitor-resistant intranasal bivalent influenza A/B vaccine.
A clinical trial was conducted with Alice/R-75 strain live attenuated intranasal influenza A/B vaccine. With double blind control 88 adult volunteers were administered 2 doses of Alice/R-75 vaccine, 93 volunteers received one dose of Alice/R-75 vaccine and one dose placebo solution and 94 subjects were administered 2 doses of placebo solution. Twenty-three other subjects received Alice strain monovalent influenza A vaccine. For comparison, data from 21 subjects who received monovalent intranasal R-75 strain influenza B in two doses is included. The vaccine was generally well tolerated. Four-fold serum hemagglutination-inhibiting (HAI) antibody titer rises to A/England/42/72 occurred in 39% of the monovalent Alice strain vaccines; in contrast 18% of those given 2 doses of bivalent Alice/R-75 vaccine and 11% of those given 1 dose of bivalent vaccine had similar four-fold HAI antibody titer rises. HAI antibody titer rises to influenza B/Hong Kong/72 occurred in 38% of R-75 strain monovalent vaccinees, 14% of Alice/R-75 2-dose vaccinees and 11% of Alice/R-75 one dose vaccinees. An epidemic of influenza at onset of the study made evaluation of the efficacy of the vaccine impossible.
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000096:biosynthesis*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009975:Orthomyxoviridae / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage*
D000914:Antibodies, Viral; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated