The effect of decreasing amounts of live virus, while antigen content remains constant, on immunogenicity of Oka/Merck varicella vaccine.

Abstract

The purpose of the study was to establish the minimum immunizing dose of stored Oka/Merck varicella vaccine and mimic effects of prolonged storage of vaccine at freezer temperatures. Ninety children were randomized to one of three groups: group A (1770 pfu/dose), group B (400-500 pfu/dose), or group C (80-160 pfu/dose). Seroconversion rates for groups A-C were 97%, 96%, and 92%, respectively. Group A and B vaccinees had higher antibody titers at 1 year than did group C subjects (P = .01). The difference between groups B and C approached significance (P = .058). At 1 year after immunization, 73%, 83%, and 80% in groups A-C, respectively, demonstrated cell-mediated responses. Since freshly reconstituted vaccine contains 1770 pfu/dose, vaccine failure from loss of potency is unlikely if vaccine is stored properly and administered promptly after reconstitution.