B. Watson et al., THE EFFECT OF DECREASING AMOUNTS OF LIVE VIRUS, WHILE ANTIGEN CONTENTREMAINS CONSTANT, ON IMMUNOGENICITY OF OKA MERCK VARICELLA VACCINE, The Journal of infectious diseases, 168(6), 1993, pp. 1356-1360
The purpose of the study was to establish the minimum immunizing dose
of stored Oka/Merck varicella vaccine and mimic effects of prolonged s
torage of vaccine at freezer temperatures. Ninety children were random
ized 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 gro
ups 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 = .0
1). 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 reco
nstituted vaccine contains 1770 pfu/dose, vaccine failure from loss of
potency is unlikely if vaccine is stored properly and administered pr
omptly after reconstitution.