Augmentation of influenza antibody response in elderly men by thymosin alpha one. A double-blind placebo-controlled clinical study

Influenza remains a major cause of illness and death in elderly people despite current vaccination programs. One factor is an immunization failure rate in the elderly that may be as high as 50%. To test whether administration of thymosin alpha 1 would result in greater antibody production, we administered it (900 micrograms/m2 subcutaneously twice weekly for eight doses) in conjunction with the 1986 trivalent influenza vaccine. Ninety men (65-99 years old, mean age 77.3 years) were randomized double-blind to receive thymosin alpha 1 or placebo by the same schedule; the sera from 85 of these men were acceptable for analysis. The two groups were similar with respect to underlying disease, medications, and age. No toxicity was observed in either group. Antibody response rate was defined as a four-fold rise in antibody titer over 3-6 weeks following vaccination and was measured by an enzyme-linked immunosorbent assay (ELISA). Analysis was performed on treatment groups and subgroups divided by the mean age: the older group consisted of subjects aged 77 years and older, and the younger group those aged from 65-76 years. Baseline and change in absolute antibody levels were compared by t test and using age as a continuous variable by multiple regression analysis.(ABSTRACT TRUNCATED AT 250 WORDS)