Defining the effects of age and gender on immune response and outcomes to XXXX vaccination: a retrospective analysis of a single-institution clinical trials' experience.

@entity1 @entity5 @entity405 @entity320 @entity1349
BACKGROUND: The impacts of @entity1 age and gender on immune response (IR) and clinical outcome after @entity5 vaccines are not known. We hypothesized younger and female @entity1 would have higher IR rates and better survival. METHODS: @entity1 with resected stage IIB-IV @entity320 in three clinical trials (Mel43, Mel44, Mel48) were vaccinated with 12 @entity320 -associated peptides restricted by class I MHC. The cumulative incidence rate of @entity405 (+) T cell responses (direct interferon-gamma ELIspot assay) by week 7 was compared by age and gender. @entity1349 ( @entity1349 ) and disease-free survival (DFS) landmark analyses were compared by Kaplan-Meier estimates and in multivariate analyses. RESULTS: T cell responses were evaluated in 327 @entity1 and detected in 50  % of males and 48  % of females, with no difference in IR by gender or menopausal status. Males had trends toward longer DFS (p  =  0.12) and @entity1349 (p  =  0.09). Cumulative incidence of IR was higher in @entity1 <64  years of age versus older @entity1 (p  =  0.03). @entity1349 and DFS were similar by age group (p  >  0.50). In multivariate modeling, younger age was associated with better IR (OR 0.40, p value 0.003), without an impact of age or gender on clinical outcomes. CONCLUSION: These data support the hypothesis that older @entity1 are less likely to develop T cell responses to a @entity5 vaccine. Nonetheless, significant proportions of older @entity1 mount immune responses with comparable survival outcomes. Thus, these data support including older @entity1 in @entity5 vaccine trials, but suggest value in stratifying @entity1 by age </>64  years.
