Bystander immune suppression as a predictor for response to a vaccine

1. A method of administering a vaccine comprising at least one of a target antigen and a nucleic acid molecule encoding the target antigen to an individual in need thereof, the method comprising the step of:

administering to the individual the vaccine and an agent that suppresses an immunosuppressive function of at least one immune regulatory cell-associated molecule selected from a cytokine and CTLA-4, wherein the agent is selected from the group consisting of a CTLA-4 antagonist, an IL-35 antagonist, a TGF beta antagonist, an IL-10 antagonist, an antagonistic anti-CTLA-4 antibody, an antagonistic anti-IL-35 antibody, an antagonistic anti-TGF beta antibody, and an antagonistic anti-IL-10 antibody, and wherein the individual is selected to receive the vaccine by a method comprising the steps of:

(i) administering to an immunocompromised animal peripheral blood mononuclear cells from the individual, wherein the immunocompromised animal is capable of mounting a delayed-type hypersensitivity response;

(ii) administering to the immunocompromised animal the target antigen; and

(iii) determining an antigen-specific immune regulatory response by measuring a delayed-type hypersensitivity response in the immunocompromised animal to the target antigen in an assay configured to distinguish between absence of an effector response to the target antigen and presence of an antigen-specific immune regulatory response, and wherein the individual is selected to receive the vaccine if the cells mediate a delayed-type hypersensitivity response otherwise suppressed by the antigen-specific immune regulatory response.

2. The method of claim 1 , wherein the vaccine and the agent are administered to the individual at the same time.

3. The method of claim 1 , wherein the vaccine is a DNA vaccine.