Abstract:
Preventive immunization with whole inactivated Mycobacterium vaccae (MV) confers protection against
HIV-associated tuberculosis (TB) in BCG-immunized adults with CD4 counts ≥200 cells/ l. We evaluated
the immunogenicity of MV in the 2013 subjects of the phase III DarDarTrial using an interferon gamma
(IFN- ) enzyme linked immunosorbent assay (ELISA), tritiated thymidine lymphocyte proliferation assay
(LPA) and an ELISA for antibodies to the TB glycolipid lipoarabinomannan (LAM).MVimmunization boosts
IFN- and LPA responses to MV sonicate, and antibody responses to LAM. Post-immunization immune
responses to MV correlated with baseline clinical factors, but the responses did not predict protection
from HIV-associated TB.