Trial Design
Previous studies suggested that poxvirus-based vaccines might be instrumental in the therapeutic
HIV field. A phase I clinical trial was conducted in HIV-1-infected patients on highly
active antiretroviral therapy (HAART), with CD4 T cell counts above 450 cells/mm3 and
undetectable viremia. Thirty participants ...»»»»
Trial Design
Previous studies suggested that poxvirus-based vaccines might be instrumental in the therapeutic
HIV field. A phase I clinical trial was conducted in HIV-1-infected patients on highly
active antiretroviral therapy (HAART), with CD4 T cell counts above 450 cells/mm3 and
undetectable viremia. Thirty participants were randomized (2:1) to receive either 3 intramuscular
injections of MVA-B vaccine (coding for clade B HIV-1 Env, Gag, Pol and Nef antigens)
or placebo, followed by interruption of HAART.
Methods
The magnitude, breadth, quality and phenotype of the HIV-1-specific T cell response were
assayed by intracellular cytokine staining (ICS) in 22 volunteers pre- and post-vaccination.
Results
MVA-B vaccine induced newly detected HIV-1-specific CD4 T cell responses and expanded
pre-existing responses (mostly against Gag, Pol and Nef antigens) that were high in magnitude,
broadly directed and showed an enhanced polyfunctionality with a T effector memory
(TEM) phenotype, while maintaining the magnitude and quality of the pre-existing HIV-1-
specific CD8 T cell responses. In addition, vaccination also triggered preferential CD8+ T
cell polyfunctional responses to the MVA vector antigens that increase in magnitude after
two and three booster doses.^^^^