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AS01 consists of a liposome formulation of MPL and QS21 whereas AS02 is a squalene-containing emulsion formulation of the same immunostimulants. AS01 and AS02 both contain MPL and the saponin QS21. Two additional MPL-containing adjuvants are currently being developed for T cell-based vaccines against Mtb and malaria. However, as with alum and oil-in-water adjuvants, the development of AS04 was based on enhanced antibody production. The recently approved vaccine adjuvant for the Cervarix vaccine for human papilloma virus, AS04 (GSK), contains the TLR4 agonist MPL and alum. Inclusion of TLR agonists is one effective method of enhancing T cell responses elicited by vaccines. Next generation adjuvants are being developed to enhance T cell immunity.
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These adjuvants efficiently enhance humoral responses, but provide little enhancement of TH1 immunity. The two most commonly used adjuvants in approved vaccines are aluminum salts collectively referred to as alum and oil-in-water emulsions such as MF59 (Novartis) and AS03 (GSK), both of which contain squalene as an oil component. Īdjuvant selection is a critical step for the development of effective subunit vaccines. Under some conditions CD8 T cells also contribute to Mtb control, although not to the same degree as CD4 T cells. cells that make a combination of IFN-γ, TNF, and IL-2 upon stimulation, correlates with vaccine efficacy, although this is not always the case. Some studies have found that the frequency of TB-specific multifunctional CD4 T helper 1 (TH1) cells, i.e. Both of these cytokines induce production of reactive nitrogen and oxygen species in Mtb-infected macrophages, which kill the bacterium. Immune control of Mtb is largely mediated by IFN-γ and TNF producing CD4 T cells. For Mtb, antibodies are thought to play a limited role in controlling the infection because Mtb is an intracellular pathogen, primarily infecting macrophages. Most vaccines against human pathogens work by eliciting protective antibody responses. Thus there is an urgent need for a new TB vaccine to either boost immunity primed by BCG or replace BCG. Mathematical modeling of the impact of implementing a hypothetical new vaccine against TB with 60% efficacy predicts an 80% drop in incidence by 2050. Mtb is primarily spread by the patients with active pulmonary TB, thus a new vaccine that will limit this manifestation is desperately needed. BCG is effective in limiting the development of miliary TB in children, but does not prevent development of active pulmonary TB in adults. The only approved vaccine for Mtb, Bacillus Calmette–Guérin (BCG) is routinely given shortly after birth. There are approximately 8 million new cases of active tuberculosis (TB), leading to 1.5 million deaths annually. One third of the world is latently infected with Mycobacterium tuberculosis (Mtb). These results demonstrate that there are multiple solutions for an effective formulation of a novel TB vaccine candidate that enhances both TH1 generation and protective efficacy. The composition of the liposome formulation of ID93/GLA does alter the magnitude of the TH1 response. For GLA containing oil-in-water emulsions, the selection of the oil component is critical for adjuvant activity, whereas a variety of lipid components may be used in liposomal formulations of GLA. We find that alum and an aqueous nanosuspension of GLA synergize to enhance generation of ID93-specific TH1 responses, whereas neither on their own are effective adjuvants for generation of ID93-specific TH1 responses. We evaluate a variety of adjuvant formulations including alum, liposomes, and oil-in-water emulsions to determine how changes in formulation composition alter adjuvant activity. Here we examine an array of adjuvant formulations containing the TLR4 agonist GLA to identify candidate adjuvants to pair with ID93, a lead TB vaccine antigen, to elicit protective TH1 responses. Mtb infection is primarily controlled by TH1 cells through the production of IFN-γ and TNF which activate infected macrophages to kill the bacterium. Development of a new vaccine to augment or replace the only approved TB vaccine, BCG, is needed to control this disease. One third of the world is infected with Mycobacterium tuberculosis (Mtb) with eight million new cases of active tuberculosis (TB) each year.