Additional Information on Research Collaboration for Vaccine Discovery and Assessment
Aeras welcomes enquires about its pre-clinical vaccine rBCG and capsid constructs. These may be used for carefully designed experiments with recognized scientific merit under standard material transfer agreements. We will only be able to provide actual clinical trial (CTM) vaccines under special circumstances. The rBCG vaccines we have made and that are currently available to investigators for their use include:
- The standard BCG from which we have derived all our rBCG constructs;
- rBCGs that over-express TB antigens from integrated chromosomal cassettes;
- rBCG constructs that escape the endosome due to expression of perfringolysin;
- rBCG constructs that escape the endosome and over-express TB antigens.
Aeras is constantly producing new constructs. These can also be made available following phenotypic, genotypic and stability characterization. Aeras can also provide, under similar conditions, shigella carrier strains with RNA capsids encoding TB antigens.
The Aeras Vaccine Evaluation Group has developed methods and reagents for analysis of rBCG for over-expression of antigens. Aeras welcomes enquires about these protocols. We have also developed methods for assay of perfringolysin expression by rBCG.
The Aeras Release Assay Group and the Process Development and Manufacturing Group, with the aid of Aeras Statistics, are developing methods based on statistical methodology to measure the numbers of CFU in a culture and validate CFU enumeration methods in rBCG vaccines. Aeras welcomes enquires from interested investigators on this approach.
The Aeras Immunology Laboratory
The Aeras Immunology Group assesses the immune response induced by candidate vaccines in pre-clinical animal models, as well as clinical trial specimens. We put high emphasis on the standardization and harmonization of laboratory protocols between the different clinical sites in order to achieve the same quality of specimens. In order to obtain consistent recoveries and high viabilities of clinical specimens to be used for cellular immunoassays, we have developed, optimized and validated methods crucial to cell separation, cryo-preservation and shipping.
Standard technologies of Aeras' laboratory include cell-mediated immunity assays such as Intracellular Cytokine Staining by flow cytometry, ELISAs and tetramer staining.
We are using an Intracellular Cytokine Staining (ICS) assay by flow cytometry, performed under GLP, to measure TB antigen specific CD4, CD8 cells producing IL- 2, IFN-γ and TNF-∝ as clinical end-point assay. This assay has undergone Phase I qualification and we are in the process of fully validating this method.
Furthermore, we are in the process of developing multi-parametric flow cytometry assays (polyfunctional cytokine or memory panels, proliferation assays, tetramers) and are developing methods for the detection of vaccine-induced, antigen-specific antibodies by ELISAs and peptide chip assays.
Aeras welcomes enquiries on our SOPs and validation reports from investigators who feel they would benefit from our experience and expertise. We also welcome discussion with investigators who can provide us with help and comment on method standardization and implementation in a clinical setting.