HIV Diagnosis in a Vaccinated World

In this project, the goal is to perform research that can lead towards the development of a new HIV diagnostic test that is not influenced by the vaccination status of the patient whose blood sample is tested. To realize this, we will search for a set of linear epitopes in the HIV proteome that are either not present in the vaccine(s) or that are minimally immunogenic in the vaccine. Based on the insights gattered on these linear epitopes, a prototype test will be designed, and its performance evaluated. The most extensive work package of this project is the identification of the linear epitopes in HIV that are capable of distinguishing between HIV vaccination and HIV infection. Although it cannot be predicted how many epitopes will (need to) be identified, we anticipate identifying a set of epitopes that together have a combined sensitivity and specificity for detecting HIV infection of >99%. Once such a set of epitopes has been identified, we will work towards a well-defined combination of these epitopes (either as a mixture of individual peptides or as a single peptide with artificially combined epitopes). These concepts will be evaluated on an extensive panel of samples, first using traditional ELISA and consecutively also using prototypes of diagnostic tests based on these concepts. The performance criteria for acceptance of any of the concepts and for transfer into formal diagnostic development (not part of this project proposal) will be based on applicable regulatory guidances (FDA, European Commission, WHO).