Objective
The injection of a DNA plasmid containing a gene encoding an antigen under the control of a eukaryotic promoter is a novel approach to vaccination which has received considerable attention in the past few years.
Immune responses have been induced with genes from a variety of infectious agents including influenza, HBV, HIV, rabies, LCMV, malaria and mycoplasma. Protection from disease has been reported. The USA has made significant progress in this field and a clinical trial of a DNA vaccine has already begun. There are several safety and regulatory concerns regarding this form of vaccination.
- The injected DNA may integrate into the host chromosome resulting in a transformation (or tumorigenic) event,
- Injected DNA may persist and be expressed for a considerable time within the recipient which could lead to the induction of immunopathological reactions, tolerance or antigenic competition,
- The inclusion of genes for regulatory cytokines, which may improve the immune response, may have serious consequences such as the stimulation of one arm of the immune response at the expense of the other leading to generalised immunosuppression or chronic inflammation.
To date, there is a paucity of scientific data in relation to the above issues regarding the safety of DNA vaccines. Two reports exist investigating whether integration of a DNA vaccine into the host chromosome occurs. The results were negative although the methods were not validated. There is a similar lack of information on potential immunopathological reactions. In order to ensure the safe application of DNA vaccines, the specific objectives of this project are:
- to validate methods for assessing integration of a DNA vaccine into the host chromosome,
- to apply such methods to the analysis of potential integration of a DNA vaccine,
- to analyze the persistence of expression of antigen and of DNA, - to investigate the immunological basis of DNA vaccination, such as the site of expression of the antigen and the nature of the B and T cell response, in order to increase our understanding of possible adverse immunological reactions,
- to investigate specific conditions likely to lead to immunopathological conditions.
The project will utilise nucleic acid vaccines containing the haemagglutinin and nucleoprotein genes of influenza virus and the fusion and glycoprotein genes of respiratory syncytial virus in mice, both viruses being likely candidates for future DNA vaccines. It is important for public confidence that safety studies are performed by independent scientists involved in the control of vaccines and that the data on safety does not derive entirely from industry. Within the EU, DNA vaccines will be regulated by the Committee for Proprietary Medicinal Products (CPMP). Two out the five partners in this consortium are members of the CPMP's Biotechnology Working Party. The data generated by this project will provide assurance of the safety of DNA vaccines, help formulate safety requirements, and will directly assist the CPMP and industry on the suitability of this novel form of vaccination. In order to give European vaccine industry swift and accurate information about developments we have established open links of communication with the European Vaccine Manufacturers (EVM).
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences health sciences infectious diseases DNA viruses hepatitis B
- medical and health sciences health sciences infectious diseases RNA viruses influenza
- medical and health sciences basic medicine immunology
- medical and health sciences health sciences infectious diseases RNA viruses HIV
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs vaccines
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
EN6 3QG Potters Bar
United Kingdom
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.