A vaccine developed by SMI scientists has now undergone the first clinical study on healthy individuals in Sweden in order to examine its safety and different methods of administration. The vaccine is what is known as a genetic vaccine, which uses parts of the virus DNA to stimulate the rapid endogenous production of the proteins for which the injected DNA codes.
The trial subjects were vaccinated on three occasions with this vaccine using a needle-free method of injection. In order to enhance the effect, the researchers also gave the subjects a fourth dose of a vaccine in which parts of the HIV virus DNA had been integrated into another virus (vaccinia = the cowpox virus). This vaccine-based HIV vaccine is produced by the USA’s National Institutes of Health and was donated for use in this Swedish study.
“Our vaccine is designed in such a way that it’s able to protect against many of the circulating HIV types in Africa and the West,” says Professor Britta Wahren at the SMI/KI.
Over 90 per cent of the trial subjects developed an immune response to HIV, and the vaccines have been tolerated well.
Data from the study will be presented at the four-day HIV vaccine conference in Amsterdam starting 29 August under the heading “Multigene, multiclade HIV-1 plasmid DNA prime and MVA boost is safe and highly immunogenic in healthy human volunteers”.
Scientists now hope to follow up the Swedish study with a larger phase 1 – phase 2 study in Tanzania, planned to commence this autumn, in order to corroborate the Swedish results on African subjects and to help train Tanzanians to carry out parts of the study, including sophisticated laboratory examinations, on site.
The project is being led by KI professors Gunnel Biberfeld and Britta Wahren at the SMI and Eric Sandström at Karolinska University Hospital.
SMI has been running major projects in the HIV field since 1986 with the support of Sida/SAREC, the EU’s 5th Framework Programme, the Swedish Research Council, Karolinska Institutet, and Karolinska University Hospital. Over the past few years, the projects have tended more and more towards developing a vaccine for the prevention of HIV.
Data from the study will be released at the conference presentation on 30 August.