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Development of a HIV Candidate Vaccine for Phase I and II Clinical Trials in China

Objective

* To create a basis for testing HIV candidate vaccines in clinical phase 1/2 trials

* To develop a novel HIV-candidate vaccine on the basis of regional virus strains

* To assess the safety, immunogenicity and efficacy of the proposed candidate vaccine in a relevant primate model
Expected Outcome

It is expected, that this project will lead to a close collaboration between the European and Chinese partners in the area of epidemiology and vaccine development. Furthermore, this study will contribute to the molecular characterization of the prevalent B1- and C-clade HIV strains from South-East Asia, which will be subsequently utilized for the construction of an innovative VLP and DNA based antigen-delivery system. A systematic evaluation of these candidate vaccines with respect to their safety, immunogenicity and efficacy is considered to be an essential prerequisite in order to proceed to further clinical trial phases.
* Careful monitoring of the epidemic situation in a given population is one of the important issues in preparing clinical phase 1/2 trials. Due to the very recent outbreak of the HIV epidemy in the rural population in the Dehong prefecture of Yunnan, the variability of the virus in this area seems to be still restricted to a HIV-1 B1-Thai subtype. However, the antigenic drift will be carefully monitored by the Chinese Academy of Preventive Medicine (CAPM) and the Health and Epidemic prevention stations (HEPS) assisted by the Institute of Medical Microbiology and Hygiene (RIMMH, Germany).

* In order to optimize the chances of a successful vaccine, recombinant virus-like particles and a corresponding DNA vaccine will be constructed based on a careful molecular characterization of prevalent B1-(Thai) and C-clade HIV strains of the endemic areas in China (CAPM).

* The long term safety, immunogenicity and toxicity of the different antigen delivery systems will be analyzed in rhesus macaques in collaboration with the Biomedical Primate Research Center (BPRC, The Netherlands) and the Institute of Molecular Biology (IMB, Kunming, China).

* The efficacy of the induced immune responses after heterologous challenge of the immunized monkeys with a pathogenic SHIV chimera will be determined.

* After having demonstrated the safety and efficacy of the antigens in the proposed animal model and in case of a favourable epidemiological situation, clinical phase 1/2 trials will be prepared.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

UNIVERSITAET REGENSBURG
Address
11,Frans-joseph-strauss-allee 11
93053 Regensburg
Germany

Participants (2)

Chinese Academy of Preventive Medicine
China
Address
29,Nan Wei Road
100050 Beijing
FOUNDATION BIOMEDICAL PRIMATE RESEARCH CENTRE
Netherlands
Address
157,Lange Kleiweg 139
2288 GJ Rijswijk Zh