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Development of therapeutic vaccine against Hepatitis C virus |
Therapeutic area |
Infectious diseases |
Goal |
The development of a vaccine formulation to generate a therapeutic immune response against the Hepatitis C virus |
Description |
According to recent WHO statistics, there are 170 millions people infected with hepatitis C virus. HCV infection is chronic in more than 80% of infected persons. There is no currently available prophylactic vaccine against this pathogen and most studies are in pre-clinical phase. Antiviral treatments (Interferons plus Ribavirin) in use are aggressive, expensive and generally effective in less than 50 % of cases.
At CIGB, the structural region of the major circulating genotype 1b strain of HCV in Cuba has been cloned and it is the base of the vaccine candidates under development. The most advanced approach is a novel DNA vaccine formulation based in a construct comprising the genes for the three main structural antigens of the virus mixed with HCV core protein, as a molecular adjuvant. This DNA vaccine candidate induces broad, strong and sustained humoral and cellular immune responses, in different animal models, including non-human primates, remarking protection in mice against the challenge with a recombinant vaccinia virus expressing the core, E1 and E2 genes. We have successfully finished the pre-clinical phase with this vaccine formulation and a phase I clinical trial (CT) in HCV chronically infected patients in Cuba. The vaccine candidate was safe, well tolerated, and preliminary evidences of relevant immune response induction against HCV structural antigens, particularly cellular immune response, were observed in vaccinated individuals. We are planning a phase II CT in Cuba at the beginning of 2008. In parallel, a CT has been planned to be carried out in China.
Variants of HCV core, E1 and E2 proteins have also been obtained from recombinant microorganisms. Immunogenicity studies with formulations based on these recombinant proteins is currently under research in different animal models. Strong humoral and cellular immune responses have been elicited with these formulations in mice and non-human primates. These formulations are being also evaluated in prime-boost strategies with live viral vectors recombinant for HCV core and E1 and with the DNA vaccine candidate.
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Patent Status |
Granted. |
Project Status |
A CT phase I in HCV infected patients already finished in Cuba.
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Type of collaboration requested |
Corporate partnership for joint development this vaccine for selected territories (Europe, North America, Japan, among others).
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Competitives advantages Milestones |
- Experience in vaccine research and highly skilled staff and self-reliant laboratories.
- After the phase II clinical trial in 2008, in HCV infected patients, clinical trial phase III in HCV patients should be started by the second semester of year 2009.
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Host Insitutions |
Center for Genetic Engineering and Biotechnology (CIGB). Ave 31, e/158 y 190 Cubanacán, Playa. PO Box 6996, La Habana, 10600, Cuba. Tel. (53-7) 2712397; 2716022. Fax. (53-7) 2736008; 2718070. E-mail: ernesto.lopez@cigb.edu.cu
Web site: http://gndp.cigb.edu.cu
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Project code:
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BIO/CIGB/2008-2 |
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