Biology:Hepacivac

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HEPACIVAC logo
New preventive and therapeutic Hepatitis C vaccines: from pre-clinical to phase 1
Funding
European Commission Sixth Framework Programme
Project
Integrated Project
Reference
LSHB-CT-2007-037435
Starting date
February 1st, 2007
Duration
5 years
Website
http://www.altaweb.eu/hepacivac[1]
Participants
CEINGECeinge Biotecnologie avanzate[2] (coordinator) (ITALY)
NVDNovartis Vaccines & Diagnostics s.r.l.[3](ITALY)
EMCErasmus Medical Centre[4] (THE NETHERLAND)
UGentGhent University[5] (BELGIUM)
UBUniversity of Birmingham[6] (UNITED KINGDOM)
GdaUniversity of Gdansk[7] (POLAND)
EGYBLOODThe Egyptian Company for Blood Transfusion Services, Egyblood[8] (EGYPT)
ALTAALTA S.r.l.u.[9] (ITALY)
UOXFUniversity of Oxford[10] (UNITED KINGDOM)
GUFKlinikum der Johann Wolfgang Goethe Universitaet, Frankfurth[11] (GERMANY)
OKAIROSOkairòs S.r.l.[12] (ITALY)
UNIPIUniversity of Pisa[13] (ITALY)

HEPACIVAC stands for “New preventive and therapeutic Hepatitis C vaccines: from pre-clinical to phase 1”. HEPACIVAC is a project of the EU 6th Framework Programme.

Summary

The aim of the HEPACIVAC project is to develop efficacious prophylactic and therapeutic vaccines to Hepatitis C virus (HCV). For this purpose, two vaccine companies in Europe, Okairos AG (a Biotech company created as a spin-off from Merck Inc., and which is now owned by British drug maker GlaxoSmithKline) and Novartis Vaccines and Diagnostics are joining their efforts with several European groups and one institution from Egypt (listed in the FP6 INCO list).[14] To increase the probability of success, the ‘ideal HCV vaccine’ should be capable of eliciting both arms of the immune system, antibody and cellular responses.

Okairos, in collaboration with Ceinge, has been working on a promising gene based HCV vaccine candidate using adenoviral vectors for delivery. This vaccine is based on the 2000 amino acid long HCV Non Structural region, elicits potent CD4+ and CD8+ T cell responses and works by eliminating infected cells, thus preventing chronic hepatitis.

A second vaccine candidate, previously developed by Novartis, consists of recombinant HCV glycoproteins, gpE1 and gpE2, associated to resemble a pre-virion envelope structure which is capable of inducing neutralizing antibodies. Both vaccine candidates have the potential to protect humans from a large number of HCV strains.

The goal of the HEPACIVAC project is to develop HCV vaccines both at the pre-clinical level by testing safety, tolerability and immunogenicity, and at the clinical level by testing in healthy volunteers for safety and dose optimization and in chronically infected patients with and without the gold standard therapy.

Partners

HEPACIVAC represents a unique consortium including cutting edge industrial and academic and research groups. A key feature of HEPACIVAC project is that this large consortium, which includes two vaccine companies, several academic and research groups with expertise in clinical vaccine development, human immunity and animal models, focuses the skills of the individual participants towards the development of new preventive and therapeutic strategies against HCV infection. The consortium integrates different approaches and disciplines and provides the necessary critical mass to test and compare different scientific ideas with the aim of delivering an efficacious HCV vaccine.

Expected results

The HEPACIVAC project will be an important step forward towards the development of a HCV vaccine that will defeat an important cause of global morbidity and mortality, and that will be cost-effective when used by the general population even in countries with low incidence of infection.[15] In particular the development of a therapeutic vaccine for the treatment of chronic hepatitis C would be one of the first demonstrations (after the treatment of herpes zoster infections[16] ) of successful immuno-therapeutic intervention in chronic viral infections. Furthermore, this project will contribute to European competitiveness in the strategic field of HCV vaccine development by combining the expertise of groups coming from several countries within Europe and one from the Mediterranean area. Each group has recognised expertise within its field and a coherent and large-scale collaboration on a single project is a guarantee for its success. The purpose of this project is to put together excellent European scientists to analyse 2 HCV vaccines targeting different components of the immune system. This study will be performed with a strong commitment to translate the results into effective approaches for prevention and therapy of HCV. For the first time this analysis will be performed combining the 2 vaccines in pre-clinical and clinical studies. This represents the originality and uniqueness of the proposed project. "In fact this is expected to generate a global vision of the effects of the cellular and humoral immune responses on HCV infection giving to the European academic and industrial scientific community an extraordinary tool to compete at high level in developing new effective strategies for HCV preventive and therapeutic vaccines. HEPACIVAC has the ambition of becoming a benchmark work for any other future HCV vaccine trial, using a comprehensive approach to standardise the pre-clinical and clinical trial procedures while taking further the development of two promising HCV vaccines.

Main achievements

Prophylactic clinical trials

The trial with Okairos vaccine candidate started in October 2008 and was completed on 31 January 2011. The primary objective of the trial is to assess the safety and the immunogenicity of the heterologous prime-boost of vaccine candidate. The vaccine showed excellent safety and immunogenicity. In the last year of the project the vaccine will be tested in healthy individuals for safety and dose optimization and in chronically infected patients (therapeutic trial).

Therapeutic clinical trials

The trial with Okairos vaccine candidate on naïve patients is in progress. The study started in November 2009. To date 23 patients have been enrolled. The primary objective of the trial is to test the safety, tolerability and immunogenicity of the heterologous prime-boost HCV vaccine candidate, when administered alone or in combination with the SOC therapy (pegylated-interferon and ribavirin – PEG-IFN/RBV). Preliminary results on safety indicate that all adverse events were scored mild to moderate and were of short duration. No serious adverse events related to vaccination were recorded.

References

  1. ↑ http://www.altaweb.eu/hepacivac
  2. ↑ http://www.ceinge.unina.it/
  3. ↑ "Archived copy". http://www.novartisvaccines.it/. 
  4. ↑ http://www.erasmusmc.nl/
  5. ↑ http://www.ugent.be/
  6. ↑ http://www.birmingham.ac.uk/
  7. ↑ http://www.ug.gda.pl/
  8. ↑ http://www.egyblood.com/
  9. ↑ http://www.altaweb.eu
  10. ↑ http://www.ox.ac.uk/
  11. ↑ http://www.klinik.uni-frankfurt.de/
  12. ↑ http://www.okairos.com/e/index.php
  13. ↑ http://www.med.unipi.it/medint/
  14. ↑ "Archived copy". http://news.msn.com/science-technology/scientists-racing-to-test-ebola-vaccines-in-humans. 
  15. ↑ Krahn (2005). 
  16. ↑ Oxman (2005). 




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