Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
, 85, 20-28

Clinical Evaluation of Terap C Vaccine in Combined Treatment With Interferon and Ribavirin in Patients With Hepatitis C


Clinical Evaluation of Terap C Vaccine in Combined Treatment With Interferon and Ribavirin in Patients With Hepatitis C

Dorta Guridi Zaily et al. Curr Ther Res Clin Exp.


Background: An estimated 170 million individuals worldwide are infected with the hepatitis C virus (HCV). Although treatment options using a combination of pegylated interferon and ribavirin (P-IFN/RBV) are available, sustained clearance of the virus is only achieved in approximately 40% of individuals infected with HCV genotype 1. Recent advances in the treatment of HCV using directly acting antiviral agents have been achieved; however, treatment can be very expensive and is associated with substantial side effects. The development of a new treatment modality is needed. One possible modality could be specific immunotherapy. Terap C is a therapeutic vaccine candidate composed of pIDKE2, a plasmid expressing HCV structural antigens, with a recombinant HCV core protein, Co.120.

Objective: To assess the safety and efficacy of concomitant therapy with the candidate vaccine, Terap C, IFN α-2b and ribavirin in untreated individuals with HCV genotype 1 infection.

Methods: This was a Phase II randomized, placebo-controlled, double-blind clinical trial evaluating the safety and efficacy of Terap C concomitant with IFN α-2b/RBV in 92 treatment-naïve patients with HCV genotype 1 infection. The study was conducted at the Gastroenterology Institute in Havana, Cuba. Patients were randomly assigned to 1 of 5 groups. The control group (Group 1) received IFN α-2b/RBV and placebo for 48 weeks. Groups 2 and 3 were administered Terap C 6 and 9 times, respectively, in addition to standard IFN α-2b/RBV treatment. In groups 4 and 5, Terap C was introduced 12 weeks after the initiation of IFN α-2b/RBV and administered 6 and 9 times, respectively, concomitant with IFN α-2b/RBV.

Results: All patients showed some adverse events. Out of 3615 adverse events, only 18.8% were considered to be probably associated with administration of Terap C. Most events (47.4%) were considered to be improbably associated with of administration Terap C. Only 33.8% were considered possibly temporarily associated with Terap C, and can be explained by the use of conventional IFN α-2b + RBV or by HCV itself. The most common adverse events (≥65%) observed were pain at the injection site, headache, asthenia, psychiatric disturbances, fever, and gastrointestinal symptoms. Regarding sustained virological response, a 20% superiority was observed in the patients who received concomitant Terap C treatments from the beginning of the study compared with those who started after Week 12.

Conclusions: Vaccination with Terap C in patients with chronic HCV infection was safe and well tolerated. Clinical trial protocol code: IG/VHI/HC/0701; Public Register Code: RPCEC00000074.

Keywords: Hepatitis C; Therapeutic vaccine.

Similar articles

See all similar articles


    1. Lavanchy D. Evolving epidemiology of hepatitis C virus. Clinical Microbiology and Infection. 2011;17(2):107–115. - PubMed
    1. Lavanchy D. The global burden of hepatitis C. Liver International. 2009;29(s1):74–81. - PubMed
    1. Lozano R., Naghavi M., Foreman K., Lim S., Shibuya K., Aboyans V. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet. 2013;380(9859):2095–2128. - PubMed
    1. Davis G.L., Alter M.J., El-Serag H., Poynard T., Jennings L.W. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138(2):513–521. .e6. - PubMed
    1. Mühlberger N., Schwarzer R., Lettmeier B., Sroczynski G., Zeuzem S., Siebert U. HCV-related burden of disease in Europe: a systematic assessment of incidence, prevalence, morbidity, and mortality. BMC public health. 2009;9(1):1. - PMC - PubMed