61 Factors Influencing Progression of Liver Fibrosis in Patients With Chronic Hepatitis C: Results of the 3-Year T2s-918-HCV Study With Hcve1 Therapeutic Vaccination

Wedemeyer, H.; Mazur, W.; Nevens, Frederik; Horsmans, Yves; Adler, Michaël; He, Blum; Inglot, Marcin; Gerken, Guido; Janczewska, Ewa; Roskams, Tania; Desmet, VJ; Renault, Jules; Joos, Erika; Coart, Els; Maertens, Geert; Winter, Hilde De

doi:10.1016/s0168-8278(08)60063-x

Cited by 10 publications

(4 citation statements)

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“…In Group IV, the course of the virological response was modified because the typical drop in virological response from Week 12 to 72, described for IFN + RBV treatment, was not observed. 72 Comparing the results with other vaccine candidates, in the case of IC-41, 73 which failed to prevent relapse in the study group. and TG4040 (Transgene, France), in a Phase II trial 74 we were able to reduce HCV viral load to approximately 0.5 log IU/mL.…”

Section: Discussionmentioning

confidence: 99%

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

Guridi

Fernández

Dueñas‐Carrera

et al. 2017

Current Therapeutic Research

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BackgroundAn 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.ObjectiveTo 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.MethodsThis 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.ResultsAll 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.ConclusionsVaccination 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.

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Section: Discussionmentioning

confidence: 99%

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

Guridi

Fernández

Dueñas‐Carrera

et al. 2017

Current Therapeutic Research

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“…La vacuna indujo anticuerpos y linfocitos T específicos 40,41 . Dicho estudio progresa en el seguimiento de 122 pacientes que recibieron inyecciones durante 3 a ños, en el cual se observa inducción de la respuesta inmunológica celular y humoral a pesar de no prevenir el da ño hepático 42 .…”

Section: Vacunas De La Cubierta Proteicaunclassified

Aspectos moleculares de la respuesta antiviral contra el virus de la hepatitis C importantes para el desarrollo de vacunas

Llanes¹,

Palacios²,

Piccione³

et al. 2015

Enfermedades Infecciosas y Microbiología Clínica

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“…As a result, this work progressed to a placebo-controlled, multicenter trial (presented in abstract form in 2008 [79]) that evaluated 122 patients who received four courses of six injections over 3 years. Humoral and cellular immune responses to the E1 protein were induced but vaccination did not prevent histological progression of liver disease [79]. Innogenetics, the company investigating this vaccine, ceased its program in 2008 and no further work has been published.…”

Section: Vaccine Approaches: Current Statusmentioning

confidence: 99%

Vaccination for hepatitis C virus: closing in on an evasive target

Halliday

Klenerman

Barnes

2011

Expert Review of Vaccines

101

106

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Hepatitis C virus (HCV) infects more than 170 million people globally and is a leading cause of liver cirrhosis, transplantation and hepatocellular carcinoma. Current gold-standard therapy often fails, has significant side effects in many cases and is expensive. No vaccine is currently available. The fact that a significant proportion of infected people spontaneously control HCV infection in the setting of an appropriate immune response suggests that a vaccine for HCV is a realistic goal. A comparative analysis of infected people with distinct clinical outcomes has enabled the characterization of many important innate and adaptive immune processes associated with viral control. It is clear that a successful HCV vaccine will need to exploit and enhance these natural immune defense mechanisms. New HCV vaccine approaches, including peptide, recombinant protein, DNA and vector-based vaccines, have recently reached Phase I/II human clinical trials. Some of these technologies have generated robust antiviral immunity in healthy volunteers and infected patients. The challenge now is to move forward into larger at-risk or infected populations to truly test efficacy.

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61 Factors Influencing Progression of Liver Fibrosis in Patients With Chronic Hepatitis C: Results of the 3-Year T2s-918-HCV Study With Hcve1 Therapeutic Vaccination

Cited by 10 publications

References 0 publications

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

Aspectos moleculares de la respuesta antiviral contra el virus de la hepatitis C importantes para el desarrollo de vacunas

Vaccination for hepatitis C virus: closing in on an evasive target

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