Infection with hepatitis C virus.
Conditions
Interventions
The study will involve four groups of treatment (A, B, C y D), 15 individuals in each one, with 8 administrations, four weeks interval, through intramuscular injection. One group will receive placebo.
Sponsors
Centro de Ingeniería Genética y Biotecnología (CIGB).
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adults of both genders Age between 18 and 60 years Chronic renal insufficiency (CRI) in stage IV (criteria for posterior hemodialysis treatment) with glomerular filtrate between 24 and 15. Informed consent signed.
Exclusion criteria
Exclusion criteria: Positive to anti-HCV. Positive to HCV RNA. Diagnosis of Lupus erithematosus or other documented collagen diseases Positive to HIV Positive to HBV Concomitant infection with HAV Women in fertile age that use hormone-based contraceptive methods. Women and men in reproductive age without contraceptive control. Pregnancy and breastfeeding. Body mass index under 16 Patients with previous diagnosis of sicklemia or hemophilia. Previous diagnosis of mental or psychiatric diseases. Patients with background of severe allergy (asthma degree III or IV). Consumption of immunosuppresive/ immunomodulators drugs at the inclusion or in the three months previous to the study. Fever above >37.8°C, in the moment or 24 hours previous to the administration of the vaccine, or acute infectious disease not related to HCV infection suggested by clinical evaluation. Temporary exclusion criterium. Previous diagnosis of active cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, during the time of treatment and follow-up, adverse events will be monitored by specialized physicians. Adverse events (AE). Time of measurement: every 28 days - Ocurrence of AE in the individual (Yes/No). - Description of AE (Name of the AE). - Time of the AE (Difference in dates for starting and ending of AE). - Intensity of the AE (Slight, Moderate, Severe) - Seriousness of the AE (Serious, No serious). - Result of the AE (improve, no improve, no change) - Causality relation (1.Very Probable, 2.Probable, 3.Possible, 4.Improbable, 5.No related, 6.No measurable). Adverse events will be actively monitored in the place of immunization up to one hour after the application of each dose of CIGB-230 (or placebo), or in a passive way in the follow-up interviews through a model that will be filled-up by patients. Adverse events will be evaluated every 28 days after each immunization with CIGB-230, considering all medical events presented, being or not causally related with the administration of the vaccine candidate. The evaluation will include: asking, temperature measuring, inspection of the inoculation site, and general physical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome: Virological - Detection of HCV RNA (presence/absence); it will be evaluated by RT-PCR method previous to the treatment (t=0), 4 weeks after finishing the treatment of 8 immunizations (t=8), before starting the hemodialysis and monthly from this moment up to 6 months in hemodialysis. Secondary Outcome: Immunogenicity - Specific immune response against HCV (yes/no); samples will be collected for evaluation, according the availability of materials and the results of viral load, of specific immunological parameters (neutralizing antibodies, lymphoproliferative response against core, E1, E2 and NS3, IFN-gamma secretion), at months 0, 8 and before starting the hemodialysis and 6 months after starting the hemodialysis. | — |
Countries
Cuba
Contacts
Public ContactZurina Cinza Estevez
Center for Genetic Engineering and Biotechnology.
Outcome results
None listed