Phase I/II clinical trial for the evaluation of vaccine candidate CIGB-230 in patients with chronic renal insufficiency.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000098
• Date of registration: 27/09/2010
• Primary sponsor: Centro de Ingeniería Genética y Biotecnología (CIGB).
• Public title: Phase I/II clinical trial for the evaluation of vaccine candidate CIGB-230 in patients with chronic renal insufficiency.
• Scientific title: Evaluation of the vaccine candidate CIGB-230 in individuals with chronic renal insufficiency for the prevention of hepatitis C virus infection. Phase I/II clinical trial, controlled, randomized, blinded, adaptive.
• Date of first enrolment: 29/10/2009
• Target sample size: 60
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000098-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Prevention

Countries of recruitment

Cuba

Contacts

• Name: Zurina Cinza Estevez
• Affiliation: Center for Genetic Engineering and Biotechnology.

• Name: Santiago Dueñas-Carrera
• Affiliation: Center for Genetic Engineering and Biotechnology.

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

Infection with hepatitis C virus.

Intervention(s)

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. The other 3 groups will receive CIGB-230, each one with a different dose: Group A: CIGB-230, dose 0.25 mg Group B: CIGB-230, dose 0.5 mg Group C: CIGB-230, dose 0.75 mg Group D: Placebo The first immunization with CIGB-230 starts in pre-dialysis stage, stage IV, and 8 injections are administered, independently of starting the hemodialysis process if necessary before finishing the last immunization. Once started the hemodialysis treatment, if detected HCV RNA at any moment, the individual will receive the registered treatment, based on IFN, according the established protocol, and in those individuals still receiving doses of CIGB-230 or placebo, the administration of the vaccine candidate will continue up to complete de planned immunizations. If the hemodialysis treatment starts at least 2 months after the last immunization with CIGB-230 or placebo, a booster dose, before starting the hemodialysis, will be applied with CIGB-230 or placebo, according to randomized list, keeping the blinded design.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

IG/VHI/HC/0801

Source(s) of Monetary Support

Heber Biotec S.A.