Change in Manufacture Process of Heberbiovac HB vaccine.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000105
• Date of registration: 30/04/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB).
• Public title: Change in Manufacture Process of Heberbiovac HB vaccine.
• Scientific title: “Safety, tolerance and immunogenicity of one Heberbiovac HB vaccine batch obtained after optimisation of manufacture process in healthy adults. A randomised, non-inferiority, controlled, doubled blinded bridge clinical trial".
• Date of first enrolment: 25/03/2008
• Target sample size: 400
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000105-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel Purpose: Prevention

Countries of recruitment

Cuba

Contacts

• Name: Dr. Arístides Aguilar Betancourt
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Dr. Arístides Aguilar Betancourt
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

Inclusion criteria: 1) Healthy apparent subjects from both sexes. 2) Age from 18 up to 65 years old. 3) Current contraceptive device use for women on reproductive age. 4) Signing of the written inform consent sheet.
Exclusion criteria: 1) History of viral hepatitis type B or previous vaccination against Hepatitis B. 2) Seropositivity for HBsAg. 3) Underlying immunosuppressive disease, intake of immunosuppressor drugs (including steroids) in the six month period prior to study entry. 4) Non-controlled Chronic diseases. 5) Feverish states (>37.5°C) at the momento of vaccination. 6) History of severe allergy. 7) History of allergy to any component of the vaccine or to thiomersal. 8) Pregnancy or breastfeeding.

Age minimum: 18 years
Age maximum: 65 years
Gender: Both

Health Condition(s) or Problem(s) studied

Viral hepatitis type B.

Intervention(s)

Study group (HeberbiovacHB vaccine obtained by optimizing the manufacturing process): 3 doses of 20µg/mL per dose by the intramuscular route, according to the schedule 0-1-2 months. Control group (Heberbiovac HB): 3 doses of 20µg/mL per dose by the intramuscular route, according to the schedule 0-1-2 months.

Primary Outcome(s)

Seroprotection percentage (+ de 10 UI of AntiHBs antibodies). Measuring time: 90 days after the administration of the first vaccine dose. Hyper-responder rate (+ de 1000 UI, Yes/No). Measuring time: 90 days after the administration of the first vaccine dose. antiHBs GMT. Measuring time: 90 days after the administration of the first vaccine dose

Secondary Outcome(s)

Local and systemic adverse events, within 72 hours, and at 7 and 30 days after vaccination in each dose.

Secondary ID(s)

IG/VHI/HB/0107

Source(s) of Monetary Support

HeberBiotec S.A.

Secondary Sponsor(s)

Ministry of Public Health, CUBA.