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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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RPCEC |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
RPCEC00000031 |
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Date of registration:
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27/02/2009 |
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Primary sponsor: |
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Public title:
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Safety and immunogenicity of commercial Hepatitis B vaccines.
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Scientific title:
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“Comparative immunogenicity and reactogenicity of Heberbiovac-HB and three commercial recombinant hepatitis B vaccines in healthy adults”. |
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Date of first enrolment:
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31/03/2004 |
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Target sample size:
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400 |
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Recruitment status: |
Closed |
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URL:
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http://registroclinico.sld.cu/trials/RPCEC00000031-En |
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Study type:
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Interventional |
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Study design:
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Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel Purpose: Prevention
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Arístides
Betancourt |
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Address:
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31st Ave. between 158 and 190, Cubanacan, Playa,
6162
Havana City
Cuba |
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Telephone:
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(53-7)-2716022 (ext.7227). |
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Email:
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aristides.aguilar@cigb.edu.cu |
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Affiliation:
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Center for Genetic Engineering and Biothecnology (CIGB), in Havana. |
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Name:
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Arístides
Betancourt |
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Address:
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31st Ave. between 158 and 190, Cubanacan, Playa.
6162
Havana City
Cuba |
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Telephone:
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(53-7)-2716022 (ext.7227). |
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Email:
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aristides.aguilar@cigb.edu.cu |
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Affiliation:
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Center for Genetic Engineering and Biothecnology (CIGB), in Havana. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Healthy adults from both sexes. 2.Age range: 18 until 45 years old. 3.Current use of contraceptive method for women of fertile age. 4.Written informed consent obtained.
Exclusion criteria: 1.Known history of infection with hepatitis B or present antibodies surface antigen (antiHBs) prior to the inclusion (including pre-vaccination anti-hepatitis B). 2.Positive for surface antigen of hepatitis B (HBsAg +). 3.Underlying immunosuppressive disease, ingestion of current immunosuppressive drugs (including steroids) or in the six months prior to study. 4.People who are decompensated chronic diseases (hypertension, diabetes mellitus, renal failure, heart failure, hyperthyroidism, malignancy, epilepsy, etc.). Or suffer from any autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, diabetes mellitus type 1 , etc). 5.Persons with a severe allergy (asthma grade III or IV, hives, dermatitis, bronchitis, etc). 6.Thiomersal allergy or any of the components of the vaccine. 7.Pregnancy and lactancy.
Age minimum:
18 years
Age maximum:
45 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis B (Prevention).
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Intervention(s)
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Volunteers were assigned (ratio 1:1:1:1) to one of the four treatment groups (recombinant hepatitis B vaccines): one cuban (Heberbiovac HB, CIGB, Havana), two Korean vaccines (Euvax-B, LG Chemical Ltd. and Hepavax-Gene, Greencross Vaccine Corp.), and one Belgian (Engerix B, GlaxoSmithKline). The schedule of administration of the vaccine was three 20?g doses of the HBsAg used intramuscularly (schedule 0-1-2 months).
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Primary Outcome(s)
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Immunogenicity (seroprotection percentage [antiHBs=10 UI/L], hyper-responders [antiHBs=1000UI/L] and geometric mean titers of anti-HBs [antiHBs GMT] at 60 and 90-days postvaccination).
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Secondary Outcome(s)
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Reactogenicity, adverse events rate in each dose (first 72 hours), 7 and 30 days post-vaccination.
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Secondary ID(s)
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IG/VHI/HB/0302
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Source(s) of Monetary Support
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Heber Biotec S.A. and Cuban Ministry of Public Health.
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