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Safety and immunogenicity of commercial Hepatitis B vaccines.
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Safety and immunogenicity of commercial Hepatitis B vaccines.
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
“Comparative immunogenicity and reactogenicity of Heberbiovac-HB and three commercial recombinant hepatitis B vaccines in healthy adults”.
Secondary indentifying numbers:
IG/VHI/HB/0302
Issuing authority of the secondary identifying numbers:
Center for Genetic Engineering and Biothecnology (CIGB)
Primary sponsor:
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Heber Biotec S.A. Cuban Ministry of Public Health.
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of the Quality of Drugs(CECMED)
Authorization date :
30/03/2004
Reference number:
637/05.006.04.B
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Francisco
Last name:
Hernandez-Bernal
Medical Specialty :
Doctor of Medical Sciences. Specialist of 2nd degree in Hygiene and Epidemiology
Affiliation:
Center for Genetic Engineering and Biothecnology (CIGB)
Postal address:
Ave. 31 between 158 and 190, Cubanacán, Playa
City:
Havana
País:
Cuba
Zip Code:
6162
Telephone:
+53-72085887
+53-72087465
Email address:
hernandez.bernal@cigb.edu.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not Applicable
Research ethics committees:
Ethics Committees of Center for Genetic Engineering and Biotechnology (February 15, 2004).
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
31/03/2004
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Hepatitis B (Prevention).
Health condition(s) code:
Hepatitis B
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Intervention(s):
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).
Intervention code:
Hepatitis B Vaccines
Vaccines, Synthetic
Injections, Intramuscular
Intervention keyword:
Heberbiovac-HB, Engerix-B, Euvax-B, Hepavax-Gene
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
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).
Key secondary outcomes:
Reactogenicity, adverse events rate in each dose (first 72 hours), 7 and 30 days post-vaccination.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
18 years
Maximum age:
45 years
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.
Type of population:
Adults
Type of participant:
Healthy volunteers
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Prevention
Allocation:
Randomized controlled trial
Masking:
Double Blind
Control group:
Active
Study design:
Parallel
Phase:
4
Target sample size:
400
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Aristides
Last Name:
Aguilar Betancourt
Specialty:
1st Degree Specialist in Immunology
Affiliation:
Center for Genetic Engineering and Biothecnology (CIGB)
Postal Address:
31st Ave. between 158 and 190, Cubanacan, Playa.
City:
Havana
País:
Cuba
Zip Code:
6162
Telephone:
+537-2085887, +537-2087465
Email :
aristides.aguilar@cigb.edu.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Aristides
Last Name:
Aguilar Betancourt
Specialty:
1st Degree Specialist in Immunology
Affiliation:
Center for Genetic Engineering and Biothecnology (CIGB)
Postal Address:
31st Ave. between 158 and 190, Cubanacan, Playa,
City:
Havana
País:
Cuba
Zip Code:
6162
Telephone:
+537-2085887, +537-2087465
Email :
aristides.aguilar@cigb.edu.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000031
Date of Registration in Primary Registry:
2009-02-27
Record Verification Date:
2017/02/28
Next update date:
2018/02/28
Link to the spanish version:
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