Safety and immunogenicity of commercial Hepatitis B vaccines.

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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)

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:

2009-02-18 19:00

Link to the spanish version:

Click here

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Ensayos Registrados

Proceso de Registro

Safety and immunogenicity of commercial Hepatitis B vaccines.

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