Change in Manufacture Process of Heberbiovac HB vaccine.

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:

“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".

Secondary indentifying numbers:

IG/VHI/HB/0107

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

HeberBiotec S.A.

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 :

26/12/2007

Reference number:

05.005.07.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Daria Rodríguez Tudela, MSc.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

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:

CIGB Scientific Ethic Committee, May 31th, 2007.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

25/03/2008

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:

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.

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):

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

Key secondary outcomes:

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

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:

65 years

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.

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:

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:

Dr. Arístides

Last Name:

Aguilar Betancourt

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022

Email :

aristides.aguilar@cigb.edu.cu [2]

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:

Dr. Arístides

Last Name:

Aguilar Betancourt

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022

Email :

aristides.aguilar@cigb.edu.cu [2]

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:

RPCEC00000105

Date of Registration in Primary Registry:

2011-04-30

Record Verification Date:

2011-04-18 20:00

Link to the spanish version:

Click here [3]