HEBERBIOVAC HB vaccine to reference material.

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:

Evaluation in adults of the immunogenicity and reactogenicity of lot 5C0701/0 of the HEBERBIOVAC HB vaccine candidate for reference material.

Secondary indentifying numbers:

IG/VHI/HB/1601

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana

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 Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Sonia

Last name:

Perez Rodriguez

Medical Specialty :

Medical Doctor

Affiliation:

National Center for Toxicology

Postal address:

Calle 114 y Ave 31

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-72607821

Email address:

cenatox@infomed.sld.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:

National Center for Toxicology, March 31, 2017

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/07/2017

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:

Prophylaxis of Hepatitis B virus infection.

Health condition(s) code:

Healthy Volunteers

Intervention(s):

Group I (Experimental): Recombinant Hepatitis B vaccine, Heberbiovac HB. A single batch of the vaccine (Batch number 5C0701/0, CIGB, La Habana) containing 20μg HBsAg will be used: 1mL by intramuscular route, with a monthly frequency during 3 months (0-1-2 scheme).

Intervention code:

Hepatitis B Vaccines

Viral Hepatitis Vaccines

Vaccines, Synthetic

Intervention keyword:

HEBERBIOVAC HB Recombinant hepatitis B vaccine

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 (defined as titers of anti-Hbs≥10 IU / L). Measurement time: 30 days after the third dose (day 90).

Key secondary outcomes:

Immunogenicity (seroprotection ≥ 10 IU / L at day 60 of the immunization schedule and ≥ 100 IU / L after the second and third doses administered). Measurement time: at 60 and 90 days after the start of the immunization schedule. Adverse clinical events-AE (Occurrence of AE (Yes, No) Description of AE (name of event) Intensity of AE (mild, moderate, severe). Measurement time: first 72 hours and at 30, 60 and 90 days of initiation of the immunization schedule.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

35 years

Maximum age:

55 years

Inclusion criteria:

1. Voluntariness of the subject through the signing of informed consent. 2. Age between 35 and 55 years. 3. Subjects of both sexes. 4. Do not present evidence of decompensated organic or psychiatric disease according to questioning and physical examination. 5. Women of childbearing age who use a contraceptive method and continue their use throughout the study. 6. Post-menopausal woman (with at least 2 years of amenorrhea) or documented history of hysterectomy and / or double annexectomy.

Exclusion criteria:

1. History of Hepatitis B virus infection. 2. Positivity for Hepatitis B surface antigen (HBsAg +) or presence of antibodies against surface antigen (Anti-HBs). 3. Pregnancy, puerperium or breastfeeding. 4. Acute infection of any type requiring specific treatment. 5. Decompensated chronic diseases (High blood pressure, Diabetes mellitus, Chronic renal failure, Heart failure, Ischemic heart disease). 6. Severe allergic history (Urticaria, Atopic dermatitis, Severe bronchitis, Grade III or IV bronchial asthma). 7. Immunosuppressive treatment in the 6 months prior to inclusion in the study. 8. Allergy to Thiomersal or any component of the vaccine.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

4

Target sample size:

190

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:

Nelvis

Last Name:

Figueroa Baile

Specialty:

Degree in Pharmaceutical Sciences.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

+537-2085887, +537-2087465

Email :

nelvis.figueroa@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:

Zurina

Last Name:

Cinza Estevez

Specialty:

Specialist of 1st degree in Clinical Biochemistry.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

La Habana

Country:

Cuba

Zip Code:

6162

Telephone:

+537-2085887, +537-2087465

Email :

zurina.cinza@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:

RPCEC00000244

Date of Registration in Primary Registry:

30/04/2017

Record Verification Date:

2017/04/30

Next update date:

2018/04/30

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HEBERBIOVAC HB vaccine to reference material.

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