Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children

NCT ID: NCT04188223

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2020-07-16

Brief Summary

This trial is an experimental, randomized, double blind, prospective intervention study

Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow:

For adult (18-40 years old)

Detailed Description

Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Recombinant Hepatitis B (Bio Farma) Vaccine

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment.

Group Type: EXPERIMENTAL

Recombinant Hepatitis B (Bio Farma) Vaccine

Intervention Type: BIOLOGICAL

Recombinant Hepatitis B vaccine produced by Bio Farma

Control Product: Recombinant Hepatitis B (Bio Farma) Vaccine®

Registered Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment.

Group Type: ACTIVE_COMPARATOR

Recombinant Hepatitis B (Bio Farma) Vaccine®

Intervention Type: BIOLOGICAL

Registered Recombinant Hepatitis B vaccine produced by Bio Farma

Interventions

Recombinant Hepatitis B (Bio Farma) Vaccine

Recombinant Hepatitis B vaccine produced by Bio Farma

Intervention Type: BIOLOGICAL

Recombinant Hepatitis B (Bio Farma) Vaccine®

Registered Recombinant Hepatitis B vaccine produced by Bio Farma

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Adult

1. Healthy individu as determined by clinical judgment, including a medical history, physical exam, rontgen thorax and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.

2. Subjects have been informed properly regarding the study and signed the informed consent form

3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial

Children:

1. Healthy individu as determined by clinical judgment, including a medical history, physical exam and rontgen thorax which confirms the absence of a current or past disease state considered significant by the investigator.

2. Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form and

3. Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial

2. Any direct relatives relationship with the study team.

3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.

4. Known history of allergy to any component of the vaccines (based on anamnesis)

5. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)

6. History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.

7. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or corticosteroid therapy and other immunosuppresant).

8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.

9. Pregnancy or planning a pregnancy within the next 3 months & lactation. (for Adults)

10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.

11. HbsAg positive

12. Subjects with known history of Hepatitis B infection.

13. Subjects who have received Hepatitis B vaccination which proven by vaccination records.

14. Subject planning to move from the study area before the end of study period.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PT Bio Farma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kusnandi Rusmil, Professor

Role: PRINCIPAL_INVESTIGATOR

Padjadjaran University

Locations

Hasan Sadikin Hospital

Bandung, West Java, Indonesia

Countries

Indonesia

Other Identifiers

Hep B 0119

Identifier Type: -

Identifier Source: org_study_id