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

PT Bio Farma

Status and phase: Completed; Phase 1

Conditions: Hepatitis B

Treatments: Biological: Recombinant Hepatitis B (Bio Farma) Vaccine; Biological: Recombinant Hepatitis B (Bio Farma) Vaccine®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04188223

Hep B 0119

Details and patient eligibility

About

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)

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 10 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Recombinant Hepatitis B (Bio Farma) Vaccine

Experimental group

Description:

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.

Treatment:

Biological: Recombinant Hepatitis B (Bio Farma) Vaccine

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

Active Comparator group

Description:

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.

Treatment:

Biological: Recombinant Hepatitis B (Bio Farma) Vaccine®