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

July 29, 2022 updated by: PT Bio Farma

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Hasan Sadikin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Biological: Recombinant Hepatitis B (Bio Farma) Vaccine
Recombinant Hepatitis B vaccine produced by Bio Farma
ACTIVE_COMPARATOR: 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.
Biological: Recombinant Hepatitis B (Bio Farma) Vaccine®
Registered Recombinant Hepatitis B vaccine produced by Bio Farma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with Immediate reaction
Time Frame: 3 months
Number of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
3 months
percentage of subjects with Immediate reaction
Time Frame: 3 months
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with Adverse Events from 1 day to 28 days after vaccination
Time Frame: 3 months
Number of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination
3 months
Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination
Time Frame: 3 months
Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination
3 months
Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination
Time Frame: 3 Months
Number of subjects with serious adverse event from inclusion until 28 day after each dose vaccination.
3 Months
Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination
Time Frame: 3 Months
Percentage of subjects with serious adverse event from inclusion until 28 day after each dose vaccination.
3 Months
Number of Lab Deviation for adults subjects in 7 days of immunization
Time Frame: 7 Days After 1st Vaccination
Number of deviation from routine biochemical (SGOT, SGPT, Ureum, Creatinine) and Hematological (Hb, Hct, Dif, Leucocyte count, Total Leucocyte, total Eryhrocyte, total Thrombocyte) laboratory evaluation that probably related to the vaccination (adults subject).
7 Days After 1st Vaccination
Safety Comparison between each intervention group
Time Frame: 3 months
incidence of any adverse event, compared between two intervention arms
3 months
Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg)
Time Frame: 3 months
Number of subjects with anti-HbsAg more than 10mIU/ml, 28 days after 1 dose or three doses of vaccination.
3 months
Protectivity of Hepatitis B vaccine (4 times increasing antibody)
Time Frame: 3 months
- Number and percentage of subjects with more than 4 folds increasing antibody
3 months
Protectivity of Hepatitis B vaccine (Geometic Mean Titers)
Time Frame: 3 months
- Geometric Mean Titers (GMT) following immunization
3 months
Anti-HBs description between groups
Time Frame: 3 months
Number of subjects with protective Anti-HBs value, compared between intervention groups after vaccination.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Bio Farma

Investigators

  • Principal Investigator: Kusnandi Rusmil, Professor, Padjadjaran University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 3, 2019

Primary Completion (ACTUAL)

July 16, 2020

Study Completion (ACTUAL)

July 16, 2020

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (ACTUAL)

December 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hep B 0119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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