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

NCT04188223 | Completed Phase 1

• 1 other identifier: Hep B 0119
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Hepatitis B

Keywords

vaccine; hepatitis b; infection; virus

Outcome Measures

Primary Outcomes (2)

• Number of subjects with Immediate reaction

  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

  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 Outcomes (10)

• Number of subjects with Adverse Events from 1 day to 28 days after vaccination

  3 months

• Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination

  3 months

• Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination

  3 Months

• Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination

  3 Months

• Number of Lab Deviation for adults subjects in 7 days of immunization

  7 Days After 1st Vaccination

Study Arms (2)

Recombinant Hepatitis B (Bio Farma) Vaccine

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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®

Interventions

Recombinant Hepatitis B (Bio Farma) Vaccine® BIOLOGICAL

Registered Recombinant Hepatitis B vaccine produced by Bio Farma

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

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult
• 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.
• Subjects have been informed properly regarding the study and signed the informed consent form
• Subjects will commit to comply with the instructions of the investigator and the schedule of the trial
• Children:
• 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.
• Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form and
• Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

You may not qualify if:

• Subject concomitantly enrolled or scheduled to be enrolled in another trial
• Any direct relatives relationship with the study team.
• Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
• Known history of allergy to any component of the vaccines (based on anamnesis)
• Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
• History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
• 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).
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• Pregnancy or planning a pregnancy within the next 3 months \& lactation. (for Adults)
• Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
• HbsAg positive
• Subjects with known history of Hepatitis B infection.
• Subjects who have received Hepatitis B vaccination which proven by vaccination records.
• Subject planning to move from the study area before the end of study period.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Hepatitis B; Infections; Virus Diseases

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Kusnandi Rusmil, Professor

  Padjadjaran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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) )

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 5, 2019
• Study Start: December 3, 2019
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)