Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)

This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaccine Adverse Reaction; Vaccine Reaction
• Intervention / Treatment: Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine; Biological: Registered Hepatitis B vaccine recombinant (Engerix-B)

Detailed Description

This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this study.

The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.

• Study Type: Interventional
• Enrollment (Estimated): 540
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rini Mulia Sari, MD; Phone Number: 14102 0222033755; Email: rini.mulia@biofarma.co.id
• Study Contact Backup: Name: Mita Puspita, MD; Phone Number: 5045 0222033755; Email: mita.puspita@biofarma.co.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy individual aged 10 - 50 years old, as determined by clinical judgment, including a medical history and physical exam 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/ informed assent form.
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. Subjects with known history of Hepatitis B contained vaccination in the last 10 years.
3. Evolving severe illness and/or chronic disease and fever (axillary temperature >= 37.5 C) within the 48 hours preceding enrollment.
4. Known history of allergy to any component of the vaccines (based on anamnesis).
5. HBsAg positive.
6. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
8. 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 immunosuppressant.
9. Pregnancy & Lactation (Adult).
10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1; 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine	Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine; 3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
Experimental: In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2; 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine	Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine; 3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
Experimental: In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3; 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine	Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine; 3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
Active Comparator: Registered Hepatitis B vaccine recombinant (Engerix-B); 3 doses Registered Hepatitis B vaccine recombinant (Engerix-B)	Biological: Registered Hepatitis B vaccine recombinant (Engerix-B); 3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protectivity	Number & percentage of subjects with anti HBsAg > 10mIU/ml	28 days after the primary series of Hepatitis B vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity: Serological response	Geometric mean of anti-HBsAg, percentage of subjects with increasing antibody titer >= 4 times and/ or percentage of subjects with transition of seronegative to seropositive	28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison between IP & control	Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer >=4 times and/ or percentage of subjects with transition of seronegative to seropositive	28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison among each batch of IP	Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer >=4 times and/ or percentage of subjects with transition of seronegative to seropositive	28 days after the primary series of Hepatitis B vaccination
Safety: Immediate reaction, Local and systemic events	Immediate reaction, Local and systemic events	within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injection
Safety: Serious adverse event	Any serious adverse event	from inclusion until 28 days after the last injection
Safety: Comparison of adverse events between Investigational Products (Hepatitis B) and Control	Adverse events occuring until 28 days after vaccination	28 days after each dose
Safety: Comparison of adverse events between each lot number of Recombinant Hepatitis B	Adverse events occuring until 28 days after vaccination	28 days after each dose

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: RS Prof. Dr. I.G.N.G Ngoerah
• Investigators: Principal Investigator: Trisna Windiani, MD, RSUP Prof. dr. I.G.N.G. Ngoerah

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Hepatitis B vaccine, Vaccine
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: HepB 0322

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