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 Hepatitis B (Bio Farma)® Vaccine in Indonesian Population

This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. 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: Hepatitis B vaccine lot 1; Biological: Hepatitis B vaccine lot 2; Biological: Hepatitis B vaccine lot 3; Biological: Hepatitis B vaccine (registered)

Detailed Description

This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. Total of 540 subjects aged 10-40 years old will be involved in this study. The subject will be divided into 4 groups, 3 groups are the investigational group and 1 group are the active comparator group. Each group consist of 135 subjects.

The objective of the study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization, to assess the safety of In-House Recombinant Hepatitis B vaccine, to evaluate immunogenicity and safety in three consecutive batches of In-House Recombinant Hepatitis B vaccine and also evaluate immunogenicity and safety after primary series of investigational product compare to control.

• 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:

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

Exclusion Criteria:

• Subject concomitantly enrolled or scheduled to be enrolled in another trial.
• Subjects with known history of Hepatitis B contained vaccination in the last 10 years.
• Evolving severe illness and/or chronic disease and fever (axillary temperature ≥ 37.5°C) within the 48 hours preceding enrollment.
• Known history of allergy to any component of the vaccines (based on anamnesis).
• HBsAg positive.
• Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
• History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
• 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.
• Pregnancy & Lactation (Adult).
• 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: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hepatitis B vaccine lot 1; 3 doses Recombinant Hepatitis B new Bulk vaccine lot 1	Biological: Hepatitis B vaccine lot 1; 3 doses of Hepatitis B vaccine lot 1
Experimental: Hepatitis B vaccine lot 2; 3 doses Recombinant Hepatitis B new Bulk vaccine lot 2	Biological: Hepatitis B vaccine lot 2; 3 doses of Hepatitis B vaccine lot 2
Experimental: Hepatitis B vaccine lot 3; 3 doses Recombinant Hepatitis B new Bulk vaccine lot 3	Biological: Hepatitis B vaccine lot 3; 3 doses of Hepatitis B vaccine lot 3
Active Comparator: Active Control: Hepatitis B vaccine (registered); 3 doses Recombinant Hepatitis B vaccine (registered)	Biological: Hepatitis B vaccine (registered); 3 doses of Hepatitis B vaccine (registered)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with increasing antibody titer >= 4 times	Percentage of subjects with increasing antibody titer >= 4 times: in all subjects;	28 days after the last dose immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with at least one immediate reaction	Immediate reaction (local reaction or systemic event)	30 minutes after each vaccination
Percentage of subjects with at least one of these adverse events	At least one of these adverse events, expected or not	within 72 hours, between 72 hours to 28 days after vaccination
Geometric Mean Titer (GMT)	GMT in all subjects; comparison of GMT between investigational products and control and comparison of GMT between each lot number of Recombinant Hepatitis B	28 days after the last dose immunization
Serious adverse event after vaccination	Serious adverse event occurring from inclusion until 28 days after vaccination.	28 days after the last dose immunization
Comparison adverse events between Investigational Products (Hepatitis B) and Control	Adverse events occuring until 28 days after vaccination	28 days after each dose
Percentage of subjects with transition of seronegative to seropositive	Percentage of subjects with transition of seronegative to seropositive: in all subjects;	28 days after the last dose immunization
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 Umum Pusat Sanglah, Denpasar
• Investigators: Principal Investigator: Trisna Windiani, MD, RS Umum Pusat Sanglah

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

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): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No