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

Phase 3

Not yet recruiting

• Conditions: Vaccine Reaction; Vaccine Adverse Reaction
• Interventions: Biological: Hepatitis B vaccine lot 3; Biological: Hepatitis B vaccine lot 1; Biological: Hepatitis B vaccine lot 2; Biological: Hepatitis B vaccine (registered)

• Registration Number: NCT05482295
• Lead Sponsor: PT Bio Farma

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05
• Study Start: 2024-06
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 540

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepatitis B vaccine lot 3	Hepatitis B vaccine lot 3	3 doses Recombinant Hepatitis B new Bulk vaccine lot 3
Hepatitis B vaccine lot 1	Hepatitis B vaccine lot 1	3 doses Recombinant Hepatitis B new Bulk vaccine lot 1
Hepatitis B vaccine lot 2	Hepatitis B vaccine lot 2	3 doses Recombinant Hepatitis B new Bulk vaccine lot 2
Active Control: Hepatitis B vaccine (registered)	Hepatitis B vaccine (registered)	3 doses Recombinant Hepatitis B vaccine (registered)

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with increasing antibody titer >= 4 times	28 days after the last dose immunization	Percentage of subjects with increasing antibody titer \>= 4 times: in all subjects;

Secondary Outcome Measures

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