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

PT Bio Farma

Status and phase: Not yet enrolling; Phase 3

Conditions: Vaccine Adverse Reaction; Vaccine Reaction

Treatments: Biological: Hepatitis B vaccine lot 1; Biological: Hepatitis B vaccine (registered); Biological: Hepatitis B vaccine lot 3; Biological: Hepatitis B vaccine lot 2

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05482295

Hep B 0322

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 estimated patients

Sex: All

Ages: 10 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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540 participants in 4 patient groups

Hepatitis B vaccine lot 1

Experimental group

Description:

3 doses Recombinant Hepatitis B new Bulk vaccine lot 1

Treatment:

Biological: Hepatitis B vaccine lot 1

Hepatitis B vaccine lot 2

Experimental group

Description:

3 doses Recombinant Hepatitis B new Bulk vaccine lot 2

Treatment:

Biological: Hepatitis B vaccine lot 2

Hepatitis B vaccine lot 3

Experimental group

Description:

3 doses Recombinant Hepatitis B new Bulk vaccine lot 3

Treatment:

Biological: Hepatitis B vaccine lot 3

Active Control: Hepatitis B vaccine (registered)

Active Comparator group

Description:

3 doses Recombinant Hepatitis B vaccine (registered)

Treatment:

Biological: Hepatitis B vaccine (registered)