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

Vaccine Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05482295
• Other study ID #: Hep B 0322
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: PT Bio Farma
• Contact: Rini Mulia Sari, MD
• Phone: 0222033755
• Email: rini.mulia[@]biofarma.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Vaccine Adverse Reaction
• Vaccine Reaction

Intervention

Biological:
• Hepatitis B vaccine lot 1
3 doses of Hepatitis B vaccine lot 1
• Hepatitis B vaccine lot 2
3 doses of Hepatitis B vaccine lot 2
• Hepatitis B vaccine lot 3
3 doses of Hepatitis B vaccine lot 3
• Hepatitis B vaccine (registered)
3 doses of Hepatitis B vaccine (registered)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
PT Bio Farma	RS Umum Pusat Sanglah, Denpasar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage of subjects with at least one immediate reaction	Immediate reaction (local reaction or systemic event)	30 minutes after each vaccination
Secondary	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
Secondary	Serious adverse event after vaccination	Serious adverse event occurring from inclusion until 28 days after vaccination.	28 days after the last dose immunization
Secondary	Comparison adverse events between Investigational Products (Hepatitis B) and Control	Adverse events occuring until 28 days after vaccination	28 days after each dose
Secondary	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