Protectivity and Safety Following Recombinant Hepatitis B Vaccine

Immunogenicity Clinical Trial

Official title:

Protectivity and Safety Following Recombinant Hepatitis B Vaccine With Different Source of Hepatitis B Bulk Compared to Hepatitis B (Bio Farma) Vaccine in Indonesian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919578
• Other study ID #: Hep B 0218
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 11, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2022
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population

Description:

Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population.

Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: February 28, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

Inclusion Criteria:

1. 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.

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 more than37.5oC) 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 immunosuppresant.

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Immunogenicity

Intervention

Biological:
• Recombinant Hepatitis B vaccine
Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.
• Recombinant Hepatitis B (Bio Farma)
Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma.

Locations

Country	Name	City	State
Indonesia	RSND	Semarang	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

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; comparison between investigational product and control and between each lot number of Recombinant Hepatitis B	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; Subjets which get investigational products and control and each lot number of Recombinant Hepatitis B	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 vaccine	Adverse events occuring until 28 days after vaccination	28 days after each dose