Protectivity and Safety Following Recombinant Hepatitis B Vaccine

NCT03919578 | Completed Phase 2

• 1 other identifier: Hep B 0218
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Geometric Mean Titer (GMT)

  28 days after the last dose immunization

• Percentage of subjects with transition of seronegative to seropositive

  28 days after the last dose immunization

• Percentage of subjects with at least one immediate reaction

  30 minutes after each vaccination

• Percentage of subjects with at least one of these adverse events

  within 72 hours, between 72 hours to 28 days after vaccination

• Serious adverse event after vaccination

  28 days after the last dose immunization

Study Arms (4)

Hep B Batch 1

EXPERIMENTAL

1 dose of 1 mL Hepatitis B Batch 1

Biological: Recombinant Hepatitis B vaccine

Hep B Batch 2

EXPERIMENTAL

1 dose of 1 mL Hepatitis B Batch 2

Biological: Recombinant Hepatitis B vaccine

Hep B Batch 3

EXPERIMENTAL

1 dose of 1 mL Hepatitis B Batch 3

Biological: Recombinant Hepatitis B vaccine

Hep B (Bio Farma)

ACTIVE COMPARATOR

1 dose of 1 mL Hepatitis B (Bio Farma)

Biological: Recombinant Hepatitis B (Bio Farma)

Interventions

Recombinant Hepatitis B vaccine BIOLOGICAL

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.

Hep B Batch 1; Hep B Batch 2; Hep B Batch 3

Recombinant Hepatitis B (Bio Farma) BIOLOGICAL

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.

Hep B (Bio Farma)

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 more than37.5oC) 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.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

RSND

Semarang, Central Java, Indonesia

Location

MeSH Terms

Interventions

Hepatitis B Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yetty M Nency, MD

  Universitas Diponegoro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational product was masking with control
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Experimental, randomized, double blind, four arm parallel group study

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 18, 2019
• Study Start: September 11, 2019
• Primary Completion: January 30, 2020
• Study Completion: February 28, 2020
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)