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Protectivity and Safety Following Recombinant Hepatitis B Vaccine

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ClinicalTrials.gov Identifier: NCT03919578
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma

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

Condition or disease Intervention/treatment Phase
Immunogenicity Biological: Recombinant Hepatitis B vaccine Biological: Recombinant Hepatitis B (Bio Farma) Phase 2 Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental, randomized, double blind, four arm parallel group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigational product was masking with control
Primary Purpose: Prevention
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hep B Batch 1
1 dose of 1 mL Hepatitis B Batch 1
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.

Experimental: Hep B Batch 2
1 dose of 1 mL Hepatitis B Batch 2
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.

Experimental: Hep B Batch 3
1 dose of 1 mL Hepatitis B Batch 3
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.

Active Comparator: Hep B (Bio Farma)
1 dose of 1 mL Hepatitis B (Bio Farma)
Biological: 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.




Primary Outcome Measures :
  1. Percentage of subjects with increasing antibody titer >= 4 times [ Time Frame: 28 days after the last dose immunization ]
    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


Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) [ Time Frame: 28 days ]
    GMT in all subjects; comparison of GMT between investigational products and control and comparison of GMT between each lot number of Recombinant Hepatitis B

  2. Percentage of subjects with transition of seronegative to seropositive [ Time Frame: after dosing ]
    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

  3. Percentage of subjects with at least one immediate reaction [ Time Frame: 30 minutes after each vaccination ]
    Immediate reaction (local reaction or systemic event)

  4. Percentage of subjects with at least one of these adverse events [ Time Frame: within 72 hours, between 72 hours to 28 days after vaccination ]
    At least one of these adverse events, expected or not

  5. Serious adverse event after vaccination [ Time Frame: 28 days ]
    Serious adverse event occurring from inclusion until 28 days after vaccination.

  6. Comparison adverse events between Investigational Products (Hepatitis B) and Control [ Time Frame: 28 days ]
    Adverse events occuring until 28 days after vaccination

  7. Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine [ Time Frame: 28 days ]
    Adverse events occuring until 28 days after vaccination



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919578


Contacts
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Contact: Novilia S Bachtiar, MD +622033755 novilia@biofarma.co.id

Sponsors and Collaborators
PT Bio Farma
Investigators
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Principal Investigator: Yetty M Nency, MD Universitas Diponegoro

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Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT03919578     History of Changes
Other Study ID Numbers: Hep B 0218
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs