Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children

Hepatitis B Clinical Trial

Official title:

Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children (Phase I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188223
• Other study ID #: Hep B 0119
• Status: Completed
• Phase: Phase 1
• Start date: December 3, 2019
• Est. completion date: July 16, 2020

Study information

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

Clinical Trial Summary

This trial is an experimental, randomized, double blind, prospective intervention study

Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow:

For adult (18-40 years old)

Description:

Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 16, 2020
• Est. primary completion date: July 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

Inclusion Criteria:

Adult

1. Healthy individu as determined by clinical judgment, including a medical history, physical exam, rontgen thorax and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.

2. Subjects have been informed properly regarding the study and signed the informed consent form

3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial

Children:

1. Healthy individu as determined by clinical judgment, including a medical history, physical exam and rontgen thorax 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 and

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. Any direct relatives relationship with the study team.

3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.

4. Known history of allergy to any component of the vaccines (based on anamnesis)

5. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)

6. History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.

7. 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).

8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.

9. Pregnancy or planning a pregnancy within the next 3 months & lactation. (for Adults)

10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.

11. HbsAg positive

12. Subjects with known history of Hepatitis B infection.

13. Subjects who have received Hepatitis B vaccination which proven by vaccination records.

14. Subject planning to move from the study area before the end of study period.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Recombinant Hepatitis B (Bio Farma) Vaccine
Recombinant Hepatitis B vaccine produced by Bio Farma
• Recombinant Hepatitis B (Bio Farma) Vaccine®
Registered Recombinant Hepatitis B vaccine produced by Bio Farma

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin Hospital	Bandung	West 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	Number of subjects with Immediate reaction	Number of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination	3 months
Primary	percentage of subjects with Immediate reaction	Percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination	3 months
Secondary	Number of subjects with Adverse Events from 1 day to 28 days after vaccination	Number of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination	3 months
Secondary	Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination	Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination	3 months
Secondary	Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination	Number of subjects with serious adverse event from inclusion until 28 day after each dose vaccination.	3 Months
Secondary	Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination	Percentage of subjects with serious adverse event from inclusion until 28 day after each dose vaccination.	3 Months
Secondary	Number of Lab Deviation for adults subjects in 7 days of immunization	Number of deviation from routine biochemical (SGOT, SGPT, Ureum, Creatinine) and Hematological (Hb, Hct, Dif, Leucocyte count, Total Leucocyte, total Eryhrocyte, total Thrombocyte) laboratory evaluation that probably related to the vaccination (adults subject).	7 Days After 1st Vaccination
Secondary	Safety Comparison between each intervention group	incidence of any adverse event, compared between two intervention arms	3 months
Secondary	Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg)	Number of subjects with anti-HbsAg more than 10mIU/ml, 28 days after 1 dose or three doses of vaccination.	3 months
Secondary	Protectivity of Hepatitis B vaccine (4 times increasing antibody)	- Number and percentage of subjects with more than 4 folds increasing antibody	3 months
Secondary	Protectivity of Hepatitis B vaccine (Geometic Mean Titers)	- Geometric Mean Titers (GMT) following immunization	3 months
Secondary	Anti-HBs description between groups	Number of subjects with protective Anti-HBs value, compared between intervention groups after vaccination.	3 months