Clinical trial NCT04188223: Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children
Official title: Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children (Phase I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Keywords: vaccine
hepatitis b
infection
virus
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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) )
Primary purpose: PREVENTION

Brief 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)

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with Immediate reaction
timeFrame: 3 months
measure: percentage of subjects with Immediate reaction
timeFrame: 3 months
Secondary outcomes:
measure: Number of subjects with Adverse Events from 1 day to 28 days after vaccination
timeFrame: 3 months
measure: Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination
timeFrame: 3 months
measure: Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination
timeFrame: 3 Months
measure: Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination
timeFrame: 3 Months
measure: Number of Lab Deviation for adults subjects in 7 days of immunization
timeFrame: 7 Days After 1st Vaccination
measure: Safety Comparison between each intervention group
timeFrame: 3 months
measure: Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg)
timeFrame: 3 months
measure: Protectivity of Hepatitis B vaccine (4 times increasing antibody)
timeFrame: 3 months
measure: Protectivity of Hepatitis B vaccine (Geometic Mean Titers)
timeFrame: 3 months
measure: Anti-HBs description between groups
timeFrame: 3 months
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin Hospital
state: West Java
Study officials:
affiliation: Padjadjaran University
name: Kusnandi Rusmil, Professor
role: PRINCIPAL_INVESTIGATOR
References: