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COMPLETEDPHASE1

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

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

NCT04188223•PT Bio Farma

View on ClinicalTrials.gov

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

Age

10 - 40 years

Sex

ALL

Healthy Volunteers

Yes

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.
+4 more criteria

Locations (1)

Hasan Sadikin Hospital

Bandung, West Java, Indonesia

Key Dates

Start Date

December 3, 2019

Primary Completion Date

July 16, 2020

Completion Date

July 16, 2020

Last Updated

August 1, 2022

Enrollment

100

ACTUAL participants

Conditions

Hepatitis B

Interventions

Recombinant Hepatitis B (Bio Farma) Vaccine

BIOLOGICAL

Recombinant Hepatitis B (Bio Farma) Vaccine®

BIOLOGICAL

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

View study

RECRUITINGPHASE1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series