Drug intelligence / Profile preview

recombinant hepatitis B vaccine + DTP-HB-Hib vaccine

Development stage
Unknown
Lead developer
Bio Farma
Modality
Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

Recombinant Hepatitis B + DTP-HB-Hib is a combination vaccine regimen developed by PT Bio Farma (Indonesia) for the prevention of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (Hib) infections in infants. The regimen consists of a birth dose of recombinant Hepatitis B vaccine (produced in the yeast Hansenula polymorpha) followed by a three-dose primary series of a pentavalent DTP-HB-Hib vaccine. The pentavalent component, marketed under the brand name Pentabio, contains diphtheria and tetanus toxoids, inactivated whole-cell pertussis bacteria, recombinant Hepatitis B surface antigen (HBsAg), and Hib conjugate. A Phase 3 bridging study (NCT04071379) completed in 2021 demonstrated that a new batch of the DTP-HB-Hib vaccine was immunogenic and well-tolerated in Indonesian infants when used in this priming regimen.

Brand names
Pentabio
Other names
DTP-HB-Hib (Bio Farma)pentavalent vaccine
02

Targets

PRNP (Cellular Prion Protein)HBsAg (Hepatitis B surface antigen)TT (Tetanus toxoid)Diphtheria toxin

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