Drug intelligence / Profile preview

mpHBV-Hib

Development stage
Unknown
Lead developer
Merck
Modality
Recombinant Proteins and Enzymes, Peptides, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

mpHBV-Hib is an investigational combination vaccine developed by Merck Sharp & Dohme (MSD) for the prevention of invasive disease caused by *Haemophilus influenzae* type b (Hib) and infection caused by the hepatitis B virus (HBV) in infants. The vaccine is a biologic containing 5 μg of hepatitis B surface antigen (HBsAg) and 7.5 μg of Hib capsular polysaccharide conjugated to the Neisseria meningitidis outer membrane protein complex (PRP-OMPC). The "modified process" refers to a manufacturing change in the HBsAg component that incorporates double the standard amount of phosphate to enhance immunogenicity. In Phase 3 clinical trials, the vaccine was evaluated in a three-dose regimen (administered at 2, 4, and 12 months of age) and demonstrated safety and immunogenicity profiles comparable to the licensed combination vaccine COMVAX, achieving 100% seroprotection rates for hepatitis B.

Other names
modified process Hib/Hepatitis B vaccinemodified process Haemophilus influenzae type b/Hepatitis B vaccinemodified process vaccine-Merck Sharp & Dohme LLC-hepatitis B-Haemophilus influenzae type B infection
02

Targets

HBsAg (Hepatitis B surface antigen)

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