Twinrix (Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine) - Summary

TWINRIX SUMMARY

TWINRIX® [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] is a sterile bivalent vaccine containing the antigenic components used in producing HAVRIX® (Hepatitis A Vaccine, Inactivated) and ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]. TWINRIX is a sterile suspension of inactivated hepatitis A virus (strain HM175) propagated in MRC₅ cells, and combined with purified surface antigen of the hepatitis B virus. The purified hepatitis B surface antigen (HBsAg) is obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic media containing inorganic salts, amino acids, dextrose, and vitamins. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.

TWINRIX is indicated for active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. As with any vaccine, vaccination with TWINRIX may not protect 100% of recipients. As hepatitis D (caused by the delta virus) does not occur in the absence of HBV infection, it can be expected that hepatitis D will also be prevented by vaccination with TWINRIX.

TWINRIX will not prevent hepatitis caused by other agents such as hepatitis C virus, hepatitis E virus, or other pathogens known to infect the liver.

Immunization is recommended for all susceptible persons 18 years of age or older who are, or will be, at risk of exposure to both hepatitis A and hepatitis B viruses.

TWINRIX NEWS HIGHLIGHTS

Published Studies Related to Twinrix (Hepatitis A Vaccine / Hepatitis B Vaccine)

A non-randomized vaccine effectiveness trial of accelerated infant hepatitis B immunization schedules with a first dose at birth or age 6 weeks in Cote d'Ivoire. [2008.05.23]

CPG 7909 adjuvant plus hepatitis B virus vaccination in HIV-infected adults achieves long-term seroprotection for up to 5 years. [2008.04.15]

Long-term antibody persistence induced by a combined hepatitis A and B vaccine in children and adolescents. [2008.03.25]

Vaccine adjuvant systems containing monophosphoryl lipid A and QS21 induce strong and persistent humoral and T cell responses against hepatitis B surface antigen in healthy adult volunteers. [2008.03.04]

Positive Impact of a Shelter-based Hepatitis B Vaccine Program in Homeless Baltimore Children and Adolescents. [2008.03]

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Clinical Trials Related to Twinrix (Hepatitis A Vaccine / Hepatitis B Vaccine)

Effectiveness of Two Hepatitis B Vaccines in HIV-Negative Youths [Active, not recruiting]

Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients [Completed]

Twinrix Alternative Schedule Study [Active, not recruiting]

Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination [Not yet recruiting]

Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of Combined Hepatitis A & B Vaccine vs Monovalent Hepatitis A & Hepatitis B Vaccines [Active, not recruiting]

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