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Twinrix (Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine) - 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.
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Published Studies Related to Twinrix (Hepatitis A Vaccine / Hepatitis B Vaccine)

Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens. [2011.04]
BACKGROUND: HIV-infected youth are at risk of hepatitis B infection and should be vaccinated. Previous reports suggest reduced response to standard hepatitis B vaccine regimens... CONCLUSIONS: In HIV-infected youth, a three-dose vaccination regimen with Engerix B, 40 mug, or Twinrix and higher baseline CD4+ T-cell counts were independently associated with improved vaccine response.

Comparative immunogenicity of two vaccination schedules of a combined hepatitis A and B vaccine in healthy volunteers. [2011.04]
In 1996, a combined vaccine against both hepatitis A and B was licensed and commercialized and has been recommended for healthcare personnel in Belgium. This study compares the immunogenicity against hepatitis B virus (HBV) and safety of two vaccination schedules (0-1-12 months and 0-1-6 months) with this vaccine...

Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. [2011.03]
Persistence of immune response was assessed in adults aged >40 years (N = 596) following primary vaccination with combined hepatitis A/B vaccine or concomitant monovalent hepatitis A and B vaccines. Anti-hepatitis A virus antibody responses persisted for at least 4 years regardless of the vaccine used, with anti-hepatitis B surface antibody responses higher and more sustained in subjects who received the combined hepatitis A/B vaccine.

A randomized clinical trial of immunization with combined hepatitis A and B versus hepatitis B alone for hepatitis B seroprotection in hemodialysis patients. [2010.10]
BACKGROUND: The Centers for Disease Control and Prevention recommend immunizing susceptible high-risk groups, such as hemodialysis patients, against hepatitis B virus. However, hemodialysis patients may not develop seroprotective antibodies despite receiving high doses of the vaccine. Recent reports indicate that combined vaccination against hepatitis B and hepatitis A viruses may improve the immunogenicity of hepatitis B vaccine in healthy individuals, but the effectiveness of this strategy in hemodialysis patients is unknown... CONCLUSION: Vaccination of hemodialysis patients with a combined hepatitis A and hepatitis B regimen resulted in a statistically significant and clinically important improvement in seroprotection against hepatitis B virus compared with hepatitis B monovalent vaccine. Copyright (c) 2010 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Comparison of long-term (10 years) immunogenicity of two- and three-dose regimens of a combined hepatitis A and B vaccine in adolescents. [2010.08.23]
300 adolescents aged 12-15 years were randomised (1:1) into two groups to compare the long-term (10 years) immunogenicity profile of two doses of an Adult formulation [Group HAB_2D: 150; 0-6 months] vs... Hence, with respect to long-term antibody persistence, the two-dose schedule of the combined HAB vaccine Adult formulation is an effective alternative to the conventional three-dose schedule of the Paediatric formulation in adolescents.

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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]
This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune response. Since these youths are also potential candidates for future HIV vaccine trials, this study will also include preliminary assessment of youths' understanding of informed consent forms, and willingness to participate in a vaccine trial and return for multiple visits (including blood draws for immunologic assessment).

Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients [Completed]
Does vaccinating hemodialysis patients with Twinrix® (combination vaccine against hepatitis A and hepatitis B) result in a difference in hepatitis B antibody response in comparison to the monovalent hepatitis B vaccine? Hepatitis B infection is an important cause of mortality and morbidity. Current standard vaccination practices have low efficacy levels in patients (eg. hemodialysis patients) who are most susceptible of infection. Efficacy of the two regiments will be studied.

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]
Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.

Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™ [Recruiting]
This study will evaluate the immune response against HAV and HBs (hepatitis B surface) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the persistence of immune response. For subjects detected with decreased immunity, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up time-point.

No new subjects will be recruited during this booster phase of the study.

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Page last updated: 2011-12-09

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