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.

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NEWS HIGHLIGHTS

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

Effects of a nurse-managed program on hepatitis A and B vaccine completion among homeless adults. [2009.01]
BACKGROUND: Hepatitis B virus (HBV) infection constitutes a major health problem for homeless persons... The finding that White homeless persons were the least likely to complete the vaccine series suggests that programs tailored to address their unique cultural issues are needed.

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]
Most African countries do not initiate hepatitis B vaccination at birth. We conducted a non-randomized controlled trial comparing hepatitis B vaccination given at age 0, 6, and 14 weeks versus the current Cote d'Ivoire schedule of 6, 10, and 14 weeks...

CPG 7909 adjuvant plus hepatitis B virus vaccination in HIV-infected adults achieves long-term seroprotection for up to 5 years. [2008.04.15]
BACKGROUND: Human immunodeficiency virus (HIV)-infected persons are hyporesponsive to hepatitis B virus (HBV) vaccination. CPG 7909 is an oligodeoxynucleotide containing immunostimulatory CpG motifs that activate human B and plasmacytoid dendritic cells via Toll-like receptor 9. We previously reported that addition of CPG 7909 to a commercial HBV vaccine enhanced the kinetics, magnitude, and longevity of the seroprotective response over 48 weeks. We now report data for the 5-year period following vaccination... CONCLUSIONS: The immunostimulatory properties of CPG 7909 present an important strategy in achieving long-term protection in HIV-infected patients and other HBV vaccine-hyporesponsive populations.

Long-term antibody persistence induced by a combined hepatitis A and B vaccine in children and adolescents. [2008.03.25]
Two cohorts, comprising of subjects aged 1-6 years and 6-15 years were vaccinated with Twinrix according to a 0-, 1- and 6-month schedule. The 1-6 years cohort was followed up for 7.5 years and the 6-15 years cohort for 10 years... The high persistence of circulating anti-HAV and anti-HBs antibodies in children and adolescents demonstrates the long-term protection offered by Twinrix in these age groups.

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]
A randomised, double-blind study assessing the potential of four adjuvants in combination with recombinant hepatitis B surface antigen has been conducted to evaluate humoral and cell-mediated immune responses in healthy adults after three vaccine doses at months 0, 1 and 10... malaria, HIV infection and tuberculosis, and for special target populations such as subjects with an impaired immune response, due to age or medical conditions.

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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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