Immune Response of Adults Vaccinated with a Hepatitis B Vaccine

• Research type

  Research Study

• Full title

  A Study to Estimate the Immune Response Following a Challenge Dose in Adults (= 50 years old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

• IRAS ID

  44372

• Contact name

  Rajiv Sharma

• Sponsor organisation

  Sanofi Pasteur MSD S.N.C

• Eudract number

  2009-016721-33

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  More than a third of the world??s population has been infected with hepatitis B virus, as there are an estimated 350 million chronic hetpatitis surface antigen (HBsAg) carriers globally. This study is designed to describe the immunogenicity (the ability to produce an immune response) of modified process RECOMBIVAX HBTM in older patients. This is an open label, multicenter extension study of V232-059. Up to two hundred and ninety-six (296) eligible subjects are to be enrolled. The extension study will start at least 2 years following the completion of the primary series vaccination of study V232-059. Blood samples for anti-HBs, anti-HBc, HBsAg will be obtained from all subjects at study entry (Day 1) prior to the administration of vaccine. Patients will receive one intramuscular vaccination at Day 1 (Visit 1). Blood samples for anti-HBs will be taken at Month 1 (30 days post-challenge dose of vaccine). The study duration will be approximately 1 month for each subject. Daily measurement of oral temperatures will occur from Day 1 through Day 5 following vaccination and collection of all adverse experiences (including injection-site and systemic) will occur from Day 1 through Day 15 following vaccination.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  10/H0206/17

• Date of REC Opinion

  22 Jun 2010

• REC opinion

  Further Information Favourable Opinion