Dynavax Completes Enrollment in Phase II/III Clinical Trial of Hepatitis B Vaccine Candidate

Strategic Insights -

Dynavax Technologies Corp. has completed enrollment and administered the first round of immunizations in a phase II/III clinical trial of its hepatitis B (HBV) prophylactic vaccine candidate containing the company's Immunostimulatory Sequence. The study, being conducted at two study centers in Singapore, began enrollment in June 2004. The double-blind study compares Dynavax's HBV vaccine candidate with GlaxoSmithKline's marketed HBV vaccine, Engerix-B, in 94 subjects. The subjects, ranging between 40-70 years of age, had not previously been immunized against HBV. The study aims to evaluate the comparative protective antibody levels measured after the third injection of the vaccine.

Key Takeaways:

  • The study is a phase II/III clinical trial of Dynavax's hepatitis B vaccine candidate, which is being compared to GlaxoSmithKline's marketed HBV vaccine, Engerix-B, in 94 subjects.
  • The subjects are adults aged 40-70 years who have not been previously immunized against HBV and will receive three injections over a 6-month period.
  • The primary endpoint of the study is to compare protective antibody levels measured after the third injection, while comparative protective antibody levels measured after the first injection are a secondary endpoint.
  • The study is being conducted by Dr. Lim Seng Gee at the National University Hospital and Dr. Chow Wan Cheng at the Singapore General Hospital.
  • Dynavax's previous phase II hepatitis B vaccine trial in young adults demonstrated superior efficacy after both 1 and 2 immunizations as compared to Engerix-B.
  • The company aims to initiate phase III studies to confirm the efficacy of the vaccine on a larger scale, and to test it more broadly in young adults and adolescents.

Statistics:

  • 94 subjects are part of the study.
  • The subjects are aged 40-70 years.
  • The study will consist of three injections over 6 months.
  • The primary endpoint will be measured after the third injection.
  • Dynavax's previous phase II trial demonstrated superior efficacy after both 1 and 2 immunizations as compared to Engerix-B.

Sources:

  • NewsRx.com & NewsRx.net, Sept 27, 2004
  • Hepatitis Weekly via NewsRx.com & NewsRx.net, copyright 2004.