KOR

3rd gen. HBV vaccine

3rd gen. HBV vaccine
(CVI-HBV-001)

Improved HBV vaccine using the 3rd generation antigen L-HBsAg containing preS and S proteins

R&D Goals

Hepatitis B is a serious infectious disease with WHO estimate of 2 billion infectees and 360 million chronic patients. Areas with higher risk of exposure to hepatitis B include Russia, Eastern Europe, India, China, LATAM, Africa and South East Asia.

Unmet Needs in Hepatitis B Vaccination
  • Existing vaccines require ~6 months for protection
  • 5-10% with first dose/ 20-30% protected with 2nd dose
  • Protection rate is high yet not perfect; presence of Non-responders
  • Reduced protection in patients with impaired immune responses
  • Lack of compliance with 3 dose regimen → 2 dose vaccine

CVI has developed two HBV vaccine projects, improved prophylactic HBV vaccine and therapeutic HBV vaccine using adjuvant, which are in clinical development stages. Having entire HBV surface antigen and Alum as adjuvant, CVI-HBV-001 can achieve higher titers of antibody response over the 2nd generation vaccines with only two injections, providing faster and enhanced immune responses.

Features ofCVI-HBV-001

  • Two dose vaccine can be developed

  • Potential target populations are non-responders and high risk groups

  • Rapid protection and higher antibody titers induced

In clinical trial, CVI-HBV-001 has induced rapid sero-protection and higher antibody titers with two immunizations, and also induced sero-protection in non-responder group.