Hecolin is a recombinant vaccine which contains the hepatitis E virus (HEV)-like particles prepared using a recombinant Escherichia coli expression system.
Hecolin is a recombinant vaccine indicated for the prevention of hepatitis E.
Hecolin during the Clinical Trial is administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Clinical Trial NCT03827395: Safety Study of Hepatitis E Vaccine (HEV239) in Healthy US Adult Population
- This is a Phase I double-blind, randomized, placebo-controlled trial (1:4 ratio of placebo to vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R) (HEV-239) in 25 US males and non-pregnant females ages 18 - 45 (inclusive) to assess the safety, reactogenicity, and immunogenicity of Hecolin (HEV-239).
- Subjects will receive 3 doses of study product on Days 1, 29, and 180. Subjects will remain in the study for up to 13 months (including screening).
- The study duration will be approximately 15 months. Subjects will be observed for 30 minutes after vaccination.
- The occurrence of solicited injection site and systemic reactogenicity events will be measured from the time of study vaccination through Day 8 after each vaccination.
- The primary objectives of the study are to; 1) assess the safety and reactogenicity of HEV-239 following delivery of each vaccine dose; and 2) assess the number of subjects with > / = 4 fold rise in Hepatitis E virus (HEV) immunoglobulin G (IgG) at any time after vaccination.