Hecolin Hepatitis E Vaccine Description
Hecolin is a recombinant vaccine that contains the hepatitis E virus (HEV)-like particles prepared using a recombinant Escherichia coli expression system.
The vaccine is approved for use in China in people aged 16 and above and is recommended for individuals at high risk of HEV infection. Hecolin® is well tolerated and has been demonstrated to be safe for use in adults.
Hecolin® has been developed and is manufactured by Xiamen Innovax Biotech Co., Ltd. in Xiamen, China.
Hecolin Hepatitis E Vaccine Indication
Hecolin is a recombinant vaccine indicated for the prevention of hepatitis E.
The main adverse events associated with its use have been local reactions at the injection site. Current evidence demonstrates that this vaccine is highly immunogenic, with nearly all the recipients seroconverting after three doses administered in a 0, 1, and 6-month schedule. Limited data show that even two doses (at 0 and 6 months, or 0 and 1 month) lead to a high rate of seroconversion through the antibody titers are lower.
The vaccine protects against symptomatic HEV infection, with a very high efficacy rate. Data on this protection are primarily applicable to genotype 4 diseases; data on diseases caused by other genotypes are either too limited (genotype 1) or are not available (genotype 2 and 3). The vaccine can effectively lower, but not eliminate, the risk of asymptomatic infection. The duration of follow-up in the available published reports has been for up to nearly 2 years; some unpublished data for up to 4 years after completing immunization are available. Long-term efficacy beyond this time point, duration of protection, and the need and timing for booster dose remain to be determined.
Also, there are no data on protection against severe forms of the disease, namely acute liver failure, which is particularly frequent in pregnant women.
Hecolin Hepatitis E Vaccine Dosage
Hecolin during the Clinical Trial is administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Hecolin Hepatitis E Vaccine Clinical Trial
Clinical Trial NCT03827395: Safety Study of Hepatitis E Vaccine (HEV239) in Healthy US Adult Population. Last Update Posted: October 26, 2020.
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.