Hecolin Hepatitis E Vaccine
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® was found well tolerated and has been demonstrated to be safe for adults.
The vaccine protects against symptomatic HEV infection with a very high efficacy rate. Data on this protection primarily applies to genotype 4 diseases; data on diseases caused by other genotypes are either too limited (genotype 1) or unavailable (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 The duration of follow-up in the available published reports has been up to nearly 2 years; some unpublished data for up to 4 years after completing immunization are available.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.
As of January 2025, a case-control study during an HEV outbreak in the Bentiu estimated the effectiveness of a two-dose regimen against HEV genotype 1 during a protracted outbreak, supporting its use in similar contexts. These findings indicate moderate to high two-dose vaccine effectiveness using several study designs and analytical methods.
Hecolin® was developed and manufactured by Xiamen Innovax Biotech Co., Ltd. in Xiamen, China.
Hecolin Hepatitis E Vaccine Indication
Hecolin is a recombinant vaccine that is indicated to prevent hepatitis E. There is no data on protection against severe forms of the disease, namely acute liver failure, which is particularly frequent in pregnant women. Hepatitis E virus (HEV) is a leading cause of acute viral hepatitis, particularly in Asia and Africa, where HEV genotypes 1 and 2 are prevalent.
Hecolin Hepatitis E Vaccine Dosage
Hecolin is administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Hecolin Hepatitis E Vaccine News
January 10, 2025 - A study published by The Lancet stated that the results of this study, combined with the existing evidence from clinical trials, suggest that a two-dose regimen of the Hecolin vaccine could be an effective and feasible strategy for controlling hepatitis E outbreaks.
July 26, 2019 - Human HEV includes four genotypes; the nonepidemic, zoonotic genotypes (typically 3 and 4) have gained increasing recognition in North America and Europe over the past decade because of the potential risk of transmission through food, blood transfusions, and organ donation. However, relatively little attention and few resources have been invested into genotypes 1 and 2 (g1/g2), which cause outbreaks among the world’s most vulnerable populations living or access to safe water and sanitation infrastructure.
May 2, 2019—On May 1, the first U.S. participants in the clinical trial of Hecolin were vaccinated. This is the first time the FDA has approved a Chinese vaccine for a clinical trial in the U.S. The trial will be carried out in three phases. Phase 1 is scheduled to enroll 25 U.S. volunteers, and Phases 2 and 3 are FDA-approved vaccine trials expected to be conducted in a third country.
Hecolin Hepatitis E Vaccine Clinical Trial
Clinical Trial NCT03827395: Safety Study of Hepatitis E Vaccine (HEV239) in Healthy U.S. 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 U.S. males and non-pregnant females ages 18 - 45 (inclusive) to assess the safety, reactogenicity, and immunogenicity of Hecolin (HEV-239).
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.