Hecolin Hepatitis E Vaccine
Hecolin is a recombinant protein-subunit hepatitis E vaccine (HEV239) that contains the hepatitis E virus (HEV)-like particles prepared using a recombinant Escherichia coli expression system. Since 2011, the vaccine has been 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. In 2015, the World Health Organization (WHO) recommended using Hecolin in disease outbreak settings.
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 The duration of follow-up in the available published reports has been up to nearly 2 years; some unpublished data for up to 4 years after completing immunization are available.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.
On January 8, 2025, a phase 3 case-control clinical study conducted during an HEV outbreak in Bentiu (South Sudan) 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 vaccine that is indicated to prevent hepatitis E. In March 2024, the WHO strongly recommended that in specific settings, women of childbearing age, including those who are pregnant, should have access to Hecolin accompanied by relevant information on its benefit-risk profile. However, there is no data on its protection against severe forms of the disease, such as acute liver failure, which is particularly frequent in pregnant women. A study by Wasuwanich et al. in 2021 focused on hepatitis E-related hospitalizations in the United States between 2010 and 2017, noting an increase in hospitalization rates over that period.
Hecolin Hepatitis E Vaccine Dosage
Hecolin is administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180.
Hecolin Stockpile
Since 2015, the World Health Organization has recommended its use in outbreak settings. The WHO’s International Coordinating Group on Vaccine Provision maintains a stockpile of hepatitis E vaccines for emergencies. In the United States, hepatitis E is relatively underexplored, and vaccine development for this disease has not been a priority.
Hecolin Hepatitis E Vaccine News
January 14, 2025 - Iza Ciglenecki, Operational research coordinator at MSF Switzerland, stated, ‘‘Our study then compared the vaccination status of 201 patients testing positive for hepatitis E between May and December 2022 with those in their neighborhood presenting no symptoms. Despite fewer hepatitis E cases than expected after vaccination, our study revealed that two doses of vaccine were effective, an excellent result given the particular context of a camp for displaced people.’’
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 17, 2024 - The Lancet: Volume 12, Issue 11 - Hepatitis E vaccination: continued benefit for pregnant women in vulnerable settings.
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.