Hecolin

Hecolin is a recombinant hepatitis E vaccine (HEV-239) designed to prevent hepatitis E caused by infection with hepatitis E virus (HEV). The vaccine contains virus-like particles formed from a truncated HEV capsid protein (ORF2, amino acids 368–606) expressed in Escherichia coli. This VLP-based formulation elicits an antibody response intended to neutralize HEV.

Dosing and efficacy: Hecolin is given as a three-dose series at 0, 1, and 6 months. In large randomized trials conducted primarily in China, the vaccine demonstrated high efficacy against symptomatic hepatitis E due to genotype 1 after completing the three-dose schedule, with protection persisting for several years in follow-up. The vaccine was generally well tolerated, with adverse events similar to placebo; the most common reactions were injection-site pain and mild systemic symptoms such as fever or fatigue.

Regulatory status and use: Hecolin was approved for use in China for adults aged 16 years and older. Outside China, regulatory approvals are limited, and there have been smaller studies and outbreak-use assessments in other populations. The vaccine is not part of routine national immunization programs in most countries.