Drugs / Hecolin®

Trials 8 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02603055 Jul 2015 → Apr 2016 hepatitis E virus infection Jiangsu Province Centers for Disease Control and Prevention Completed No outcome recorded
Phase 22 trials
Phase 2 NCT05808166 May 2024 → Nov 2025 overdue hepatitis E virus infection International Vaccine Institute Recruiting No outcome recorded
Phase 2 NCT06306196 Apr 2024 → Jan 2026 overdue hepatitis E virus infection International Vaccine Institute Recruiting No outcome recorded
Phase 45 trials
Phase 4 NCT05415345 Oct 2021 → Nov 2022 hepatitis E virus infection, human papilloma virus infection Xiamen Innovax Biotech Co., Ltd Unknown No outcome recorded
Phase 4 NCT03365921 Oct 2018 → Jun 2019 hepatitis E virus infection Xiamen Innovax Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT02964910 Aug 2016 → Aug 2017 hepatitis E virus infection Xiamen Innovax Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT02584543 Oct 2015 → Aug 2016 hepatitis B virus infection, hepatitis E virus infection Xiamen Innovax Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT02417597 Apr 2015 → May 2016 hepatitis E virus infection Xiamen Innovax Biotech Co., Ltd Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT06564116 Comparator Mar 2023 → Mar 2024 hepatitis E virus infection Xiamen Innovax Biotech Co., Ltd Completed No outcome recorded
Phase 4 NCT02759991 Comparator Oct 2017 → Sep 2019 hepatitis E virus infection Norwegian Institute of Public Health Completed No outcome recorded
Phase 4 NCT03168412 Comparator May 2017 → Jul 2018 hepatitis E virus infection Xiamen Innovax Biotech Co., Ltd Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as Hecolin “The first recombinant hepatitis E vaccine (Escherichia Coli), Hecolin® (Xiamen Innovax, China), was approved for people aged ≥16 years.” PMID 40690851 Jul 2025
5

“An Randomized, Double-blinded Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® to Evaluate Lot-to-lot Consistency” NCT03365921

NCT02759991

NCT05808166

NCT06306196

NCT05415345

Known as Hepatitis E vaccine “The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6;” NCT02584543
1

NCT02603055

Known as HEV vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT02584543
Known as HEV239 “Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind,...” PMID 20728932 Aug 2010
1

HEV239 (Hecolin®), a recombinant vaccine containing the immunodominant protruding (E2) domain of the HEV capsid protein” PMID 40733519 Jun 2025

Known as p239 “This is consistent with the fact that p239 was demonstrated to be an effective prophylactic vaccine (recently licensed as Hecolin(®) in China) against HEV-induced hepatitis in...” PMID 24662711 Mar 2014
Known as Recombinant Hepatitis E Vaccine (Escherichia Coli) “A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)” NCT02584543
5

“An Randomized, Double-blinded Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® to Evaluate Lot-to-lot Consistency” NCT03365921

NCT06564116

NCT02964910

NCT03168412

NCT02417597

Modality Vaccine “The hepatitis E vaccine, Hecolin®, has been shown to be safe and highly efficacious among healthy adults aged 16-65 years old.” PMID 31262585 Jun 2019
Route Intramuscular “Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.” NCT02417597