Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals

NCT Number	NCT06306196
Lead Sponsor	International Vaccine Institute Collaborators: Xiamen Innovax Biotech Co., Ltd, Bill and Melinda Gates Foundation
Conditions	Hepatitis E Virus Infection
Enrollment	1,040 participants
Start Date	2024-04-04
Primary Completion	2026-01 (estimated)
Study Completion	2026-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-29