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

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated April 29, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 860 to 1040
    • Study sites: 0 to 3
    • Start date changed from estimate of Apr 2024 to Apr 4, 2024
    • Secondary endpoints: 13 to 18
    • Study description expanded, about 156 words
    • Study arms: 11 to 17
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06306196
Lead Sponsor International Vaccine Institute
Collaborators: Xiamen Innovax Biotech Co., Ltd, Bill and Melinda Gates Foundation
Conditions
(from sponsor)		 Hepatitis E Virus Infection
Related terms Hepatitis E
Enrollment 1,040 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov