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

NCT06306196 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2025-04-29

No results posted yet for this study

Summary

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

Conditions

  • Hepatitis E Virus Infection

Interventions

BIOLOGICAL

Hecolin® Recombinant Hepatitis E Vaccine

30㎍/dose, 0.5mL administered intramuscularly

BIOLOGICAL

Isotonic Sodium Chloride injection

0.5mL administered intramuscularly

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Tarun Saluja · International Vaccine Institute

  • Sanet Aspinall · Ardent Consulting (Pty) Ltd

  • Elizabeth Hellström · Be Part Research

  • Maphoshane Nchabeleng · MeCRU Clinical Research Unit

  • Essack Mitha · Newtown Clinical Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306196 on ClinicalTrials.gov