Condition: Hepatitis E Virus Infection · Sponsor: International Vaccine Institute
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
This description comes directly from the study's public registry record.
Tarun Saluja · +82-10-9736-2810 · tarun.saluja@ivi.int
Sanet Aspinall · +27 21 569 0611 · sanet.aspinall@ardent.consulting
Always discuss trial participation with your own doctor first.
| MeCRU Clinical Research Unit | Ga-Rankuwa, South Africa | Recruiting |
| Newtown Clinical Research Centre | Johannesburg, South Africa | Recruiting |
| Be Part Research | Paarl, South Africa | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06306196