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

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

Timeline

Start

2024-04-04

Primary completion

2026-01

Completion

2026-01

Publications

• Saluja T, Telele N, Hellstrom E, Mitha E, Nchabeleng M, Baiden R, D'Cor NA, Vemula S, Park JY, Yang L, Lee J, Kim DR, Park S, Aspinall S, Pan H, Shih JW, Lynch JA. Hepatitis E virus seroprevalence in South Africa: a multi-site study among HIV-negative and HIV-positive adults and age-stratified children (2-17 Years). BMC Infect Dis. 2026 Jul 7;26(1):1272. doi: 10.1186/s12879-026-13905-3.

Drugs

Indications