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
Healthy participants 2 to 45 years of age at enrollment,
Participants/Parent(s)/LAR who have voluntarily given informed consent/assent,
Participants/Parent(s)/LAR willing to follow the study procedures and available for the entire duration of the study and agrees to the collection of all biospecimens,
HIV negative,
Has received any hepatitis E vaccine in the past,
Febrile illness (body temperature ≥ 38°C) or acute illness within 3 days prior to the study vaccination,
Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies or medical history deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome),
Major congenital abnormalities which in the opinion of the investigator may affect the participant's participation in the study,
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Treatment groupsSee each treatment group below.
International Vaccine Institute
Lead sponsor
Xiamen Innovax Biotech Co., Ltd
Collaborator
Bill and Melinda Gates Foundation
Collaborator