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,
Parallel
Hecolin® Recombinant Hepatitis E Vaccine
Biological/Vaccine30㎍/dose, 0.5mL administered intramuscularly
Isotonic Sodium Chloride injection
Biological/Vaccine0.5mL administered intramuscularly
17
Treatment groupsSee each treatment group below.
Seroresponse rate
Seroresponse rate (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years) as compared to healthy adults (18-45 years)
Proportion of immediate adverse events
Proportion of immediate adverse events within 30 minutes post each dose of vaccination in all study participants
Proportion of solicited local and systemic adverse events
Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in all study participants
Proportion of unsolicited adverse events
Proportion of unsolicited adverse events within 28 days post each dose of vaccination in all study participants
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years) as compared to healthy adults (18-45 years)
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) 4 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
SR and GMC of anti-HEV IgG
SR and GMC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months in healthy older children (6-17 years) and healthy adults (18-45 years)
SR and GMC of anti-HEV IgG
SR and GMC of anti-HEV IgG at 4 weeks post first, second and third dose of Hecolin® /Placebo administered at 0, 1 and 6 months in healthy children (12-17 years), (6-11 years), (2-5 years) and adults (18-45 years) collectively and individually as per gender distribution
Safety in all participants as per gender distribution and serostatus
1. Proportion of immediate adverse events within 30 minutes post each dose of vaccination in all study participants. 2. Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in all study participants. 3. Proportion of unsolicited adverse events within 28 days post each dose of vaccination in all study participants. 4. Proportion of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse of special interest (AESI) until 6 months post last dose of vaccination.
Safety profile intra and inter age strata
1. Proportion of immediate adverse events within 30 minutes post each dose of vaccination in all study participants. 2. Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in all study participants. 3. Proportion of unsolicited adverse events within 28 days post each dose of vaccination in all study participants. 4. Proportion of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse events of special interest (AESI) post dose 1 until 6 months post last dose of vaccination.
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International Vaccine Institute
Lead sponsor
Xiamen Innovax Biotech Co., Ltd
Collaborator
Bill and Melinda Gates Foundation
Collaborator
