Hepatitis E Virus Infection Clinical Trial
Official title:
A Phase 2b, Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adult Participants Followed by a Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin® in Children
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
The primary objective of the study is to demonstrate immune non-inferiority of 30 µg Hecolin® when given to healthy children (2-17 years) as compared to healthy adults (18-45 years) as measured by seroresponse rates (SR) of anti- HEV IgG ELISA antibody titers, 4 weeks after the 3 doses given at 0, 1- & 6-months. Co-primary objective is to assess safety in each age cohort and descriptively compare lower age cohorts with higher age cohorts. Other immune parameters would be assessed as secondary objectives. Healthy children and adolescents collectively (2-17 years) will be compared for immune non-inferiority with healthy adults (18-45 years) as measured by geometric mean concentration (GMC) of anti-HEV IgG ELISA antibody titers, 4 weeks after the 3 doses given at 0, 1- & 6-months. Among children (2-17 years) 3 doses of Hecolin® given at 0, 1 and 6 months will be compared with 2 doses of Hecolin® given at 1 and 6 months in terms of immune non-inferiority of SR and GMC of anti-HEV IgG ELISA antibody titers. The immune response will be compared between HIV positive and HIV negative adults in terms of SR and GMC as measured by anti-HEV IgG ELISA antibody titers at 4 weeks after completing 3 doses of Hecolin® (0, 1 and 6 months). A total of 860 participants will be enrolled in the study and will be divided into 4 age strata; 18-45 years (Cohort A), 12-17 years (Cohort B), 6-11 years (Cohort C) and 2-5 years (Cohort D) having 410, 175, 175 and 100 participants respectively. Cohort A will be further divided into Arm A1 and A2 having 232 HIV -ve and 178 HIV +ve participants respectively. All participants in cohort A will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Cohort B will be further divided into Arm B1, B2 and B3 having 70, 70 and 35 participants respectively. Arm B1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm B2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm B3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0, 1 and 6 months. Similarly, Cohort C will be further divided into Arm C1, C2 and C3 having 70, 70 and 35 participants respectively. Arm C1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm C2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm C3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0, 1 and 6 months. Cohort D will be further divided into Arm D1, D2 and D3 having 40, 40 and 20 participants respectively. Arm D1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm D2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm D3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0,1 and 6 months. A total of 6 blood samples for immunogenicity will be collected from all participants at Day 0 (baseline), one month after first vaccination, one month after second vaccination, 6 months after first vaccination, one month after third vaccination, and at 6 months after third vaccination. Blood samples will be collected at screening and one month after third vaccination from the HIV + arm to document CD4 T cells and HIV Viral load. All participants will be observed at the study site for 30 minutes after each Investigational Product (IP) injection for any reactogenicity events. Local and systemic solicited adverse events will be recorded in a diary card during 7 days after each IP dose while unsolicited adverse events will be recorded during the 4 weeks after each IP injection. Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse of special interest (AESI) will be recorded during the entire study period i.e., until 6 months post last dose. ;
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