Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06306196 | Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children | PHASE2 | RECRUITING | 1,040 | — | — | Apr 4, 2024 | Jan 1, 2026 | Apr 29, 2025 | 3 | South Africa |
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 within 30 minutes post each dose of vaccination in all study participants
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 within 28 days post each dose of vaccination in all study participants
Proportion of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse events of special interest (AESIs) post dose 1 until 6 months post last dose of vaccination
| Arm | Type | Description |
|---|---|---|
| Group A1 (Three doses of Hecolin®; HIV negative adults aged 18-45 years) | EXPERIMENTAL | Three doses of Hecolin® Recombinant Hepatitis E Vaccine administered at 0, 1 and 6 months to HIV negative participants, age 18-45 years old, 232 participants |
| Group A2 (Three doses of Hecolin®; HIV positive adults aged 18-45 years) | EXPERIMENTAL | Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to HIV positive participants, age 18-45 years old, 178 participants |
| Group B1 (Three doses of Hecolin®; healthy adolescents aged 12-17 years) | EXPERIMENTAL | Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 12-17 years old, 70 participants |
| Group B2 (Two doses of Hecolin®; healthy adolescents aged 12-17 years) | EXPERIMENTAL | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months) and one dose of Placebo, administered at 1-month timepoint, to age 12-17 years old, 70 participants |
| Group B3 (Placebo; healthy adolescents aged 12-17 years) | PLACEBO_COMPARATOR | Three doses of Placebo, administered at 0, 1 and 6 months, to age 12-17 years old, 35 participants |
| Group C1 (Three doses of Hecolin®; healthy children aged 6-11 years) | EXPERIMENTAL | Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 6-11 years old, 70 participants |
| Group C2 (Two doses of Hecolin®; healthy children aged 6-11 years) | EXPERIMENTAL | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0 and 6 months and one dose of Placebo, administered at 1-month timepoint, to age 6-11 years old, 70 participants |
| Group C3 (Placebo; healthy children aged 6-11 years) | PLACEBO_COMPARATOR | Three doses of Placebo, administered at 0, 1 and 6 months, to age 6-11 years old, 35 participants |
| Group D1 (Three doses of Hecolin®; healthy children aged 2-5 years) | EXPERIMENTAL | Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants |
| Group D2 (Two doses of Hecolin®; healthy children aged 2-5 years) | EXPERIMENTAL | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0 and 6 months and of Placebo, administered at 1-month timepoint, to age 2-5 years old, 40 participants |
| Group D3 (Placebo; healthy children aged 2-5 years) | PLACEBO_COMPARATOR | Three doses of Placebo, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants |
| Group B4 (Two doses of Hecolin®; healthy children aged 12-17 years) | EXPERIMENTAL | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 12-17 years old, 50 participants |
| Group B5 (Placebo; healthy children aged 12-17 years) | EXPERIMENTAL | Two doses of Placebo, administered at 0, and 1 month, to age 12-17 years old, 10 participants |
| Group C4 (Two doses of Hecolin®; healthy children aged 6-11 years) | EXPERIMENTAL | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 6-11 years old, 50 participants |
| Group C5 (Placebo; healthy children aged 6-11 years) | EXPERIMENTAL | Two doses of Placebo, administered at 0, and 1 month, to age 6-11 years old, 10 participants |
| Group D4 (Two doses of Hecolin®; healthy children aged 2-5 years) | EXPERIMENTAL | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 2-5 years old, 50 participants |
| Group D5 (Placebo; healthy children aged 2-5 years) | EXPERIMENTAL | Two doses of Placebo, administered at 0, and 1 month, to age 2-5 years old, 10 participants |
| Name | Type | Description |
|---|---|---|
| Hecolin® Recombinant Hepatitis E Vaccine | BIOLOGICAL | 30㎍/dose, 0.5mL administered intramuscularly |
| Isotonic Sodium Chloride injection | BIOLOGICAL | 0.5mL administered intramuscularly |
Inclusion Criteria (healthy participants only): 1. Healthy participants 2 to 45 years of age at enrollment, 2. Participants/Parent(s)/LAR who have voluntarily given informed consent/assent, 3. Participants/Parent(s)/LAR willing to follow the study procedures and available for the entire duration of...