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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02496897 | Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B | PHASE1 | COMPLETED | 61 | — | — | Jul 1, 2015 | Jun 5, 2018 | May 22, 2025 | 21 | South Korea, United Kingdom |
Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,
Incidence of local injection site reactions occurring up to 7 days after each injection
| Arm | Type | Description |
|---|---|---|
| FP-02.2 Low Dose | EXPERIMENTAL | A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57. |
| FP-02.2 High Dose | EXPERIMENTAL | A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57. |
| FP-02.2 Low Dose with IC31® Adjuvant | EXPERIMENTAL | A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57. |
| FP-02.2 High Dose with IC31® Adjuvant | EXPERIMENTAL | A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered by IM injection on Days 1, 29, and 57. |
| IC31® Adjuvant | EXPERIMENTAL | IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57. |
| Name | Type | Description |
|---|---|---|
| FP-02.2 Vaccine | BIOLOGICAL | Synthetic Peptide Hepatitis B Vaccine |
| Placebo | OTHER | Placebo |
| IC31® Adjuvant | OTHER | IC31® Adjuvant |
Inclusion Criteria: 1. Male and female subjects aged 18-65 years. 2. Diagnosed with chronic hepatitis B defined as HBsAg positive for at least 24 months. 3. Subject has received entecavir or tenofovir for at least 2 years with a stable dose for at least 6 months prior to screening. 4. HBeAg negativ...