Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FP-02.2 Vaccine · 1 trial · 1 indication
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...
FP-02.2 Vaccine is an investigational therapeutic vaccine being developed for the treatment of Hepatitis B. It is designed to be used in patients with chronic Hepatitis B, as indicated by the Phase 1 clinical trial that evaluated its safety and immunogenicity in this population.
FP-02.2 Vaccine is being developed by Altimmune, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALT. The company is conducting clinical research to evaluate the vaccine's potential as a treatment for Hepatitis B.
FP-02.2 Vaccine is in Phase 1 clinical development. A Phase 1 trial has been completed to assess its safety and immunogenicity in patients with chronic Hepatitis B. The vaccine is investigational and has not yet been approved by regulatory authorities.
FP-02.2 Vaccine has been studied in one completed Phase 1 clinical trial, registered as NCT02496897. This trial, titled 'Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B,' enrolled 61 participants and was conducted in South Korea and the United Kingdom.
Yes, FP-02.2 Vaccine is the same as FP-02.2. The vaccine is referred to as FP-02.2 in clinical trial documentation, and it is being developed by Altimmune, Inc. for the treatment of Hepatitis B.