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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02370589 | Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects | PHASE1 | COMPLETED | 230 | — | — | Feb 1, 2015 | Apr 1, 2016 | Nov 24, 2021 | 3 | Australia |
Numbers and percentages (with 95% confidence intervals \[CIs\]) of subjects with solicited local and systemic AEs over the 7 days post-injection; and all AEs, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 84 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year after the second dose.
* Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Day 0: Base Dose EBOV GP Vaccine; IM Day 21: Base Dose EBOV GP Vaccine; IM |
| Group B | EXPERIMENTAL | Day 0: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM |
| Group C | EXPERIMENTAL | Day 0: Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM |
| Group D | EXPERIMENTAL | Day 0: 2x Base Dose EBOV GP Vaccine; IM Day 21: 2x Base Dose EBOV GP Vaccine; IM |
| Group E | EXPERIMENTAL | Day 0: 2x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: 2x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM |
| Group F | EXPERIMENTAL | Day 0: 2x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM |
| Group G | EXPERIMENTAL | Day 0: 4x Base Dose EBOV GP Vaccine; IM Day 21: 4x Base Dose EBOV GP Vaccine; IM |
| Group H | EXPERIMENTAL | Day 0: 4x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: 4x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM |
| Group J | EXPERIMENTAL | Day 0: 4x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM |
| Group K | EXPERIMENTAL | Day 0: 8x Base Dose EBOV GP Vaccine; IM Day 21: 8x Base Dose EBOV GP Vaccine; IM |
| Group L | EXPERIMENTAL | Day 0: 8x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: 8x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM |
| Group M | EXPERIMENTAL | Day 0: 8x Base Dose EBOV GP Vaccine and Matrix-M Adjuvant; IM Day 21: Placebo; IM |
| Group N | PLACEBO_COMPARATOR | Day 0: Placebo; IM Day 21: Placebo; IM |
| Name | Type | Description |
|---|---|---|
| Base Dose EBOV GP Vaccine | BIOLOGICAL | - |
| 2x Base Dose EBOV GP Vaccine | BIOLOGICAL | - |
| 4x Base Dose EBOV GP Vaccine | BIOLOGICAL | - |
| 8x Base Dose EBOV GP Vaccine | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
| Matrix-M Adjuvant | BIOLOGICAL | - |
Inclusion Criteria: 1. Healthy adult male or females, ≥18 years of age, with an upper limitation of \<50 years. 2. Willing and able to give informed consent prior to study enrollment, 3. Able to comply with study requirements, and 4. Women of childbearing potential must have a negative urine pregna...