Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Base Dose EBOV GP Vaccine · 1 trial · 1 indication
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...
Base Dose EBOV GP Vaccine is an investigational vaccine being studied for the prevention of Ebola. It is designed to elicit an immune response against the Ebola virus glycoprotein. The vaccine is currently in clinical development and has completed a Phase 1 trial.
Base Dose EBOV GP Vaccine is being developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol NVAX. The company conducted a Phase 1 clinical trial to evaluate the vaccine's immunogenicity and safety in healthy subjects.
Base Dose EBOV GP Vaccine is in Phase 1 clinical development. A Phase 1 trial has been completed, but the vaccine remains investigational and has not been approved for use. Further clinical studies would be needed to establish its safety and efficacy.
Base Dose EBOV GP Vaccine has been studied in one completed Phase 1 trial, identified as NCT02370589. This trial evaluated the immunogenicity and safety of the vaccine in 230 healthy subjects in Australia. The trial was randomized, double-blind, and placebo-controlled.
Base Dose EBOV GP Vaccine is a vaccine targeting the Ebola virus glycoprotein (GP). It is specifically formulated as a base dose for immunization against Ebola. The vaccine is being developed by Novavax and has undergone a Phase 1 clinical trial to assess its immune response and safety profile.