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...
The Base Dose EBOV GP Vaccine is an investigational vaccine developed by Novavax, Inc. for protection against Ebola virus. It is designed to present the Ebola virus glycoprotein (GP) to the immune system. The vaccine has been studied in a Phase 1 clinical trial in healthy adult volunteers.
The Base Dose EBOV GP Vaccine is being developed for the prevention of Ebola virus disease. Its only recorded clinical study enrolled healthy adult volunteers in Australia to evaluate immune response and safety against Ebola. It is an investigational product and is not an approved Ebola vaccine.
Novavax, Inc., which trades on the Nasdaq under the ticker NVAX, is the developer of the Base Dose EBOV GP Vaccine. The company sponsored the Phase 1 study of the vaccine in healthy subjects.
The Base Dose EBOV GP Vaccine is in Phase 1 development. Its single recorded trial, NCT02370589, has been completed. The study was randomized, double-blind, and placebo-controlled, and it enrolled 230 healthy volunteers aged 18 years and older in Australia.
The Base Dose EBOV GP Vaccine has been evaluated in one clinical trial, NCT02370589, titled a study to evaluate the immunogenicity and safety of an Ebola virus glycoprotein vaccine in healthy subjects. That Phase 1 trial is completed, enrolled 230 participants in Australia, and was randomized, double-blind, and placebo-controlled.