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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03232567 | Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX | PHASE2 | COMPLETED | 60 | — | — | Sep 18, 2017 | Jun 15, 2018 | Apr 30, 2024 | 1 | United States |
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Reactogenicity: counts and percentages of subjects with 'yes' to any reactogenicity event (nasal irritation, sneezing, nasal congestion, sore throat, change in smell, change in taste, change in vision, eye pain, headache, fatigue, muscle ache, nausea, vomiting, diarrhea, chills, fever)
| Arm | Type | Description |
|---|---|---|
| NasoVAX low dose | EXPERIMENTAL | NasoVAX administered by intranasal spray at a single dose of 1×10(9th) viral particles (vp) versus placebo |
| NasoVAX medium dose | EXPERIMENTAL | NasoVAX administered by intranasal spray at a single dose of 1×10(10th) viral particles (vp) versus placebo |
| NasoVAX high dose | EXPERIMENTAL | NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo |
| Placebo | PLACEBO_COMPARATOR | Normal saline administered by intranasal spray at a single dose |
| Name | Type | Description |
|---|---|---|
| NasoVAX | BIOLOGICAL | Single ascending dose study |
Subjects who meet all of the following criteria may be included in the study: 1. Men and women 18 to 49 years of age, inclusive 2. Good general health status as determined by the Investigator 3. Adequate venous access for repeated phlebotomies 4. Screening laboratory results within institutional no...