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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04415749 | NasoShield in Healthy Adults to Study Safety and Immunogenicity | PHASE1 | COMPLETED | 43 | — | — | Jun 15, 2020 | Mar 15, 2021 | Jun 24, 2025 | 1 | United States |
| NCT03352466 | NasoShield Study of Safety and Immunogenicity | PHASE1 | COMPLETED | 145 | — | — | Jan 18, 2018 | May 13, 2019 | Jun 24, 2025 | 2 | United States |
Subjects will record solicited local and systemic events for 7 days after each dose
All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210
Subjects will record solicited local and systemic events for 14 days after each dose
All adverse events from Day 1 to Day 57, SAEs, medically attended AEs and new onset chronic illnesses Day 1 to Day 361
| Arm | Type | Description |
|---|---|---|
| NasoShield One Dose in Position 1 | EXPERIMENTAL | NasoShield (1 x 10\^11 vp) on Day 1 and saline placebo on Day 29 in position 1 (Group 1) in normal sitting position (no dose holding time) |
| Placebo in Position 1 | PLACEBO_COMPARATOR | Saline placebo on Day 1 and saline placebo on Day 29 in position 1 (Group 1) |
| NasoShield Two Doses in Position 2 | EXPERIMENTAL | NasoShield (1 x 10\^11 vp) on Day 1 and Day 29 in position 2 (Group 2) in sitting position with nostrils elevated above head for 3 minutes followed by sitting for 27 minutes |
| Placebo in Position 2 | PLACEBO_COMPARATOR | Saline placebo on Day 1 and Day 29 in position 2 (Group 2) |
| NasoShield Two Doses in Position 3 | EXPERIMENTAL | NasoShield (1 x 10\^11 vp) on Day 1 and Day 29 in position 3 (Group 3) in supine position for 30 minutes |
| Placebo in Position 3 | PLACEBO_COMPARATOR | Saline placebo on Day 1 and Day 29 in position 3 (Group 3) |
| NasoShield very low dose - 1 X 10^8 vp | EXPERIMENTAL | Single intranasal spray (Part A) |
| NasoShield low dose - 1 X 10^9 vp | EXPERIMENTAL | Single intranasal spray (Part A) |
| NasoShield medium dose - 1 X 10^10 vp | EXPERIMENTAL | Single intranasal spray (Part A) |
| NasoShield high dose - Part A -1 X 10^11 vp | EXPERIMENTAL | Single intranasal spray (Part A) |
| NasoShield high dose - Part B - 1 X 10^11 vp | EXPERIMENTAL | 2 intranasal sprays 21 days apart (Part B) |
| Placebo | PLACEBO_COMPARATOR | Normal saline, single intranasal spray (Part A) or two intranasal sprays 21 days apart (Part B) |
| BioThrax | ACTIVE_COMPARATOR | Three intramuscular injections 15 days apart (Part A) |
| Name | Type | Description |
|---|---|---|
| NasoShield | BIOLOGICAL | NasoShield is an adenovirus-vectored anthrax vaccine |
| Placebo | OTHER | Normal saline |
| BioThrax | BIOLOGICAL | Commercially available anthrax vaccine |
Inclusion Criteria: 1. Men and women 18 to 49 years of age, inclusive 2. Good general health status 3. Adequate venous access for repeated phlebotomies 4. Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Cre...