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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02738450 | Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome | PHASE1 | COMPLETED | 20 | — | — | Mar 1, 2016 | Jun 1, 2020 | Oct 15, 2021 | 4 | United States |
All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. The measure is expressed in Arbitrary Units per mL (AU/mL). AU/mL in a sample is obtained by back-calculation towards the standard curve.
| Arm | Type | Description |
|---|---|---|
| ACI-24 low dose | ACTIVE_COMPARATOR | Vaccine formulation will be administrated s.c. 7 times. |
| ACI-24 high dose | ACTIVE_COMPARATOR | Vaccine formulation will be administrated s.c. 7 times. |
| Placebo | PLACEBO_COMPARATOR | The placebo is ready-to-use solution for injection, administrated s.c. 7 times. |
| Name | Type | Description |
|---|---|---|
| ACI-24 low dose | BIOLOGICAL | ACI-24 administered as a sterile suspension in PBS via s.c. injection. |
| ACI-24 high dose | BIOLOGICAL | ACI-24 administered as a sterile suspension in PBS via s.c. injection. |
| Placebo | BIOLOGICAL | Placebo is a standard PBS sterile solution administrated via s.c. injection. |
Inclusion Criteria: * Males or females with Down Syndrome aged ≥25 to ≤45 years, with a cytogenetic diagnosis being either Trisomy 21 or Complete Unbalanced Translocation of the Chromosome 21. * Subjects and their study partner/legal representative in the opinion of the investigator able to underst...