Ignite Creation Date:
2024-05-06 @ 8:25 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02738450
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2016-04-01
Brief Title:
Safety Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome
Sponsor:
AC Immune SA
Organization:
AC Immune SA
Study Overview
Official Title:
A Phase Ib Multi-Center Double-Blind Randomized Placebo-Controlled Dose Escalation Study of the Safety Tolerability and Immunogenicity of ACI-24 in Adults With Down Syndrome
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3-Star
Brief Summary:
The purpose of this study is to test in adults with Down Syndrome the safety tolerability and immunogenicity of a vaccine ACI-24
Detailed Description:
This is a prospective multi-center placebo controlled double-blind and randomized dose escalation study of 2 doses of ACI-24 versus Placebo over 24 months with a total of 21 visits
All subjects will receive the study medication ACI-24 or Placebo 7 times via sc injection 12 months and will be followed up for 12 months after the last dose with a final safety and efficacy assessment
All subjects will receive the study medication ACI-24 or Placebo 7 times via sc injection 12 months and will be followed up for 12 months after the last dose with a final safety and efficacy assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG047922-01 | NIH | None | httpsreporternihgovquickSearch1R01AG047922-01 |