Trials / Completed
CompletedNCT02738450
Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- AC Immune SA · Industry
- Sex
- All
- Age
- 25 Years – 45 Years
- Healthy volunteers
- Not accepted
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 s.c. injection (12 months) and will be followed up for 12 months after the last dose with a final safety and efficacy assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ACI-24 low dose | ACI-24 administered as a sterile suspension in PBS via s.c. injection. |
| BIOLOGICAL | ACI-24 high dose | ACI-24 administered as a sterile suspension in PBS via s.c. injection. |
| BIOLOGICAL | Placebo | Placebo is a standard PBS sterile solution administrated via s.c. injection. |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2020-06-01
- Completion
- 2020-06-01
- First posted
- 2016-04-14
- Last updated
- 2021-10-15
- Results posted
- 2021-09-21
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02738450. Inclusion in this directory is not an endorsement.