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NCT02738450 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome
A Phase 1 study of Down Syndrome, sponsored by AC Immune.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 4
- Study locations
NCT02738450: Completed Phase 1 study of Down Syndrome, sponsored by AC Immune.
NCT02738450 is a Phase 1 study of Down Syndrome that has completed, run by AC Immune. The registered enrollment target is 20 participants, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02738450, a Phase 1 study of Down Syndrome, has completed, sponsored by AC Immune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to test in adults with Down Syndrome the safety, tolerability and immunogenicity of a vaccine, ACI-24.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL ACI-24 low dose
- BIOLOGICAL ACI-24 high dose
Study Locations (4)
Arizona
- St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics - Phoenix
California
- UCSD Adult Down Syndrome Program - La Jolla
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-06 |
| Phase | Phase 1 |
What the finished NCT02738450 record still lists
NCT02738450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Down Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02738450 reports a single indexed study location in Arizona, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT02738450 about?
NCT02738450 is a clinical study titled "Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome". The purpose of this study is to test in adults with Down Syndrome the safety, tolerability and immunogenicity of a vaccine, ACI-24.
What is the current status of trial NCT02738450?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2016-03. Estimated completion is 2020-06.
What conditions does trial NCT02738450 study?
This clinical trial studies the following conditions: Down Syndrome.
What interventions are being tested in trial NCT02738450?
The interventions under investigation include: Placebo (BIOLOGICAL), ACI-24 low dose (BIOLOGICAL), ACI-24 high dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT02738450?
This trial is sponsored by AC Immune, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02738450 being conducted?
This trial has 4 study locations across Arizona, California, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Down Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02738450's enrollment target sits among peer trials
20 44th of 54 higher than 9 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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