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Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome

NCT02738450 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-10-15

Study results available
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Summary

The purpose of this study is to test in adults with Down Syndrome the safety, tolerability and immunogenicity of a vaccine, ACI-24.

Conditions

  • Down Syndrome

Interventions

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Alzheimer's Disease Cooperative Study (ADCS)

    collaborator OTHER

  • LuMind IDSC Foundation

    collaborator OTHER

  • AC Immune SA

    lead INDUSTRY

Principal Investigators

  • Michael S. Rafii, MD, PhD · USC Keck School of Medicine of the University of Southern California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02738450 on ClinicalTrials.gov