Down SyndromePhase 13-StarNCT02738450

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

A Phase 1 study testing ACI-24 low dose and ACI-24 high dose in people with Down Syndrome, run by AC Immune SA at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 25 to 45 years
Conditions the study is for: Down Syndrome
What is being tested?: ACI-24 low dose and ACI-24 high dose
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 4 sitesUnited States
Study dates: Mar 2016to Jun 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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 understand and to provide written informed consent.
Written informed consent obtained from subjects and their study partner/legal representative before any trial-related activities.
In the opinion of the investigator able to fully participate in the trial and sufficiently proficient in English to be capable of reliably completing study assessments.
Subjects have a study partner/legal representative who have direct contact with the subjects at least 10 hours per week and who can be asked questions about the subjects.

Who cannot join

Subjects weighing less than 40 kg.
IQ less than 40 (as assessed by Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
In the investigators opinion, any clinically significant current psychiatric or neurologic illness, including a past illness with a risk of recurrence, other than Down syndrome.
Any medical condition likely to significantly hamper the evaluation of safety of the study drug.
DSM-IV criteria for drug or alcohol abuse or dependence currently met within the past five years.
History or presence of uncontrolled seizures. If history of seizures, they must be well controlled with no occurrence of seizures in the past 2 years prior to study screening. The use of anti-epileptic medications is permitted.

Show all 33Show fewer

History of meningitis or meningoencephalitis.
History of malignant neoplasms within 3 years prior to study screening or where there is current evidence of recurrent or metastatic disease.
History of persistent cognitive deficits immediately following head trauma.
History of inflammatory neurology disorders.
History of autoimmune disease with potential for CNS involvement.
MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or evidence of a prior macrohemorrhage, or showing more than four cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite").
MRI examination cannot be done for any reason, including metal implants contraindicated for MRI studies and/or severe claustrophobia.
Significant hearing or visual impairment or other issues judged relevant by the investigator preventing to comply with the protocol and to perform the outcome measures.
Severe infections or a major surgical operation within 3 months prior to screening.
History of chronic or recurrent infections judged to be clinically significant by the investigator.
History or presence of immunological or inflammatory conditions which are judged to be clinically significant by the investigator.
Celiac disease not on a gluten free diet for at least 3 months prior to study screening.
Chronic benign skin pathologies, unless viewed as clinically insignificant in the investigator's opinion.
Any vaccine received within the past 2 months before baseline, except influenza vaccine which if indicated must be given at least 2 weeks prior to baseline.
Clinically significant arrhythmias or other abnormalities on ECG at screening. (Minor abnormalities documented as clinically insignificant by the investigator will be allowed.)
Clinically significant abnormal vital signs including sustained sitting blood pressure greater than 160/90 mmHg.
In the opinion of the site investigator, deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, that are judged to be clinically significant.
Subjects with treated hypothyroidism not on a stable dose of medication for at least 3 months prior to screening and having clinically significant abnormal serum T-4 and TSH at screening.
Subjects with diabetes mellitus with an HbA1c of ≥ 8.0%.
Subjects who have been receiving any experimental drug for Down Syndrome with a washout less than 30 days or less than five halflives of the drug, whichever is longer.
Female subjects being pregnant as confirmed by serum testing at screening or planning to be pregnant or lactating.
Female subjects not using a reliable method of contraception (unless abstaining).
Patient receiving any anticoagulant drug, or aspirin at doses greater than 100 mg daily in the 7 days prior to lumbar puncture (in order to avoid risk of bleeding during scheduled or unscheduled lumbar puncture)
Use of antidepressants other than SSRI/SNRIs at stable dose, antipsychotics (typical or atypical), GABA agonists (e.g. gabapentin), or stimulants (e.g. methylphenidate, modafinil). In exceptional cases, low doses of atypical antipsychotics (e.g. risperidone up to 0.5 mg/day or quetiapine up to 50 mg/day) or benzodiazepines are only allowed after review by the site principal investigator, in consultation with the project director and/or medical monitors.
Current use of immunosuppressant or immunomodulating drugs or their use within the past 6 months prior to study screening. Current use of steroids or their use within the past 3 months prior to study screening.
Use of Cholinesterase Inhibitor or use of Glutamatergic drugs (Topiramate, Memantine, Lamotrigine) if not on stable dose for at least 3 months prior to screening.
Subjects who have donated blood or blood products during the 30 days prior to screening who plan to donate blood while participating in the study or within four weeks after completion of the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Johns Hopkins University
Baltimore, Maryland, 21224
Massachusetts General Hospital
Boston, Massachusetts, 02114
UCSD Adult Down Syndrome Program
La Jolla, California, 92037-1712
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, 85013

Other trials in United States

About this study

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

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

Read the 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: Down Syndrome
Being tested: ACI-24 low dose, ACI-24 high dose, Placebo
Keywords: cognitive decline
Medical subject headings: Down Syndrome, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACI-24 low doseBiological
ACI-24 administered as a sterile suspension in PBS via s.c. injection.
ACI-24 high doseBiological
ACI-24 administered as a sterile suspension in PBS via s.c. injection.
PlaceboBiological
Also called PBS
Placebo is a standard PBS sterile solution administrated via s.c. injection.

Study groups in NCT02738450
Study group	Role	What they receive
ACI-24 low dose	Active comparator	Vaccine formulation will be administrated s.c. 7 times. Receives: Biological: ACI-24 low dose
ACI-24 high dose	Active comparator	Vaccine formulation will be administrated s.c. 7 times. Receives: Biological: ACI-24 high dose
Placebo	Placebo comparator	The placebo is ready-to-use solution for injection, administrated s.c. 7 times. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Antibody Titer (Serum Anti-Aβ1-42 Free IgG) - Mean Absolute Value
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.
Measured: Values at baseline (week 0) and week 50 are reported

Secondary outcomes (9)

Amyloid Beta 1-40 in Blood - Mean Absolute Value
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.
Measured: Values at baseline (week 0) and week 50 are reported
CANTAB - MOT Latency Score
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.
Cambridge Neuropsychological Test Automated Battery (CANTAB), Motor Screening Task (MOT) is a cognitive scale to be completed by the subject.
Range score from 0 to ∞, lower score means a better outcome
Measured: Values at baseline (week 0) and week 50 are reported
CANTAB - PAL First Attempt Memory Score
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.
Cambridge Neuropsychological Test Automated Battery (CANTAB), Paired Associate Learning (PAL) is a cognitive scale to be completed by the subject.
Range score from 0 to 20, higher score means a better outcome
Measured: Values at baseline (week 0) and week 50 are reported
Brief Praxis Test (BPT) - Total Score
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.
Brief Praxis Test (BPT) is a cognitive scale to be completed by the subject.
Range score from 0 to 80, higher score means better outcome
Measured: Values at baseline (week 0) and week 50 are reported
Vineland II - Communication Domain Standard Score
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.
Vineland II is a behavioral questionnaire to be completed by the study partner of the subject.
Range score from 0 to 113, higher score means a better outcome
Measured: Values at baseline (week 0) and week 50 are reported
Vineland II - Daily Living Skill - Domain Standard Score
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.
Vineland II is a behavioral questionnaire to be completed by the study partner of the subject.
Range score from 0 to 114, higher score means a better outcome
Measured: Values at baseline (week 0) and week 50 are reported
Vineland II - Socialisation - Domain Standard Score
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.
Vineland II is a behavioral questionnaire to be completed by the study partner of the subject.
Range score from 0 to 115, higher score means a better outcome
Measured: Values at baseline (week 0) and week 50 are reported
NPI - Total Score
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.
Neuropsychiatric Inventory (NPI) is a behavioral questionnaire to be completed by the study partner of the subject.
Range score from 0 to 144, higher score means a worse outcome
Measured: Values at baseline (week 0) and week 50 are reported.
Clinical Global Impression of Change (CGIC) - Change From Baseline at Week 50
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.
Clinical Global Impression of Change (CGIC) is a global assessment to be completed by the investigator.
Measured: Values at baseline (week 0) and week 50 are reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jun 2020

First posted14 Apr 2016 (estimated)
Study startMar 2016
Primary completionJun 2020
Study completionJun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Down SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02738450
Sponsor's protocol ID: ACI-24-1301
Other IDs: 1R01AG047922-01
Acronym: 3-Star
Status last verified: Sep 2021
First submitted: 1 Apr 2016
Last updated: 15 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Access to de-identified, individual and trial -level data (analysis datasets), and other information (e.g., protocols) will be provided.

Publications

Rafii MS, Sol O, Mobley WC, Delpretti S, Skotko BG, Burke AD, Sabbagh MN, Yuan SH, Rissman RA, Pulsifer M, Evans C, Evans AC, Beth G, Fournier N, Gray JA, Dos Santos AM, Hliva V, Vukicevic M, Kosco-Vilbois M, Streffer J, Pfeifer A, Feldman HH. Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome: A Phase 1b Randomized Clinical Trial. JAMA Neurol. 2022 Jun 1;79(6):565-574. doi: 10.1001/jamaneurol.2022.0983.
PubMed 35532913

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02738450
Acronym / sponsor ID: 3-Star / ACI-24-1301
Conditions: Down Syndrome
Keywords: cognitive decline
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: AC Immune SAIndustry (pharma, biotech, devices)
Collaborators: National Institute on Aging (NIA), Alzheimer's Disease Cooperative Study (ADCS), LuMind IDSC Foundation
Study start: Mar 2016 (actual)
Primary completion: Jun 2020 (actual)
Study completion: Jun 2020 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Posted 21 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ACI-24 low dose	Active comparator	Biological: ACI-24 low doseVaccine formulation will be administrated s.c. 7 times.
ACI-24 high dose	Active comparator	Biological: ACI-24 high doseVaccine formulation will be administrated s.c. 7 times.
Placebo	Placebo comparator	Biological: PlaceboThe placebo is ready-to-use solution for injection, administrated s.c. 7 times.

Who may qualify

Ages: 25 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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 understand and to provide written informed consent.
Written informed consent obtained from subjects and their study partner/legal representative before any trial-related activities.
In the opinion of the investigator able to fully participate in the trial and sufficiently proficient in English to be capable of reliably completing study assessments.
Subjects have a study partner/legal representative who have direct contact with the subjects at least 10 hours per week and who can be asked questions about the subjects.

Key exclusion criteria (33 listed)

Subjects weighing less than 40 kg.
IQ less than 40 (as assessed by Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
In the investigators opinion, any clinically significant current psychiatric or neurologic illness, including a past illness with a risk of recurrence, other than Down syndrome.
Any medical condition likely to significantly hamper the evaluation of safety of the study drug.
DSM-IV criteria for drug or alcohol abuse or dependence currently met within the past five years.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACI-24 low doseACI-24 administered as a sterile suspension in PBS via s.c. injection.	Biological	ACI-24 low dose
ACI-24 high doseACI-24 administered as a sterile suspension in PBS via s.c. injection.	Biological	ACI-24 high dose
PlaceboAlso: PBSPlacebo is a standard PBS sterile solution administrated via s.c. injection.	Biological	Placebo

Primary outcome

Antibody Titer (Serum Anti-Aβ1-42 Free IgG) - Mean Absolute Value
Time frame: Values at baseline (week 0) and week 50 are reported
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.

9 secondary outcomes

Amyloid Beta 1-40 in Blood - Mean Absolute Value
Time frame: Values at baseline (week 0) and week 50 are reported
CANTAB - MOT Latency Score
Time frame: Values at baseline (week 0) and week 50 are reported
CANTAB - PAL First Attempt Memory Score
Time frame: Values at baseline (week 0) and week 50 are reported
Brief Praxis Test (BPT) - Total Score
Time frame: Values at baseline (week 0) and week 50 are reported
Vineland II - Communication Domain Standard Score
Time frame: Values at baseline (week 0) and week 50 are reported
Vineland II - Daily Living Skill - Domain Standard Score
Time frame: Values at baseline (week 0) and week 50 are reported
Vineland II - Socialisation - Domain Standard Score
Time frame: Values at baseline (week 0) and week 50 are reported
NPI - Total Score
Time frame: Values at baseline (week 0) and week 50 are reported.
Clinical Global Impression of Change (CGIC) - Change From Baseline at Week 50
Time frame: Values at baseline (week 0) and week 50 are reported

Results and safety

Results posted to the registry on 21 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACI-24 300µg	6	6
ACI-24 1000µg	6	4
Placebo	4	4

Primary outcome: Antibody Titer (Serum Anti-Aβ1-42 Free IgG) - Mean Absolute Value

Time frame: Values at baseline (week 0) and week 50 are reported. Mean (Standard Deviation). Unit: AU/mL (AU: Arbitrary Unit)

Measure	ACI-24 300µg n = 6	ACI-24 1000µg n = 6	Placebo n = 4
Week 0	632.3 (570.9)	335.4 (157.4)	162.8 (84.5)
Week 50	751.5 (825.6)	434.3 (224.3)	153.3 (140.7)

Population analysed: Modified Intent to Treat Population (mITT)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACI-24 300µg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
ACI-24 1000µg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Placebo Cohort 1	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Placebo Cohort 2	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Limitations and caveats (from the sponsor): The study included a limited number of subjects, and, as a consequence, was not powered on cognition and clinical efficacy outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35532913Rafii MS, Sol O, Mobley WC, Delpretti S, Skotko BG, Burke AD, Sabbagh MN, Yuan SH, Rissman RA, Pulsifer M, Evans C, Evans AC, Beth G, Fournier N, Gray JA, Dos Santos AM, Hliva V, Vukicevic M, Kosco-Vilbois M, Streffer J, Pfeifer A, Feldman HH. Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome: A Phase 1b Randomized Clinical Trial. JAMA Neurol. 2022 Jun 1;79(6):565-574. doi: 10.1001/jamaneurol.2022.0983.
Individual participant dataSharing planned: Yes. Access to de-identified, individual and trial -level data (analysis datasets), and other information (e.g., protocols) will be provided.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael S. Rafii, MD, PhD study director

USC Keck School of Medicine of the University of Southern California, San Diego

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACI-24 low dose and ACI-24 high dose in people with Down Syndrome, run by AC Immune SA at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody Titer (Serum Anti-Aβ1-42 Free IgG) - Mean Absolute Value (time frame: Values at baseline (week 0) and week 50 are reported). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738450, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.