AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65-80
SponsorInstitute for Molecular Medicine
About this trial
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose-escalation study evaluating the safety, tolerability, and immunogenicity of AV-1980R, an investigational vaccine targeting pathological tau, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65 to 80 years with biomarker evidence of preclinical Alzheimer's disease will be enrolled into three ascending-dose cohorts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
AV-1980R 20 µg
Biological/VaccineAV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 20 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.
AV-1980R 60 µg
Biological/VaccineAV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 60 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.
AV-1980R 180 µg
Biological/VaccineAV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 180 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.
Placebo
Other interventionThe placebo consists of 10 mM phosphate buffer without active AV-1980R, formulated with Advax-CpG55.2, consisting of Advax and CpG55.2. It is administered by intramuscular injection at Weeks 0, 4, and 38.
Treatment groups
48 Participants
are divided into 4 treatment groupsGroup A: AV-1980R 20 µg ArmExperimental treatment 1 intervention
Group B: AV-1980R 60 µg ArmExperimental treatment 1 intervention
Group C: AV-1980R 180 µg ArmExperimental treatment 1 intervention
Group D: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events
Number of participants who experience one or more treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs), summarized by severity and relationship to study intervention.
Time frame
Baseline through Week 58Secondary outcomes
1
Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant abnormalities or changes in blood pressure, heart rate, respiratory rate, or body temperature.
Time frame
Baseline through Week 582
Number of Participants with Clinically Significant Changes in ECG Results
Number of participants with new or worsening clinically significant ECG abnormalities.
Time frame
Baseline through Week 583
Number of Participants with Clinically Significant Changes in Laboratory Tests
Number of participants with new or worsening abnormalities in hematology, serum chemistry, coagulation, or urinalysis results.
Time frame
Baseline through Week 584
Number of Participants with Clinically Significant Changes in Physical Examinations
Number of participants with new or worsening abnormal findings on physical examination.
Time frame
Screening through Week 58Other outcomes
1
Change from Baseline in Plasma Alzheimer's Disease Biomarker Concentrations
Change from baseline in plasma concentrations of Aβ42, Aβ40, p-tau217, p-tau181, p-tau231, total tau, neurofilament light chain, and glial fibrillary acidic protein.
Time frame
Baseline through Week 582
Change from Baseline in Serum Immunoglobulin Isotypes and IgG Subclasses
Change from baseline in serum levels of IgM, total IgG, and IgG subclasses IgG1, IgG2, IgG3, and IgG4.
Time frame
Baseline through Week 583
Change from Baseline in Activated T-Cell Subsets
Change from baseline in activated T-cell subsets in peripheral blood mononuclear cells, assessed by flow cytometry.
Time frame
Baseline through Week 584
Change from Baseline in T-Cell Proliferative Response
Change from baseline in the proliferative response of T cells following antigen stimulation, assessed by flow cytometry.
Time frame
Baseline through Week 58Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute for Molecular Medicine
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov