DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-65
SponsorNuravax, Inc.
About this trial
This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy males and non-pregnant, non-lactating females, 40-65 years old
BMI between 18.0 and 32.0 kg/m²
Medically healthy with no significant abnormalities in medical history, exam, labs, ECG, or MRI
Signed informed consent
Disqualifiers
Clinically significant medical or psychiatric illness that may affect safety or study results
MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI
Significant lab abnormalities (e.g., liver, kidney, hematology) or positive HIV/HBV/HCV tests
Uncontrolled blood pressure, abnormal heart rate, or prolonged QTc interval
Trial design
Design model
Parallel
Treatments tested in this trial
DUVAX 200 µg
Biological/VaccineIntramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
DUVAX 400 µg
Biological/VaccineIntramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
Placebo (Adjuvant only)
Biological/VaccineIntramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Active - DUVAX 200 µgExperimental treatment 1 intervention
Group B: Active - DUVAX 400 µgExperimental treatment 1 intervention
Group C: Placebo (Adjuvant only)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)
Safety will be assessed by recording the number and type of treatment-emergent adverse events (TEAEs), including adverse events of special interest (AESI), reported from baseline through the follow-up period. Events will be summarized by severity and relationship to study treatment.
Time frame
From baseline (Day 1) through Week 74 (end of study follow-up)Secondary outcomes
1
Serum anti-Aβ antibody titers (IgM, IgG, and IgG subclasses)
Immunogenicity will be assessed by measuring antibody titers against amyloid-beta (Aβ), including total IgM, total IgG, and IgG subclasses (IgG1, IgG2, IgG3, IgG4). Changes from baseline will be compared.
Time frame
Baseline, Weeks 2, 4, 6, 22, 25, and 38Other outcomes
1
Serum anti-Tau antibody titers (IgM, IgG, and IgG subclasses)
Immunogenicity will be assessed by measuring antibody titers against tau protein, including total IgM, total IgG, and IgG subclasses (IgG1, IgG2, IgG3, IgG4). Changes from baseline will be compared.
Time frame
Baseline, Weeks 2, 4, 6, 22, 25, and 382
Serum anti-MultiTEP antibody titers (IgM, IgG, and IgG subclasses)
Immunogenicity will be assessed by measuring antibody titers against MultiTEP carrier epitopes, including total IgM, total IgG, and IgG subclasses (IgG1, IgG2, IgG3, IgG4). Changes from baseline will be compared.
Time frame
Baseline, Weeks 2, 4, 6, 22, 25, and 38Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nuravax, Inc.
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Institute for Molecular Medicine
Collaborator
Source ClinicalTrials.gov