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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44AG091903 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Institute for Molecular Medicine | OTHER |
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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.
This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 trial of DUVAX, an adjuvanted vaccine, in up to 24 healthy participants aged 40-65 years. Two dose levels (200 µg and 400 µg) will be evaluated. Participants will receive three intramuscular doses at Weeks 0, 4, and 22, with safety and immunogenicity monitoring through one year after the last vaccination.
The primary objective is to assess safety and tolerability. The secondary objective is to measure immunogenicity by evaluating antibody responses against amyloid beta (Aβ) and tau proteins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active - DUVAX 200 µg | Experimental | Participants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22. |
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| Active - DUVAX 400 µg | Experimental | Participants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22. |
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| Placebo (Adjuvant only) | Placebo Comparator | Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUVAX 200 µg | Biological | Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (Day 1) through Week 74 (end of study follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Weeks 2, 4, 6, 22, 25, and 38 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Weeks 2, 4, 6, 22, 25, and 38 |
| Serum anti-MultiTEP antibody titers (IgM, IgG, and IgG subclasses) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anahit Ghochikyan, PhD | IMM | Principal Investigator |
| David Cribbs, PhD | Nuravax, Inc. | Principal Investigator |
| Roman Kniazev | Nuravax, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palm Springs Community Health Center | Miami Lakes | Florida | 33014 | United States |
De-identified individual participant data underlying published results (demographics, outcomes, and adverse events) will be shared.
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At the time of primary publication or within 9 months of database lock, whichever occurs first.
Available to qualified researchers upon request and subject to review by the study investigators.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Parallel assignment of participants to DUVAX or placebo within two dose cohorts (200 µg and 400 µg). Each cohort will be randomized 3:1 (DUVAX: placebo), with sentinel participants enrolled first for safety review before the full cohort is enrolled.
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Participants, investigators, study staff, care providers, and outcomes assessors will remain blinded to treatment allocation. The investigational product and placebo are identical in appearance, packaging, and administration. Randomization codes will be maintained by an unblinded pharmacist or designee and will not be disclosed until study unblinding, except in case of medical emergency.
| DUVAX 400 µg | Biological | Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22 |
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| Placebo (Adjuvant only) | Biological | Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22 |
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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. |
| Baseline, Weeks 2, 4, 6, 22, 25, and 38 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |