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| Name | Class |
|---|---|
| Arvax | UNKNOWN |
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This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted AV-1959R vaccine in healthy adults aged 40-60. Participants will receive three intramuscular injections of either adjuvanted AV-1959R (100 µg or 300 µg) or adjuvanted placebo at Weeks 0, 4, and 14, followed by an 8-week follow-up. Researchers will monitor for side effects and measure anti-Aβ antibody levels to assess immune response. This study will help determine if AV-1959R is safe and effective in generating a targeted immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1 | Experimental | Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection |
|
| Arm 2: Placebo (Adjuvant Only) - Cohort 1 | Experimental | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection |
|
| Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2 | Experimental | Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection |
|
| Arm 4: Placebo (Adjuvant Only) - Cohort 2 | Experimental | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV-1959R (Abeta vaccine) | Biological | AV-1959R is an investigational adjuvanted vaccine designed to induce a targeted immune response against beta-amyloid (Aβ) to support the primary prevention of Alzheimer's disease and the treatment of asymptomatic preclinical Alzheimer's disease. It is administered intramuscularly (IM) at doses of 100 µg or 300 µg on Weeks 0, 4, and 14, in combination with the adjuvant. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of AV-1959R Compared to Placebo | Safety will be assessed by the incidence of AEs and SAEs after intramuscular administration of AV-1959R (100 mcg and 300 mcg) or placebo through Week 26. Injection site reactions, clinical laboratory results, vital signs, physical examinations, and MRI will also be monitored through Week 26. | Up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of AV-1959R: Anti-Aβ Antibody Response | Immunogenicity will be assessed by quantifying anti-Aβ antibody levels in plasma samples collected at predefined study visits. Antibody titers will be determined using a validated ELISA method. | Day 42 (after two immunizations) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Kniazev | Nuravax, Inc. | Study Chair |
| Hovhannes Madoyan, MD | Arvax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arvax | Adelaide | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1 | Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection |
| FG001 | Arm 2: Placebo (Adjuvant Only) - Cohort 1 | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection |
| FG002 | Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2 | Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection |
| FG003 | Arm 4: Placebo (Adjuvant Only) - Cohort 2 | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1 | Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection |
| BG001 | Arm 2: Placebo (Adjuvant Only) - Cohort 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants were eligible if aged 40-60 years; all enrolled participants fell within this range |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of AV-1959R Compared to Placebo | Safety will be assessed by the incidence of AEs and SAEs after intramuscular administration of AV-1959R (100 mcg and 300 mcg) or placebo through Week 26. Injection site reactions, clinical laboratory results, vital signs, physical examinations, and MRI will also be monitored through Week 26. | All participants who received at least 1 dose of study treatment were analyzed by randomized treatment arm. No participants were excluded from the safety analysis. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
From first dose through Week 26
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the first dose through Week 26. A TEAE was defined as an AE with onset on/after the first dose or worsening of a pre-existing condition after dosing. Analysis population: all participants who received ≥1 dose (active vaccine or placebo).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1 | Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roman Kniazev, CEO | Nuravax Inc. | 6573659397 | rk@nuravax.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2024 | Feb 17, 2026 | Prot_SAP_000.pdf |
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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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|
|
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
| BG002 | Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2 | Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection |
| BG003 | Arm 4: Placebo (Adjuvant Only) - Cohort 2 | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection |
| OG002 | Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2 | Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection |
| OG003 | Arm 4: Placebo (Adjuvant Only) - Cohort 2 | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection |
|
|
| Secondary | Immunogenicity of AV-1959R: Anti-Aβ Antibody Response | Immunogenicity will be assessed by quantifying anti-Aβ antibody levels in plasma samples collected at predefined study visits. Antibody titers will be determined using a validated ELISA method. | All participants who received at least 1 dose of study treatment (active vaccine or placebo) and had the antibody assessment were analyzed by randomized treatment arm. | Posted | Mean | Standard Deviation | endpoint titer (ET) | Day 42 (after two immunizations) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Arm 2: Placebo (Adjuvant Only) - Cohort 1 | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2 | Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Arm 4: Placebo (Adjuvant Only) - Cohort 2 | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection | 0 | 2 | 0 | 2 | 2 | 2 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|