Adults 40 to 60, any sex, with Alzheimer Disease or Alzheimer Disease (AD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety and Tolerability of AV-1959R Compared to PlaceboPrimary· Up to 26 weeks
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.
Participants with ≥1 TEAE
Group
Value
95% CI
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
5
Arm 2: Placebo (Adjuvant Only) - Cohort 1
1
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
6
Arm 4: Placebo (Adjuvant Only) - Cohort 2
2
Participants with ≥1 SAE
Group
Value
95% CI
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
0
Arm 2: Placebo (Adjuvant Only) - Cohort 1
0
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
0
Arm 4: Placebo (Adjuvant Only) - Cohort 2
0
Immunogenicity of AV-1959R: Anti-Aβ Antibody ResponseSecondary· Day 42 (after two immunizations)
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.
Group
Value
95% CI
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
71175
± 49725
Arm 2: Placebo (Adjuvant Only) - Cohort 1
126
± 37
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
60439
± 33140
Arm 4: Placebo (Adjuvant Only) - Cohort 2
115
± 12
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose through Week 26.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nuravax, Inc.
Last refreshed: 24 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06831812.