Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine

NCT06831812 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: AU-AV1959R-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Alzheimer Disease (AD); Alzheimers Disease Prevention

Keywords

vaccine; AD; prevention; precinical AD; asymptomatic AD; Alzheimer disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Immunogenicity of AV-1959R: Anti-Aβ Antibody Response

  Day 42 (after two immunizations)

Study Arms (4)

Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1

EXPERIMENTAL

Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection

Biological: AV-1959R (Abeta vaccine)

Arm 2: Placebo (Adjuvant Only) - Cohort 1

EXPERIMENTAL

Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection

Biological: AV-1959R (Abeta vaccine)

Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2

EXPERIMENTAL

Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection

Biological: AV-1959R (Abeta vaccine)

Arm 4: Placebo (Adjuvant Only) - Cohort 2

EXPERIMENTAL

Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection

Biological: AV-1959R (Abeta vaccine)

Interventions

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.

Also known as: Beta-amyloid vaccine, Aβ vaccine

Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1; Arm 2: Placebo (Adjuvant Only) - Cohort 1; Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2; Arm 4: Placebo (Adjuvant Only) - Cohort 2

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female adults, 40-60 years old.
• BMI 18.0-32.0 kg/m².
• No significant medical conditions or abnormal MRI, ECG, or lab tests.
• Signed informed consent and ability to follow study procedures.
• Females must be postmenopausal or surgically sterile.
• Males must use contraception or be vasectomized.

You may not qualify if:

• History of Alzheimer's, stroke, or neurodegenerative disease.
• MRI abnormalities, such as infarcts or microbleeds.
• Serious illness, surgery, or hospitalization in the last 4 weeks.
• Significant heart, lung, liver, kidney, or immune disorders.
• Recent drug/alcohol abuse or severe allergies.
• Abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, HIV, Hepatitis B/C positive).
• Use of investigational drugs or amyloid/tau therapies in the last year.
• Chronic use of immunosuppressants, anticoagulants, or blood products.
• Pregnant, breastfeeding, or women of childbearing potential.
• Recent blood donation (\>400 mL) in the last 30 days.

Sponsors & Collaborators

• Nuravax, Inc.: lead
• Arvax: collaborator

Study Sites (1)

Arvax

Adelaide, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Roman Kniazev, CEO
• Organization: Nuravax Inc.

rk@nuravax.com

6573659397

Study Officials

• Roman Kniazev

  Nuravax, Inc.

  STUDY CHAIR

• Hovhannes Madoyan, MD

  Arvax

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: June 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Locations

AU (1)