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Completed

NCT Number: NCT06831812

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

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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Key information

Conditions

Alzheimer Disease Alzheimer Disease (AD) Alzheimers Disease Prevention Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arvax

Adelaide, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Beta-amyloid vaccine, Aβ vaccine

Primary outcomes

  1. Safety and Tolerability of AV-1959R Compared to Placebo

    Time frame: 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.

Secondary outcomes

  1. Immunogenicity of AV-1959R: Anti-Aβ Antibody Response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nuravax, Inc.

Industry

Collaborators

  • Arvax

Registry information

Official study title

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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