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

NCT ID: NCT06831812

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

AV-1959R (Abeta vaccine)

Intervention Type: 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.

Arm 2: Placebo (Adjuvant Only) - Cohort 1

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

Group Type: EXPERIMENTAL

AV-1959R (Abeta vaccine)

Intervention Type: 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.

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

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

Group Type: EXPERIMENTAL

AV-1959R (Abeta vaccine)

Intervention Type: 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.

Arm 4: Placebo (Adjuvant Only) - Cohort 2

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

Group Type: EXPERIMENTAL

AV-1959R (Abeta vaccine)

Intervention Type: 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.

Interventions

AV-1959R (Abeta vaccine)

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Beta-amyloid vaccine; Aβ vaccine

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arvax

UNKNOWN

Sponsor Role: collaborator

Nuravax, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Kniazev

Role: STUDY_CHAIR

Nuravax, Inc.

Hovhannes Madoyan, MD

Role: STUDY_DIRECTOR

Arvax

Locations

Arvax

Adelaide, , Australia

Countries

Australia

Other Identifiers

AU-AV1959R-101

Identifier Type: -

Identifier Source: org_study_id