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

Nuravax, Inc.

Status and phase: Active, not recruiting; Phase 1

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

Treatments: Biological: AV-1959R (Abeta vaccine)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06831812

AU-AV1959R-101

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: AV-1959R (Abeta vaccine)

Arm 2: Placebo (Adjuvant Only) - Cohort 1

Experimental group

Description:

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

Treatment:

Biological: AV-1959R (Abeta vaccine)

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

Experimental group

Description:

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

Treatment:

Biological: AV-1959R (Abeta vaccine)

Arm 4: Placebo (Adjuvant Only) - Cohort 2

Experimental group

Description:

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

Treatment:

Biological: AV-1959R (Abeta vaccine)