CompletedPhase 1

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

Australia16 participantsStarted 2024-06-12

Plain-language 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.

Who can participate

Age range40 Years – 60 Years

SexALL

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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.

What they're measuring

Safety and Tolerability of AV-1959R Compared to Placebo

Timeframe: Up to 26 weeks

Trial details

NCT IDNCT06831812

SponsorNuravax, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-01

Results submitted2026-01-29