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

Launched by NURAVAX, INC. · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new vaccine called AV-1959R, which aims to help prevent Alzheimer’s disease by targeting a specific protein in the brain associated with the condition. The study is currently looking for healthy adults aged 40 to 60 who meet certain criteria, such as having a Body Mass Index (BMI) between 18 and 32 and no significant medical issues. Participants should not have a history of Alzheimer’s or other serious neurological conditions and must be willing to follow the study procedures.

If you participate, you will receive three injections of either the AV-1959R vaccine or a placebo (a harmless substance that does not contain the vaccine) over about 14 weeks. After the injections, there will be an 8-week follow-up period where researchers will check for any side effects and measure your immune response to see if the vaccine is working as intended. This study is important because it will help determine if the AV-1959R vaccine is safe and effective in generating an immune response that could potentially prevent Alzheimer’s disease in the future.

Gender

ALL

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.