Alzheimer Disease, Alzheimer Disease (AD), Alzheimers Disease Prevention
Conditions
Keywords
vaccine, AD, prevention, precinical AD, asymptomatic AD, Alzheimer disease
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.
Interventions
BIOLOGICALAV-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.
Sponsors
Nuravax, Inc.
Arvax
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of AV-1959R Compared to Placebo | 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
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of AV-1959R: Anti-Aβ Antibody Response | 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. |
| Participants With an Anti-Aβ Antibody Response | Day 42 (after two immunizations) | Number of participants who showed an increase in anti-Aβ antibody titer from baseline at Day 42 following two immunizations. Anti-Aβ antibody titers were measured by ELISA. |
Countries
Australia
Contacts
STUDY_CHAIRRoman Kniazev
Nuravax, Inc.
STUDY_DIRECTORHovhannes Madoyan, MD
Arvax
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 |
| other Total, other adverse events | 5 / 6 | 1 / 2 | 6 / 6 | 2 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 |
Outcome results
None listed