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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06831812




Registration number
NCT06831812
Ethics application status
Date submitted
12/02/2025
Date registered
18/02/2025
Date last updated
18/02/2025

Titles & IDs
Public title
Phase I Study of AV-1959R: Safety, Tolerability, and Immunogenicity in Healthy Participants
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants
Secondary ID [1] 0 0
AU-AV1959R-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Alzheimer Disease (AD) 0 0
Alzheimer's Disease Prevention 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - AV-1959R (Abeta vaccine)

Experimental: Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1 - Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection

Experimental: Arm 2: Placebo (Adjuvant Only) - Cohort 1 - Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection

Experimental: Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2 - Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection

Experimental: Arm 4: Placebo (Adjuvant Only) - Cohort 2 - Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection


Treatment: Other: AV-1959R (Abeta vaccine)
AV-1959R is an investigational adjuvanted vaccine designed to induce a targeted immune response against beta-amyloid (Aß) 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 code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of AV-1959R compared to placebo
Timepoint [1] 0 0
Up to 26 weeks
Secondary outcome [1] 0 0
Immunogenicity of AV-1959R: Anti-Aß antibody response
Timepoint [1] 0 0
Up to 26 weeks

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Arvax - South Australia
Recruitment postcode(s) [1] 0 0
- South Australia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nuravax, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Arvax
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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-Aß antibody levels to assess immune response. This study will help determine if AV-1959R is safe and effective in generating a targeted immune response.
Trial website
https://clinicaltrials.gov/study/NCT06831812
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06831812