Trial Outcomes & Findings for Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine (NCT NCT06831812)
NCT ID: NCT06831812
Last Updated: 2026-02-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Up to 26 weeks
Results posted on
2026-02-24
Participant Flow
Participant milestones
| Measure |
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 2: Placebo (Adjuvant Only) - Cohort 1
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 4: Placebo (Adjuvant Only) - Cohort 2
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
n=6 Participants
Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 2: Placebo (Adjuvant Only) - Cohort 1
n=2 Participants
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
n=6 Participants
Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 4: Placebo (Adjuvant Only) - Cohort 2
n=2 Participants
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
16 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
12 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: All participants who received at least 1 dose of study treatment were analyzed by randomized treatment arm. No participants were excluded from the safety analysis.
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.
Outcome measures
| Measure |
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
n=6 Participants
Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 2: Placebo (Adjuvant Only) - Cohort 1
n=2 Participants
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
n=6 Participants
Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 4: Placebo (Adjuvant Only) - Cohort 2
n=2 Participants
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
|---|---|---|---|---|
|
Safety and Tolerability of AV-1959R Compared to Placebo
Participants with ≥1 TEAE
|
5 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Safety and Tolerability of AV-1959R Compared to Placebo
Participants with ≥1 SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 42 (after two immunizations)Population: All participants who received at least 1 dose of study treatment (active vaccine or placebo) and had the antibody assessment were analyzed by randomized treatment arm.
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.
Outcome measures
| Measure |
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
n=6 Participants
Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 2: Placebo (Adjuvant Only) - Cohort 1
n=2 Participants
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
n=6 Participants
Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 4: Placebo (Adjuvant Only) - Cohort 2
n=2 Participants
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
|---|---|---|---|---|
|
Immunogenicity of AV-1959R: Anti-Aβ Antibody Response
|
71175 endpoint titer (ET)
Standard Deviation 49725
|
126 endpoint titer (ET)
Standard Deviation 37
|
60439 endpoint titer (ET)
Standard Deviation 33140
|
115 endpoint titer (ET)
Standard Deviation 12
|
Adverse Events
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 2: Placebo (Adjuvant Only) - Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 4: Placebo (Adjuvant Only) - Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
n=6 participants at risk
Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 2: Placebo (Adjuvant Only) - Cohort 1
n=2 participants at risk
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
n=6 participants at risk
Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection
|
Arm 4: Placebo (Adjuvant Only) - Cohort 2
n=2 participants at risk
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
83.3%
5/6 • Number of events 22 • From first dose through Week 26
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the first dose through Week 26. A TEAE was defined as an AE with onset on/after the first dose or worsening of a pre-existing condition after dosing. Analysis population: all participants who received ≥1 dose (active vaccine or placebo).
|
50.0%
1/2 • Number of events 4 • From first dose through Week 26
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the first dose through Week 26. A TEAE was defined as an AE with onset on/after the first dose or worsening of a pre-existing condition after dosing. Analysis population: all participants who received ≥1 dose (active vaccine or placebo).
|
100.0%
6/6 • Number of events 26 • From first dose through Week 26
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the first dose through Week 26. A TEAE was defined as an AE with onset on/after the first dose or worsening of a pre-existing condition after dosing. Analysis population: all participants who received ≥1 dose (active vaccine or placebo).
|
100.0%
2/2 • Number of events 3 • From first dose through Week 26
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the first dose through Week 26. A TEAE was defined as an AE with onset on/after the first dose or worsening of a pre-existing condition after dosing. Analysis population: all participants who received ≥1 dose (active vaccine or placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place