Alzheimer DiseasePhase 1DU-PRISMNCT07142278
DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
A Phase 1 study testing DUVAX 200 µg and DUVAX 400 µg in people with Alzheimer Disease and Alzheimer Disease (AD), run by Nuravax, Inc. at 1 site in United States.
Trial summary
This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Alzheimer Disease (AD), Preclinical Alzheimer's Disease
- What is being tested?
- DUVAX 200 µg and DUVAX 400 µg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and non-pregnant, non-lactating females, 40-65 years old
- BMI between 18.0 and 32.0 kg/m²
- Medically healthy with no significant abnormalities in medical history, exam, labs, ECG, or MRI
- Signed informed consent
- Women of childbearing potential: negative pregnancy test and use of effective contraception
- Men: vasectomized or agree to use condoms / not donate sperm during the study period
Who cannot join
- Clinically significant medical or psychiatric illness that may affect safety or study results
- MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI
- Significant lab abnormalities (e.g., liver, kidney, hematology) or positive HIV/HBV/HCV tests
- Uncontrolled blood pressure, abnormal heart rate, or prolonged QTc interval
- Recent serious illness, surgery, or investigational drug use within 30 days
- Prior amyloid-beta or tau immunotherapy within 1 year
- Use of immunosuppressive agents or chronic anticoagulants
- History of severe vaccine reactions, autoimmune disease, or significant allergies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
Mailin Perez, 786-334-6675, mperez@palmspringschc.com
Vivianne Gonzalez, 786-334-6675, vgonzalez@palmspringschc.com
About this study
Official title: A Phase 1 Study of the Safety and Tolerability of DUVAX, a Dual-Target Alzheimer's Vaccine (Amyloid-Beta and Tau), in Healthy Volunteers
This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.
Read the detailed description
This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 trial of DUVAX, an adjuvanted vaccine, in up to 24 healthy participants aged 40-65 years. Two dose levels (200 µg and 400 µg) will be evaluated. Participants will receive three intramuscular doses at Weeks 0, 4, and 22, with safety and immunogenicity monitoring through one year after the last vaccination.
The primary objective is to assess safety and tolerability. The secondary objective is to measure immunogenicity by evaluating antibody responses against amyloid beta (Aβ) and tau proteins.
- Being tested
- DUVAX 200 µg, DUVAX 400 µg, Placebo (Adjuvant only)
- Keywords
- Asymptomatic Alzheimer Disease, Preclinical Alzheimer's disease, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUVAX 200 µgBiological
Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
DUVAX 400 µgBiological
Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
Placebo (Adjuvant only)Biological
Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22
| Study group | Role | What they receive |
|---|---|---|
| Active - DUVAX 200 µg | Experimental | Participants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22. Receives: Biological: DUVAX 200 µg |
| Active - DUVAX 400 µg | Experimental | Participants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22. Receives: Biological: DUVAX 400 µg |
| Placebo (Adjuvant only) | Placebo comparator | Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22. Receives: Biological: Placebo (Adjuvant only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)
Safety will be assessed by recording the number and type of treatment-emergent adverse events (TEAEs), including adverse events of special interest (AESI), reported from baseline through the follow-up period. Events will be summarized by severity and relationship to study treatment.
Measured: From baseline (Day 1) through Week 74 (end of study follow-up)
Secondary outcomes (1)
Serum anti-Aβ antibody titers (IgM, IgG, and IgG subclasses)
Immunogenicity will be assessed by measuring antibody titers against amyloid-beta (Aβ), including total IgM, total IgG, and IgG subclasses (IgG1, IgG2, IgG3, IgG4). Changes from baseline will be compared.
Measured: Baseline, Weeks 2, 4, 6, 22, 25, and 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start25 Sep 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment of participants to DUVAX or placebo within two dose cohorts (200 µg and 400 µg). Each cohort will be randomized 3:1 (DUVAX: placebo), with sentinel participants enrolled first for safety review before the full cohort is enrolled.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuravax, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Institute for Molecular Medicine
- Responsible party
- Sponsor
- Investigators
- Anahit Ghochikyan, PhD, Principal investigator, IMMDavid Cribbs, PhD, Principal investigator, Nuravax, Inc.Roman Kniazev, Study chair, Nuravax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142278
- Sponsor's protocol ID
- DUVAX-101
- Other IDs
- 1R44AG091903
- Acronym
- DU-PRISM
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying published results (demographics, outcomes, and adverse events) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Tolerability of DUVAX, a Dual-Target Alzheimer's Vaccine (Amyloid-Beta and Tau), in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07142278
- Acronym / sponsor ID
- DU-PRISM / DUVAX-101
- Keywords
- Asymptomatic Alzheimer Disease, Preclinical Alzheimer's disease, Alzheimer's disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nuravax, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Institute for Molecular Medicine
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.
Detailed description
This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 trial of DUVAX, an adjuvanted vaccine, in up to 24 healthy participants aged 40-65 years. Two dose levels (200 µg and 400 µg) will be evaluated. Participants will receive three intramuscular doses at Weeks 0, 4, and 22, with safety and immunogenicity monitoring through one year after the last vaccination.
The primary objective is to assess safety and tolerability. The secondary objective is to measure immunogenicity by evaluating antibody responses against amyloid beta (Aβ) and tau proteins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment of participants to DUVAX or placebo within two dose cohorts (200 µg and 400 µg). Each cohort will be randomized 3:1 (DUVAX: placebo), with sentinel participants enrolled first for safety review before the full cohort is enrolled.
| Arm | Type | Receives |
|---|---|---|
| Active - DUVAX 200 µg | Experimental | Biological: DUVAX 200 µgParticipants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22. |
| Active - DUVAX 400 µg | Experimental | Biological: DUVAX 400 µgParticipants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22. |
| Placebo (Adjuvant only) | Placebo comparator | Biological: Placebo (Adjuvant only)Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy males and non-pregnant, non-lactating females, 40-65 years old
- BMI between 18.0 and 32.0 kg/m²
- Medically healthy with no significant abnormalities in medical history, exam, labs, ECG, or MRI
- Signed informed consent
- Women of childbearing potential: negative pregnancy test and use of effective contraception
Key exclusion criteria (8 listed)
- Clinically significant medical or psychiatric illness that may affect safety or study results
- MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI
- Significant lab abnormalities (e.g., liver, kidney, hematology) or positive HIV/HBV/HCV tests
- Uncontrolled blood pressure, abnormal heart rate, or prolonged QTc interval
- Recent serious illness, surgery, or investigational drug use within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DUVAX 200 µgIntramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22 | Biological | Active - DUVAX 200 µg |
| DUVAX 400 µgIntramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22 | Biological | Active - DUVAX 400 µg |
| Placebo (Adjuvant only)Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22 | Biological | Placebo (Adjuvant only) |
Primary outcome
Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)
Time frame: From baseline (Day 1) through Week 74 (end of study follow-up)
Safety will be assessed by recording the number and type of treatment-emergent adverse events (TEAEs), including adverse events of special interest (AESI), reported from baseline through the follow-up period. Events will be summarized by severity and relationship to study treatment.
1 secondary outcome
Serum anti-Aβ antibody titers (IgM, IgG, and IgG subclasses)
Time frame: Baseline, Weeks 2, 4, 6, 22, 25, and 38
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published results (demographics, outcomes, and adverse events) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anahit Ghochikyan, PhD principal investigator
IMM
David Cribbs, PhD principal investigator
Nuravax, Inc.
Roman Kniazev study chair
Nuravax, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DUVAX 200 µg and DUVAX 400 µg in people with Alzheimer Disease and Alzheimer Disease (AD), run by Nuravax, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI) (time frame: From baseline (Day 1) through Week 74 (end of study follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.