Recruiting
Phase 1

DUVAX

Sponsor:

Nuravax, Inc.

Code:

NCT07142278

Conditions

Alzheimer Disease

Alzheimer Disease (AD)

Preclinical Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Interventions

DUVAX 200 µg

DUVAX 400 µg

Placebo (Adjuvant only)

Study Details

Brief 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. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.

Conditions

Alzheimer Disease

Alzheimer Disease (AD)

Preclinical Alzheimer's Disease

Study ID

NCT07142278

Start date

Sep 25, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Active - DUVAX 200 µg

Participants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22.

experimental: Active - DUVAX 400 µg

Participants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22.

placebo comparator: Placebo (Adjuvant only)

Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22.

Interventions

DUVAX 200 µg

Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22

DUVAX 400 µg

Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22

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

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) ]

Central Contacts and Locations

Locations

Palm Springs Community Health Center

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Mailin Perez

786-334-6675mperez@palmspringschc.com

Vivianne Gonzalez

786-334-6675vgonzalez@palmspringschc.com

More Information

Sponsor

Nuravax, Inc.

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • Asymptomatic Alzheimer Disease
  • Preclinical Alzheimer's disease
  • Alzheimer's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Nuravax, Inc. on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.