DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau

NCT ID
NCT07142278
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
Nuravax, Inc.
Conditions
Alzheimer Disease, Alzheimer Disease (AD), Preclinical Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 24 participants (Estimated).

What is being studied

  • Biological: DUVAX 200 µg
  • Biological: DUVAX 400 µg
  • Biological: Placebo (Adjuvant only)

Who may be eligible

Ages
40 Years to 65 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Florida, United States: 1

Sample of listed locations

  • Palm Springs Community Health Center — Miami Lakes, Florida, 33014, United States — Recruiting

Study details

Start date
September 25, 2026
Primary completion date
April 1, 2027
Completion date
July 31, 2027
First posted
August 26, 2025
Collaborators
Institute for Molecular Medicine, National Institute on Aging (NIA)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07142278
Registry last updated
September 30, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07142278 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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