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Article History

Received: 3 April 2026

Accepted: 15 July 2026

First Online: 22 July 2026

Declarations

Ethics approval and consent to participate: This study was conducted at CMAX Clinical Research (Adelaide, South Australia) in accordance with the study protocol, the ethical principles of the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, and the International Council for Harmonization Good Clinical Practice (ICH-GCP) guidelines, as well as all applicable local laws and regulations. The study protocol was reviewed and approved by the Bellberry Human Research Ethics Committee (Eastwood, South Australia) (Approval No.: 2023-12-1501). Written informed consent was obtained from all participants prior to enrollment.

Consent for publication: Not applicable. This manuscript does not contain any identifiable individual participant data.

Competing interests: M. G. A. is an employee of the non-profit Institute for Molecular Medicine (IMM), a principal investigator on grants from the National Institute on Aging (U01 AG060965, AG074983, AG084528, and AG092949), and a co-author of patents covering the MultiTEP technology used in the development of AV-1959R, which have been assigned by IMM to its spin-off company Nuravax, Inc. A. G. is also an employee of IMM and a co-author of patents covering the MultiTEP platform technology used in the development of AV-1959R. H. M., R. K., G. M. and G. C. are employees of Nuravax, Inc., the sponsor of the clinical trial. A. Gr. is an employee of Arvax, Inc., a co-sponsor of the trial. N.P. is affiliated with Vaxine Pty Ltd, which supplied the adjuvant used in the vaccine formulation. All other authors declare no competing interests.