A Study to Characterize the Safety and Immunogenicity of AZD6489 in Participants 60 Years of Age and Older (ARIES)

Conditions

• RSV Respiratory Syncytial Virus

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Accepted

Interventions

• AZD6489 — BIOLOGICAL
  Participants will receive AZD6489 as a single intramuscular injection.
• Licensed RSV vaccine #1 — BIOLOGICAL
  Participants will receive licensed RSV vaccine #1 as a single intramuscular injection.
• Licensed RSV vaccine #2 — BIOLOGICAL
  Participants will receive licensed RSV vaccine #2 as a single intramuscular injection.

Study Details

This Phase I/II study is to characterize the safety and immunogenicity of 2 dose levels of AZD6489, an investigational RSV recombinant prefusion F protein VLP vaccine.

Key Dates

First listed

Jul 21, 2026

Start date

Jul 8, 2026

Status verified

Jul 2026

Primary completion

Oct 15, 2026

Completion

Sep 6, 2027

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: AZD6489 Dose A
  Participants will receive AZD6489 Dose A as a single dose intramuscular injection on Day 1.
• Experimental: AZD6489 Dose B
  Participants will receive AZD6489 Dose B as a single dose intramuscular injection on Day 1.
• Active Comparator: Licensed RSV vaccine #1
  Participants will receive licensed RSV vaccine #1 as a single dose intramuscular injection on Day 1.
• Active Comparator: Licensed RSV vaccine #2
  Participants will receive licensed RSV vaccine #2 as a single dose intramuscular injection on Day 1.

Primary Outcome Measure

Incidence of immediate unsolicited adverse events (AEs) [ Time Frame: 30 minutes post-study intervention ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (6)