A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progression in Adults >=50 Years of Age at Risk for Cardiovascular Events

Sponsor
GlaxoSmithKline
Study ID
NCT07712380
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Disease

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — COMBINATION_PRODUCT
    Placebo will be administered intramuscularly.
  • Adjuvanted RZV vaccine — COMBINATION_PRODUCT
    Adjuvanted RZV vaccine will be administered intramuscularly.
  • Adjuvanted RSVPreF3 vaccine — BIOLOGICAL
    Adjuvanted RSVPreF3 vaccine will be administered intramuscularly.

Study Details

This study is designed to evaluate whether the adjuvanted recombinant zoster vaccine (RZV) or the adjuvanted respiratory syncytial virus PreFusion protein 3 (RSVPreF3) vaccine can attenuate the progression of coronary plaque in adult individuals at risk for cardiovascular events.

Key Dates

First listed
Jul 17, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
May 4, 2029
Completion
May 4, 2029

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo group
    Participants in this group receive placebo, the first dose being administered at Day 1 and the second dose at Month 2.
  • Experimental: Adjuvanted RZV group
    Participants in this group receive the adjuvanted RZV vaccine, the first dose being administered at Day 1 and the second dose at Month 2.
  • Experimental: Adjuvanted RSVPreF3 group
    Participants in this group receive a single dose of placebo at Day 1 and a single dose of the adjuvanted RSVPreF3 vaccine at Month 2.

Primary Outcome Measure

Change from Baseline in total coronary non-calcified plaque volume (NCPV) as measured on coronary computed tomography angiography (CCTA) [ Time Frame: At Baseline (Day 1) and at Month 14 ]

Central Contacts

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