Last updated: 07/14/2026 12:40:12

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

GSK study ID
309767
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Observer-blind, Placebo-controlled Exploratory Study to Evaluate whether Administration of Adjuvanted RZV or RSVPreF3 Vaccine Can Attenuate Coronary Plaque Progression in Individuals 50 Years of Age and Above Who Are at Risk for Cardiovascular Events
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in total coronary non-calcified plaque volume (NCPV) as measured on coronary computed tomography angiography (CCTA)

Timeframe: At Baseline (Day 1) and at Month 14

Secondary outcomes:

Change from Baseline in total coronary plaque volume as measured on CCTA

Timeframe: At Baseline (Day 1) and at Month 14

Change from Baseline in low attenuation plaque as measured on CCTA

Timeframe: At Baseline (Day 1) and at Month 14

Change from Baseline in peri-coronary fat attenuation index as measured on CCTA

Timeframe: At Baseline (Day 1) and at Month 14

Number of participants with any serious adverse events (SAEs)

Timeframe: From Day 1 to Month 15

Number of participants with SAEs related to study participation or study procedures

Timeframe: From start of screening (Day -15) to Month 15

Number of participants with SAEs leading to withdrawal from the study

Timeframe: From Day 1 to Month 15

Interventions:
Combination product: Placebo
Combination product: Adjuvanted RZV vaccine
Biological/vaccine: Adjuvanted RSVPreF3 vaccine
Enrollment:
450
Observational study model:
Not applicable
Primary completion date:
2029-04-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cardiovascular Disease
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2026 to May 2029
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
  • Participants, including participants with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
  • Cardiovascular conditions
  • Prior atherosclerotic cardiovascular disease (ASCVD) event.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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