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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

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.

Medically stable patients as established by medical history and clinical examination at screening.

Male or female participants >=50 years of age (YOA) at the time of the first study intervention administration.

Disqualifiers

Prior atherosclerotic cardiovascular disease (ASCVD) event.

History or planned coronary artery bypass grafting (CABG), any cardiovascular surgery, percutaneous coronary intervention (PCI), or valvular intervention.

Heart failure with Class III or IV symptoms according to the New York Heart Association and/or unstable heart failure at the screening visit.

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).

Trial design

Treatments tested in this trial

  • Placebo
  • Adjuvanted RZV vaccine
  • Adjuvanted RSVPreF3 vaccine

Treatment groups

450 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators