July 22, 2016: Preparing for a Pragmatic Influenza Vaccine Clinical Trial

July 22, 2016: Preparing for a Pragmatic Influenza Vaccine Clinical Trial

Topic

Preparing for a Pragmatic Influenza Vaccine Clinical Trial: A One-shot Deal

Presenters

Scott D. Solomon, MD, Professor of Medicine at Harvard Medical School, and Director, Noninvasive Cardiology at Brigham and Women's Hospital

Orly Vardeny, PharmD, MS, Associate Professor of Pharmacy and Medicine at the University of Wisconsin-Madison

Keywords

Influenza; Pragmatic clinical trial; Vaccine doses; Cardiovascular risk; Flu; INVESTED; Cardiopulmonary outcomes

Key Points

  • Several analyses have documented an association between acute respiratory infections and cardiovascular events. Patients with heart failure are especially susceptible to influenza-related complications. A new pragmatic influenza vaccine trial will examine whether preventing influenza, particularly by means of vaccination, can reduce influenza-triggered cardiovascular risk.
  • The INVESTED trial (Influenza Vaccine to Effectively Stop Cardiothoracic Events and Decompensated Heart Failure in Patients with Cardiovascular Disease) is a large, simple, adequately powered, double-blind, comparative effectiveness multicenter trial of vaccine strategy. Results of INVESTED have the potential to inform healthcare policy regarding the optimal influenza vaccination for individuals with high-risk cardiovascular disease.
  • The INVESTED intervention is a “one-shot deal” and presents no concerns about adherence. The simple endpoint requires minimal adjudication.
  • INVESTED is piloting a single IRB process developed from a CTSA IRB reliance project funded by NCATS. An IRB master reliance agreement was developed specifically for the INVESTED trial, with the University of Wisconsin-Madison serving as the IRB of record. The INVESTED network includes PCORnet, a VA consortium, Midwest CTSAs, and a Canadian consortium, among other sites.

Discussion Themes

Recruitment for INVESTED will include high-risk cardiovascular patients, who will be randomized to either a high-dose (4x) trivalent influenza vaccine or a standard-dose quadrivalent influenza vaccine.

The 3-year strategy will allow realistic seasonal variation in influenza virulence and protection.

How are clinicians engaged in this trial, and will recruitment focus on a single clinic or an entire health system?

For More Information

Read more about IRB reliance and the SMART IRB platform at NIH’s National Center for Advancing Translations Sciences (NCATS): http://www.ncats.nih.gov/expertise/clinical/smartirb.

Tags
#pctGR
@NIH_NHLBI, @PCTGrandRounds, @Collaboratory1, @PCORnetwork