University of Iowa VTEU Initiates Phase 3 Novavax Clinical Trial Investigating COVID-19 Vaccine

University of Iowa VTEU Initiates Phase 3 Novavax Clinical Trial Investigating COVID-19 Vaccine

The University of Iowa Health Care (UIHC) gains a more prominent role as a trial site hub investigating COVID-19 investigational vaccines now taking on leadership to help conduct the Novavax study. UIHC played a prominent role in the Pfizer/BioNTech study, enrolling 250 participants for the randomized, controlled, double-blind study which led to the emergency use authorization (EUA) for that candidate known as BNT162b. The prominent university’s Vaccine Treatment and Evaluation Unit (VTEU), led by Executive Dean Patricia Winokur, now gears up for a more traditional vaccine, albeit an investigational one. Recently, Dean Winokur took time with the local press to answer questions concerning among other things what were the differences between the Pfizer/BioNTech vaccine and the Novavax candidate. Novavax is working with global contract research organization ICON plc as well to help manage the large study.

From Nothing to Something

Novavax has come a long way from small obscure American vaccine biotech firm to global player, with an infusion of $1.6 billion from the U.S. federal government as part of the Operation Warp Speed initiative combating COVID-19.  

The Product

As Dean Winokur articulates, NVK-CoV-2373 represents a more traditional product, similar to those used to target influenza.  Although NVK-CoV-2373 doesn’t involve the use of any virus (e.g. like some of vaccines out of China that are known as ‘inactivated’) but rather target SARS-CoV-2’s spike protein with another approach involving messenger RNA.  Hence she described in The Gazette recently, “Your body creates that spike protein” further explaining “the instruction manual for making that protein.” For more on NVK-CoV-2373, see the link to the sponsor

The Study

Their first study was conducted in Australia as TrialSite reported back in May. How times have changed. Now the sponsor has a couple trials in South Africa sponsored along with the Bill and Melinda Gates Foundation.

In the study (NCT04611802) led in part by University of Iowa Healthcare or UIHC, the team investigates the effectiveness, immune response and safety of the vaccine also referred to as SARS-CoV-2 with Matrix-M1 adjuvant in adults 18 years of age and older in the United States and Mexico.

The vaccine helps the body to have an immune response while the adjuvant that can help make the vaccine work better. This particular study evaluates the protective effect, body’s immune response, and safety of this vaccine with adjuvant in the participant base. Each participant in this study will receive a total of 2 intramuscular injections over the course of the study. The sponsor, in partnership with the U.S. Department of Health and Human Service (HHS), will seek up to 30,000 participants for this study.

With 113 disclosed trial site locations, the study started in December and runs through to the estimated primary completion date of March, 2021 and a study completion date of December 2022.

University of Iowa Vaccine Treatment and Evaluation Unit

The VTEU was established in 2007 with a $23.7 million contract from a branch of the National Institutes of Health (NIH) called the National Institute of Allergy and Infectious Diseases (NIAID). One of nine trial site hubs selected to serve as VTEUs, they are responsible for testing vaccines in specific populations. As a VTEU, the University of Iowa helps bolster the NIAID’s ability to direct clinical research to quickly respond to public health needs.

Lead Research/Investigator (UIHC)

Patricia Winokur, MD, Executive Dean, Carver College of Medicine, Professor of Internal Medicine—Infectious Diseases

Call to ActionTrialSite follows the Novavax study and will update the network with any material news. Follow the link at the source to read the piece from The Gazette in Iowa.