UW Medicine Brings Innovative Approaches to Pivotal Phase 3 Novavax COVID-19 Vaccine Clinical Trial Including Mobile Sites

UW Medicine Brings Innovative Approaches to Pivotal Phase 3 Novavax COVID-19 Vaccine Clinical Trial Including Mobile Sites

Led by Principal Investigator Dr. Scott McClelland and Dr. Anna Wald, the University of Washington School of Medicine (UW Medicine) kicks off the Phase 3 Novavax clinical trial investigating whether the vaccine candidate can protect against COVID-19. Led by UW Medicine’s trial site organization for this study—the Virology Research Clinic at Harborview Medical Center’s Ninth and Jefferson Building—the academic medical center will enroll up to 1,000 volunteers in Seattle and around the state of Washington. UW Medicine’s initiative includes participant-centricity where and when feasible. That is, the importance of making the clinical trial as accessible, convenient, and comfortable as possible for the participant. It’s all about the participants and with a need for involvement of underrepresented populations, that is those cohorts that were hit harder by the contagion, from minorities to rural inhabitants to the elderly, UW Medicine smartly will deploy mobile sites around the state. UW Medicine, set in one of America’s most beautiful cities, has a high reputation for clinical research excellence 

The Study Context

The Novavax clinical trial is part of the National Institutes of Health newly established COVID-19 Protection Network (a consolidation of a number of trial site organizations to streamline actions and activities including volunteer enrollment) led by the National Institute of Allergy and Infectious Diseases (NIAID). This network plans on enrolling thousands of volunteers for the Phase 3 efficacy trials for select COVID-19 vaccines and monoclonal antibodies, reports the UW Medicine Newsroom.

This network actually serves as an enabling force for Operation Warp Speed (OWS), a partnership initiated under the outgoing POTUS and led by the U.S. Department of Health and Human services to invest in and coordinate the development, manufacturing and distribution of COVID-19 diagnostics, therapeutics and vaccines.

The Sponsors

The actual vaccine for this study was produced by Novavax, a U.S.-based late-stage biotechnology company, serving the role as sponsor. Funds for the trial come from the $1.6 billion awarded Novavax by the U.S. federal government via the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.

The Vaccine Candidate

Known as NVX-CoV2373, Novavax’s vaccine candidate is actually a prefusion protein coronavirus vaccine investigational product developed via the company’s proprietary nanoparticle technology, Matrix-M—an adjuvant to boost an individual’s immune response as well as trigger more neutralizing antibodies.

According to the sponsor and associated literature, Novavax secured a patent for their saponin-based Matrix-M adjuvant, which demonstrates evidence of a well-tolerated effect by triggering the entry of antigen-presenting cells into the injection site. This serves to enhance antigen presentation in local lymph nodes and hence improving an individual’s response which helps the then immunized person produce more antibodies targeting the invading virus. In summary, the Novavax method combines their vaccine candidate NVX-CoV2373 and their proprietary Matrix-M adjuvant.

Novavax Key Milestones

·         March 2020: the Coalition for Epidemic Preparedness Innovations (CEPI) invests $4 million to advance vaccine candidate

·         April 2020: Novavax announced that NVX-CoV2373 evidences high degree of immunogenic response in animal models measuring spike protein—specific antibodies, which serve to block the binding of the SARS-CoV-2 spike protein to the receptor and wild-type virus neutralizing antibodies.

·         May 2020:

o   Phase 11 clinical trial starts in May (Australia)    

o   The Coalition for Epidemic Preparedness Innovations (CEPI) invests up to $384 million in annual funding

·         June 2020: Novavax awarded up to $70 million by the U.S. Department of Defense

·         July 2020: Novavax selected to participate in Operation Warp Speed and can receive up to $1.6 billion (includes funding for late-stage, Phase 3 clinical trial including up to 30,000 subjects)

·         August 2020:  Phase 1 data results from Phase 1/2 randomized, observer-blinded, placebo-controlled trial of the vaccine without Matrix-M adjuvant in healthy adults aged 18-59). The investigational vaccine was generally well tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera (this was the Australian trial funded by CEPI).

Clinical Trials Investigating Novavax Vaccine

Novavax is involved with four clinical trials disclosed in Clinicaltrials.gov including what was an evolution of the first study in Australia: now a Phase 1/2 clinical trial (NCT04368988) across at least 18 trial site locations in both Australia and the United States. Targeting 1,419 total participants (and mentioned above in milestones), the study is sponsored by both the company (Novavax) and CEPI.

Another clinical trial is sponsored by the Bill and Melinda Gates Foundation in South Africa. The Phase 2 study (NCT04533399) seeks to evaluate the effectiveness and safety of the vaccine with Matrix-M1 adjuvant in a minimum of 2,960 and a maximum of 4,164 healthy HIV-negative adult participants and in approximately 240 medically stable, HIV-positive adult participants in up to 15 sites across South Africa. Leading the overall study is Principal Investigator Shabir A. Madhi, MBBCH, PhD, with University of Witwatersrand, South Africa. This study started August 2020 and runs until November, 2021.

Novavax is conducting a Phase 3 study (NCT04583995) in the UK targeting up to 15,000 volunteers across 33 trial site locations in the UK. Led by Paul T. Hearth, MB, BS, FRACP, FRCPCH with the Vaccine Institute, St. Georges, University of London, the study started September 2020 and runs to the estimated primary completion date of January 2021 and estimated study completion date of January 2022.

Finally, the big Phase 3 study (NCT04611802) evaluates the effectiveness of the immune response and safety of the product also known as SARS-CoV-2 with Matrix-M1 adjuvant in adults 18 and above in the United States and Mexico. Commencing in December, this is the study that UW Medicine is helping to drive up in the Pacific Northwest. In partnership with global contract research organization (CRO) ICON, the study is led by Novavax and utilizes the U.S. OWS funding. The key contacts includes Novavax’s Lisa Dunkle, VP, Global Medical Lead, and ICON’s Lisa Ciccarelli, project management lead for this mission-critical study. The study should produce considerable data by estimated primary completion date of March 2021; final estimated study completion date target is December, 2022.

UW Medicine Participation

For those up in Washington that are interested in participating, they should be 18 or older—reach out to the UW Medicine Virology Research Clinic in the following ways.  

UW Medicine, mindful of the health equity issues generally in the U.S. and particularly in association with the pandemic, encourage participation in minority communities such as those from Black, Latinx and Native American communities, mentioned Dr. Scott McClelland, the Principal Investigator heading the study along with the Virology Research Clinic director, Dr. Anna Wald.

Meanwhile, Dr. Wald brings deep expertise in virology to this study and reports that the underlying Novavax technology is similar to what she has seen used to produce vaccines over the years.

Lead Research/Investigator

Scott McClelland, MD, MPH, professor of medicine, epidemiology and global health, PI

Anna Wald, MD, MPH, professor of medicine, epidemiology and laboratory medicine and pathology, director of the Virology Research Clinic

Call to Action: Follow up with UW Medicine if interested in participating in this study. Volunteering for studies is a major contribution in the scientific battle against the pandemic. Interested in learning more about UW Medicine, check out their website