The National Institute of Allergy and Infectious Disease (NIAID) launched a new clinical trials network to enroll thousands of volunteers into studies for potential coronavirus vaccines and therapeutics.
Called the COVID-19 Prevention Trials Network (COVPN), the goal is to enroll eligible U.S. adult study participants into at least five large-scale, late-stage (Phase 3) clinical trials to test vaccines and monoclonal antibodies for passive immunization through a new website by the end of the month.
“Having a safe and effective medical countermeasure to prevent COVID-19 would enable us to not only save lives, but also help end the global pandemic,” said NIAID Director Anthony Fauci in the news release. “Centralizing our clinical research efforts into a single trials network will expand the resources and expertise needed to efficiently identify safe and effective vaccines and other prevention strategies against COVID-19.”
As part of a functional unit within Operation Warp Speed — a partnership among various health agencies that aim to begin distributing millions of effective vaccine doses every day to the public by January 2021 — the network will use a “harmonized vaccine protocol” from the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership for speed and efficacy.
The network also merges four existing, worldwide collaborative clinical trials networks from NIAID that focus on HIV/AIDS and infectious disease research, which will operate as joint sites for ongoing research and COVID-19 studies. It anticipates comprising over 100 clinical trials sites domestically and abroad.
“Each of the Phase 3 clinical trials that the COVPN will conduct will require thousands of volunteers,” said Francis Collins, director of the National Institutes of Health. “Community engagement, particularly with the communities most vulnerable to COVID-19’s severe outcomes, will be critical to the success of this research endeavor.”
Moreover, ensuring equitable representation in these studies is critical to their success to ensure that the trial population is representative of those who will ultimately be helped by the vaccine. Limiting barriers to vaccine participation and effective recruitment are, therefore, crucial to these efforts.
To gather a diverse group of participants who are most at-risk for the virus in upcoming trials, the website features a brief questionnaire that assesses the likelihood of infection. This includes information about race and the number of public activities someone is exposed to daily for participant qualification. The customized and secure data platform for collecting participant information on eligible study participants was constructed by Oracle.
Meanwhile, the first clinical trial through the network will be the mRNA-1273 vaccine developed by NIAID and the biotechnology company Moderna, while four other vaccine trials are also anticipated in the coming months.