NIAID Creates Clinical Trials Network

 

The National Institute of Allergy & Infectious Diseases (NIAID) has founded a new clinical trials network focused on enrolling volunteers in clinical trials for COVID-19 vaccines and monoclonal antibodies. It was recently reported that sponsor companies are struggling to enroll patients in clinical trials for COVID-19 vaccines, essentially competing against each other.

“We not only have to find the number of volunteers, but they need to be in an area where the virus is currently spreading, otherwise you learn nothing about the effectiveness of the vaccine,” said Francis Collins, director of the U.S. National Institutes of Health, the umbrella organization for NIAID. “It is a big task, and it means pulling together all of the clinical trial capacity that we can.”

The COVID-19 Prevention Trials Network (COVPN), the new network, merged four existing NIAID-funded clinical trials networks. They are the HIV Vaccine Trials Network (HVTN), which is located in Seattle; the HIV Prevention Trials Network (HPTN), based in Durham, North Carolina; the Infectious Diseases Clinical Research Consortium (IDCRC), headquartered in Atlanta; and the AIDS Clinical Trials Group, based in Los Angeles.

Each of those networks will still run clinical trials for HIV vaccine and prevention and other infectious diseases while adding on the new COVID-19 activities.

“Establishing a unified clinical trial network is a key element of President Trump’s Operation Warp Speed, which aims to deliver substantial quantities of a safe, effective vaccine by January 2021,” said Alex Azar, secretary of the U.S. Department of Health and Human Services (HHS). “Starting this summer, this new network will leverage existing infrastructure and engage communities to secure the thousands of volunteers needed for late-stage clinical trials of promising vaccines.”

The new network’s vaccine testing will be led by Larry Corey of the Fred Hutchinson Cancer Research Center in Seattle and Kathleen M. Neuzil of the University of Maryland School of Medicine.

Myron S. Cohen of the University of North Carolina, Chapel Hill and David S. Stephens of Emory University in Atlanta will head the network’s monoclonal antibody clinical testing.

The HVTN is located at the Fred Hutchinson Cancer Research Center and will act as the new COVPN’s operational center. COVPN is “functional unit” of Operation Warp Speed, which is President Trump’s program to speed efforts to have a usable and safe vaccine against COVID-19 by January 2021. The network will rely on a harmonized vaccine protocol developed by the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. This protocol allows researcher to analyze data from multiple vaccine trials. It is expected to run more than 100 clinical trial locations across the U.S. and internationally.

“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 Anthony S. Fauci, director of NIAID. “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.”

The first Phase III trial that COVPN is expected to run is for Moderna and NIAID’s mRNA-1273 vaccine, which is generally viewed as the leader in vaccine development for COVID-19. On June 11, Moderna indicated it had finalized the Phase III clinical trial structure for mRNA-1273 with plans to begin the trial in 30,000 participants in July. On July 2, there were indications that Moderna was making changes to the trial structure with the start date being pushed back. Despite the changes, Moderna’s chief executive officer Stephane Bancel told CNBC’s Meg Tirrell, “we have always said July. And I confirm July.”