Volunteer getting ready for an injection.

 

About

As part of the COVID-19 Prevention Network, established by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), GW was selected as a clinical research site to test experimental vaccines and monoclonal antibodies, which are laboratory-produced molecules engineered to serve as substitute antibodies. In July, the university began enrolling volunteers in a late-stage (Phase 3) study of the mRNA-1273 vaccine, co-developed by NIH scientists and the U.S. biotechnology company Moderna, Inc. The vaccine uses a chemical messenger called ribonucleic acid, or RNA, that instructs the body’s cells to create a protein that mimics one found on the outer surface of the novel coronavirus that causes COVID-19. On Dec. 18, 2020, the U.S. Food and Drug Administration approved Moderna's vaccine for emergency use. 

GW is also testing other investigational vaccines against COVID-19. In February 2021, GW began enrolling volunteers in a Phase 2 study of an adjuvanted recombinant protein-based vaccine developed by Sanofi, in partnership with GlaxoSmithKline. The backbone of this vaccine is a manufactured form of the SARS-CoV-2 spike protein that aims to stimulate the immune system to produce neutralizing antibodies against the virus.

While a Phase 3 study (Moderna) measures a vaccine's efficacy, a Phase 2 study (Sanofi-GSK) focuses on safety and immune response.

 


Vaccine Trial Volunteer Recruitment

GW recruits volunteers to take part in its clinical trials from the Washington, D.C. community and beyond. Extensive community partnerships forged through GW’s HIV Prevention Network Clinical Research Site and its Vaccine Research Unit, in addition to word-of-mouth and widespread local news coverage, helps GW’s vaccine research team quickly get the word out to the D.C.-area community about trials and the need for volunteers. The team works closely with its many partners to listen and respond to the community’s questions and concerns about participating in the trial.

 


Testing & Observation 

Trial volunteers come to either the Foggy Bottom clinic or a trailer provided by the U.S. Department of Defense for the study to serve as additional clinical space. There, the volunteers provide informed consent, have their medical history recorded, and undergo a physical examination.

For GW's Moderna trial, 349 volunteers participated in a double-blind, placebo-controlled study. A computer program randomly assigned the volunteers to either the vaccine or the placebo group and two unblinded team members administered the first injection. As a double-blind study, neither the volunteer nor the research team knew which injection the volunteer received. Approximately 4 weeks later, the volunteer returned to receive a second injection. Volunteers were encouraged to continue the safety precautions they were already taking, and were instructed to keep an electronic diary to track their symptoms. The team monitored volunteers for symptoms and side effects through notifications from an electronic diary and telephone check-ins.

For GW's Sanofi trial, GW's research team will recruit 40 volunteers. Unlike Moderna's Phase 3 study, Sanofi's Phase 2 study will not be blinded or include a placebo. All volunteers will receive 2 injections of the Sanofi-GSK vaccine candidate, spaced about a month apart, and the research team will monitor for safety and an immune response in the body.

 


Sample Processing

Blood and nasal swab samples collected from volunteers throughout the trials are brought back to GW labs. The blood is spun down in a centrifuge to separate the red and white blood cells from the blood serum. The serum is then divided into smaller sample sizes and sent to another central lab for antibody testing that looks for signs of an immune response. The team also feezes the nasal swabs and ships them to a separate laboratory that performs a polymerase chain reaction (PCR) test to look for presence of the virus through acute or active infection.

 


About Vaccine Research at GW

Researchers at GW have long been involved in vaccine development and conducting vaccine trials for investigational products. The GW Vaccine Research Unit, for example, conducts clinical trials of experimental vaccines and products that are designed to prevent infectious diseases such as HIV and the Zika virus, and neglected tropical diseases such as hookworm infection and schistosomiasis. GW also runs an HIV Prevention Trials Network Clinical Research Site, led by GW’s Milken Institute School of Public Health, which is part of a network of sites worldwide supported by the National Institutes of Health that develop and test the safety and efficacy of experimental HIV treatments.

The experience and infrastructure of the GW Vaccine Research Unit, the HPTN site, GW labs and the university’s deep ties to the community, allowed GW to pivot in a moment of crisis to serve as a COVID-19 clinical vaccine site.

Timeline

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May 15, 2020

U.S. government announces launch of Operation Warp Speed, a vast public-private initiative led by the U.S. Department of Health and Human Services and the Department of Defense to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

 

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July 8, 2020

National Institutes of Health's National Institute of Allergies and Infectious Diseases launches the COVID-19 Prevention Trials Network, which works with global research partners to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. CoVPN helped establish a network of clinical trial sites where thousands of volunteers will be enrolled to test investigational vaccines.

 

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July 27, 2020

GW announces participation in a clinical trial for an investigational COVID-19 vaccine, co-developed by the biotechnology company Moderna and NIH scientists, and begins enrolling trial volunteers.

 

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August 12, 2020

GW’s clinical team sees its first volunteer.

 

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Oct. 21, 2020

Operation Warp Speed’s Dr. Moncef Slaoui tours GW’s vaccine trial site. ABC News airs exclusive coverage of Dr. Slaoui’s visit to GW’s Vaccine Research Center.

 

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Oct 22, 2020

Moderna completes enrollment for the late-stage (Phase 3) study of its mRNA-1273, having reached its target of enrolling 30,000 volunteers. GW and all clinical trial sites cease enrolling new volunteers.

 

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Nov. 23, 2020

GW's clinical team administers its final vaccination to a volunteer. The team will continue to monitor all volunteers for two years. On Nov. 30, Moderna files for Emergency Use Authorization for its vaccine with the U.S. Food and Drug Administration.

 

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Dec. 18, 2020

The U.S. Food and Drug Administration approves Moderna's mRNA-1273 vaccine--which is 94.1% against COVID-19--for emergency use. 

 

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February 24, 2021

GW announces participation in a Phase 2 study to test an adjuvanted recombinant protein-based vaccine candidate developed by Sanofi, in partnership with GlaxoSmithKline.