Coronavirus Vaccine Phase 3 Study Recruiting 30,000 Participants
According to the US National Institutes of Health (NIH), a Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun.
This late-stage study is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19 disease, which is caused by the SARS-CoV-2 betacoronavirus.
The NIH stated on July 27, 2020, the vaccine candidate, known as mRNA-1273, was co-developed by the Massachusetts-based company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID).
NIAID scientists developed the stabilized SARS-CoV-2 spike immunogen (S-2P). The spike protein on its surface facilitates entry into a cell.
Moderna’s mRNA-1273 uses the mRNA (messenger RNA) delivery platform to encode for an S-2P immunogen. The investigational vaccine directs the body’s cells to express the spike protein to elicit a broad immune response.
The vaccine efficacy trial is the first to be implemented under Operation Warp Speed, a US multi-agency collaboration that aims to accelerate the development, manufacturing, and distribution of medical countermeasures for COVID-19. https://www.coronavirustoday.com/covid-19-disease
US Health Secretary Alex Azar added, “Operation Warp Speed is supporting a portfolio of vaccines like the NIH/Moderna candidate so that, if the results of clinical trials meet FDA’s gold standard, these products can reach Americans without a day’s delay.”
The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms.
The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.
Trial volunteers will receive 2-intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram injections of mRNA-1273 or 2-shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.
Volunteers must provide informed consent to participate in the trial. They will be asked to provide a nasopharyngeal swab and a blood sample at an initial screening visit and additional blood samples at specified time points after each vaccination and over the 2-years following the second vaccination. Scientists will examine blood samples in the laboratory to detect and quantify immune responses to SARS-CoV-2.
Investigators will closely monitor participant safety. They will call participants after each vaccination to discuss any symptoms and will provide participants with a diary to record symptoms and a thermometer for temperature readings.
If a participant is suspected to have COVID-19, the participant will be asked to provide a nasal swab for testing within 72 hours. If the test is positive for SARS-CoV-2 infection, the participant will be followed closely and referred for medical care if symptoms worsen.
Participants will be asked to provide a daily assessment of symptoms through resolution and have saliva sampled periodically, so investigators can test for SARS-CoV-2 infection.
Study investigators will regularly review trial safety data. An independent data and safety monitoring board will review blinded and unblinded data—including safety data and cases of COVID-19 in both groups—at scheduled data review meetings.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” said NIH Director Francis S. Collins, M.D., Ph.D., in a related press statement.
“The launch of this Phase 3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal.”
As part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, NIH and other HHS agencies and government partners, in collaboration with representatives from academia, philanthropic organizations and numerous biopharmaceutical companies, advised on the trial protocol design and endpoints to ensure a harmonized approach across multiple vaccine efficacy trials.
The NIH is the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services.
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