Phase 3 clinical trial of clinical trial vaccine for COVID-19 begins

A Phase 3 clinical trial designed to evaluate whether the investigational vaccine can prevent adult symptomatic coronavirus disease 2019 (COVID-19) has begun. The vaccine, known as mRNA-1273, was co-developed by Moderna, Inc., a biotechnology company based in Cambridge, Mass., and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. It was The trial, conducted at a US clinical research site, will enroll approximately 30,000 adult volunteers without COVID-19.

“Face covering, physical distance, and proper isolation and isolation of infected individuals and contacts can help mitigate the spread of SARS-CoV-2, but safe and effective precautions are urgent. Is required vaccine NIAID director Anthony S. Fauci, MD, finally decided to control this pandemic, “The results of early-stage clinical trials show that the mRNA-1273 vaccine under investigation is safe and immunogenic. And supports the initiation of Phase 3 clinical trials: This scientifically rigorous, randomized, placebo-controlled trial determines whether vaccines can prevent COVID-19 and how long such protection lasts Is designed to do.”

Moderna is the sponsor of the clinical trial and provides the clinical trial vaccine for clinical trials. The Bureau of Biomedical Advanced Research and Development (BARDA) and NIAID, the Secretariat for the US Department of Health and Human Services’ Assistant Secretary for Preparation and Response, are funding clinical trials. The vaccine efficacy trial will be conducted first under the Operation Warp Speed, a HHS-led multi-agency collaboration aimed at accelerating the development, manufacturing, and distribution of COVID-19 healthcare measures. ..

“Getting a safe and effective vaccine to be delivered by the end of 2020 is a big goal, but it’s the right one for Americans,” said Dr. Francis S. Collins of NIH. “Starting this Phase 3 trial in record time while maintaining this rigorous safety measure was a combination of American ingenuity and stakeholder impractical objectivity towards a common goal. Shows what you can do.”

The NIH Coronavirus Prevention Network (CoVPN) will participate in conducting the exam. This network brings together the expertise of existing clinical research networks supported by NIAID. The mRNA-1273 vaccine candidate has been tested at approximately 89 clinical research sites in the United States, 24 of which are part of CoVPN. Using public health data and incidence trajectory modeling, investigators can identify areas of persistent high incidence and emerging hot zones, and preferentially register sites near these locations. I will.

“Thanks to President Trump’s leadership and the efforts of American scientists, the clinical vaccines developed by NIH and Moderna have reached this phase III trial at a record pace,” said HHS General Secretary Alex Hazard. It was “Operation Warp Speed ​​supports a portfolio of vaccines like the NIH/Modana Candidate. Clinical trial Compliant with FDA’s gold standards, these products reach Americans in less than a day. “

NIAID scientists have developed a stabilized SARS-CoV-2 spiked immunogen (S-2P). SARS-CoV-2 is a virus that causes COVID-19. The spike proteins on its surface facilitate cell entry. Moderna’s mRNA-1273 encodes the S-2P immunogen using the mRNA (messenger RNA) delivery platform. The investigational vaccine expresses spike proteins in cells of the body and induces a wide range of immune responses. In Phase 1 clinical trials, the candidate vaccine was found to be safe, generally well tolerated, and able to induce antibodies with high levels of virus neutralizing activity. Moderna began Phase 2 trials of the vaccine in May 2020.

Hana M. Elsally, MD, principal investigator at the NIAID-funded Infectious Diseases Clinical Research Consortium Site at the Baylor College of Medicine in Houston. Lindsey R. Baden, MD, Principal Investigator, Harvard HIV Vaccine Clinical Trials Unit, funded by NIAID at Brigham and Women’s Hospital in Boston. Dr. Brandon Essing, MD, MD, Principal Investigator and Director of Medicine at Meridian Clinical Research, will be the Co-Principal Investigator for the Phase 3 trial of mRNA-1273.

As part of accelerating the COVID-19 Therapeutic Intervention and Vaccine (ACTIV) Public-Private Partnership, NIH and other HHS agencies and government partners are working with representatives of academia, charities and numerous biopharmaceutical companies to: Advised on the design of trial protocols and endpoints to ensure a harmonized approach across the efficacy of multiple vaccines trial..

This study aims to evaluate the safety of mRNA-1273 and determine if the vaccine can prevent symptomatic COVID-19 after two doses. As a secondary goal, the study also aims to study whether the vaccine can prevent severe COVID-19 or test-confirmed SARS-CoV-2 infections with or without disease symptoms. I am. The study also answers whether the vaccine can prevent death caused by COVID-19, and among other purposes, prevent symptomatic COVID-19 with a single dose. Is seeking.

Study volunteers will receive two intramuscular injections approximately every 28 days. Participants are randomly assigned 1:1 and receive two 100 microgram (mcg) injections of mRNA-1273 or two shots of saline placebo. The case is blinded, so investigators and participants do not know who is assigned to which group.

Volunteers must provide informed consent to participate in the trial. They have nasopharyngeal swabs Blood sample Additional blood samples for 2 years after the second vaccination, at the first screening visit, and at designated times after each vaccination. Scientists examine blood samples in the laboratory to detect and quantify the immune response to SARS-CoV-2.

The investigator will carefully monitor the safety of the participants. They will call participants to discuss symptoms after each vaccination, provide participants with a diary to record symptoms and a thermometer to measure temperature.

If a participant is suspected of having COVID-19, the participant will be asked to provide a test nasal swab within 72 hours. If the test is positive for SARS-CoV-2 infection, or if symptoms worsen, participants are carefully tracked and referred to a healthcare provider. Participants are required to provide a daily assessment of symptoms through resolution and saliva collection on a regular basis. This allows investigators to test for SARS-CoV-2 infections.

The investigator will regularly review the study safety data. The Independent Data and Safety Oversight Board (DSMB) will review blind and non-blind data at scheduled data review meetings, including safety data and COVID-19 cases in both groups.