In a study published in the NEJM, researchers announced the candidate vaccine mRNA-1273 appeared to prompt an antibody response that neutralized the SARS-CoV-2 virus, which causes COVID-19. The trial included 45 healthy adults aged between 18 and 55 years old.
They received two vaccines, 28 days apart, with participants given different doses. The antibody response was found to be higher among those who received a higher dose after the first injection. However, after the second dose, serum-neutralizing activity was reported in all participants.
The vaccine development is being supported by the National Institute of Allergy and Infectious Diseases (NIAID). It aims to create antibodies that can neutralize the virus at its “spike protein.” This is the spiky outer layer seen in images of the virus that help it enter a host cell.
A recently published analysis showed the spike protein of SARS-CoV-2 is far more stable than its closest known relative, and is able to bind to human cells around 1,000 tighter.
In a statement, the NIAID said the vaccine will now move to Phase 3 clinical trials. This is the stage of drug development where a product has been deemed safe and efficient in smaller human trials, so now moves to larger groups of people for testing. In the Phase 2 trial, no serious side effects were found.
Over half of participants reported headaches, fatigue, chills and pain at the injection site. These symptoms were more common after the second injection and among those who received the higher dose.
The NAIAD says plans are now “underway” to start the trial this month. A trial has now been posted to the National Institutes of Health’s clinical trials website on July 14. It says it will enroll an estimated 30,000 participants for a randomized trial, with participants either given the vaccine or a placebo. The trial is expected to begin on July 27 and end on October 27.
To be eligible to enroll, people must be over the age of 18 and healthy. They must be at risk of SARS-CoV-2 infection. Women must not be pregnant and must agree to use contraception throughout the study period. They must also not be breastfeeding. Men must refrain from sperm donation from the point of the first dose and for three months before enrollment.
People not eligible to join include those who have already been infected with SARS-CoV-2, people who are acutely ill, have previously been infected with the coronaviruses MERS-CoV and SARS.
Trials will be taking place at 87 locations across the U.S.. A full list can be found at the end of the NIH’s clinical trial page, along with contact details for Moderna’s clinical trials. Researchers are not yet recruiting for the trial. More details will become available on how to enrol once recruitment opens. Further information on the trial will also be available via Moderna’s COVID-19 vaccine page.
You can also register interest in volunteering for clinical trials of COVID-19 vaccines under development via the NIAID here. The COVID-19 Prevention Network has been set up to combine four clinical trial networks dedicated to the new coronavirus, including the Moderna trial.
