Clinical Trials with Experimental COVID-19 Vaccine

Posted on 2020-07-24

Global efforts to find a suitable vaccine for COVID-19 have increased with urgency in the past few months, as clinical trials have begun all around the world. One of the vaccines currently being trialed is mRNA-1273, an experimental vaccine designed to protect against SARS-CoV-2. This has been found to be generally well-tolerated, prompting neutralizing antibody activity in healthy adults.

Trials are currently in Phase 1, with the support of the National Insitute of Allergy and Infectious Diseases (NIAID). The vaccine is being co-developed by researchers at NIAID and Moderna, Inc. who have manufactured the investigational vaccine at Cambridge, Massachusetts. It is designed to induce neutralizing antibodies directed at a portion of the SARS-CoV-2 Spike Protein. The virus uses this to bind to and enter human cells.

Led by Lisa A. Jackson, M.D., MPH of Kaiser Permanent Washington Health Research Institute, the trial in Seattle began with the first participant receiving the candidate vaccine on March 16. Initial findings from the first 45 participants (aged 18 - 55 years old) are detailed below.

Three groups of 15 participants received two intramuscular injections, 28 days apart, of 25, 100, or 250 micrograms (mcg) of the vaccine. All participants received at least one injection, 42 received both of the scheduled injections.

In April, the trial expanded to include adults older than 55 years of age, and now makes up 120 participants. The newly published results have, however, only covered the 18 - 55-year-old age group thus far.

No serious adverse events have been reported. Side effects reported by more than half of the participants include fatigue, headache, chills, myalgia, or pain at the injection site. Systemic side effects were more common in the participants who received the highest vaccine dose, following the second vaccination.

Observed levels of vaccine-induced neutralizing activity through day 43, following the second injection, were included in the interim analysis. Two doses of the vaccine induced high levels of neutralizing antibody activity; activity which exceeded the average values measured in convalescent sera collected from confirmed COVID-19 positive individuals.

Data on these adverse events at various dosages helped inform the doses planned for use in Phase 2 and 3 of the clinical trials.

Phase 2 trialling the use of mRNA-1273 began enrolment in late May. They are hoping to launch a Phase 3 efficacy trial in July 2020, sponsored by Moderna.

You can find out more information on Phase 1 of this clinical trial at ClinicalTrials.gov using NCT04283461. Trials are also showing promise across the world, with more than 100 projects focused on the development of a COVID-19 vaccine. For example, the University of Oxford in England are running a clinical trial using the ChAdOx1 nCoV-19 vaccine.

Abbexa are proud to offer an extensive range of SARS-CoV-2 products for research into COVID-19. View the full list of products here.

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