Emory University’s Vaccine and Treatment Evaluation Unit (VTEU) joins a state-of-the-art Phase I clinical trial assessing Moderna’s mRNA-1273 as a potential COVID-19 vaccine. The study started out west at the Kaiser Permanente Washington Health Research Institute. Is the mRNA-based vaccine safe and effective? Hopefully the world will know soon.
A Phase I, open-label, dose ranging clinical trial in males and non-pregnant females age 18 to 55, the participants must be in good health and of course meet all eligibility criteria. The sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), seeks to assess this novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccines that encodes for a full-length prefusion stabilized spike (S) protein of SARS-CoV-2.
The study includes 45 participants enrolled into one of three cohorts; each one will receive an intramuscular (IM) injection of mRNA-1273 on days 1 and 29 in the deltoid muscle. The participants will be followed through for 12 months post second vaccination on day 394. NIAID and the clinical investigators will assess the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, administered 28 days apart across three dosages in healthy participants.
What is mRNA-1273?
Developed by Moderna, mRNA-1273 leverages the emerging mRNA platform. They have demonstrated its potential in vaccines across more than 1,000 subjects in clinical trials according to their website. This has included what they report as a successful early-stage study against five other respiratory viruses (two pandemic influenza strains, RSV, hMPV and PIV3) and have initiated a total of nine clinical trials.
An information molecule, they design their mRNA vaccine utilizing the sequence of the virus and not the actual virus itself. Hence their platform supports faster development. They presently have nine development candidates in its prophylactic vaccines’ modality with some evidence of success based on Phase I outcomes for 6 prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3 and CMV).
How was it Created?
SARS-CoV-2 are circular and have spikes protruding from their surface and have SSRNA as their genetic material. Human cells also include various receptors on their surfaces that the virus can exploit for entry. Now researchers have uncovered that spikes of the virus latch on to human cells using the ACE2 receptor. After this handshake between the virus and the human cell, some structural changes allow the viral membrane to fuse with the human cell membrane. Then the viral genes can penetrate the human cell and produce more viruses.
Scientists have learned a lot about this virus. For example, they analyzed the structure of this spike using cryo-electron microscopy. This process included 1) freeze the virus 2) bombard with high energy electrons 3) produce images and 4) create a 3D structure of the virus. At Moderna the scientists used high powered 3D images to help develop mRNA-1273. Upon injection into the human cell, mRNA1273 will make the viral protein. Research scientists hope that the viral protein will awaken the human immune response and help protect the body against the virus.
And in fact, mRNA-1273 worked in an animal models and this is the first attempt to test in humans.
David S. Stephens, MD, IDCRC contact Principal Investigator, Professor and chair of the Department of Medicine, Emory University School of Medicine; vice president for research of Emory Woodruff Health Sciences Center