Experimental COVID-19 vaccine safe, generates immune response
NIAID-sponsored Phasetrial tested mRNA vaccine

Date:
July 14, 2020
Source:
NIH/National Institute of Allergy and Infectious Diseases
Summary:
An investigational vaccine, mRNA-1273, designed to protect against
SARS- CoV-2, the virus that causes coronavirus disease 2019
(COVID-19), was generally well tolerated and prompted neutralizing
antibody activity in healthy adults, according to interim results.



FULL STORY ========================================================================== [Coronavirus vaccine | Credit: (c) myskin / stock.adobe.com] Coronavirus vaccine photo concept (stock image).

Credit: (c) myskin / stock.adobe.com [Coronavirus vaccine | Credit: (c)
myskin / stock.adobe.com] Coronavirus vaccine photo concept (stock image).

Credit: (c) myskin / stock.adobe.com Close An investigational vaccine, mRNA-1273, designed to protect against SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), was generally well tolerated and
prompted neutralizing antibody activity in healthy adults, according
to interim results published online today in the New England Journal
of Medicine.


==========================================================================
The ongoing Phase 1 trial is supported by the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National Institutes
of Health. The experimental vaccine is being co-developed by researchers
at NIAID and at Moderna, Inc. of Cambridge, Massachusetts. Manufactured
by Moderna, mRNA-1273 is designed to induce neutralizing antibodies
directed at a portion of the coronavirus "spike" protein, which the
virus uses to bind to and enter human cells.

The trial was led by Lisa A. Jackson, M.D., MPH, of Kaiser Permanente Washington Health Research Institute in Seattle, where the first
participant received the candidate vaccine on March 16. This interim
report details the initial findings from the first 45 participants ages 18
to 55 years enrolled at the study sites in Seattle and at Emory University
in Atlanta. Three groups of 15 participants received two intramuscular injections, 28 days apart, of either 25, 100 or 250 micrograms (mcg) of
the investigational vaccine. All the participants received one injection;
42 received both scheduled injections.

In April, the trial was expanded to enroll adults older than age 55 years;
it now has 120 participants. However, the newly published results cover
the 18 to 55-year age group only.

Regarding safety, no serious adverse events were reported. More than
half of the participants reported fatigue, headache, chills, myalgia
or pain at the injection site. Systemic adverse events were more common following the second vaccination and in those who received the highest
vaccine dose. Data on side effects and immune responses at various
vaccine dosages informed the doses used or planned for use in the Phase
2 and 3 clinical trials of the investigational vaccine.

The interim analysis includes results of tests measuring levels of
vaccine- induced neutralizing activity through day 43 after the second injection. Two doses of vaccine prompted high levels of neutralizing
antibody activity that were above the average values seen in convalescent
sera obtained from persons with confirmed COVID-19 disease.

A Phase 2 clinical trial of mRNA-1273, sponsored by Moderna, began
enrollment in late May. Plans are underway to launch a Phase 3 efficacy
trial in July 2020.

Additional information about the Phase 1 clinical trial design is
available at ClinicalTrials.gov using the identifier NCT04283461. This
trial was supported in part by the NIAID grants UM1AI148373 (Kaiser
Permanente Washington), UM1AI148576 (Emory University) and UM1AI148684 (Infectious Diseases Clinical Research Consortium). Funding for the
manufacture of mRNA-1273 Phase 1 material was provided by the Coalition
for Epidemic Preparedness Innovations (CEPI).


========================================================================== Story Source: Materials provided by NIH/National_Institute_of_Allergy_and_Infectious Diseases. Note: Content
may be edited for style and length.


========================================================================== Journal Reference:
1. Lisa A. Jackson, Evan J. Anderson, Nadine G. Rouphael, Paul
C. Roberts,
Mamodikoe Makhene, Rhea N. Coler, Michele P. McCullough, James D.

Chappell, Mark R. Denison, Laura J. Stevens, Andrea J. Pruijssers,
Adrian McDermott, Britta Flach, Nicole A. Doria-Rose, Kizzmekia
S. Corbett, Kaitlyn M. Morabito, Sijy O'Dell, Stephen D. Schmidt,
Phillip A. Swanson, II, Marcelino Padilla, John R. Mascola,
Kathleen M. Neuzil, Hamilton Bennett, Wellington Sun, Etza Peters,
Mat Makowski, Jim Albert, Kaitlyn Cross, Wendy Buchanan, Rhonda
Pikaart-Tautges, Julie E. Ledgerwood, Barney S. Graham, John
H. Beigel, for the mRNA-1273 Study Group. An mRNA Vaccine against
SARS-CoV-2 -- Preliminary Report. New England Journal of Medicine,
July 14, 2020; DOI: 10.1056/NEJMoa2022483 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/07/200714171338.htm

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