NIH is now enrolling older adults for phase 1 trials of COVID-19 vaccine
The vaccine under trial is an mRNA vaccine developed at Moderna Inc, a pharmaceutical company based in Massachusetts, USA.
On April 17, the National Institute of Allergy and Infectious diseases (NIAID), USA, released a piece of news that they are enrolling older candidates (above the age of 55) for phase 1 of the clinical trial of their COVID-19 vaccine.
The trial had begun on March 16 and originally been designed to enrol about 45 individuals between the ages of 18 and 55. Now, the NIAID says that after the first enrollment they are set to enrol older candidates to get a better understanding of the effect of the vaccine and the immunological response against it.
Here is the timeline of the trial.
The first trial
On March 16, the National Institute of Allergy and Infectious diseases, USA, announced that they are beginning phase 1 trial of their COVID-19 vaccine. The clinical trial was to be done at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle and was to enrol 45 healthy candidates in the age group of 18 and 55. They had started recruiting people since March 3, 2020.
The vaccine under trial is an mRNA vaccine developed at Moderna Inc, a pharmaceutical company based in Massachusetts, USA. This vaccine uses pieces of mRNA (nucleic acid) that on being introduced in the body, produce specific viral proteins (but do not cause disease). Our immune system recognises these viral proteins and makes antibodies against them like it was the virus itself. These antibodies will protect against the SARS-CoV-2 virus if the person is exposed to it in a natural setting.
KPWHRI gave the first dose of the vaccine to volunteers in Seattle on March 16.
National Institute of Allergy and Infectious Diseases is an institute under the National Institute of Health, USA. It works for understanding and dealing with infections and allergies. The NIH is funding the Moderna research.
On March 27, NIH also added Emory University, Atlanta as their second site for phase 1 of the clinical trial of the same vaccine.
Both Kaiser and Emory are a part of the NIAID’s Infectious Diseases and Clinical Research Consortium. This consortium consists of all the units that work on the clinical trials of vaccines and treatments under the NIAID as well as a consortium leadership group that consists of investigators of the vaccine and other infectious disease experts.
Under the first trial, the 45 volunteers were to be given two shots of the mRNA vaccine one month apart and a third shot a year later.
The latest developments
After enrolling the first 45 candidates, the NIAID has now announced that they are expanding the original study to include 60 more people. Out of these 60, 30 volunteers would be in the age group of 56 to 70 years and the rest 30 would be above the age of 70.
As per the news release on the NIAID’s page, the trial on younger people have proven to be safe so far and they have not yet noticed any significant safety issues in young volunteers. Now, expanding the trial to include older volunteers would help the scientists to study the effects of the vaccine on the older people (the most high-risk group) and look for side effects, if any, in that age group.
With this trial, the NIH has also included another of its sites - Vaccine Research Center (VRC) clinic in Bethesda, Maryland - increasing the total testing sites to three.
All the three sites will now be enrolling candidates and once the enrollments are complete, all the volunteers would be given the Moderna vaccine as per the same schedule as was tested in younger adults - 2 doses one month apart and a third after a year.
The NIH will keep releasing all the data as soon as they can to make it available to public health officials and the scientific community.
For more information, read our article on WHO Solidarity Project to find a treatment for COVID-19.
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