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Phase 1 human studies initiated for a vaccine to protect against COVID-19

Phase 1 human studies initiated for a vaccine to protect against COVID-19 Phase 1 human studies initiated for a vaccine to protect against COVID-19
Phase 1 human studies initiated for a vaccine to protect against COVID-19 Phase 1 human studies initiated for a vaccine to protect against COVID-19

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Enrolment of healthy volunteers in phase 1 clinical study evaluating the safety of an investigational vaccine for COVID-19 has been started by the National Institute of Allergy and Infectious Diseases and Moderna, Inc. in USA.

As per a recent report of National Institutes of Health (NIH), the phase 1 clinical trial of the investigational vaccine for COVID-19 has been initiated at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, USA.

The funding agency of this trial is National Institute of Allergy and Infectious Diseases (NIAID) an institution under NIH. This open-label study has been designed to enrol 45 healthy volunteers between 18 to 55 years of age. The study will be estimating safety and ability to induce an immune response in participants of different doses of the investigational vaccine.

This vaccine is designed by NIAID in collaboration with a biotech company Moderna, Inc., Massachusetts, and named it as mRNA-1273. This fast attempt to start the Phase 1 study is an important first step toward protecting against COVID-19. As there is no vaccine for COVID-19 so far this investigational vaccine was quickly developed based on the prior studies of related coronaviruses causing severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS).

The investigational vaccine is hoped to evoke a strong immune response to prevent COVID-19 in future. The vaccine has shown promising results during animal studies. Lisa A. Jackson, M.D., a senior investigator at KPWHRI is leading the Phase 1 of human studies. The participants will be divided into 3 groups with 15 participants in each. The 3 groups will receive 25 micrograms (mcg), 100 mcg or 250 mcg dose of the vaccine administered as 2 doses of vaccine via intramuscular injection in the upper arm with a gap of 28 days. Safety data will be reviewed by the researchers before administering 2nd dose to 25 mcg and 100 mcg groups and before enrolment of participants in 250 mcg groups. Along with any medical issues, common vaccination symptoms like fever or soreness at the injection site will be monitored by a team of clinicians. Participants will be followed up for 1 year post-2nd dose of vaccine. The immune response to the experimental vaccine will be examined in the blood samples of the study participants.

Dr Jackson said, "this work is critical to national efforts to respond to the threat of this emerging virus.”

Source:

National Institutes of Health, News release

Article:

NIH clinical trial of investigational vaccine for COVID-19 begins

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