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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.”
National Institutes of Health, News release
NIH clinical trial of investigational vaccine for COVID-19 begins
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