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* Phase 1/2 trial enrols 440 adults in the U.S.
* Final testing stage expected to start in December
(Recasts with detail, context)
By Sudip Kar-Gupta
PARIS, Sept 3 (Reuters) - French drugmaker Sanofi
and Britain's GlaxoSmithKline said they had started a
clinical trial of their protein-based COVID-19 vaccine
candidate, and aimed to reach the final testing stage by
December.
If the results are conclusive, Sanofi and GSK hope to get
the vaccine approved in the first half of next year.
The trial is currently in a "Phase 1/2 study" aimed at
evaluating the safety, tolerability and immune response of the
vaccine in 440 healthy adults across 11 investigational sites in
the United States.
The vaccine candidate uses the same recombinant
protein-based technology as one of Sanofi's seasonal influenza
vaccines. It will be coupled with an adjuvant, a substance that
acts as a booster to the vaccine, made by GSK.
The two companies are scaling up manufacturing in order to
be ready to produce up to one billion doses in 2021.
Drugmakers and government agencies worldwide are racing to
develop vaccines and treatments for COVID-19, the illness caused
by the new coronavirus, which has claimed more than 861,000
lives and crippled economic activity around the globe. (https://tmsnrt.rs/3aIRuz7)
Sanofi and GSK are not the first in the race - several
vaccine candidates have already reached the final, wider testing
stage known as "Phase 3" - but they believe their respective
experience in the fields of vaccines is an advantage.
The French group is also working on another vaccine
candidate to prevent COVID-19 with U.S. company Translate Bio
which will rely on a different technology called mRNA.
In an interview with Reuters last week, Sanofi's CEO Paul
Hudson said readings of preclinical data had increased the
group's confidence in its two coronavirus vaccine candidates.
Sanofi and GSK have secured deals for the
vaccine-plus-adjuvant with the United States and Britain, and
are in advanced talks with the European Union to supply it with
up to 300 million doses.
They also plan to supply COVAX, a COVID-19 vaccine and
treatment allocation plan co-led by the World Health
Organization (WHO) that aims to help buy and fairly distribute
shots across the globe.
Earlier this month, Sanofi said a rheumatoid arthritis drug,
Kevzara, had failed as a COVID-19 treatment.
(Reporting by Sudip Kar-Gupta; Additional reporting by Matthias
Blamont; Editing by Tom Hogue, Uttaresh.V and Hugh Lawson)
