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Sanofi and GSK launch a new phase 2 study for an anti Covid vaccine with the help of the public agency Barda

Sanofi and GSK launch a new phase 2 study for an anti Covid vaccine with the help of the public agency Barda

Sanofi and GSK launch a new Phase 2 study on their Covid-19 vaccine candidate. All the details and financial support from the American federal agency Barda

New phase 2 study for the vaccine developed by Sanofi and Gsk. The two pharmaceutical companies intend, in this Barda-funded trial, to select the most appropriate antigen dosage for the phase 3 evaluation, which is expected to begin in the second quarter of 2021. Full details.

ANTIGEN REFORMULATION

Sanofi and Gsk start a new trial of the Covid-19 vaccine that exploits the potential of the adjuvanted recombinant protein, with a new formulation of the antigen.

"In recent weeks, our teams have been working to refine the antigen formulation of our recombinant protein vaccine, based on the learnings from our initial Phase 1/2 study," said Thomas Triomphe, Executive Vice President and Chief of Sanofi. Pasteur.

THE EXPERIMENTATION OF SANOFI AND GSK

The new Phase 2 multicenter dose-finding study will involve 720 volunteers, aged 18 and over, in the United States, Honduras and Panama. It will be randomized, double-blind and will evaluate “the safety, reactogenicity and immunogenicity of two injections administered 21 days apart. The study will include an equal number of adults aged 18 to 59 and those aged 60 and over, ”Sanofi explains in a press release.

During the trial, three different doses of antigen will be tested with a fixed dose of adjuvant.

THE FUNDING OF BARDA

The study is funded by the American Biomedical Advanced Research and Development Authority , the American Barda, which had already granted Sanofi an additional $ 30 million in May as part of a loan to develop an influenza vaccine.

THE OLD PHASE 2 STUDY OF THE SANOFI AND GSK VACCINE

There has already been, in fact, a phase 2 study. The results, arriving in December 2020, showed an immune response comparable to that of patients who had recovered from Covid-19 in adults between the ages of 18 and 49. years, but a lower immune response in the elderly. The reason could be the insufficient concentration of the antigen.

PHASE 3 STUDY IN THE SECOND QUARTER 2021

If the data from the new phase 2 study is positive, Sanofi and GSK will launch "a global phase 3 study for the second quarter of 2021. The positive results of the phase 3 study would lead to regulatory requests in the second half of 2021, with the vaccine which should be available in the fourth quarter of 2021, if approved, ”Sanofi says .

WORKING AGAINST VARIATIONS

Parallel to the Phase 2 study, Sanofi has begun development work against new variants of the coronavirus, which will be used to inform the next stages of the Sanofi and Gsk program.


This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/sanofi-e-gsk-avviano-nuovo-studio-di-fase-2-per-vaccino-anti-covid-con-laiuto-dellagenzia-pubblica-barda/ on Tue, 23 Feb 2021 05:35:44 +0000.