By CAPosts 22 February, 2021 - 06:59pm 187 views
Sanofi and GSK announced the initiation of a new phase 2 study with 720 volunteers over 18 years of age to select the most appropriate antigen dose for their adjuvanted recombinant protein covid-19 vaccine candidate.
© Provided by Milenio La Sanofi's new vaccine will be developed in conjunction with the pharmaceutical company Translate Bio. (Reuters)
"Over the past few weeks, our teams have worked to refine the antigen formulation of our recombinant protein vaccine, building on what we learned from our initial Phase 1/2 study," said Thomas Triomphe, executive vice president and director, Sanofi Pasteur.
“We are confident that our candidate vaccine has great potential and we are very encouraged by the latest preclinical data. This new phase 2 study will allow us to identify the final formulation of the vaccine for adults of all ages. We have demonstrated our commitment to focus efforts and capabilities towards the global fight against the pandemic, and this new study brings us one step closer to achieving our main objective of developing a covid-19 vaccine with a good efficacy and safety profile . " added.
Roger Connor, President of GSK Vaccines, added: “We are pleased to begin this new phase 2 study. The world needs multiple vaccines and we are confident that the combination of our proven pandemic adjuvant system with this improved antigen formulation will have potential. significant as the pandemic evolves . We hope to continue advancing with this vaccine candidate for phase 3 in the second quarter of 2021, if this phase 2 study is successful. "
Parallel to the new phase 2 study, and recognizing the global emergence of new variants of SARS-CoV- 2 and its potential impact on the efficacy of the vaccine, Sanofi has begun development work against new variants , which will be used to inform the next stages of the Sanofi / GSK development program.
The new phase 2 study is searching randomized, double-blind, multicenter dose- testing procedure performed in adults 18 years of age and older to assess the safety, reactogenicity, and immunogenicity of two injections given 21 days apart . The study will include an equal number of adults ages 18 to 59 years and 60 years or más.
be tested three different doses of antigen with a fixed dose of adjuvant in a total study population of 720 volunteers in the United States, Honduras and Panama. the results of The phase 2 study will inform the phase 3 protocol.
In December 2020, the results of the phase 1 and 2 study showed an immune response comparable to that of patients who had recovered from COVID-19 in adults aged 18 to 49 years, but with a lower immune response in older adults, probably due to insufficient antigen concentration
If the data from the new Phase 2 study is positive, a global Phase 3 study is planned for the second quarter of 2021 . the positive results of the phase 3 study would result in regulatory submissions in the second half of 2021 and it is expected that, if approved, the vaccine is available in the fourth quarter 2021.
the advance of the test program is supported of the United States Advanced Biomedical Research and Development Authority (BARDA), part of the Office of Health and Human Services of the Assistant Secretary for Preparedness and Response in virtu d of contract W15QKN-16-9-1002.
Sanofi and GSK's adjuvanted recombinant protein-based covid-19 vaccine candidate was selected in July 2020 by the United States government to accelerate its development and manufacture.
The partnership consists of : Sanofi provides its recombinant antigen and GSK provides its pandemic adjuvant , both established vaccine platforms that have proven successful against influenza
Recombinant technology combined with GSK adjuvant offers the benefits of temperature stability used for routine vaccines, the ability to generate sustained and elevated immune responses and the potential to prevent transmission of the virus.
In addition to the recombinant protein-based vaccine in collaboration with GSK , Sanofi is developing a messenger RNA vaccine in association with Translate Bio.
Preclinical data showed that two immunizations of the mRNA vaccine induced high levels of neutralizing antibodies that are comparable to the upper range of those seen in infected humans. Sanofi and Translate Bio plan to begin a Phase 1 and 2 study in the first quarter of 2021.
Sanofi previously announced an agreement with Pfizer-BioNTech under which Sanofi will support the manufacture and supply of more than 125 million doses of its covid-19 vaccine.