Sanofi and GSK conducts Phase 3 trial of the vaccine
Sanofi and GlaxoSmithKline (GSK) have been approved to conduct phase 3 clinical studies in India to evaluate the safety, efficacy and immunogenicity of their COVID-19 adjuvant recombinant protein vaccine candidates. In a statement on Thursday, Sanofi said that the global, randomized, double-blind Phase 3 study would include more than 35,000 volunteers aged 18 and over in the United States, Asia, Africa and Latin America.
Annapurna Das, Country head, Pasteur India, said: “India is participating in the key phase 3 study of Sanofi Pasteur. After obtaining follow-up approval, we should start recruiting research participants in the country soon. She added that as the virus continues to evolve, “we anticipate what will be necessary for the coming months and years, and adjust our vaccine development plan accordingly.”
Das said the vaccine could make a significant contribution to the fight against COVID-19. Sanofi said the study’s primary endpoint is to prevent symptomatic COVID-19 in adults who are not infected with SARS-CoV-2, and the secondary endpoint is to prevent severe COVID-19 disease and prevent asymptomatic infection.
In a two-stage approach, the study will first investigate the efficacy of vaccine formulations against the parent virus strain. In contrast, the second phase will test a second formulation against Beta variants, she added.
The statement said that the design of the third phase of the study was carried out in a wide geographic range and allowed the evaluation of the efficacy of the candidate drugs against several popular variants. In addition, Sanofi and GlaxoSmithKline will also conduct clinical studies to evaluate the ability of the COVID-19 vaccine candidate recombinant adjuvant protein to produce a strong response regardless of the type of vaccine initially received.
Sanofi said that the combination of recombinant technology and GlaxoSmithKline’s adjuvant is designed to provide the advantages of being stable at the temperatures used in conventional vaccines, making it easy to deploy, and through the existing vaccine storage infrastructure worldwide, easy to distribute.
In addition to the adjuvant recombinant protein vaccine developed in cooperation with GlaxoSmithKline, Sanofi has also developed a messenger RNA vaccine in cooperation with Translate Bio.