Sanofi (NASDAQ: SNY) and GlaxoSmithKline Plc (NYSE: GSK) disclosed that they have commenced the Phase II study of their adjuvanted recombinant protein COVID-19 vaccine candidate. Both the firms will enroll 720 participants of age 18 and above.
The Phase II study is carried out by the firms to identify the protection of two injections given 21 days away from each other. Three unique antigens will be assessed in a total of 720 participants. The purpose of the Phase II study is to choose a more suitable antigen prescription for the Phase III research.
Sanofi and GSK have been striving for the past weeks to enhance the antigen preparation of their recombinant-protein vaccine, based on the data from its preliminary Phase 1/2 research. The Phase II research of the firm is to design the vaccine for adults of all ages. Sanofi has been endeavoring to stop the spread of the virus.
GSK has also stated that currently, the world needs several vaccines to fight against the emerging variants. Sanofi has also started the advancement against new variants whilst the start of Phase II research. Phase II study will enroll adults of 18 to 59 years of patients and adults above 60 years of age.
In three different locations, three different antigen dosages will be assessed. The trial program of the firm will be backed by US BARDA. US government has chosen Sanofi and GSK’s recombinant protein-based COVID-19 in July 2020. In the trials, Sanofi is offering recombinant antigens and GSK will provide its pandemic adjuvant. The firms have disclosed that if results are positive, Phase 3 study to commence in Q2 2021, with vaccine anticipated to be accessible in Q4 2021.