GlaxoSmithKline PLC (LSE:GSK) has started phase III trials of a Covid-19 vaccine that will test itself against rival AstraZeneca PLC (LSE:AZN)’s jab.
This study will be one of the first global Phase 3 trials to compare two different Covid-19 vaccine candidates said Glaxo, with AstraZeneca/Oxford University’s Covid-19 vaccine the active comparator in the trial.
Glaxo is working alongside Korean firm SK Bio on the vaccine and will test 4,000 patients in the study.
If successful, the vaccine will be made available to COVAX for distribution globally in the first half of 2022, said the statement.
The final stage study follows a successful phase II study that indicated the candidate was safe and had some effect in preventing infection from the Covid-19 virus.
SK Bio is supplying the vaccine candidate, GBP510, while Glaxo will provide its pandemic adjuvant to help the vaccine work better by boosting the immune response.
Thomas Breuer, GSK’s chief global health officer, said, "While many countries have made good progress with vaccination, there remains a need for accessible and affordable COVID-19 vaccines to ensure equitable access and to protect people across the world.
“The advance to Phase 3 study follows positive interim Phase 1/2 data which showed that all participants who received the adjuvanted vaccine candidate developed strong neutralizing antibody responses, demonstrating a 100% seroconversion rate,” he added.
“Neutralizing antibody titres were between five and a maximum of eight times higher compared to sera from people recovered from COVID-19.”
There were no safety concerns identified to date in this ongoing study.
GBP510 is a self-assembled nanoparticle targeting the receptor-binding domain of the SARS-CoV-2 Spike protein, combined with GSK's pandemic adjuvant.