South Korean company SK bioscience (SK)’s COVID-19 vaccine candidate, GBP510, will be compared directly to the AstraZeneca/Oxford University COVID-19 vaccine in a new clinical trial, GlaxoSmithKline (GSK) has announced.
Enrolling around 4,000 participants from a number of countries, the randomised, active-controlled global trial will evaluate the safety and immunogenicity of GBP510 in combination with GSK’s pandemic adjuvant.
GBP510 is a self-assembled nanoparticle vaccine candidate targeting the receptor binding domain of the SARS-CoV-2 spike protein. It is being developed by SK in collaboration with the Institute for Protein Design (IPD) at the University of Washington with support from the Bill & Melinda Gates Foundation (BMGF) and Coalition for Epidemic Preparedness Initiative (CEPI) as part of the ‘Wave 2’ vaccine investment project to develop more accessible and affordable COVID-19 vaccines.
The move to phase 3 trial follows ‘promising interim data’ from phase 1/2 for GBP510. In the first stage of the trial, 80 healthy adults received the adjuvanted vaccine, showing a 100% seroconversion rate, while in the second stage, no adverse events were reported by the 247 participants, which included elderly people.
The study will be one of the first global phase 3 trials to compare two different COVID-19 vaccine candidates, following French biotech Valneva’s announcement in April of phase 3 testing of its COVID-19 vaccine candidate against AstraZeneca’s Vaxzevria.
Thomas Breuer, chief global health officer, GSK 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. We are pleased to contribute with GSK’s pandemic adjuvant and to be working with SK to deliver the vaccine at scale via COVAX if it is approved.”
Although GSK has been a relative latecomer in the COVID-19 vaccine race, this trial marks its second move in recent months. GSK is also supplying its adjuvant for use with a Sanofi-partnered shot, Vidprevtyn, which started a 35,000-patient phase 3 trial in May. The European Medicines Agency has already started a rolling review of the Sanofi/GSK vaccine.