# of subjects in Phase 3 of SK's COVID vaccine is 93

"Nothing has been decided yet," the company said, accounting for 2.3% of the 3,990

The MFDS recommended more than 10% of domestic subjects and implemented 14 hospitals in Korea

SK Bioscience researcher is conducting research to develop vaccines

When looking at SK Bioscience's clinical plan for "GBP510," which entered phase 3 for the first time as a vaccine developed in Korea, the number of people tested in Korea was 93.

 

This is only 2.3% of 3,990.

 

The MFDS recommends that domestic test subjects recruit more than 10% of the total subjects for domestic development vaccines, which is not enough.

 

Accordingly, SK Bioscience said, "There are 93 test subjects in Korea based on the approved plan," adding, "Nothing has been decided yet." The clinical trial plan for SK Bioscience's COVID-19 vaccine "GBP510," approved by the MFDS on the 10th, contains this.

 

GBP510 is a recombinant vaccine that injects surface antigen protein of COVID, which is made using genetic recombination technology, to induce immune responses.

 

When surface antigen protein is administered, it stimulates immune cells in the body to induce the production of neutralized antibodies, and neutralizes and removes the virus when COVID enters the body.

 

In particular, it increases immune effects by exposing antigens to produce a lot of antibodies.

 

The vaccine includes GSK's immune enhancer "AS03.

 

In January, SK Bioscience received approval for phase 1/2 and is currently completing phase 1 and proceeding with phase 2.

 

It was planned to recruit 320 people (80 people for phase 1 and 240 for phase 2).

 

According to the company, as a result of phase 1 administering GBP510 to 80 healthy adults, antibodies that neutralize COVID were formed in the entire dosing group, which was administered with immune enhancers, showing 100% neutral antibody formation rate.

 

The level of inducing neutralized antibodies is five to eight times higher than that of serum panels of people cured of COVID-19.

 

In terms of safety, no significant adverse event has occurred that is related to the administration of GBP510.

 

It is also explained that 247 participants in phase 2, which includes elderly people, have completed the second injection in late June and are monitoring safety, and no special safety issues have occurred so far.

 

Based on the interim results of phase 1/2, SK Bioscience applied to the MFDS for phase 3 in June.

 

Phase 3 is conducted in multi-agency, parallel comparison, observer blindfolding, active contrast, and random allocation to evaluate the immunogenicity and stability of COVID-19 vaccine using immunosuppressive AS03 in adults over the age of 18.

 

To confirm this, it is conducted in a comparative clinical manner with AZ vaccine.

 

The test vaccine will be given to 3,000 people out of 3,990 test subjects, and the control vaccine will be given to 990 people twice every four weeks, 0.5ml each.

 

The number of test subjects in Korea was 93 people.

 

This is not more than 10% of all test subjects recommended by the MFDS.

 

The MFDS recommended in its comparative clinical guidelines for the domestic COVID vaccine that multinational clinical trials, including more than 10% of the domestic population, are possible.

 

However, SK Bioscience said that there are 93 subjects in the plan, but nothing has been decided yet.

 

Clinical trials will be conducted in South Korea, Southeast Asia, and Eastern Europe.

 

It will be held at Korea University Medicine, Ewha womans university medical center, KNUH Chilgok, Hallym University Medical Center, Severance Hospital, CNHU, KNUH, Dong-A university hospital, Inha university hospital, Ajou University Hospital , Korea University Ansan Hospital, Korea University Guro Hospital.

 

It is expected that interim analysis results of Phase 3 will be produced as early as the first quarter of next year.

 

Based on this, the MFDS plans to conduct a quick review.