GBP510 has been approved for Phase 3, the 1st time in Korea

GBP510, comparable to AZ vaccine for a total of 3,990

Domestic developed COVID-19 vaccine has entered the final stage of commercialization.

 

A candidate for the COVID-19 vaccine developed by SK Bioscience will conduct phase 3 clinical trial.

 

The MFDS announced on Tuesday that it approved phase 3 clinical trial plan for the first domestic COVID-19 vaccine after thoroughly verifying its safety and scientific feasibility.

 

With the approval, COVID-19 vaccine developed by a Korean company will enter phase 3 clinical trial for the first time.

 

GBP510 is a recombinant vaccine that injects surface antigen protein of the coronavirus created using genetic recombination technology to induce immune response, stimulating immune cells in the body and neutralizing and eliminating the virus when it enters the body.

 

This vaccine has been developed to enhance immune effectiveness by generating a large number of antibodies, especially by utilizing techniques that increase antigen exposure.

 

The three-phase clinical trial approved this time is a clinical trial to evaluate the immune origin and safety of GBP510 for adults aged 18 and older.

 

phase 3 clinical trial is conducted in a comparative clinical manner using Astrazeneca COVID-19 vaccine stocks, which are licensed in Korea and used for vaccination, as a control group.

 

As a control group, AstraZeneca COVID-19 Vacine was selected, considering the absence of a licensed COVID-19 recombinant vaccine.

 

and was designed to confirm the superiority of neutral antibodies and the non-equivalence of serum reactions.

 

Neutralized antibodies are the amount of antibodies that can neutralize a particular virus, and the serum reaction rate is the percentage of test subjects whose antibody price increases more than four times compared to before vaccination.

 

The total number of test subjects is 3,990, 3,000 for the test vaccine, and 990 for the control group will be vaccinated twice every four weeks with 0.5 mg each, and safety and immunogenicity will be evaluated.

 

Phase 3 will be conducted simultaneously not only in Korea but also in Southeast Asia and Eastern Europe.

 

Phase 3 clinical trial is a test to verify the safety and validity of a drug, and its validity is reviewed based on the results of a prior clinical trial, quality of a clinical drug, non-clinical data, etc.

 

In the case of GBP510, phase 2 is currently in progress, but phase 1 showed sufficient safety and immunogenicity, showing the possibility of entering phase 3.

 

After phase 1 and phase 2 was approved on January 26, a phase 1 clinical trial was conducted on 80 healthy adults (ages 19 to 55 years old) and a phase 2 clinical trial is underway on 240 people.

 

As a result of phase 1 intermediate analysis, neutralized antibodies were produced in all vaccinators in terms of efficacy, which was more than five times higher than that of the International Standard Serum (perfection and autoclave).

 

No special side effects have been reported other than cases (injection pain, fatigue, muscle pain, headache, etc.) that are common when vaccinated.

 

In addition, the MFDS explained that it reviewed non-clinical test data such as reproductive toxicity and animal model attack tests, and quality data such as batch analysis results.

 

The MFDS held an advisory meeting with clinical experts on the 9th and consulted on the appropriateness of the evidence data and feasibility of the clinical trial plan to enter phase 3.

 

The MFDS said the approval of the clinical trial is meaningful that it has taken the first step toward self-sufficiency of the domestic vaccine as the first domestic vaccine enters phase 3 amid the coronavirus epidemic.

 

Even though there is no global vaccine leader, it approved phase 3 clinical trials for the development of the COVID vaccines in Korea, and even before the establishment of the Immunological Correlate of Protection (ICP), it introduced a comparative clinical method with active and close screening.

 

Immunological Correlate of Protection(ICP) is most commonly defined as a type and amount of immunological response that correlates with vaccine-induced protection against a clinically apparent infectious disease and that is consider The MFDS stressed that it will continue to communicate with the clinical site after the product's clinical approval so that clinical trials can proceed smoothly, and other products that are undergoing clinical trials in Korea can quickly enter phase 3.

 

It also added that it will thoroughly monitor safety issues such as unexpected adverse reactions of clinical trial participants and medication information that affects clinical trials, and make sure clinical trials are carried out safely.