Genexine Changes COVID-19 Vaccine Clinical Strategy with 'Booster Shot'

Number of Clinical Participants Reduced from 30,000 to 14,000

[Asia Economy Reporter Jihee Kim] Genexine announced on the 30th that it has changed the target population for the global Phase 2/3 clinical trials of its COVID-19 vaccine candidate ‘GX-19N’ from healthy adults to adults who have previously been vaccinated. This revision of the clinical strategy aims to verify the protective efficacy through a booster shot.

To this end, Genexine has applied for a clinical trial protocol amendment to the ethics committees of hospitals such as the Faculty of Medicine, Universitas Indonesia (FKUI), and the Indonesian Food and Drug Authority (BPOM). Additionally, the clinical trials will be expanded to countries including Argentina, with a total planned enrollment of 14,000 participants.

The GX-19N booster shot clinical trial targets individuals who received the inactivated vaccines Sinovac or Sinopharm at least three months prior. Fifty percent of participants will receive GX-19N, while the remaining will receive a placebo, in a design to evaluate efficacy by assessing protection against symptomatic infection. Regarding the choice of inactivated vaccines as the primary vaccine platform, a Genexine official explained, “Among the vaccines granted emergency approval so far, more breakthrough infections have been reported with inactivated vaccines, making this design suitable for preventing actual breakthrough infections.” The official added, “We plan to expand to other vaccine platforms such as recombinant protein, adenovirus, and messenger RNA (mRNA) vaccines in the future.”

Recently, Indonesia has seen a sharp increase in breakthrough infections not only among unvaccinated individuals but also among vaccinated individuals, most of whom received the Sinovac vaccine. Furthermore, as the Indonesian government considers policies such as banning unvaccinated individuals from entering shopping malls and public places, some medical staff participating in the clinical trial ethics committee have expressed concerns about conducting the trial including a placebo group and have requested a review of the clinical trial changes.

Genexine and PT Kalbe Farma have also determined from a business perspective that conducting clinical trials for booster shots is a more appropriate strategy and decided to change the clinical trial design. Considering the current vaccination pace, it is advantageous to conduct trials that can be used for the growing booster shot market and annual revaccination. In Indonesia, approximately 21% of the population has been vaccinated so far, mainly with Sinovac and Sinopharm vaccines.

Seong Young-cheol, Chairman of Genexine, stated, “The DNA vaccine GX-19N is a safe vaccine with low risk of side effects even upon additional doses, making it the most suitable vaccine platform for booster shots.” He added, “Especially when GX-19N is used as a booster shot, it can induce a broad antigen-specific T cell response as well as higher levels of antibodies against already primed specific antigens.”

This content was produced with the assistance of AI translation services.