CHA Vaccine Institute confirms shingles vaccine safety at higher doses
CHA Vaccine Institute, an affiliate of Cha Biotech, announced Tuesday that it has received the clinical study report (CSR) of the Korean phase 1 clinical trial of its recombinant shingles vaccine candidate, CVI VZV 001.
According to the report, the safety and tolerability results are consistent with the topline announcement made in April. The 48-week post-vaccination follow-up in the phase 1 study of 32 healthy adults aged 50 to 65 years confirmed tolerability and safety in both the low-dose and high-dose groups.
No serious adverse events were observed in any of the study arms, including the control arm.
The CSR includes immunogenicity data (both humoral and cellular immune responses).
By 48 weeks post-dose, antibody levels to varicella-zoster virus (VZV) increased more than 2.7-fold in all dose groups. Four weeks after the second dose, antibodies increased by more than 100 percent in all subjects, resulting in a 100 percent seroprotection rate (SPR). It means that everyone vaccinated developed sufficient antibodies, which is comparable to those achieved with current commercially available recombinant protein vaccines.
CVI-VZV-001 was found to effectively induce not only humoral immune responses that produce antibodies but also cellular immune responses that attack virus-infected cells. This is expected to result in stronger and more durable immunity against the shingles virus.
Cha Vaccine Institute plans to submit a phase 2 IND (Investigational New Drug Application) and enter phase 2 clinical trials this year. Development is underway to launch the product in 2029.
“This is a meaningful result that shows the potential of a domestic vaccine to replace the shingles vaccine market, which relies on expensive imported products,” Cha Vaccine Institute CEO Yum Jung-sun said. “We will continue to promote phase 2 clinical trials and commercialization smoothly to provide a new alternative to the domestic and international shingles vaccine market.”