Taipei, Taiwan.-- April 11th, 2021--MVC today announced unblind immunogenicity results for MVC’s EV71 vaccine trial, a phase 3 multi-regional, multi-central clinical trial in Taiwan and Vietnam. Over 3,000 subject were recruited and serum samples were collected and analyzed one year after vaccination. The immunogenicity results indicated MVC’s EV71 vaccine’s immunogenicity data meet TFDA recommendation for accelerated approval.
This is a Phase 3, prospective, randomized, double-blind, placebo-controlled, multi-region study to evaluate the efficacy, safety, and immunogenicity of inactivated EV71 vaccine produced in Vero cells with adjuvant in infants and children (NCT03865238).
Subjects were divided into three age groups: 2 months to 6 months, 6 months to 2 years old, and 2 years children under 6 years old. For infants and children under 2 years old, subjects were given 2 + 1 booster vaccinations. All subjects completed 1 year follow up after 2 dose vaccinations and their immunogenicity data was analyzed and unblinded by the Data and Safety Monitoring Committee as follows:
1. The seroprotection rate (defined as serum NT Ab titer≥ 1:32) at 28 days after the first 2 doses of vaccination achieved 99.5% in EV71 vaccine group (The immunogenicity endpoint should be ≥ 90% per TFDA recommendation for accelerated approval).
2. The seroprotection rate (defined as serum NT Ab titer≥ 1:32) at 6 months after the first 2 doses of vaccination achieved 97.9% in EV71 vaccine group (The immunogenicity endpoint should be ≥ 70% per TFDA recommendation for accelerated approval).
3. The seroprotection rate at 1 year remained 97.9%.
MVC is glad to announce that EV71 vaccine’s immunogenicity results has met the TFDA recommendation for accelerated approval and MVC will submit the clinical study report for NDA application in the near future.