By Fineline Cube China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the immunization of the first group of patients in a double-blind, randomized, controlled Phase III clinical study. The trial is assessing the safety and immunogenicity of its COVID-19 vaccine candidate SCB-2019 (CpG 1018/Alum) as a booster shot. Participants previously received two doses of Sinovac’s inactivated vaccine CoronaVac, Pfizer’s mRNA vaccine Comirnaty, or AstraZeneca’s viral vector vaccine Vaxzevria.
Study Design and Control Groups
Subjects who received a homologous booster shot of CoronaVac, Comirnaty, or Vaxzevria will serve as the control group. They will be compared against those receiving the SCB-2019 heterologous booster shot. The study aims to produce key data for the third-dose booster shot group (CoronaVac and Comirnaty) during the third quarter of 2022 and data for the Vaxzevria group during the fourth quarter of 2022.
Sub-Cohort Study in the Philippines
Clover Bio will also initiate a sub-cohort study in the Philippines, expected to enroll 1,200 adult and elderly subjects. This study will assess the effects of SCB-2019 as the fourth booster shot compared to individuals who received three doses of CoronaVac. Preliminary results are anticipated during the fourth quarter of 2022.
Previous Study Results
Results from a study conducted in April this year indicated that among individuals previously vaccinated with two doses of the AstraZeneca coronavirus vaccine, those who received a heterologous booster shot of SCB-2019 showed about three times higher levels of neutralizing antibodies against the Omicron variant compared to those who received three doses of AstraZeneca. The vaccine also demonstrated a stronger neutralizing antibody response to the Beta, Gamma, Delta, and Omicron variants of concern.-Fineline Info & Tech