The Phase 2 trial will evaluate SCB-2019 (CpG 1018/Alum) as a booster dose in individuals previously vaccinated with CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz)
Also Read: ABI Wellness Tackles Cognitive Dysfunction Affecting People with “Long-COVID
The Phase 2 trial is an investigator initiated study, sponsored by the Instituto D’Or de Pesquisa e Ensino (IDOR) and funded by the Bill & Melinda Gates Foundation
The study will evaluate the immunogenicity and safety of SCB-2019 in approximately 520 healthy adult participants at multiple sites in Brazil
Initial safety and immunogenicity data are anticipated in the first half of 2022
CHENGDU, china Clover Biopharmaceuticals, Ltd. (, a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, announced that an investigator-led, Phase 2 trial initiated to evaluate the immunogenicity and safety of heterologous and homologous COVID-19 booster vaccines. Clover’s COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), will be assessed as a heterologous booster dose in individuals previously vaccinated with either CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz).
The Phase 2 trial is an investigator initiated study, sponsored by IDOR with funding from the Bill & Melinda Gates Foundation and supported by the Brazilian Ministry of Health. The study is a double blind, randomized, controlled design that will be conducted in two stages. Stage one will evaluate three formulations of SCB-2019 (9µg with alum, 9µg with CpG 1018/alum, and 30µg with CpG 1018/alum), administered as a booster dose, approximately 6 months after the primary vaccination with recombinant Covid-19 vaccine (AstraZeneca/Fiocruz).
The purpose of this stage is to define the optimal vaccine formulation in comparison to a homologous booster of recombinant Covid-19 vaccine (AstraZeneca/Fiocruz). Stage two will evaluate the immunogenicity and safety of a booster dose of selected SCB-2019 formulation in individuals previously vaccinated with 2 doses of either CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz). Homologous boosters of CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz) will be used as controls.