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SPECTRA has been amended to evaluate SCB-2019 (CpG 1018/Alum) as a homologous booster in approximately 4,000 adult participants previously vaccinated with SCB-2019 (CpG 1018/Alum)
Initial immunogenicity and safety data for SCB-2019 (CpG 1018/Alum) as a homologous booster and for adolescents are anticipated in the first half of 2022
CHENGDU, China, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; Stock code: 2197.HK), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced that the first participants have been dosed with Clover’s COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a homologous booster dose following primary vaccination of SCB-2019 (CpG 1018/Alum) in the ongoing global Phase 2/3 SPECTRA clinical trial. Clover reported final efficacy data for SCB-2019 (CpG 1018/Alum) in SPECTRA in September 2021 and the study is continuing to generate additional immunogenicity and safety data.
This double-blind, randomized, controlled study will evaluate the immunogenicity and safety of two formulations of SCB-2019 (full dose: 30 µg with CpG 1018/Alum and half dose: 15 µg with CpG 1018/Alum) as a homologous booster dose administered approximately 6 months following 2-dose primary vaccination with SCB-2019 (CpG 1018/Alum) in approximately 4,000 adult participants.
In addition, the evaluation of the immunogenicity and safety of SCB-2019 (CpG 1018/Alum) for primary vaccination in the adolescent (12-18 years) subgroup has been expanded to 1,200 adolescents. Initial data on both the homologous booster arm and adolescents are anticipated in the first half of 2022.
Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals said, “We are pleased to announce that the first participants have been dosed with SCB-2019 (CpG 1018/Alum) as a homologous booster in the Philippines. The data generated from this study combined with previously reported positive data on previously-infected individuals in SPECTRA as well as data from other heterologous booster studies will potentially position SCB-2019 (CpG 1018/Alum) as an attractive universal booster vaccine candidate globally.”
The development of SCB-2019 (CpG 1018/Alum) is funded by the Coalition for Epidemic Preparedness Innovations (CEPI), which has awarded Clover up to $397.4 million in funding. Through this collaboration, Clover will supply up to 414 million doses of SCB-2019 (CpG 1018/Alum) to the COVAX Facility for equitable distribution.
About SCB-2019 (CpG 1018/Alum)
SCB-2019 (CpG 1018/Alum), our COVID-19 vaccine candidate, is anticipated to potentially be one of the first protein-based COVID-19 vaccines commercialized globally through the COVAX Facility. Employing the Trimer-Tag™ technology platform, Clover developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein (referred to as S-Trimer™) based on the original strain of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavax’s CpG 1018 advanced adjuvant and aluminum hydroxide (alum).
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates. The Trimer-Tag™ technology platform is a product development platform for the creation of novel vaccines and biologic therapies. Clover leveraged the Trimer-Tag™ technology platform to become a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to address the COVID-19 pandemic caused by SARS-CoV-2.
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