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Clover’s COVID-19 Vaccine Candidate Administered as Heterologous Booster in Investigator-Led Phase 2 Clinical Trial

  • 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)
  • 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, Nov. 26, 2021 (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 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.

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Nachrichtenquelle: globenewswire
26.11.2021, 01:30  |  132   |   |   

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Clover’s COVID-19 Vaccine Candidate Administered as Heterologous Booster in Investigator-Led Phase 2 Clinical Trial 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) The Phase 2 trial is an investigator initiated study, sponsored by …

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