Brazilian health regulator Anvisa has granted approval for a new Phase II/III (CLO-SCB-2019-003) clinical trial of Covid-19 vaccine candidate SCB-2019.
Co-administered with a CpG 1018 / Alum adjuvant in two doses 22 days apart, SCB-2019 is a recombinant SARS-CoV-2 spike trimer (S) fusion protein.
Chinese company Sichuan Clover Biopharmaceuticals is sponsoring the clinical development.
The double-blind, randomised, placebo-controlled trial will evaluate the efficacy, immunogenicity and safety of the SARS- CoV-2 (SCB-2019) with the adjuvant CpG 1018 / Alum for prevention of Covid-19 mediated by the virus in participants aged 18 and above.
It will enrol up to 22,000 volunteers from countries in Latin America, in addition to South Africa, Belgium, China, Spain, Poland, and the UK.
In Brazil, 12,100 volunteers, distributed between Rio Grande do Sul, Rio Grande do Norte, and Rio de Janeiro, are planned to be included in the trial of the Covid-19 vaccine.
Anvisa granted the authorisation after assessing data from previous product development stages.
They included non-clinical studies in vitro and in animals, and preliminary data from ongoing clinical studies.
An acceptable safety profile has been observed for candidate vaccines based on the results obtained so far.
The agency held meetings with the team at Sichuan Clover Biopharmaceuticals to align all the technical requirements necessary for the tests and approved the clinical trial.
This is the sixth Covid-19 vaccine study authorised by Anvisa.
On 2 June 2020, it granted authorisation to University of Oxford and AstraZeneca’s clinical trial of their vaccine.
The following month, Sinovac Research & Development’s vaccine and partnership with the Butantan Institute received authorisation.