View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
April 20, 2021updated 12 Jul 2022 11:19am

Brazil’s Anvisa approves new Covid-19 vaccine candidate trial

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.

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.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena