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March 23, 2020updated 12 Jul 2022 11:57am

China begins Phase I trial of Covid-19 vaccine

China has commenced a Phase I clinical trial of a vaccine against Covid-19, the infection caused by the novel coronavirus that is so far responsible for 341,700 infections and 14,750 deaths globally.

Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates

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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
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Follow the latest updates of the outbreak on our timeline.

China has commenced a Phase I clinical trial of a vaccine against Covid-19, the infection caused by the novel coronavirus that is so far responsible for 341,700 infections and 14,750 deaths globally.

According to Chinese media, a staff member associated with the government-funded project said that participants in the trial are already being vaccinated.

The trial is designed to enrol 108 volunteers aged 18-60 years who are residents of Wuhan, the city where the virus originated. Participants will be divided into three groups and administered with different dosages.

The experimental candidate is a recombination vaccine developed by biotechnology company CanSino Biologics in alliance with a research team from the PLA Academy of Military Medical Sciences.

Last week, CanSino Biologics received regulatory approval to conduct a Phase I trial of its recombinant novel coronavirus vaccine (adenovirus type 5 vector) candidate.

Global Times reported that participants will not be infected with the novel coronavirus following the vaccination in the Phase I trial.

The aim is to investigate whether the vaccine will trigger antibody generation and make participants immune to the new coronavirus.

Trial investigators will quarantine volunteers for 14 days and follow them for six months to monitor any adverse reactions.

The Covid-19 vaccine trial in China follows the first trial launched in the US at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.

Funded by the US National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID), the trial is evaluating Moderna’s mRNA-1273 vaccine candidate.

Gilead Sciences’ antiviral drug remdesivir is currently in the final stages of clinical trials in Asia. Researchers in China reported an encouraging profile for the drug in treating Covid-19 coronavirus infection.

However, further randomised trials are to be conducted to validate remdesivir’s effectiveness.

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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.

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