Chinese Firm Develops a Vaccine for Coronavirus: 500 Volunteers Needed for Second Phase Trial

By Updated at 2020-04-29 21:09:12 +0000


BEIJING — Chinese biopharma firm CanSino Biologics is recruiting 500 volunteers for the second phase of a clinical trial of a vaccine that is the country’s biggest hope for preventing a new coronavirus epidemic.

  • • Tianjin-based CanSino Biologics is recruiting 500 people for the second stage of the country’s main prospect for a preventive injection for Covid-19

  • • This time participants will be able to remain at home rather than have to stay in one facility for two weeks

The Tianjin-based company announced on Thursday night that it and the Institute of Biotechnology at the Academy of Military Medical Sciences would begin the second phase of the trial after preliminary data from the first stage indicated that it was safe to proceed.

The pharmaceutical industry and public health bodies are in an urgent quest to develop a vaccine for the highly contagious new coronavirus that has already infected 1.5 million people around the world, killing at least 90,000.

Vaccines usually take years to develop but a number of trials are already up and running.

US biotech start-up Moderna started the world’s first clinical trial last month while Inovio Pharmaceuticals is partnering with Beijing Advaccine Biotechnology in China for its first human trials. More clinical trials from China’s other vaccine candidates are expected to start this month.

In the first stage of the CanSino Biologics trial, 108 volunteers from Wuhan, Hubei province, where the coronavirus was first reported in late December, were injected with the vaccine candidate from mid-March to April 2. They were divided into three groups, receiving either a low, medium or high dose of the vaccine to test its effectiveness and safety.

Researchers said there were some adverse effects in the first phase, with the high-dose group having more people with a fever 38.5 degrees Celsius, according to a report in Science and Technology Daily on Thursday.

The fevers usually broke within 24 hours but the second stage will proceed with low and medium doses. The report said 250 volunteers would be given a medium dose, another 125 a low dose and another 125 would get a placebo.

Vaccine clinical trials comprise three phases. The first stage involves a small number of people to prove the product is safe; the second phase involves hundreds to observe safety and effectiveness and determine a vaccination plan; and the third phase involves more volunteers to enable the scientists to better understand the protective capacity of the vaccine.

Volunteers for the CanSino trial must be 18 to 60 years old with no history of coronavirus infection or vaccine allergy.

In the first phase, volunteers were observed for 14 days in a central facility but in the second phase, volunteers will be able to record and monitor their condition in their own home. Researchers will visit the volunteers on the first day, the 14th day, the 28th day and the sixth month after the injection and conduct blood tests.

Last month, Wu Zunyong, chief epidemiologist with the Chinese Centre for Disease Control and Prevention, said that even with fast-track permission, it would still take at least three months to complete the three phases of the trial.

The vaccine candidate developed by CanSino and military researchers, led by virologist Chen Wei, is genetically engineered.

“Spikes” on the surface of the coronavirus bind to human cells and enable the virus to invade the human cells, causing the sometimes fatal infection known as Covid-19. In theory, vaccines can rehearse such an attack and trigger the human body to be primed to respond to a real infection.

- Zhuang Pinghui in Beijing

This article appeared in the South China Morning Post print edition as: Volunteers needed for second stage of vaccine quest