Details have emerged on the selection criteria and process for the first group of volunteers for a COVID-19 vaccine developed in China.
On 16 March the first stage of clinical trials of a COVID-19 recombinant vaccine commenced in the Hubei-province capital of Wuhan where the disease first emerged.
The vaccine was developed by a team led by epidemiologist Chen Wei (陈薇) from the Academy of Military Medical Sciences, with the involvement of Hong Kong-listed CanSino Bio-B.
A total of 18 of the vaccine volunteers have already completed the quarantine and observation period and returned home, and are reportedly in sound physical condition.
Information made public via the Chinese Clinical Trial Registry sheds light on the selection process and criteria for the clinical trials of the COVID-19 vaccine.
The trials have been conducted at the Chinese People’s Armed Police Force Wuhan Special Service Rehabilitation Centre (中国人民武装警察部队武汉特勤疗养中) and the Tongji Hospital affiliated with the Tongji Medical College of Huazhong University of Science and Technology (华中科技大学同济医学院附属同济医院).
The trial volunteers are divided into three groups of 36 individuals receiving different dosage levels (low, medium and high), and subject to a quarantine and observation period of 14 days.
This involves a total of 108 trial participants, with a research and observation period of at least six months.
The stage one trials also set a total of 11 conditions for vaccination volunteers:
- Aged between 16 to 60.
- Have consented to the trials as well as signed a letter of agreement,
- Trial participants can and are willing to abide by clinical testing plan requirements, and are capable of completing research and interviews for a period of six months,
- HIV negative,
- Body temperature of under 37.0 degrees Celsius,
- Testing negative for novel coronavirus antibodies (IgG and IgM),
- Chest scans are regular (no signs of novel coronavirus pneumonia),
- Negative PCR tests of the throat, phlegm and anus,
- BMI index of 18.5 – 30.0,
- Blood results within normal levels,
- A health medical history satisfying requirements for vaccination volunteers.
The test also excluded the participation of volunteers with a prior history of SARS, convulsions, epilepsy, encephalopathy and mental illness.
Testing of the first volunteers commenced on 16 March, while by 25 March the Chinese Clinical Trial Registry announced that it had received applications from nearly 5,000 volunteers within the space of several days, before closing applications on 23 March.
By 27 March the selection of the full set of 108 coronavirus vaccine volunteer was officially completed.
Volunteers will be subject to testing for anti-S protein-specific antibodies and anti-Ad5 neutralising antibodies 14 and 28 days, as well as 3 and 6 months, following vaccination, as well as testing for anti-SARS-CoV-2 neutralising anti-body and specific T cell responses 14 days, 28 days and 6 months after vaccination.
At a press conference held on 18 March Zhong Nanshan (钟南山), a senior expert with China’s National Health Commission (国家卫生健康委) said that China was in the process of working on five different types of vaccines, including a whole virus vaccine, a nucleic acid vaccine, an adenovirus vaccine, a protein vaccine involving genetic engineering, and an influenza vaccine.
Zhong also said that China was “racing” to develop a vaccine by September in advance of the US, and that a product would be ready around that time.