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Coronavirus: Recruitment of volunteers for Phase III vaccine trial to start in Abu Dhabi

Gulf News logo Gulf News 16/07/2020 Samihah Zaman, Staff Reporter
a person wearing a blue hat: Sheikh Abdullah © Provided by Gulf News Sheikh Abdullah

Abu Dhabi: The world’s first WHO-listed Phase III clinical trial of a COVID-19 inactivated vaccine officially began in Abu Dhabi today, with Sheikh Abdullah bin Mohammed Al Hamed, chairman at Abu Dhabi's healthcare regulator - Department of Health - becoming the first to participate in it.

Dr Jamal Al Kaabi, DoH acting undersecretary, will also participate in the trial, which highlights the UAE's global efforts to combat COVID-19, as well as Abu Dhabi's research and development capabilities.

A dedicated website has been launched to register volunteers, senior officials said during a virtual press conference today.

Volunteers will have to be in good physical health, and should not have contracted COVID-19 in the past, announced Dr Nawal Al Kaabi, UAE prinicipal investigator and chief medical officer at Abu Dhabi’s premier public health facility, the Sheikh Khalifa Medical City.

“We are looking at recruiting volunteers between the ages of 18 and 60 years. Of course, we will follow strict inclusion and exclusion criteria for the recruitment. So anyone who is suffering from a severe disease like cancer, is immunocompromised, has received a recent live vaccine or blood products, or suffered from COVID-19, will be excluded,” Dr Al Kaabi told Gulf News.

UAE trials begin

The trials pertain to the vaccine being developed by Chinese pharmaceutical giant, Sinopharm China National Biotec Group, in collaboration with Abu Dhabi-based artificial intelligence and cloud computing company, G42. Although other Phase III trials for vaccines against COVID-19 are in progress across the world, this is the first Phase III trial for an inactivated vaccine.

The trials in the UAE will be open to individual volunteers, and will last 42 days. They will be monitored by the UAE Ministry of Health and Prevention, as well as Abu Dhabi’s healthcare regulator, Department of Health (DoH).

DOH Chairman Sheikh Abdullah bin Mohammed Al Hamed was announced as the first to participate in the trial, followed by DoH Acting Undersecretary Dr Jamal Al Kaabi.

What are the stages of vaccine development?

The clinical trial in the UAE is expected to last between three to six months.

This particular vaccine by Sinopharm CNBG – the world’s sixth largest vaccine producer – has been developed from an inactivated virus, which means that the virus has been grown in culture and has lost disease-producing capacity. It has already gone through the first two phases of a vaccine trial.

In keeping with international protocols for vaccine development, the first phase looked at the safety of the vaccine, while the second phase evaluated immunogenicity and explored the immunisation process in a limited number of individuals.

The third phase will consider the safety and efficacy of the vaccine in a larger population sample, and officials said the UAE is a preferred choice for these large-scale trials because of its diverse population comprising people from more than 200 nationalities.

Multinational demographic

“There is a strong willingness to participate, and a multinational demographic,” said Ashish Koshy, chief executive officer at G42 Healthcare.

UAE health authorities have recently issued a permit for up to 15,000 volunteers to take part in the trials. G42 Healthcare and Abu Dhabi’s public health provider, the Abu Dhabi Health Services Company (Seha) are working towards achieving a minimum of 5,000 participants in the first stage of the programme to ensure the robustness of the results.

The fourth and final phase is conducted after the vaccine is manufactured and distributed post production.

Trial process

Dr Al Kaabi explained that two strains of the inactivated vaccine will be tested on participants during the Phase III trials, along with a group receiving the placebo.

As announced earlier, participants in the first two phases of the vaccine trial did not show any serious adverse reactions, with all of them generating antibodies after two doses in 28 days.

“We will administer two doses of the vaccine three weeks apart. Two doses are needed because a single dose is not enough to generate an immune response when using an inactivated vaccine,” Dr Al Kaabi said.

Safety of participants

All participants who register will first be assessed and evaluated via a physical exam. So far, five Seha facilities in Abu Dhabi and Al Ain, as well as a mobile clinic, will carry out the trials.

“Once a participant gets the vaccine, they will receive a vaccine diary to record every sign and symptom. They will also be evaluated periodically [in person], and through teleconsultations; there is no need for them to be admitted,” Dr Al Kaabi told Gulf News.

She also testified to the safety of the inactivated vaccine.

“The inactivated virus in the vaccine cannot cause the disease. It is a dead virus, and many other vaccines around the world use an inactivated virus. There was also no significant side effect note in the first two phases of the trial. In fact, there was no difference in the people who received the placebo or the inactivated vaccine [in terms of side effects],” Dr Al Kaabi said.

The participants will all be monitored for a whole year on a monthly basis, even after the trial itself concludes.

Data protection

Officials also confirmed measures to protect volunteer medical data.

“G42 will sponsor the trial, and harness our resources. These include a supercomputer that can build models to accelerate the clinical trial. But the patient data will be held by healthcare facilities, and no one on the outside will have access to them. If the data is shared, the data will have to be de-identified, and the entire process will be monitored by two clinical research organisations – one local and other international,” Koshy said.

Vaccine production

Conducting the third phase of the vaccine trial through the Sinopharm-G42 partnership is also expected to enable quick access to the vaccine for UAE residents.

Dr Walid Abbas Zaher, group research director at G42 Healthcare, said the agreement also allows for the vaccine, if it passes the third phase successfully, to be produced in Abu Dhabi.

“The agreement allows for production in Abu Dhabi, and a production plan will be announced after the end of the trial,” Dr Zaher confirmed.

Trial preparations

In preparation for the trial, G42 Healthcare has already established a massive throughput laboratory over the last few months to speed up the detection of the disease, manufactured essential PPE, conducted research into new vaccines and drug therapies, and used its advanced AI capabilities to map and predict trends in the outbreak and virus mutations.

Abu Dhabi-based G42 Healthcare is performing trials in cooperation with Sinopharm CNBG, under the administration of DoH and the Ministry of Health.

The partnership will help provide quick access to the vaccine for UAE residents, with manufacturing taking place in Abu Dhabi.

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