KARACHI: The Indus Hospital (TIH) — one of the five sites in Pakistan selected for the multi-country phase-III clinical trial of a potential Covid-19 vaccine — has seen a positive public response to the recent low-key launch of the trial, raising the hope that the effort would meet its target.

Till Saturday — day 18 of the trial — over 500 people volunteered for the research supported by CanSinoBio, a Chinese company which has developed the single dose adenovirus type-5 (Ad5)-vectored Covid-19 vaccine in collaboration with the Beijing Institute of Biotechnology.

According to researchers at TIH, the specific vaccine has already established its safety and efficacy in the previous trials held in China with no serious adverse effects.

It’s now being tested on a wider population in Russia, Mexico, Chile, Argentina, Saudi Arabia and Pakistan; the country has been allocated 8,000 recruits out of a total of 40,000 and is currently conducting the trial at five centres in Islamabad, Lahore and Karachi.

‘It’s the first time a vaccine trial is taking place in the country’

International data suggests there are currently more than 100 Covid-19 vaccine candidates under development, with a number of these in the human trial phase in over 150 countries.

2,000-volunteer target

The vaccine, the researchers say, may cause minor side effects such as pain at injection site and fever, which are common to other vaccines and that it cannot cause Covid-19 infection as it doesn’t contain the live virus.

At TIH, a makeshift research centre has been developed in a large iron container. A peek inside the facility showed the staff engaged with intending candidates, documenting their personal details and carrying out laboratory-specific work. Some volunteers were getting a detailed briefing about the trial’s objectives while others were waiting for their turn to get a vaccination dose.

“I am here because I believe that countless lives can be saved if the whole exercise ends successfully,” said Nisar Hussain, a young man sitting in the observation room, adding that he opted for the initiative after getting positive feedback from his friends who had earlier volunteered for the trial.

According to the researchers, only healthy/stable people, aged 18 or older with no uncontrolled illness or disorder or history of lab-proven Covid-19, are inducted into the trial that will last for two months.

“Our job is to explain each and every step involving the clinical trial including its need, participation requirements, risks and potential benefits, so people can make an informed decision,” said Fizza Asif, a third-year student of the Dow Medical College, part of the student-volunteer team assisting the hospital in the research.

The participation criteria, according to experts, includes willingness to receive weekly phone calls from the hospital for a year, reporting any illness including Covid-like symptoms and willingness to give blood samples on the enrolment day and after one year.

“There have been cases of refusals and rejections as one of the inclusion criteria is that women shouldn’t be pregnant or lactating or planning to become pregnant within 90 days after getting the vaccine,” said Dr Naila Baig-Ansari, who heads the TIH’s research centre.

Each volunteer, she pointed out, received Rs3,000 on the enrolment day as compensation amount while R5,000 would be given on the last visit after a year, emphasising that the step was very much in line with international practices elsewhere in the world.

The team hoped that it would meet the 2,000-volunteer target for the trial in two months.

How it works

According to Dr Naseem Salahuddin, the principal investigator of the research at TIH, it’s a randomised placebo-controlled trial — the gold standard for evaluating the safety and efficacy of a new vaccine — which means a section of the volunteers would receive the vaccine while others an injection without the active components of the vaccine.

Explaining this methodology further, Dr Baig-Ansari said the reason to give placebo was to compare the outcome of the two groups when the results would be analysed.

In order to prevent bias, each volunteer received a computer-generated study ID and a code for the injection and the information about the code was not disclosed to the medical staff or the volunteer.

“Only researchers in China [who have designed the trial] have the code information. They would stop the trial and break the code, if 100 or 150 cases of Covid-19 are reported in the 40,000 volunteer groups participating in the trial. The hope is the volunteers who received the vaccine are not the ones who caught Covid-19.”

“The Ad5-vectored Covid-19 vaccine is made from a non-infectious adenovirus which contains a subset of the coronavirus. It confers stronger immunity than several other vaccines being tested in other countries,” Dr Salahuddin said, adding that it would take over a year when the vaccine would actually be available in the market.

Experts believe that getting an effective vaccine against Covid-19 is the only way to get rid of the pandemic and Pakistan has a great incentive to be in this trial.

“It’s the first time a vaccine trial is taking place in the country. We have a chance to get the Covid-19 vaccine, if proven successful, on a priority basis at a reduced cost. In addition, this process will help train researchers and attract investment in the neglected pharmaceutical sector,” concluded Dr Baig-Ansari.

Published in Dawn, November 1st, 2020