Spain starts Covid vaccine clinical trials in September: Researchers explain process

The first clinical trials authorised by the Spanish Medications and Healthcare Products Agency (AEMPS) will involve a team of 190 volunteers who have not had the SARS-CoV-2 virus, and who will be monitored closely over the two to four months following their inoculation.

This will allow researchers to work out whether the Ad26Cov2S vaccine is effective and safe.

It is not a lifelong vaccine – nowhere on the planet has as yet found one that provides lifetime immunity – but is expected to last about a year before a repeat or booster is needed, rather like the 'flu jab.

Spain's home-grown vaccine is being developed by the firm Janssen, part of Johnson & Johnson.

Head researcher and development coordinator at Madrid's La Paz Hospital's Clinical Trials Unit, Dr Alberto Borobia, says 40 people have already been pre-selected this week among staff at the centre.

The hospital has 'wide experience in contributing to development of other vaccines', and its staff have been volunteers for clinical trials plenty of times before, assures Dr Borobia, so he is expecting to receive the AEMPS authorisation very shortly.

A total of 75 volunteers will be selected from La Paz Hospital (second picture, by Luis García/Zaqarbal on Wikimedia Commons), another 75 from La Princesa Hospital in Madrid, and a further 40 from the Marqués de Valdecilla University Hospital in Santander, Cantabria.

As well as staff at La Paz, volunteers will include professionals at Madrid Autonomous University's Faculty of Medicine, and members of the public not connected with the medical profession.

Dr Borobia says there will probably be plenty of others among the general public, since the hospital has 'received numerous calls' from people keen to join in.

'Young and healthy' and 'high-risk' volunteers tested together for first time

All volunteers are required to be 'young and healthy' at first – aged between 18 and 55 – and a second group will be made up of over-65s.

The normal procedure with these type of trials in early stages is for 'young and healthy' participants to be selected at first, because the initial aim is 'not to evaluate the drug in typical everyday conditions of use' but to select the right dose from a point of view of 'safety and efficiency'.

This said, in the case of the Covid vaccine, the procedure will be sped up somewhat, 'due to the exceptional context' it is being created in, and for this reason, the second group, of the higher-risk population, will take part in the trials almost straight away.

“Under normal circumstances, we would have been studying the higher-risk group during more advanced phases of the vaccine's development,” explains Dr Borobia, “but here, as we've accelerated the process, we're hoping to study the higher-risk group at the same time as the young and healthy group.”

Before inoculating the volunteers, the team – made up of at least a dozen professionals – will begin screening on September 1, a process that will continue until September 11.

“This involves drawing up an exhaustive clinical history, a detailed physical examination, and samples will be taken to ensure that the volunteer has never had the virus and does not have it at present,” Dr Borobia reveals.

“Everyone who fulfils these criteria and the requisites for inclusion in the study will be signed off as a 'suitable patient', and will have the vaccine the following week.”

Volunteers will then have weekly checks during the first month following vaccination, and will be inoculated again in the second month, before being monitored weekly again.

The trials will be double-blind, meaning neither the monitoring staff nor the patient will know whether he or she has been administered a vaccine or a placebo on each of the two occasions.

It is aimed at working out how many doses, and of how much, are needed, for it to work properly, and to be safe for the human organism.

Given the pressing need for a vaccine at global level, it is likely that phase two of the trials will not need to be completed before phase three begins, and that this can start before researchers receive authorisation for the vaccine to be distributed commercially.

“We live in exceptional times, and regulatory agencies also have mechanisms that allow drug development to be fast-tracked and for their authorisations for use to be conditioned by preliminary results,” says Dr Borobia.

“Testing will carry on in the meantime – first and foremost to evaluate safety, and if this is guaranteed, immunity levels.

“With all these analyses, along with all the information the laboratory has available on all trials being carried out, we will then need to ascertain whether the data we have are sufficiently robust to allow us to request a provisional approval for the drug from the regulatory body.”

Safety 'guaranteed', but 'some side-effects are crucial for any drug'

As for possible risks, Dr Borobia says: “No treatment is completely free from side-effects. A drug that does not produce side-effects during this phase of trials will probably not produce any therapeutic effect, either. But no regulatory board would approve clinical trials of any drug containing a new molecule if it does not have sound data confirming it can be safely administered to volunteers.

“All trials are conducted under the highest quality standards, and we're very used to carrying these out.

“It's true that we're under pressure, though, since we need to carry them out to the same standards as normally followed, but in a very short space of time – it's not the norm for us to have to recruit all patients within a week and a half and start treatment the following week, and that's the level of pressure we're under: Deadlines we absolutely have to meet to enable us to have a vaccine available as soon as possible.”

The research leader is confident that there will be 'more than one vaccine that works', and considers this 'essential'.

“We cannot have a situation where the entire weight of producing a massive amount of inoculations to immunise the world's population falls on the shoulders of one laboratory – but I hope that ours will be, at least, one of the ones that turns out to be efficient and will be able to be on the market soon.

“However, it's an enormous challenge. We're trying to cut down the usual timeframes as much as possible – but under no circumstances can we cut them down to the point where they put the safety of clinical trials volunteers at risk.”

He has words of comfort for the layperson, though: “The public can rest assured that once a vaccine is on the market, it will follow the absolute maximum level of safety standards – in the same way as all other pharmaceutical drugs in mainstream use do.”