Healthy, uninfected volunteers who have come forward to test a Covid-19 vaccine under construction in Spain will receive their first jabs between 14th – 22nd September, meaning full results are expected to be available between mid-November and mid-January.
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, 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.
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 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.”