Covid-19 Health authorizes the first clinical trial of a Spanish vaccine against Covid-19
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The first clinical trial of a vaccine against covid-19 developed in Spain has begun this week with its
inoculation to 6 of the 30 participants
included in the research and a record of adverse effects of grade 1 or 2 "which is
normal in these cases
and indicates that we are doing very well. "
This has been explained by
Lorna Leal
, specialist of the Infectious Diseases Service of the
Hospital Clínic
, member of the AIDS and HIV infection group of the
IDIBAPS
and Principal Investigator of the study. This new vaccine has been developed by the
multinational pharmaceutical company Hipra
, based in Amer (Girona) and has led to the
first study in people of a vaccine against Covid-19
carried out in Spain and approved by the Spanish Agency for Medicines and Medical devices. The current phase I / IIa of the trial is being carried out at the
Dr. Josep Trueta University Hospital of Girona
and at the
Hospital Clinic
of Barcelona.
Rafael Ramos
, researcher at the Institut Universitari d'Investigació en Atenció Primària (
IDIAP
)
has spoken along the same lines.
Jordi Gol
and from the Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (
IDIBGI
), who has indicated that "we have not registered
any relevant effect to highlight
, which indicates that we are on the right track".
Known technology
Lorna Leal has highlighted as one of the fundamental values of this new vaccine that is based on an already known technology, such as that of
recombinant proteins
. "Having experience in the general population with this type of vaccine that we know offers advantages and gives us
confidence and security
, which is a very important aspect."
The trial that is being carried out is
randomized
and
double-blind
with the participants being divided into two groups, randomly distributed, so that
25 will receive the Hipra vaccine while the remaining 5 will receive an RNA vaccine messenger
.
And the Pfizer vaccine has been chosen because it uses exactly the same administration schedule in two doses: a first on day 0 and a second on 21 days.
The vaccine is being tested in
healthy individuals
, with an age range
between 18 and 39 years old,
who as inclusion criteria in the trial should not have been vaccinated against covid-19 or have had the disease.
The call for the selection of candidates was presented by more than 400 volunteers, which has led those responsible for the trial to value the interest aroused and the commitment of society to collaborate in the fight against the pandemic.
The data has been highlighted by
Marga Nadal
, director of IDIBGI, who wanted to thank the
involvement of society
in the research.
In this
phase I / IIa
of the trial, what is intended to be evaluated is the safety of the vaccine and its immunogenicity, that is, the cellular response it generates and the capacity to generate antibodies.
The first group of the trial
receives the lowest dose
, and from there
the doses
are
scaled
in the following groups, working with three levels of vaccine. "Depending on the results, we will define the final dose to use," explained Leal. An independent surveillance committee monitors the entire trial and precisely one of the objectives of the clinical trial is to determine the optimal dose of vaccine, which is why it is done with a small group of people.
After the administration of the first dose, the participants in the trial are
closely followed for the next two hours
, during which their vital signs and physical reactions are monitored, surveillance that continues over time and is repeated when they receive. the second dose, as Ramos explained.
New vaccines against new variants
Alex Soriano
, head of the Infectious Diseases service at the Hospital Clínic de Barcelona,
also participated in the press conference to present the trial
, who highlighted the
importance of having new vaccines
in the face of the appearance of new variants of the virus and also in the face of risk of new biological threats.
The technology used for the development of this new vaccine makes it
compatible with the appearance of new variants
and that it can better adapt in the strategies against the changes that the virus may undergo, said Rafael Ramos.
One year of rehearsal
The first phase of the trial will last between 2 and 3 months, as calculated by those responsible for it, a period in which it is expected to have the necessary results to define the next steps.
Once the vaccine is confirmed to be safe and produces the expected immunogenicity, phase IIb / III will begin
.
The forecast is that the trial can last a year.
The Hipra vaccine against covid 19, which
is preserved between 2 and 8 degrees
, has been designed, according to the researchers, to optimize its safety and induce a powerful neutralizing immune response of the virus.
The
adjuvant
used is an oil-in-water emulsion like the one that has been used for over 20 years in thousands of doses of flu vaccines and has been shown to be safe.
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