Malena revolt
07/15/2021 10:55 PM
Clarín.com
Zonal
Updated 07/15/2021 10:55 PM
For not having reached the expected number of registrants, the study of
combination of vaccines against the coronavirus in the Province of Buenos Aires
extended its call for a week, and continues to receive volunteers at least until this Friday.
Volunteers for the trial, which is carried out in hospitals in Greater Buenos Aires (in Avellaneda and Lanús) and
La Plata
, must have -among other requirements- a dose already applied of any of the available vaccines.
The quotas that were not filled until now are those of volunteers who have received the first dose of
AstraZeneca
or -mainly-
Sinopharm
.
On the other hand, the necessary number of patients was reached with a dose of
Sputnik V
, something that does not seem to be accidental since the Russian vaccine is the one that is having the most delays in the application of the second dose.
The consequence seems to be simple: those who received
Sputnik
are enrolled in the study with the prospect of being able to receive another dose, even if it is another vaccine, within a framework of scientific control and monitoring.
Those who have
AstraZeneca
or
Sinopharm
probably prefer to wait for the second dose within the national
Covid
vaccination
program
.
AstraZeneca, Sputnik V and Sinopharm, the three vaccines whose combination they will analyze.
Photo: Ignacio Blanco / Los Andes
The objective of the research is to verify the efficacy and multiply the possibilities of immunization, especially before the new variants of coronavirus.
The Buenos Aires government opened a quota of
1,200 volunteers
over 18 years of age who already have the first dose applied.
It seeks to evaluate the defense of the immune system through the combination of drugs to fight the virus.
Enrollment was expected to end on Monday, July 12, but was later extended,
in principle, until Friday, 16.
The Buenos Aires Ministry of Health confirmed that the call
did not reach the necessary number of registrants,
taking into account that
specific groups
of inoculated with each of the different vaccines available in the country need to be completed.
Precisely, the Ministry indicated that the group of volunteers with the first dose of the
Sputnik V
vaccine
reached the necessary number and that the
AstraZeneca
and
Sinopharm groups will
continue to register registrants.
Hospital Evita, of Lanús.
One of the three participating in the study of combination of doses of different vaccines.
According to data from this Wednesday, to complete the group of those vaccinated with AstraZeneca, only
30 people
were missing
.
In contrast, Sinopharm still needed 300 more volunteers to move forward with the research.
The form, which is available online,
will accept applications until
all control groups have been
completed
.
The Ministry assures that the delay in obtaining the volunteers
does not put the study at risk,
although it may delay the beginning of the tests of any of the seven combinations of vaccines that they are going to analyze, but that none of them will be canceled.
Of these seven combinations, three require the first dose of Sinopharm, two of AstraZeneca or Covishield and two of Sputnik (see
What they are ...
)
Volunteers should be tested for up to a year after the second dose is applied.
Photo: Lucia Merle
The trial also has several more requirements to participate.
Those who have signed up must not have contracted Covid at any time.
In addition, they must have the first dose applied between 10 days and 2 months prior to enrollment.
And they also have to reside in Avellaneda, Lanús or La Plata and / or have mobility to attend health centers.
As indicated by the Ministry, on Monday the 12th
the first calls were made
to coordinate the assistance of volunteers, who will have to go to the hospitals several times to take successive blood tests.
In the South of Greater Buenos Aires, the hospitals defined to carry out the trial are the
Dr. Pedro Fiorito
de Avellaneda
Hospital
, and the
Evita
de Lanús
Interzonal De Agudos Hospital
.
The method of the test is to define a control group and "divide the groups randomly according to the combination of doses".
This combination can be
heterologous
(two doses from different laboratories) or
homologous
(both from the same laboratory).
Volunteers must be residents of the three districts or have mobility to attend the centers.
Photo: Maxi Failla
In other words, those who participate will not necessarily receive two different doses of vaccines.
They may randomly
integrate a control group
with the two doses of the same vaccine.
Through this random system, it will be evaluated, as explained by the Ministry, if it is possible that the effect obtained with vaccines from different laboratories
is equal to or greater
than the scheme of a single laboratory.
Once the combination has been carried out - that is, the application of the second dose - each participant will have a blood draw "to measure the antibodies and their ability to neutralize the virus."
In addition,
cellular immunity will be measured
and a seven-day telephone follow-up will be carried out.
It is essential that volunteers have the first dose applied between 10 days and 2 months prior to enrollment.
Photo: Andres D'Elia
In the digital registration form, it was specified that several blood draws will also be carried out
up to a year after the second dose is applied,
to measure the immune response to the virus.
"The
first stage
is short-term, the first
14, 28 and 56 days
post-vaccination
will be evaluated
with the second dose," they indicate from the Ministry of Health of the Province.
In this instance, the first results will be obtained, to later continue with the test and take samples at
90, 180 and 360 days.
The study, likewise, does not guarantee the participation of all registered persons.
The distribution of volunteers in each group will depend on sanitary selection criteria and the number of people required.
The selected people will be contacted by phone call or via email during the days after the closing of the call.
What are the seven combinations
The vaccine combinations from different laboratories to be evaluated are:
Dose 1: Sputnik V (first component).
Dose 2: Sinopharm.
Dose 1: Oxford / AstraZeneca-Covishield.
Dose 2: Oxford / AstraZeneca.
Dose 1: Oxford / AstraZeneca-Covishield.
Dose 2: Sinopharm.
Dose 1 Sputnik V (first component).
Dose 2: Oxford / AstraZeneca-Covishield.
Dose 1: Sinopharm.
Dose 2: Sinopharm;
Dose 1: Sinopharm, Dose 2: Sputnik-V (first component).
Dose 1: Sinopharm.
Dose 2: Oxford / AstraZeneca-Covishield.
Only in the case of
Sputnik V
is it specified that the application is of the first component, since in the rest of the vaccines the first and second doses have the same compositions.