In an interview with TN.com.ar, the main researcher Gonzalo Pérez Marc explained what the process consists of, what the process is like and what are the expectations of the research that seeks to enroll some 10,000 Argentines.
Two perfectly organized sheds, a constant flow of cars and a constant flow of volunteers. Although the Phase 3 trial of the plant-based vaccine at the Military Hospital could be defined with these simple phrases, the reality is much more complex. So far, there are more than six thousand volunteers who have already received the first dose of this novel immunization and some 2 thousand who have completed their regimen. However, the researchers' goal is to reach 30 thousand volunteers worldwide, of which 10 thousand will be Argentineans.
The mastermind of this operation is Gonzalo Pérez Marc, the doctor who participated in the renowned Pfizer study and who is now back at the head of a huge study that promises good results: "In phase 2 it was seen that the neutralizing antibodies against the coronavirus produced by this vaccine are between 50 and 75 times more powerful than with other vaccines that are effective today", he told TN.com. TN.com.ar.
What is and how is the vegetable vaccine produced?
Although some call it "vegan", the truth is that the development that is in phase 3 in Argentina can only be defined as "vegetarian". Far from food preferences, these nicknames are related to its production. The process of generating the active ingredient takes place in a plant and is produced by the Canadian biopharmaceutical company Medicago Medicago. The immune system enhancer (adjuvant), meanwhile, is one of the most widely used on the market and is produced by Glaxo.
The "magic" of this vaccine that gave it several names lies in its production, since a plant native to northern Australia is responsible for mimicking the composition of the virus, without any chance of infection. In fact, it is so effective in its simulation that the organism does not notice the difference and responds to the "green" invader as it would to Covid-19.
"It's a new platform. It's called VLP (virus-like particle virus-like particle) and its characteristic is that it is produced inside a plant. is produced inside a plant. It is a vaccine that had already been developed against H1N1 (influenza) and Ebola, but it is being developed for the first time on a large scale against Covid-19. is being made for the first time on a large scale against Covid-19.″, highlighted Pérez Marc, pediatrician (MN 110,813) and principal investigator of the Central Military Hospital of the plant vaccine and added: "The plant is called Nicotiana benthamianafrom northern Australia, and it is used as a natural bioreactor. natural bioreactor where a particle is produced that is so similar to the coronavirus that a very good simulation of the disease can be generated".
In the scientist's words, the process for the plant to generate "simulators" starts when the spike protein (Spike or S), the culprit of the infection, is introduced. "This plant allows this DNA to replicate in a very particular way: in groups of three (trimers), just as Covid-19 does, inserted in a fatty membrane. At the end of the process, inside the plant you have a particle that is very similar to the coronavirus, but it has neither virus nor infectious character."he explained.
After extracting this particle, at the time of making the vaccine that will finally be applied in the arms of the volunteers (at this stage), an adjuvant is added to it that "greatly" boosts the immune response. "In phase 2, it was seen that the generation of neutralizing antibodies against the coronavirus produced by this vaccine is between 50 and 75 times more potent than that of other vaccines that are currently efficient"he stressed.
Even beyond these numbers, this immunization has several advantages, including advantagesto be able to scale up production, it is only necessary to planting a larger number of plants to apply the technology to them, can be kept in the refrigerator (which makes it easier to transport and store), and it proposes a "green vision". "green vision of the pharmaceutical world. "The vaccine is not vegan because the adjuvant is not, but it has a much more natural process that makes many people who aim at a healthy life and the consumption of natural things approach it in a much more important way than they would do with other vaccines", highlighted Pérez Marc.
Argentine volunteers
Walking through the corridors of the various buildings of the Military Hospital involved in the project means coming across dozens of volunteers and various staff members, numbering around 1,000 in all. However, differentiating them is not so complicated. Those who join the project to test the vaccine are provided with a pendant detailing what they did and what they missed that day. Although the almost inescapable indicator is the smile under the chinstrap when they recognize Pérez Marc, who even asks for a photo.
Each post has an estimated time delay and volunteers are accompanied to each of them by the staff working in the study. Process checks are performed before, during and after each step. Even, the information is updated almost in real time. "The Phase 3 study is worldwide and multicenter and is being carried out in Canada, the United States, Europe and Latin America, with the participation of Brazil, Colombia, Mexico, Peru and Argentina. There are five centers here and ours is the largest in the world."explained Perez Marc.
At this stage, the study will enroll 30,000 individuals. "This sample that would allow you to have 160 people who maybe get infected after two doses and so you can test the efficacy by seeing who gets placebo and who gets vaccines. We plan to enroll 10,000 or more.. That is to say that one third of the world study will be carried out in this hospital alone. Today there are six thousand vaccinated with one dose, two thousand with the complete schedule and we continue with the enrollment of more people at our web page", he explained.
Among the requirements to be met by those who wish to join the study are: to be between 18 and 59 years old, not to have had Covid-19 with a positive PCR and not to be vaccinated with any vaccine dose. "This is a challenge. It is a positive thing for Argentina that people have access to vaccination and get vaccinated, but it complicates the work a bit. In this study, if you are participating and you have access to a government appointment.you can certify it and we, if you wish, we can open the blind.. The person can stay in the study, if he/she was vaccinated, or, if he/she had placebo, he/she can leave and get vaccinated. There is no problem, although, in general, the population that requests it is less than 2%."said the researcher.
"We aim, above all, to involve people between 18 and 30 years of age, which will allow us to give them two vaccines, either in the trial stage or when the efficacy is proven, since those who received the placebo will receive the vaccine; and these are people who would not have the complete scheme in the short term, at least in the country," he pointed out.
In any case, the principal investigator of the Central Military Hospital of the vegetable vaccine assured that the volunteers choose to join this trial for several reasons: despite having access to the vaccine they decided not to apply it for some reason, others because they have "a more naturist tendency and are more reluctant to apply any medicine in general", some others because they want to participate in a study of this caliber and the last ones because they did not have access to any turn because they are very young.
However, regardless of the reasons that led them to join the trial, Perez Marc emphasizes that "the Argentine clinical trial volunteer is of the highest quality.the Argentinean clinical trial volunteer is of the highest qualityThey stay in the study for a long time, comply with all the requirements, do not violate the imposed rules, are very informed and ask many questions, and assert their autonomy. It is a pleasure to work in Argentina doing clinical research and it is not by chance that so many centers with such high quality can be sustained".
When will the first results be available?
As with the rest of the vaccines, the ultimate goal of this study is to add a new immunization to confront Covid-19 and stop the pandemic that is still ravaging the world. That is why timing is decisive. "The interim efficacy analysiswhich is now being done for the first time, will be carried out as soon asfor example, 160 infected persons"the doctor pointed out.
When this number is reached, a portion of the cecum can be opened and the efficacy of the vaccine will be analyzed, since it will be compared how many people were infected with vaccine and how many with placebo, and from the difference the number will be obtained. Now, in order to know the effectiveness, it will be necessary to wait until the immunization is approved and its inoculation in the general population begins.
"With the first data emergency use approval is allowed.. And thinking about what happened with Pfizer, which was a study of this magnitude, I imagine that in two months we will be able to have an interim efficacy analysis .. The FDA, if the efficacy is good efficacy, will give it a fast track. fast track or fast track or abbreviated hearing because it is of special interest to them, so that in three months we could have the vaccine approved to apply it to those who were placebo, produce it on a large scale and distribute it around the world", summarized Pérez Marc.
The total duration of the study will be approximately one year, since being a vaccine that advances on data from other studies, even if it has a late start, the times are shortened. However, the interval between the two doses (which are the same but are given at the same time) must still be considered. between the two doses (which are the same but administered 21 days apart) and how difficult it is to achieve the number of doses. and how difficult it is to reach the indicated number of volunteers.
"This pandemic put a very important focus on clinical research and showed that there is a lot of care for the subjects who participate. Although people may see secondary benefits, such as follow-up by doctors, systematic anti-Covid-19 surveillance and perhaps access to a new medication in the short term, the truth is that participating in clinical research is an absolutely altruistic and autonomous act.. All centers in Argentina and the world have hyper-strict standards that guarantee this care and are highly audited by regulatory agencies, sponsors, and national and international ethics committees. It is safe and it is important for people to participate, because if we do not have new medicines and in Argentina we have a quality that is at the top of the world range in this", concluded Perez Marc.
By Romina Cansler
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