Phase 3 trials of Medicago's plant-derived vaccine are being conducted at the Buenos Aires Military Hospital and also in other countries; approval for emergency use could be granted in September.
One remis enters through the access to 11 de Septiembre Street, then another, then another, then another, then another. Thus up to 700 cars a day can pass through that go as far as the Central Military Hospital and transport volunteers for a new clinical trial being conducted in Argentina to test the efficacy of a vaccine against the coronavirus coronavirus. vaccine against the coronavirus. The place has been transformed: a white tent, located in the parking lot, is now used to inoculate the members of the Force, because the hall where it was done before is crowded with people who read attentively, medical offices where medical examinations are performed and laboratories that process up to 300 blood samples. laboratories that process up to 300 blood samples daily. daily.
The Phase 3 study of the Canadian biopharmaceutical Canadian biopharmaceutical company Medicagowhich brings together in the country 10,000 of the 30,000 volunteers from the United States, Canada, Mexico, Brazil and some European countries, began on June 19. This is the most important stage of development. This instance, under the double-blind methodology by the use of placebos in half of the placebos in half of the applicants, could lead to the approval of the use of the drug.could lead to the approval of the emergency use of a vaccine that uses a novel platform of plant origin. The objective is to have the authorization in September.
More than 1,000 people are involved in the logistics, coordinated by the research team at the Hospital Militar Central where the Phase 3 trial of the Pfizer/BioNTech vaccine was also conducted. Phase 3 trial of the Pfizer/BioNTech vaccine was also conducted there, although with half the volunteers.vaccine trial was also conducted, although with half of the volunteers. Everyone has a role in each of the seven stages of the first visit of the applicants of the applicants who, before receiving the first dose, had to go through a thorough screening to confirm whether or not they were eligible to participate in the trial.
Total anonymity until the end of the trial guarantees the confidentiality of the identity of the volunteers who can still register to participate. volunteers who can still register to participate in the trial.. "I wasn't going to get vaccinated because I didn't trust any of the vaccines they were giving. But I heard about the trial, did some research, and realized that in this case it was something different, which didn't have a lot of manipulation in the lab. I was convinced and here I am", says a woman who has already received the first dose at one of the vaccinator's booths.
She, like the rest of the participants, does not know if she was given a placebo (a physiological solution); and she will not know until the end of the trial. She should 21 days later to receive the second dose of the same component, which, if it is the vaccine which, if it is the vaccine, will achieve peak antibodies within seven days, about 75 times more powerful than other vaccines. 75 times more powerful than other vaccinesaccording to the researchers. Afterwards, he will have other visits in which blood will be extracted to be sent to the United States where it will be analyzed. Before starting the procedure, they had to read an expanded package insert to confirm that this is a voluntary participation in a clinical trial.
For the next seven days they should complete a diary to record their health status and detail symptoms such as nausea, headache, fever or the condition of the area where the vaccine was given. But also any other situation that would trigger medical attention, for example, a traffic accident or a trip. Nothing is left to chance: if several volunteers are found to have gone through the same thing, it could be an indication of a sequelae after the vaccine was administered.
"Of the 30,000 volunteers, half have already been vaccinated and in the Military Hospital we have reached 5,000. This month we should finish enrolling the participants so that in August we can have the 160 infected people 160 infected people needed to open the double blind. The intention is to have the internal efficacy study and for the US FDA (Food and Drug Administration) to approve its emergency use in September", explains the physician researcher Gonzalo Pérez Marcin charge of the project.
Advancing vaccination
No number is whimsical. The statistical variables used for the trial showed that to perform the internal efficacy evaluation with 30,000 volunteers, it is necessary that at least 160 contract Covid-19 during the seven days following the trial. at least 160 volunteers need to contract Covid-19 during the seven days after the second dose, when the maximum antibody response is after the second dose is applied, when the maximum antibody response is achieved. "The 160 are obtained on a sample basis taking into account the predictability of virus circulation and, if that number is not reached, the efficacy test cannot be done.. Then, among those infected, those who had the vaccine are taken and a formula is used to determine the relative risk of getting sick. By converting it into a percentage, the efficacy of the vaccine is obtained", explains Pérez Marc.
The logistics at the Central Military Hospital are well oiled. The remiseros announce themselves at the security checkpoint and then they can take two paths: the Medicago third stage volunteers or the Pfizer checkups. "Welcome. Your volunteer experience in the Covid-19 plant-based vaccine study starts here. Together we make history," reads a sign next to one of the guides indicating where to start the journey. After admission and reading the expanded package insert, the women are required to undergo a urine test to rule out a urine test to rule out pregnancy (if they are pregnant or breastfeeding they cannot participate in the trial) and later the medical examination and blood draw, which also corresponds to men.
The vaccination takes place in another of the hospital's buildings. "I saw the possibility of accessing a vaccine as a distant possibility, so I signed up. Besides, I like to think that we are helping to put the pandemic behind us," says one of the women waiting her turn. "Symptoms? None, just a little discomfort in the area where I was vaccinated", says a young man who is waiting for the second dose. In the same module, but on different floors, there are other areas of the trial, such as the pharmacy, where vaccines and placebos are assembled. There, where the vaccines are where the vaccines are stored in common refrigerators, doctors cannot enter.This is the "unblinded" part of the study, since they know what is applied to each person.
Among the 1,000 people working for the trial throughout the metropolitan area, they have roles in clinical trial coordination, regulations, logistics, supplies, pharmacy, production, dispensing, supervision, maintenance, laboratory contact and monitoring, medical records archiving, participant documentation, physicians, remote volunteer surveillance, recruiters, visit coordinators, intake, volunteer preparation, information, blood collection, vaccination, among others.
In addition to the maintenance in common refrigerators, the vaccine that is being tested in Buenos Aires (also in Rosario, Córdoba and Tucumán on a smaller scale), has another advantage: production is easily scalable because it depends on how many plants are available. The platform is novel and is called VLP (Virus Likes Particles) because it uses a plant, the because it uses a plant, the nicotiana benthamianawhich acts as a natural bioreactor and allows a particle very similar to the coronavirus to be generated. "That particle is removed from the plant and added to the vaccine with an adjuvant, an enhancer. The particle acts like the virus and fools the human body.. When you get the coronavirus, the immune defense is already made with this simulator that could not infect before," explains Pérez Marc.
The expectation is great and it is believed that the efficacy will be high due to the response of the vaccine in previous phases. If it is effective, the researcher in charge of the project estimates that having contributed one third of volunteers to the global study, priority access to the products can be requested for Argentina. The process is already underway.
By Mauricio Giambartolome-La Nación
Link to the complete article:
