Inactivated vaccines use the dead version of the germ that causes disease. Some examples of vaccines of this type are Hepatitis A, Flu, Polio (injectable Salk vaccine) and Rabies (. / Tingshu Wang)
Fundación Hupedes started in Argentina phase 3 of an inactivated Chinese vaccine against the SARS-CoV-2 virus, after the end of August The Ministry of Health will agree with the Chinese government to test this candidate vaccine developed by the Sinopharm laboratory in the country. It’s about a randomized study, which means that each of the 3 thousand volunteers They will be selected to receive the vaccine or a placebo, that is, an inert substance, according to randomness.
In turn, the test uses a double masking technique, where neither the volunteer nor the research team know whether they received the vaccine or the placebo, controlled with placebo, in parallel groups to evaluate immunogenicity or the ability to activate the immune system and the safety of an inactivated vaccine, technology applied by this candidate vaccine.
China has at least 3 candidate vaccines in phase 3 (. / Tingshu Wang)
Developed by the CNBG (China National Biotech Group in English), in collaboration with the BIBP (Beijing Institute of Biological Products) and Chinese state pharmaceutical company Sinopharm, is one of the 10 vaccines already being tested in humans in phase 3. The BIBP is a prequalified institute by the WHO (World Health Organization), it is the main manufacturer of vaccines in China and the only Institute that has the regulatory approval of Biosafety Level 3 for the manufacture of vaccines based on virus culture .
The sponsor of the study in Argentina are the Elea-Phoenix Laboratories, a company with national capitals founded in 1939 that since its inception has been dedicated to Research and Development of therapies for human health, prioritizing quality and accessibility. At the same time, Fundación Hupedes will coordinate the research, which will be carried out in three of the Vacunar group centers.
The study will last 12 months and will include 3,000 volunteers, older than 18 years, who by their medical history and physical examination are in good health are eligible. All people over 18 years of age interested in participating can access the web page of Fundación Hupedes and complete the form.
The three vaccines that have developments in the country use different technologies. At the Fundación Guest, the Sinopharm candidate will be tested on 3,000 volunteers (. / Tingshu Wang)
« We are very happy with this possibility, It is a joint effort with the pharmaceutical company Sinopharm -company that develops the candidate vaccine associated with the Argentine laboratory Elea, Fundación Huiuda, organizing the study and the Vacunar network that will have the exclusive use of 3 exclusive centers for the volunteers to come, ”he explained Pedro Cahn, prestigious infectious disease doctor and scientific director of Fundación Huiuda, consulted by Infobae.
« It is an inactivated virus vaccine, such as hepatitis A, polio and rabies, that is, vaccines that are absolutely safe from that point of view because contain no live virus elements”. specified the key adviser to the President in the fight against the new coronavirus in Argentina.
As detailed to this medium by Dr. Cahn, « What is sought with this study is to verify what was seen in phase 1 and 2, that the vaccine is safe and that it is effective in producing antibodies”. « Now it is time to test it against placebo and that is what we are going to start doing with the volunteers who are already signing up on Monday of next week”He added.
The Argentine infectologist Pedro Cahn, director of Fundación Hupedes and member of the Advisory Committee of President Alberto Fernández in the fight against the new coronavirus (. / Fundación Hupedes)
“What we see in phase 2 are results obtained in a limited number of patients, while now the vaccine will be tested in more volunteers. This will generate a database that will allow us to see, for example, the adverse events that it may produce, which in general are very few and include fever and pain at the injection site.Are they different if we inject placebos or if we give the vaccine? ”Cahn wondered, adding: If they are different, how different are they?
« Second, this test allows us to see what happens with the increase in antibody concentration in these patients.; and thirdly, see what happens during the year that the observational study will last, because the result of the antibodies we will have 28 days after the second injection, there are two injections that this inactivated vaccine has« Cahn specified to Infobae. « This will allow us to know what happens with the incidence of clinical cases of COVID-19 in the course of a year, we will see all this in time”He warned.
Argentina will produce the Oxford-AstraZeneca coronavirus vaccine for all of Latin America in a joint effort with Mexico (. / Juan Ignacio Roncoroni)
« That is We will have preliminary results regarding the immunogenic capacity of the vaccine and there will be results that will take longer in relation to the incidence of new cases of COVID-19 in the participants, depending on how long the antibodies last in them.”, He explained.
« People are already signing up, we open the call at 3 in the afternoon and we already have more than 800 registered, now a few hours later. We will surely have a good number of candidates”, Exclusively advanced to Infobae, At the same time, it stated that “a similar number of men and women will be weighed, who will be summoned and will be given written material to read with a signed consent, they have the right to read it and decide not to be part of the test as Participating in a clinical study is a right and not an obligation, they will have blood tests, a swab to know that they do not have COVID-19 at that time and between 3 to 7 approximately they will be cited to receive the first dose, then they pass 21 days and receive the second dose”.
800 Argentines have already signed up to be volunteers (Europa Press)
Also in dialogue with Infobae And in an interview granted in June, Cahn exclusively analyzed fundamental aspects of the vaccine against COVID-19 in June: “Science has to take over the debate regarding the accessibility and distribution of the vaccine, absolutely. First, it is a logistical problem, it implies a monumental effort and necessarily a public-private cooperation. You cannot make a business out of this, because if it does not mean leaving 70% of humanity without a vaccine, there is also a scalability issue that will have to be solved ”.
In relation to seasonality and in particular the incidence of winter in respiratory infections, he stated: “The cold favors all respiratory infections, from colds and flu, for which we have a vaccine. It is true that the cold increases respiratory infections, but this winter ‘grabs’ us better off: washing our hands, wearing a mask and using public transport less”.
Sinopharm Group Co Ltd a state company in Hong Kong has an advanced stage COVID-19 vaccine (.)
The world changed dramatically at the end of 2019, when a new SARS-CoV-2 coronavirus was known and the disease that causes COVID-19 began to spread rapidly around the planet at a dizzying rate. The WHO classified the epidemic as a public health emergency of international concern. Airborne drops and transmission through close contact with people infected with the condition or infected but asymptomatic people are the main routes of infection. At the same time, there is more and more scientific evidence which suggests that transmission is possible also from aerosols, which are dehydrated viral microparticles that can remain in the air suspended for a time, for example in ventilation systems without adequate filters, and especially in closed spaces.
Although there are several phase III studies of different developments, there are currently no approved vaccines for SARS-CoV-2 on the market.
Prevention measures – social distancing, hand washing, use of a chinstrap, respiratory hygiene – have proven useful in reducing the risk of contagion, but they have not managed to control the spread of this disease. This has motivated an intense scientific research effort to obtain a vaccine that can prevent new infections.
10 vaccines are today in phase 3 according to the WHO (. / HOTLI SIMANJUNTAK / File)
Questions and answers about the study according to Fundación Hupedes
-What is a vaccine?
-Vaccines are preparations that are used to generate immunity against different diseases. They generate antibodies that protect the human body against microorganisms -viruses or bacteria-, which prevents diseases or generates mild manifestations and, in addition, cuts the chain of transmission between people.
-What does it mean to be inactivated?
– Inactivated vaccines use the dead version of the germ that causes a disease. Some examples of vaccines of this type are Hepatitis A, Flu, Polio (injectable Salk vaccine) and Rabies.
In this case, it is an inactivated SARS-CoV-2 virus preparation, which aims to develop the body’s own defenses -antibodies- against the virus.
Has this vaccine already been tested in humans?
-Yes, in phase 1 and 2 studies more than 800 volunteers were vaccinated with good preliminary results and without serious adverse effects. In addition, simultaneously with the study carried out by Fundación Huiuda, the vaccine is currently undergoing different international multicenter clinical studies. The participating countries are the United Arab Emirates, with 45,000 volunteers, Bahrain with 6,000, Peru also with 6,000, Morocco, Pakistan, Serbia and Jordan. Finally, the vaccine is already being applied in China, in risk groups, that is, people more exposed to COVID-19.
Vials of a COVID-19 vaccine candidate, co-developed by Chinese biopharmaceutical firm CanSino Biologics Inc. and a team led by a Chinese military infectious disease expert, in Wuhan, Hubei province, China (China Daily via .)
-How is the procedure for volunteers?
-Once the volunteers have given their consent in writing, the research team in charge will ask questions about medical history and clinical tests will be carried out. A swab will also be done to rule out that the volunteer has COVID-19.
A few days later, the first dose of vaccine or placebo will be applied. 21 days later the second dose will be applied. After each dose, the volunteer must remain 30 minutes under observation.
Finally, you will be contacted frequently by phone to check your health status and you must report symptoms in an app on your cell phone. Your participation will end approximately one year after you have received the first dose of vaccine or placebo.
-Are there any adverse effects?
-To date the adverse effects recorded are limited to pain at the injection site and short-term fever.
File photo of a failure with the measles, mumps and rubella (MMR) vaccine at the International Community Health Services clinic in Seattle, Washington, United States. March 20, 2019. . / Lindsey Wasson / Archive
-Will all people interested in participating enter the study?
-The protocol provides inclusion and exclusion criteria that may determine that a candidate is not eligible. The call for volunteer candidates will be opened according to the methodological requirements of the different studies.
– Those who enter the study, will they receive the vaccine?
-To study the effectiveness of the vaccine, it is necessary to compare it with an inert substance, called a placebo. At the time of inclusion in the study, each volunteer will be randomly assigned to a group that will receive the inactivated vaccine or a group that will receive the placebo. The volunteers and the treating medical team will not know which group each participant belongs to, as the placebo will look the same as the inactivated vaccine.
Thanks to a coding system that will be kept confidential, only a team in charge of analyzing the results of the study will know what each person has received. In order to correctly interpret the observed results, the amount of antibodies obtained in those who received the inactivated vaccine will be compared with that of the group that received the placebo.
-Is there a cost or an economic stimulus for participation in the study?
-The participation is voluntary, free and unpaid. No volunteer will receive a payment for participating nor will they incur expenses. It is expected that mobility will be provided and / or that the cost of travel to the vaccination center will be reimbursed, if necessary.
Argentina today exceeded 10,000 deaths from COVID-19 (. / Juan Ignacio Roncoroni)
-Whoever enters the study voluntarily, is he obliged to finish it?
-Each volunteer has the right to withdraw at any time from the study. However, those who are interested are asked to avoid entering the study if they do not intend to complete the year of follow-up, since the evaluation of the efficacy and safety of the vaccine would not be completed.
-Are the study volunteers exempt from complying with prevention measures?
-No, all health care measures such as the chinstrap, physical distance of at least 2 meters and frequent hand washing must be maintained.
This is because the volunteer could have received the placebo. Also, this is an experimental study, so no absolute benefit is guaranteed. Even participating in this study, volunteers will have to take care of the diseases caused by the new coronavirus.
-Can the volunteer contract the disease through the vaccine?
-No, the virus used in this vaccine is inactivated.
The Argentine health system has 61.9% of its intensive care beds occupied so far (. / Juan Ignacio Roncoroni / Archive)
-What happens if a volunteer contracts the disease after receiving a dose of study medication?
-If any volunteer has symptoms compatible with COVID-19, they must immediately notify the medical research team. In the event of confirmed infection, medical staff will immediately contact the person and their family to reinforce protection and provide necessary protective materials such as masks, medical alcohol, and other supplies. The study staff will send a technician to the home of the person with symptoms consistent with CoVID-19, to perform a swab. The medical staff will immediately contact the corresponding assistance center to give him admission and timely symptomatic treatment.
-If a volunteer enters the study, can another vaccine for covid-19 be applied if it is approved and available on the market before the study ends?
-If an approved SARS-CoV-2 vaccine is available for application, there is no problem for the volunteer to access it. However, this will involve exiting the clinical trial.
-If I am a relative of someone on the research team or member of the host foundation, can I participate?
-To guarantee voluntariness and autonomy in the decision to participate in the study, neither people employed by Fundación Hupedes nor family members of the research team may be part of it. The same applies to staff and family members of Vaccinate researchers.
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