The ARVAC Cecilia Grierson vaccine, designed to protect against the SARS-CoV-2 variants circulating in the region, begins the final stage of the call for volunteers concerning the last stretch of phase 2/3 clinical trials. In this stage, the safety and immunogenicity of three ARVAC formulas -including a bivalent version against Ómicron- will be evaluated in 1,782 volunteers. It should be noted that the first stage of phase 2/3 has already recruited 151 volunteers, as expected. Those interested can now apply. here
Phase2/3
The results of the first stage of the investigation showed that the ARVAC vaccine is safe, and the preliminary values of immune response are promising; now the most advanced phase of vaccine development must continue to generate the results that will be presented to the National Administration of Medicines, Food and Medical Technology (ANMAT) for approval as a booster vaccine.
Phase 2/3 has two stages. In the first, which is ongoing, the vaccine is administered to 232 people in two centers in the Autonomous City of Buenos Aires (CABA): CEMIC and Clinical Pharma; this stage began in January 2023.
Now the beginning of stage 2 is expected, in which the ARVAC formula will be applied in 10 centers distributed in four Argentine provinces and in the city of Buenos Aires, and requires the participation of 1,782 volunteers who are 18 years of age or older; who have received up to three doses of vaccines against COVID-19 (complete scheme and up to a reinforcement) and who reside in one of these cities: CABA, La Plata, Mar del Plata, Córdoba capital, Mendoza capital, or Salta capital. The medical staff that will carry out the trials is made up of outstanding professionals, such as in stage 2 of phase 2/3 of the clinical trials, by Dr. Gonzalo Pérez Marc, who carried out the vaccine trial together with his team. against COVID-19 from Pfizer in Argentina.
During a meeting at the National University of San Martín (UNSAM), the head of the scientific portfolio, Daniel Filmus; the Minister of Health, Carla Vizzotti; the leader of the ARVAC project and researcher at UNSAM and CONICET, Juliana Cassataro; the president of the National Agency for the Promotion of Research, Technological Development and Innovation (R+D+i Agency), Fernando Peirano; the rector of UNSAM, Carlos Greco, and Jorge Cassará from Fundación Cassará. They reviewed the results of the phase 1 work, the research centers and teams involved in the phase 2 and 3 clinical studies, and the imminent call for proposals.
Filmus expressed in this regard: “All the investigations show that booster vaccination campaigns will have to be carried out every year, in some cases several times a year, and Argentina will be the first country in South America to have this self-developed vaccination, which meant years of basic research. It is the first time that our country can carry out a phase 2/3 development in humans and that allows security in a bivalent vaccine that, in case of changing the variant in three months, can have a vaccine ready that addresses it. It is a huge advance for Argentine science” and pointed out that “this means not having to import vaccines and at the same time being able to export them. It is extremely important to put the right to health in the hands of Argentines without waiting for them to sell us vaccines or not” and mentioned that there are agreements so that this same phase can be replicated in other Latin American countries and can be approved by regulatory bodies such as ANMAT in Argentina.
For his part, Vizzotti stressed that the development of the ARVAC vaccine “is a priority, not only to have a vaccine booster against Argentine COVID-19, but also to start this path that had never been done in our country” and detailed “the study of phase 1, phase 2/3 and public clinical investigation of a national product, financed by the State and accompanied by our regulatory entity, which gives it quality, transparency and generates trust”. The minister pointed out that this process constitutes a milestone that “will open the way for new strategic inputs to continue to be developed in Argentina.” Finally, he congratulated the researchers who are part of the teams and called on them “to work hard together to be able to enroll the volunteers as quickly as possible to have the results as soon as possible, so that ANMAT can evaluate them and we can define the steps to follow”.
“The latest trials are underway to show that ARVAC is a safe and effective vaccine. We are grateful for the support of society. So far, 151 volunteers have participated in the first stage of phase 2/3, and this number will continue to increase until reaching 232 volunteers. Our next challenge is to recruit 1,782 volunteers in different provinces and CABA,” said Juliana Cassataro. It should be noted that during phase 1 the vaccine was tested on 80 people.
The principal investigators of the participating centers (in the regulatory stage) are: Dr. Gonzalo Pérez Marc, leader of phase 3 of the ARVAC trial; Dr. Oscar Roldán, CDS, Clínica Privada del Sol (Córdoba); Dr. Tomás Smith, CIC, Salta Clinical Research Center (Salta); Dr. Jorge Llensa, CDC Medical Center (Mendoza); Dr. Gonzalo Corral, IIC, Clinical Research Institute (Mar del Plata); Dr. Ignacio Uriarte, CNyF, Children and Family Clinic (Mar del Plata); Dr. M. Fernanda Alzogaray, IMP, Plata Medical Institute (La Plata); Dr. Nicolás Itcovici, CICB, Belgrano Clinical Research Center (CABA); Dr. Miriam Bruno, Vaccinate (CABA); Dr. Gabriela Vidiella, SMG, Barrio Parque Medical Center (CABA); Dr. Pablo Lapadula, Otamendi, Otamendi and Miroli Sanatorium Medical Center (CABA); Dr. Pablo Bomvehi, CEMIC (CABA); Dr. Gustavo Yerino, FP Clinical Pharma (CABA).
*It is important to note that this is possible thanks to the volunteers who participated in the trials. Participating is a personal decision, completely voluntary and not final. Each volunteer in the study can withdraw at any time, free of charge.
The first Argentine vaccine against COVID-19
ARVAC Cecilia Grierson is an initial development of the National University of San Martín, CONICET and the Cassará Laboratory, with support from the National Agency for the Promotion of Research, Technological Development and Innovation (R+D+i Agency), the Ministry of Science, Technology in Innovation, and Health of the Nation, added to the joint effort of more than 20 public and private institutions in the country.
