The National Administration of Medicines, Food and Medical Technology (ANMAT) authorized the start of phase 2 and 3 studies to evaluate the safety, tolerability and immunogenicity of the national vaccine ARVAC Cecilia Grierson. It was developed jointly by CONICET, the National University of San Martín (UNSAM) and the Pablo Cassará Laboratory.
“The study will be carried out in at least ten institutions throughout Argentina with 2,014 volunteers. What was approved yesterday (by Monday) is the clinical trial at Cemic. Then each of the participating institutions will be presented to ANMAT”he told telam Juliana Cassataroone of the researchers on the team.
In this sense, he pointed out that “in a phase 2/3 clinical trial the ARVAC vaccine Cecilia Grierson It will be applied as a booster to people who have received the full schedule and no more than one booster dose of any vaccine against SARS-Cov-2and what is mainly going to be measured is the safety and the neutralizing antibody response.”
The researcher, PhD in Immunology and Conicet researcher, explained that in the second phase of the trial there will be three branches: “One of the volunteers who will receive the vaccine made based on the Gamma variant, another that was made based on Ómicron and the third branch will receive a bivalent vaccine (Gamma-Ómicron)”.
In this context, Cassataro recalled that during phase 1 trials, the ARVAC Cecilia Grierson developed based on the Gamma variant generated an immune response against the ancestral virus (known as Wuhan), Delta, Gamma and Ómicron.
During its first phase it was tested on 80 people, for whom it turned out to be safe and immunogenic, increasing antibodies against the virus up to 30 times. pic.twitter.com/oMfR9YDP5u
— UNSAM (@unsamoficial) January 10, 2023
Referring to this phase 2/3, he explained that “In the first stage, the response of the population between 18 and 60 years of age will be evaluated, and later it will be studied in the population over 60 years of age and in people with comorbidities”.
This is the first time that phase 2 and 3 studies have been carried out in the country for a nationally developed vaccine against coronavirus.
In the official statement released on Monday, with the news of ANMAT’s approval of these new trials, it was highlighted that from the partial results of phase 1, preliminary safety information was obtained that showed that the vaccine ARVAC Cecilia Grierson it is safe and very “immunogenic”this is that it generates a high response in the immune system.
Indeed, it was found that a booster dose increases up to 30 times the neutralizing antibodies against the Omicron and Gamma virus variants.
After the authorization of the @anmatsaludthe phase II and III trials will be carried out, in which the results will be repeated in 2,014 more people. pic.twitter.com/phEXVVS5pr
— UNSAM (@unsamoficial) January 10, 2023
Intended for booster doses in people already immunized, the ARVAC Cecilia Grierson it is based on recombinant protein technology, a safe technology that has already been applied in hepatitis B vaccines in newborn children for more than 20 years, or more recently HPV. It is a platform that has demonstrated security and can be easily adapted to the emergence of new variants at a regional or global level.
In addition, this vaccine can be stored between 2°C and 8°C (refrigerator temperature), which will allow the doses of ARVAC Cecilia Grierson, unlike the first vaccines against COVID-19, to be cheaper, easier to produce and distribute.
