Phase 2/3 Study to Evaluate Safety, Tolerability and Immunogenicity of a Recombinant Protein-based Vaccine Against SARS-CoV-2, in a Population of Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.

The goals of this clinical trial are:
Phase 2: to test a gamma adapted recombinant vaccine against SARS-CoV-2 in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus.
Phase 3 (first volunteer enrollement on March 25, 2023): to test a recombinant vaccine against SARS-CoV-2 comparing three different versions (Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine, Bivariant Gamma/Omicron RBD-based ARVAC-CG vaccine), in adult volunteers previously vaccinated against the SARS-CoV-2 virus
The main questions to be answered are:
Phase 2:
What si the immune response after one dose of vaccine?
What is the safety and tolerability profile of this vaccine?
Phase 3 :
What is the immune response triggered by each vaccine formulation against Wuhan, gamma, and omicron variants.
What is the safety and tolerability profile of this vaccine?
In phase 2, participants will receive one dose of the study vaccine and one dose of placebo 28 days apart, in a cross-over design.
In phase 3 (not yet recruitment), participants will be randomized to receive one of the three possible types of vaccines and all of them will receive one dose of the corresponding vaccine and 1 dose of placebo 28 days apart, in a cross over design.

Start Date06 Feb 2023

Sponsor / Collaborator

National University of General San Martín

[+1]

NCT05656508

/ CompletedPhase 1

Phase 1 Study to Evaluate Safety, Tolerability and Immunogenicity of a New Recombinant Protein-based Vaccine (ARVAC CG) Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), in a Population of Healthy Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.

The objective of this clinical trial is to test a new vaccine against SARS-CoV-2 (ARVAC-CG) in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus.
The main questions it aims to answer are:
What is the safety and tolerability profile of the two-dose schedule of this new vaccine?
What is the immune response after each dose of vaccine Participants will receive two doses of the study vaccine 28 days apart. They will be required to complete a total of 7 safety and immunogenicity follow-up visits over a 1-year period.

Start Date20 Apr 2022

Sponsor / Collaborator

Laboratorio Pablo Cassara Srl

[+1]

100 Clinical Results associated with National University of General San Martín

0 Patents (Medical) associated with National University of General San Martín

1,461

Literatures (Medical) associated with National University of General San Martín

01 Jul 2025·Water Research

Insights into chlorination-induced degradation of sulfonylurea herbicides: Unraveling kinetics and intermediates during water treatment

Article

Author: Mosca, Agustín ; De Gerónimo, Eduardo ; Cabrerizo, Franco M ; Vargas, Ronald

Chlorination is a common method for drinking water disinfection due to its efficiency and low cost. The strong oxidative properties of chlorine can lead to reactions with dissolved organic compounds, resulting in various transformation products. This study investigates the chlorination-induced degradation of the sulfonylurea herbicides metsulfuron-methyl and chlorimuron-ethyl, which are frequently found in surface and groundwater. The degradation of these herbicides follows a second-order kinetic model. The apparent second-order rate constants for metsulfuron-methyl range from 3.2 to 244 M⁻¹ s⁻¹, while those for chlorimuron-ethyl range from 2.2 to 287.7 M⁻¹ s⁻¹ within a pH range of 4 to 9. Reaction with HClO effectively reduced the concentration of pesticides. Under acidic conditions, the reaction was significantly enhanced, likely due to hydrolysis or changes in the speciation of the organic compounds. In fact, the rate constant under acidic conditions was approximately 35 and 27 times higher than the reaction rate at more neutral pH for chlorimuron-ethyl and metsulfuron-methyl, respectively. The reaction rate with ClO⁻ approached zero for both herbicides, suggesting a minor or negligible pathway involving the hypochlorite anion. Mass spectrometry identified six chlorination products for metsulfuron-methyl and five for chlorimuron-ethyl. Although the specific reaction mechanisms were not fully elucidated, these products provided valuable insights into the fate of sulfonylureas under chlorination. Under typical disinfection conditions (pH 7 and 4 mg L⁻¹ chlorine), the half-lives of 17.8 minutes for metsulfuron-methyl and 26.6 minutes for chlorimuron-ethyl demonstrate the potential for effective degradation in relatively short timeframes. This study underscores the potential for effective removal of these herbicides in drinking water treatment and highlights the importance of evaluating degradation products over time, as they remain detectable even after seven days.

01 Jul 2025·Journal of Hazardous Materials

Assessment of nicotine and degradation products in cigarette butts leachates after detoxification by white rot fungi

Article

Author: Butler, Matías ; Itria, Raúl Fabio ; Calfayan, Laura Mariel ; Núñez, María Del Pilar ; López Loveira, Elsa Gabriela ; Domínguez, Sofía Eugenia

Cigarette butts (CBs) are widespread hazardous waste contaminating the environment due to the recalcitrance of the filter and the toxicity of the contaminants leached. This paper evaluated through analysis of contaminants and toxicity bioassays on Raphanus sativus seeds, the ability of four fungal strains of white rot fungi to treat cigarette butts, including 2 native strains of Trametes sp. (strains BAFC 4765 and BAFC 4767), one of Irpex lacteus (strain BAFC 4766) and one commercial strain of Pleurotus ostreatus (strain BAFC 2034). Each strain was grown in a medium of water-soaked CBs in axenic conditions at Erlenmeyer-scale during six weeks, analyzing leachate samples periodically by HPLC-MSⁿ. Temporal evolution of nicotine as well as the transformations of tobacco alkaloids and other contaminants generated by the different fungal treatments were characterized. Nicotine was degraded significantly by the end of the treatments although variations were found among the fungal strains, proposing a degradation mechanism based on the 12 tobacco alkaloid transformation products identified. Leachates from CBs showed a total inhibition of germination on Raphanus sativus seeds whereas those obtained after 6 weeks of treatment displayed a significant decrease of phytotoxicity (7-20 % inhibition of germination) exhibiting sublethal effects. The results obtained in this work support the development of CBs fungal treatment for waste detoxification on a larger scale.

01 May 2025·International Journal of Biological Macromolecules

Multifunctional cassava starch bilayers with basil extract and eco-friendly synthesized silver nanoparticles for scalable and sustainable food packaging

Article

Author: Guz, Lucas ; Iacovone, Carolina ; Famá, Lucía ; Fernández, Leiza

Plastic packaging remains essential for food safety; however, improper disposal severely affects ecosystems. The challenge lies in developing sustainable packaging that preserves food quality while reducing environmental harm. This research focused on developing biodegradable bilayer nanocomposites made from two layers of cassava starch. One-layer incorporated basil extract, while the other varying concentrations (1 %, 2 %, or 3 % w/w) of silver nanoparticles (AgNPs), which were synthesized using basil extract and cassava starch. All films were produced through an extrusion-thermoforming process. The bilayer with 3 % w/w AgNPs could not be evaluated due to early cracking during thermoforming process. The bilayers with 1 % and 2 % w/w nanoparticles exhibited antimicrobial activity against E. coli and demonstrated enhanced mechanical resistance. The basil extract-infused layer offered antioxidant properties, UV protection, and reduced water wettability. The bilayer nanocomposite containing 1 % w/w AgNPs demonstrated better interlayer compatibility and material integrity when in contact with water than the 2 % w/w formulation. The starch-based bilayer nanocomposite with 1 % w/w nanoparticles shows great potential for sustainable functional food packaging, combining antioxidant and antimicrobial properties, UV protection, improved mechanical strength, and reduced water wettability. However, increasing the concentration of AgNPs is challenging due to the differences in the thermoforming behavior of the layers.

100 Deals associated with National University of General San Martín

100 Translational Medicine associated with National University of General San Martín

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Drug(Targets)	Indications	Global Highest Phase

ARVAC-CG vaccine(Laboratorio Pablo Cassara S.R.L.) ( SARS-CoV-2 antigen )	-	Phase 1

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