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Article ; Online: Extraction-free protocol combining proteinase K and heat inactivation for detection of SARS-CoV-2 by RT-qPCR.

Genoud, Valeria / Stortz, Martin / Waisman, Ariel / Berardino, Bruno G / Verneri, Paula / Dansey, Virginia / Salvatori, Melina / Remes Lenicov, Federico / Levi, Valeria

PloS one

2021 Volume 16, Issue 2, Page(s) e0247792

Abstract: Real-time reverse transcription PCR (RT-qPCR) is the gold-standard technique for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection in nasopharyngeal swabs specimens. The analysis by RT-qPCR usually requires a previous extraction step ...

Abstract	Real-time reverse transcription PCR (RT-qPCR) is the gold-standard technique for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection in nasopharyngeal swabs specimens. The analysis by RT-qPCR usually requires a previous extraction step to obtain the purified viral RNA. Unfortunately, RNA extraction constitutes a bottleneck for early detection in many countries since it is expensive, time-consuming and depends on the availability of commercial kits. Here, we describe an extraction-free protocol for SARS-CoV-2 detection by RT-qPCR from nasopharyngeal swab clinical samples in saline solution. The method includes a treatment with proteinase K followed by heat inactivation (PK+HID method). We demonstrate that PK+HID improves the RT-qPCR performance in comparison to the heat-inactivation procedure. Moreover, we show that this extraction-free protocol can be combined with a variety of multiplexing RT-qPCR kits. The method combined with a multiplexing detection kit targeting N and ORF1ab viral genes showed a sensitivity of 0.99 and a specificity of 0.99 from the analysis of 106 positive and 106 negative clinical samples. In conclusion, PK+HID is a robust, fast and inexpensive procedure for extraction-free RT-qPCR determinations of SARS-CoV-2. The National Administration of Drugs, Foods and Medical Devices of Argentina has recently authorized the use of this method.
MeSH term(s)	Animals ; COVID-19/diagnosis ; COVID-19 Nucleic Acid Testing/methods ; Chlorocebus aethiops ; Endopeptidase K/chemistry ; Hot Temperature ; Humans ; Molecular Diagnostic Techniques/methods ; Nucleic Acid Amplification Techniques/methods ; SARS-CoV-2/genetics ; SARS-CoV-2/isolation & purification ; Sensitivity and Specificity ; Specimen Handling/methods ; Vero Cells
Chemical Substances	Endopeptidase K (EC 3.4.21.64)
Language	English
Publishing date	2021-02-26
Publishing country	United States
Document type	Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0247792
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: A Novel Bacterial Protease Inhibitor Adjuvant in RBD-Based COVID-19 Vaccine Formulations Containing Alum Increases Neutralizing Antibodies, Specific Germinal Center B Cells and Confers Protection Against SARS-CoV-2 Infection in Mice.

Coria, Lorena M / Saposnik, Lucas M / Pueblas Castro, Celeste / Castro, Eliana F / Bruno, Laura A / Stone, William B / Pérez, Paula S / Darriba, Maria Laura / Chemes, Lucia B / Alcain, Julieta / Mazzitelli, Ignacio / Varese, Augusto / Salvatori, Melina / Auguste, Albert J / Álvarez, Diego E / Pasquevich, Karina A / Cassataro, Juliana

Frontiers in immunology

2022 Volume 13, Page(s) 844837

Abstract: In this work, we evaluated recombinant receptor binding domain (RBD)-based vaccine formulation prototypes with potential for further clinical development. We assessed different formulations containing RBD plus alum, AddaS03, AddaVax, or the combination ... ...

Abstract	In this work, we evaluated recombinant receptor binding domain (RBD)-based vaccine formulation prototypes with potential for further clinical development. We assessed different formulations containing RBD plus alum, AddaS03, AddaVax, or the combination of alum and U-Omp19: a novel
MeSH term(s)	Adjuvants, Immunologic/metabolism ; Alum Compounds/metabolism ; Animals ; Antibodies, Neutralizing/blood ; Antibodies, Viral ; Antibody Formation ; B-Lymphocytes/immunology ; Bacterial Outer Membrane Proteins/immunology ; Bacterial Outer Membrane Proteins/metabolism ; Brucella/immunology ; Brucella/metabolism ; COVID-19/immunology ; COVID-19 Vaccines/immunology ; Disease Resistance ; Female ; Germinal Center/immunology ; Humans ; Mice ; Mice, Inbred BALB C ; Mice, Inbred C57BL ; SARS-CoV-2/physiology ; Spike Glycoprotein, Coronavirus/immunology
Chemical Substances	Adjuvants, Immunologic ; Alum Compounds ; Antibodies, Neutralizing ; Antibodies, Viral ; Bacterial Outer Membrane Proteins ; COVID-19 Vaccines ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2 ; unlipidated outer membrane protein 19, Brucella ; aluminum sulfate (34S289N54E)
Language	English
Publishing date	2022-02-28
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.844837
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Article ; Online: Design, synthesis and biological evaluation of quinoxaline compounds as anti-HIV agents targeting reverse transcriptase enzyme.

Fabian, Lucas / Taverna Porro, Marisa / Gómez, Natalia / Salvatori, Melina / Turk, Gabriela / Estrin, Darío / Moglioni, Albertina

European journal of medicinal chemistry

2019 Volume 188, Page(s) 111987

Abstract: Infection by human immunodeficiency virus still represents a continuous serious concern and a global threat to human health. Due to appearance of multi-resistant virus strains and the serious adverse side effects of the antiretroviral therapy ... ...

Abstract	Infection by human immunodeficiency virus still represents a continuous serious concern and a global threat to human health. Due to appearance of multi-resistant virus strains and the serious adverse side effects of the antiretroviral therapy administered, there is an urgent need for the development of new treatment agents, more active, less toxic and with increased tolerability to mutations. Quinoxaline derivatives are an emergent class of heterocyclic compounds with a wide spectrum of biological activities and therapeutic applications. These types of compounds have also shown high potency in the inhibition of HIV reverse transcriptase and HIV replication in cell culture. For these reasons we propose, in this work, the design, synthesis and biological evaluation of quinoxaline derivatives targeting HIV reverse transcriptase enzyme. For this, we first carried out a structure-based development of target-specific compound virtual chemical library of quinoxaline derivatives. The rational construction of the virtual chemical library was based on previously assigned pharmacophore features. This library was processed by a virtual screening protocol employing molecular docking and 3D-QSAR. Twenty-five quinoxaline compounds were selected for synthesis in the basis of their docking and 3D-QSAR scores and chemical synthetic simplicity. They were evaluated as inhibitors of the recombinant wild-type reverse transcriptase enzyme. Finally, the anti-HIV activity and cytotoxicity of the synthesized quinoxaline compounds with highest reverse transcriptase inhibitory capabilities was evaluated. This simple screening strategy led to the discovery of two selective and potent quinoxaline reverse transcriptase inhibitors with high selectivity index.
MeSH term(s)	Anti-HIV Agents/chemical synthesis ; Anti-HIV Agents/chemistry ; Anti-HIV Agents/pharmacology ; Cell Line ; Cell Survival/drug effects ; Dose-Response Relationship, Drug ; Drug Design ; HIV Reverse Transcriptase/antagonists & inhibitors ; HIV Reverse Transcriptase/metabolism ; HIV-1/drug effects ; HIV-1/enzymology ; Humans ; Microbial Sensitivity Tests ; Molecular Structure ; Quinoxalines/chemical synthesis ; Quinoxalines/chemistry ; Quinoxalines/pharmacology ; Reverse Transcriptase Inhibitors/chemical synthesis ; Reverse Transcriptase Inhibitors/chemistry ; Reverse Transcriptase Inhibitors/pharmacology ; Structure-Activity Relationship
Chemical Substances	Anti-HIV Agents ; Quinoxalines ; Reverse Transcriptase Inhibitors ; HIV Reverse Transcriptase (EC 2.7.7.49)
Language	English
Publishing date	2019-12-23
Publishing country	France
Document type	Journal Article
ZDB-ID	188597-2
ISSN	1768-3254 ; 0009-4374 ; 0223-5234
ISSN (online)	1768-3254
ISSN	0009-4374 ; 0223-5234
DOI	10.1016/j.ejmech.2019.111987
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Article ; Online: Persistence of SARS-CoV-2 RNA shedding and infectivity in immunized population: Prospective study along different epidemiological periods in Argentina.

Theaux, Clara / Martin, Yamila / Montoto Piazza, Luciana / Wenk, Gretel / Notaristefano, Guillermo / Miño, Laura / Sevilla, María Eugenia / Aprea, Valeria / Claps, Aldana / Nabaes Jodar, Mercedes / Acuña, Dolores / Salvatori, Melina / Álvarez, Laura / Langan, María Eugenia / Turk, Gabriela / Del Olmo, Ricardo / Viegas, Mariana / Bruno, Miriam / Bokser, Vivian

PloS one

2023 Volume 18, Issue 5, Page(s) e0285704

Abstract: During the pandemic of COVID-19, numerous waves of infections affected the two hemispheres with different impacts on each country. Throughout these waves, and with the emergence of new variants, health systems and scientists have tried to provide real- ... ...

Abstract	During the pandemic of COVID-19, numerous waves of infections affected the two hemispheres with different impacts on each country. Throughout these waves, and with the emergence of new variants, health systems and scientists have tried to provide real-time responses to the complex biology of SARS-CoV-2, dealing with different clinical presentations, biological characteristics, and clinical impact of these variants. In this context, knowing the extent period in which an infected individual releases infectious viral particles has important implications for public health. This work aimed to investigate viral RNA shedding and infectivity of SARS-CoV-2 beyond 10 days after symptom onset (SO). A prospective multicenter study was performed between July/2021 and February/2022 on 116 immunized strategic personnel with COVID-19 diagnosed by RT-qPCR, with asymptomatic (7%), mild (91%) or moderate disease (2%). At the time of diagnosis, 70% had 2 doses of vaccines, 26% had 2 plus a booster, and 4% had one dose. After day 10 from SO, sequential nasopharyngeal swabs were taken to perform RT-qPCR, viral isolation, and S gene sequencing when possible. Viral sequences were obtained in 98 samples: 43% were Delta, 16% Lambda, 15% Gamma, 25% Omicron (BA.1) and 1% Non-VOC/VOI, in accordance with the main circulating variants at each moment. SARS-CoV-2 RNA was detected 10 days post SO in 57% of the subjects. Omicron was significantly less persistent. Noteworthy, infective viruses could not be isolated in any of the samples. In conclusion, a 10-days isolation period was useful to prevent further infections, and proved valid for the variants studied. Recently, even shorter periods have been applied, as the Omicron variant is prevalent, and worldwide population is largely vaccinated. In the future, facing the possible emergence of new variants and considering immunological status, a return to 10 days may be necessary.
MeSH term(s)	Humans ; Prospective Studies ; Argentina/epidemiology ; RNA, Viral/genetics ; SARS-CoV-2/genetics ; COVID-19/epidemiology
Chemical Substances	RNA, Viral
Language	English
Publishing date	2023-05-17
Publishing country	United States
Document type	Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0285704
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Article ; Online: Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in healthy adults.

Pasquevich, Karina A / Coria, Lorena M / Ceballos, Ana / Mazzitelli, Bianca / Rodriguez, Juan Manuel / Demaría, Agostina / Pueblas Castro, Celeste / Bruno, Laura / Saposnik, Lucas / Salvatori, Melina / Varese, Augusto / González, Soledad / González Martínez, Veronica V / Geffner, Jorge / Álvarez, Diego / Feleder, Ethel / Halabe, Karina / Perez Lera, Pablo E / de Oca, Federico Montes /

Vega, Julio C / Lombardo, Mónica / Yerino, Gustavo A / Fló, Juan / Cassataro, Juliana

Nature communications

2023 Volume 14, Issue 1, Page(s) 4551

Abstract: A Gamma Variant RBD-based aluminum hydroxide adjuvanted vaccine called ARVAC CG was selected for a first in human clinical trial. Healthy male and female participants (18-55 years old) with a complete COVID-19-primary vaccine scheme were assigned to ... ...

Abstract	A Gamma Variant RBD-based aluminum hydroxide adjuvanted vaccine called ARVAC CG was selected for a first in human clinical trial. Healthy male and female participants (18-55 years old) with a complete COVID-19-primary vaccine scheme were assigned to receive two intramuscular doses of either a low-dose or a high-dose of ARVAC CG. The primary endpoint was safety. The secondary objective was humoral immunogenicity. Cellular immune responses were studied as an exploratory objective. The trial was prospectively registered in PRIISA.BA (Registration Code 6564) and ANMAT and retrospectively registered in ClinicalTrials.gov (NCT05656508). Samples from participants of a surveillance strategy implemented by the Ministry of Health of the Province of Buenos Aires that were boosted with BNT162b2 were also analyzed to compare with the booster effect of ARVAC CG. ARVAC CG exhibits a satisfactory safety profile, a robust and broad booster response of neutralizing antibodies against the Ancestral strain of SARS-CoV-2 and the Gamma, Delta, Omicron BA.1 and Omicron BA.5 variants of concern and a booster effect on T cell immunity in individuals previously immunized with different COVID-19 vaccine platforms.
MeSH term(s)	Adolescent ; Adult ; Female ; Humans ; Male ; Middle Aged ; Young Adult ; Adjuvants, Immunologic ; Antibodies, Neutralizing ; Antibodies, Viral ; BNT162 Vaccine ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; SARS-CoV-2 ; Vaccines
Chemical Substances	Adjuvants, Immunologic ; Antibodies, Neutralizing ; Antibodies, Viral ; BNT162 Vaccine ; COVID-19 Vaccines ; Vaccines
Language	English
Publishing date	2023-07-28
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2553671-0
ISSN	2041-1723 ; 2041-1723
ISSN (online)	2041-1723
ISSN	2041-1723
DOI	10.1038/s41467-023-40272-3
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Article ; Online: Extraction-free protocol combining Proteinase K and heat inactivation for detection of SARS-CoV-2 by RT-qPCR

Genoud, Valeria / Stortz, Martin / Waisman, Ariel / Berardino, Bruno G / Verneri, Paula / Dansey, Virginia / Salvatori, Melina / Remes Lenicov, Federico / Levi, Valeria

medRxiv

Abstract	Real-time reverse transcription PCR (RT-qPCR) is the gold-standard technique for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection in nasopharyngeal swabs specimens. The analysis by RT-qPCR usually requires a previous extraction step to obtain the purified viral RNA. Unfortunately, RNA extraction constitutes a bottleneck for early detection in many countries since it is expensive, time-consuming and depends on the availability of commercial kits. Here, we describe an extraction-free protocol for SARS-CoV-2 detection by RT-qPCR from nasopharyngeal swab clinical samples in saline solution. The method includes a treatment with proteinase K followed by heat inactivation (PK+HID method). We demonstrate that PK+HID improves the RT-qPCR performance in comparison to the heat-inactivation procedure. Moreover, we show that this extraction-free protocol can be combined with a variety of multiplexing RT-qPCR kits. The method combined with a multiplexing detection kit targeting N and ORF1ab viral genes showed a sensitivity of 0.99 and a specificity of 0.99 from the analysis of 106 positive and 106 negative clinical samples. In conclusion, PK+HID is a robust, fast and inexpensive procedure for extraction-free RT-qPCR determinations of SARS-CoV-2.
Keywords	covid19
Language	English
Publishing date	2020-12-17
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2020.12.16.20248350
Database	COVID19

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Article ; Online: Humoral response and neutralising capacity at 6 months post-vaccination against COVID-19 among institutionalised older adults in Argentina.

Frontiers in immunology

2022 Volume 13, Page(s) 992370

Abstract: The COVID-19 pandemic has particularly affected older adults residing in nursing homes, resulting in high rates of hospitalisation and death. Here, we evaluated the longitudinal humoral response and neutralising capacity in plasma samples of volunteers ... ...

Abstract	The COVID-19 pandemic has particularly affected older adults residing in nursing homes, resulting in high rates of hospitalisation and death. Here, we evaluated the longitudinal humoral response and neutralising capacity in plasma samples of volunteers vaccinated with different platforms (Sputnik V, BBIBP-CorV, and AZD1222). A cohort of 851 participants, mean age 83 (60-103 years), from the province of Buenos Aires, Argentina were included. Sequential plasma samples were taken at different time points after vaccination. After completing the vaccination schedule, infection-naïve volunteers who received either Sputnik V or AZD1222 exhibited significantly higher specific anti-Spike IgG titers than those who received BBIBP-CorV. Strong correlation between anti-Spike IgG titers and neutralising activity levels was evidenced at all times studied (rho=0.7 a 0.9). Previous exposure to SARS-CoV-2 and age <80 years were both associated with higher specific antibody levels. No differences in neutralising capacity were observed for the infection-naïve participants in either gender or age group. Similar to anti-Spike IgG titers, neutralising capacity decreased 3 to 9-fold at 6 months after initial vaccination for all platforms. Neutralising capacity against Omicron was between 10-58 fold lower compared to ancestral B.1 for all vaccine platforms at 21 days post dose 2 and 180 days post dose 1. This work provides evidence about the humoral response and neutralising capacity elicited by vaccination of a vulnerable elderly population. This data could be useful for pandemic management in defining public health policies, highlighting the need to apply reinforcements after a complete vaccination schedule.
MeSH term(s)	Aged ; Aged, 80 and over ; Antibodies, Viral ; Argentina/epidemiology ; COVID-19/epidemiology ; COVID-19/prevention & control ; ChAdOx1 nCoV-19 ; Humans ; Immunoglobulin G ; Pandemics ; SARS-CoV-2 ; Vaccination
Chemical Substances	Antibodies, Viral ; Immunoglobulin G ; ChAdOx1 nCoV-19 (B5S3K2V0G8)
Language	English
Publishing date	2022-09-26
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.992370
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Article ; Online: Safety, tolerability, and immunogenicity of a new SARS-CoV-2 recombinant Gamma variant RBD-based protein adjuvanted vaccine, used as heterologous booster in healthy adults: a Phase 1 interim report.

Pasquevich, Karina A. / Coria, Lorena M. / Ceballos, Ana / Mazzitelli, Bianca / Rodriguez, Juan M. / Demaria, Agostina / Pueblas Castro, Celeste / Bruno, Laura / Saposnik, Lucas / Salvatori, Melina / Varese, Augusto / Gonzalez, Soledad / Gonzalez Martinez, Veronica V. / Geffner, Jorge / Alvarez, Diego / Laboratorio Pablo Cassará R&D and CMC group for ARVAC-CG / Feleder, Ethel C. / Halabe, Karina E. / Perez Lera, Pablo E. /

Montes de Oca, Federico / Vega, Julio C. / Lombardo, Monica / Yerino, Gustavo A. / Flo, Juan / Cassataro, Juliana

medRxiv

Abstract: Background In view of the emergence of SARS-CoV-2 immune escape variants and evidence of waning immunity, new immunisation strategies and variant-adapted vaccines are needed. Based on preclinical proof of concept studies and requirement of variant- ... ...

Abstract	Background In view of the emergence of SARS-CoV-2 immune escape variants and evidence of waning immunity, new immunisation strategies and variant-adapted vaccines are needed. Based on preclinical proof of concept studies and requirement of variant-adapted and booster vaccines, the Gamma Variant RBD-based ARVAC-CG vaccine was selected for a first clinical trial in humans. Methods Eighty participants (healthy adults, 18-55 years-old) were sequentially assigned to receive two (28 days apart) intramuscular doses of 25-lower case Greek mug (n=60) or 50-lower case Greek mug (n=20) of a Gamma RBD-based subunit vaccine adjuvanted with aluminium hydroxide. The primary endpoint was safety. The secondary objective was to describe the neutralising antibody response against the SARS-CoV-2 Ancestral strain and several variants of concern (Gamma, Delta, Omicron BA.1 and Omicron BA.5) measured by a live virus-based neutralisation assay. Cellular immune responses were studied as an exploratory objective by an enzyme-linked immunospot (ELISpot) assay. This trial is registered in ClinicalTrials.gov (NCT05656508). Findings The interim results from the ongoing phase 1 study are described. ARVAC-CG exhibited a satisfactory safety profile, a robust and broad booster response of neutralising antibodies against the Ancestral strain of SARS-CoV-2, the Gamma variant, and other VOCs (Delta, Omicron BA.1 and Omicron BA.5) and a booster effect on T cell immunity. Interpretation ARVAC-CG is safe and highly immunogenic when used as booster in individuals previously immunised with different COVID-19 vaccine platforms. These results warrant further clinical evaluation of this vaccine candidate for boosting other COVID-19 vaccines.
Keywords	covid19
Language	English
Publishing date	2023-01-11
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2023.01.10.22284009
Database	COVID19

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Article ; Online: Immunogenicity and Safety of Gamma, Omicron BA.4/5 and Bivalent SARS-CoV-2 RBD-based Protein Booster Vaccines in Adults Previously Immunized with Different Vaccine Platforms: a Phase II/III, Randomized, Clinical Trial.

Perez-Marc, Gonzalo / Coria, Lorena M. / Ceballos, Ana / Rodriguez, Juan Manuel / Lombardo, Mónica E. / Bruno, Laura / Páez Córdoba, Federico / Fascetto Cassero, Clara Griselda / Salvatori, Melina / Rios Medrano, Mayra A. / Fulgenzi, Fabiana R. / Alzogaray, María Fernanda / Mykietiuk, Analía / Uriarte, Ignacio Leandro / Itcovici, Nicolás / Smith Casabella, Tomás E. / Corral, Gonzalo / Bruno, Miriam Edith / Roldán, Oscar /

Núńez, Sebastián A. / Cahn, Florencia / Bianchi, Alejandra / Braem, Virginia Micaela / Christmann, Analía / Corradetti, Santiago / Darraidou, Martín C. / Di Nunzio, Lucila / Estrada, Tatiana B. / López Castelo, Rocío / Marchionatti, Carla Graciela / Pitocco, Lucila / Trias Uriarte, Virgina Macarena / Wood, Cristian Jorge / Zadoff, Romina / Bues, Florencia / Garrido, Rosa M. / Laboratorio Pablo Cassará group for ARVAC / Demaría, Agostina / Prado, Lineia / Pueblas Castro, Celeste V. / Saposnik, Lucas / Geffner, Jorge / Yerino, Gustavo A / Montes de Oca, Federico / Vega, Julio C / Fló, Juan / Bonvehí, Pablo / Cassará, Jorge / Pasquevich, Karina A. / Cassataro, Juliana

medRxiv

Abstract: Background: This study (ARVAC-F2-3-002) assessed the immunogenicity, safety, and tolerability of a recombinant booster vaccine (ARVAC) containing the receptor binding domain of the SARS-CoV-2 Spike protein in three different versions: Gamma (ARVACGamma), ...

Abstract	Background: This study (ARVAC-F2-3-002) assessed the immunogenicity, safety, and tolerability of a recombinant booster vaccine (ARVAC) containing the receptor binding domain of the SARS-CoV-2 Spike protein in three different versions: Gamma (ARVACGamma), Omicron BA.4/5 (ARVACOmicron), and Gamma/Omicron Bivalent (ARVACBivalent). Methods: Randomized, double-blind, crossover, placebo-controlled, multicenter (11 centers in Argentina) Phase II/III trial including adult volunteers previously vaccinated against SARS-CoV-2 with ≤3 booster doses. Participants were randomized to receive ARVACGamma (50 μg)+placebo and vice-versa (1:1 ratio) (Phase II), and ARVACGamma (50 μg)+placebo, ARVACOmicron (50 μg)+placebo, and ARVACBivalent (Gamma/Omicron 25 μg/25 μg)+placebo and vice-versa (Phase III) (1:1:1:1:1:1 ratio) 28 days apart. The primary endpoint was the seroconversion rate of neutralizing antibodies compared to placebo. The vaccine immunogenicity was considered acceptable at >75% seroconversion rate to variants homologous to the antigen contained in the vaccine (prespecified primary endpoint). Results: Participants (n=2012) (mean 48.2 years, SD 16.7; 48.1% women) were randomized and allocated to ARVACGamma (n=232 in Phase II and n=592 in Phase III), ARVACOmicron (n=594), and ARVACBivalent (n=594); 232 in Phase II and 370 in each Phase III group were included in the immunogenicity subset. Seroconversion rates to all SARS-CoV-2 variants were significantly higher after receiving any vaccine than placebo. All vaccine versions met the prespecified primary endpoint in all participants and in those 18−60 years old. In participants >60 years, the ARVACOmicron and the ARVACBivalent met the prespecified primary endpoint, whereas the ARVACGamma did not. The ARVACBivalent induced seroconversion rates were significantly higher than 75% across all tested SARS-CoV-2 variants (homologous and heterologous) and age groups. No vaccine-related serious adverse events were recorded; most local and systemic adverse events were grade 1-2. Conclusion: Booster vaccination with Gamma, Omicron BA.4/5, and Bivalent protein subunit recombinant ARVAC vaccine versions elicited protective neutralizing antibody responses to several SARS-CoV-2 variants, with very low reactogenicity and a favorable safety profile. Trial registration: NCT05752201
Keywords	covid19
Language	English
Publishing date	2024-05-06
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2024.05.06.24306575
Database	COVID19

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Article ; Online: Immunogenicity and Safety of Gamma, Omicron BA.4/5 and Bivalent SARS-CoV-2 RBD-based Protein Booster Vaccines in Adults Previously Immunized with Different Vaccine Platforms: a Phase II/III, Randomized, Clinical Trial

Perez-Marc, Gonzalo / Coria, Lorena M. / Ceballos, Ana / Rodriguez, Juan Manuel / Lombardo, Mónica E. / Bruno, Laura / Córdoba, Federico Páez / Fascetto Cassero, Clara G. / Salvatori, Melina / Medrano, Mayra Rios / Fulgenzi, Fabiana / Alzogaray, María F. / Mykietiuk, Analía / Uriarte, Ignacio Leandro / Itcovici, Nicolás / Casabella, Tomás Smith / Corral, Gonzalo / Bruno, Miriam / Roldán, Oscar /

Nuñez, Sebastián A. / Cahn, Florencia / Yerino, Gustavo A. / Bianchi, Alejandra / Braem, Virginia Micaela / Christmann, Analía / Corradetti, Santiago / Darraidou, Martín Claudio / Nunzio, Lucila Di / Estrada, Tatiana Belén / Castelo, Rocío López / Marchionatti, Carla Graciela / Pitocco, Lucila / Trias Uriarte, Virgina Macarena / Wood, Cristian Jorge / Zadoff, Romina / Bues, Florencia / Garrido, Rosa M. / Laboratorio Pablo Cassará group for ARVAC / Demaría, Agostina / Prado, Lineia / Castro, Celeste Pueblas / Saposnik, Lucas / Geffner, Jorge / Montes de Oca, Federico / Vega, Julio C. / Fló, Juan / Bonvehí, Pablo / Cassará, Jorge / Pasquevich, Karina A. / Cassataro, Juliana

medRxiv

Abstract	Background: This study (ARVAC-F2-3-002) assessed the immunogenicity, safety, and tolerability of a recombinant booster vaccine (ARVAC) containing the receptor binding domain of the SARS-CoV-2 Spike protein in three different versions: Gamma (ARVACGamma), Omicron BA.4/5 (ARVACOmicron), and Gamma/Omicron Bivalent (ARVACBivalent). Methods: Randomized, double-blind, crossover, placebo-controlled, multicenter (11 centers in Argentina) Phase II/III trial including adult volunteers previously vaccinated against SARS-CoV-2 with ≤3 booster doses. Participants were randomized to receive ARVACGamma (50 μg)+placebo and vice-versa (1:1 ratio) (Phase II), and ARVACGamma (50 μg)+placebo, ARVACOmicron (50 μg)+placebo, and ARVACBivalent (Gamma/Omicron 25 μg/25 μg)+placebo and vice-versa (Phase III) (1:1:1:1:1:1 ratio) 28 days apart. The primary endpoint was the seroconversion rate of neutralizing antibodies compared to placebo. The vaccine immunogenicity was considered acceptable at >75% seroconversion rate to variants homologous to the antigen contained in the vaccine (prespecified primary endpoint). Results: Participants (n=2012) (mean 48.2 years, SD 16.7; 48.1% women) were randomized and allocated to ARVACGamma (n=232 in Phase II and n=592 in Phase III), ARVACOmicron (n=594), and ARVACBivalent (n=594); 232 in Phase II and 370 in each Phase III group were included in the immunogenicity subset. Seroconversion rates to all SARS-CoV-2 variants were significantly higher after receiving any vaccine than placebo. All vaccine versions met the prespecified primary endpoint in all participants and in those 18−60 years old. In participants >60 years, the ARVACOmicron and the ARVACBivalent met the prespecified primary endpoint, whereas the ARVACGamma did not. The ARVACBivalent induced seroconversion rates were significantly higher than 75% across all tested SARS-CoV-2 variants (homologous and heterologous) and age groups. No vaccine-related serious adverse events were recorded; most local and systemic adverse events were grade 1-2. Conclusion: Booster vaccination with Gamma, Omicron BA.4/5, and Bivalent protein subunit recombinant ARVAC vaccine versions elicited protective neutralizing antibody responses to several SARS-CoV-2 variants, with very low reactogenicity and a favorable safety profile. Trial registration: NCT05752201
Keywords	covid19
Language	English
Publishing date	2024-05-06
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2024.05.06.24306575
Database	COVID19

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