Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico.

There is still a need for safe, efficient, and low-cost coronavirus disease 2019 (COVID-19) vaccines that can stop transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that expresses a stable version of the spike protein in infected cells as well as on the surface of the viral particle (AVX/COVID-12-HEXAPRO, also known as NDV-HXP-S). This vaccine candidate can be grown in embryonated eggs at a low cost, similar to influenza virus vaccines, and it can also be administered intranasally, potentially to induce mucosal immunity. We evaluated this vaccine candidate in prime-boost regimens via intramuscular, intranasal, or intranasal followed by intramuscular routes in an open-label non-randomized non-placebo-controlled phase I clinical trial in Mexico in 91 volunteers. The primary objective of the trial was to assess vaccine safety, and the secondary objective was to determine the immunogenicity of the different vaccine regimens. In the interim analysis reported here, the vaccine was found to be safe, and the higher doses tested were found to be immunogenic when given intramuscularly or intranasally followed by intramuscular administration, providing the basis for further clinical development of the vaccine candidate. The study is registered under ClinicalTrials.gov identifier NCT04871737.

Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico.

There is still a need for safe, efficient and low-cost coronavirus disease 2019 (COVID-19) vaccines that can stop transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that expresses a stable version of the spike protein in infected cells as well as on the surface of the viral particle (AVX/COVID-12-HEXAPRO, also known as NDV-HXP-S). This vaccine candidate can be grown in embryonated eggs at low cost similar to influenza virus vaccines and it can also be administered intranasally, potentially to induce mucosal immunity. We evaluated this vaccine candidate in prime-boost regimens via intramuscular, intranasal, or intranasal followed by intramuscular routes in an open label non-randomized non-placebo-controlled phase I clinical trial in Mexico in 91 volunteers. The primary objective of the trial was to assess vaccine safety and the secondary objective was to determine the immunogenicity of the different vaccine regimens. In the interim analysis reported here, the vaccine was found to be safe and the higher doses tested were found to be immunogenic when given intramuscularly or intranasally followed by intramuscular administration, providing the basis for further clinical development of the vaccine candidate. The study is registered under ClinicalTrials.gov identifier NCT04871737. Funding was provided by Avimex and CONACYT.

Effects of phenolic and protein extracts from Melipona beecheii honey on pathogenic strains of Escherichia coli and Staphylococcus aureus.

Antimicrobial effects of Melipona beecheii honey have been attributed to diverse factors, in this sense, certain components such as proteins and phenolics could explain relevant aspects of its antimicrobial activity. The aim of this study was to evaluate the antibacterial activity of phenolic and protein extracts from M. beecheii honey against two bacterial pathogens: Staphylococcus aureus and Escherichia coli. With respect to phenolic content, HPLC analysis allowed the identification of phenolic acids like chlorogenic acid, caffeic acid, and flavonoids like catechin, myricetin, quercetin and apigenin. On the other hand, seven bands with molecular weight from 7.6 to 95 kDa were detected in protein extract by SDS-PAGE system. It was determined the antibacterial activity of both extracts, with MICs lower than 145 µg/mL and 60 µg/mL for the phenolic and protein extracts respectively. These results indicate that phenolic and protein components of M. beecheii honey contribute significantly to the antibacterial activity.

Osteoporosis juvenil idiopatica / Idiopathic juvenile osteoporosis

Se describe un caso de osteoporosis juvenil idiopática, en un paciente masculino de 12 2/12 años de edad. La presentación clínica fue con un dolor en la cara posterior de tórax y la osteoporosis, un hallazgo radiológico. La evaluación de la función paratiroidéa, adrenal y gonadal por exploración física y exámenes paraclínicos fue normal. Se trató con analgésicos comunes y a 16 meses de seguimiento está asintomático. A pesar de que en las radiografías simples no existe mejoría en la densidad ósea, ésta es notoria en una tomografía axial computarizada practicada seis meses después de la primera. Consideramos que el diagnóstico de osteoporosis juvenil idiopática es por exclusión el tratamiento debe ser sintomático y la tomografía axial en nuestro caso demostró ser un método eficiente para evaluar cambios en la densidad ósea en un plazo corto