Valoración del estado Nutricional en enfermos mentales institucionalizados / Assessing nutritional status in institutionalized mental patients

Introducción y objetivos: la malnutrición continúa siendo un problema no reconocido en los centros psiquiátricos. El objetivo del presente estudio fue conocer la prevalencia de la malnutrición y reconocer la importancia de la dieta en la alimentación de los enfermos mentales. Métodos: se evaluó el estado Nutricional de 65 pacientes mediante medidas antropométricas (peso, talla, índice de masa corporal, pliegue cutáneo tricipital, pliegue cutáneo bicipital, pliegue cutáneo subescapular, pliegue cutáneo suprailíaco, pliegue cutáneo tibial, pliegue cutáneo abdominal, índice cintura-cadera, circunferencia de la cadera y circunferencia de la cintura), analíticas (ferritina, triglicéridos, albúmina, colesterol, glucosa), otras variables (presión arterial), el cuestionario MNA-2009 y el menú de una semana. De cada paciente, además, se registraron datos personales, sexo, hábito tabáquico, edad, tipo de enfermedad, actividad física, visitas familiares y las variables enmarcadas en el cuestionario MNA-2009. Resultados: la muestra estuvo formada por 13 mujeres y 52 hombres, todos ellos enfermos mentales de una institución psiquiátrica. El 43,1 % presentaban sobrepeso y el 21,5 % obesidad, siendo estos índices superiores en las mujeres que en los hombres. Respecto a los valores bioquímicos, se observó que los niveles de triglicéridos y colesterol eran superiores a los valores recomendados. Además, los sujetos presentaron un gran desequilibrio en macronutrientes y micronutrientes en la valoración Nutricional diaria. Conclusión: en este estudio se ha demostrado la gran prevalencia de la malnutrición en los pacientes psiquiátricos, en concreto de la obesidad por el gran exceso que presentan cada uno de los macronutrientes y micronutrientes repartidos en el menú durante el día de los pacientes psiquiátricos (AU)

Introduction and objectives: malnutrition remains an unrecognised problem in psychiatric centers. The aim of the present study was to find out the prevalence of malnutrition and to recognize the importance of diet in the nutrition of the mentally ill. Methods: the nutritional status of 65 patients was assessed by anthropometric measurements (weight, height, body mass index, tricipital skin fold, bicipital skin fold, subscapular skin fold, suprailiac skin fold, tibial skin fold, abdominal skin fold, waist-hip index, hip circumference and waist circumference), blood tests (ferritin, triglycerides, albumin, cholesterol, glucose), other variables (blood pressure), the MNA-2009 questionnaire, and the one-week menu. Personal data, sex, smoking habits, age, type of disease, physical activity, family visits and the variables included in the MNA-2009 questionnaire were also recorded for each patient. Results: the sample consisted of 13 women and 52 men, all of whom were mentally ill patients in a psychiatric institution. A total of 43.1 % were overweight and 21.5 % obese, with more women than men in each category. Regarding biochemical values, it was observed that triglyceride and cholesterol levels were higher than recommended values. In addition, they presented a great imbalance in macronutrients and micronutrients in the daily nutritional assessment. Conclusion: this study has demonstrated the high prevalence of malnutrition in psychiatric patients, in particular obesity, due to the large excess of each of the macronutrients and micronutrients in the daily menu of psychiatric patients (AU)

CIGB-258, a peptide derived from human heat-shock protein 60, decreases hyperinflammation in COVID-19 patients.

Hyperinflammation distinguishes COVID-19 patients who develop a slight disease or none, from those progressing to severe and critical conditions. CIGB-258 is a therapeutic option for the latter group of patients. This drug is an altered peptide ligand (APL) derived from the cellular stress protein 60 (HSP60). In preclinical models, this peptide developed anti-inflammatory effects and increased regulatory T cell (Treg) activity. Results from a phase I clinical trial with rheumatoid arthritis (RA) patients indicated that CIGB-258 was safe and reduced inflammation. The aim of this study was to examine specific biomarkers associated with hyperinflammation, some cytokines linked to the cytokine storm granzyme B and perforin in a cohort of COVID-19 patients treated with this peptide. All critically ill patients were under invasive mechanical ventilation and received the intravenous administration of 1 or 2 mg of CIGB-258 every 12 h. Seriously ill patients were treated with oxygen therapy receiving 1 mg of CIGB-258 every 12 h and all patients recovered from their severe condition. Biomarker levels associated with hyperinflammation, such as interleukin (IL)-6, IL-10, tumor necrosis factor (TNF-α), granzyme B, and perforin, significantly decreased during treatment. Furthermore, we studied the ability of CIGB-258 to induce Tregs in COVID-19 patients and found that Tregs were induced in all patients studied. Altogether, these results support the therapeutic potential of CIGB-258 for diseases associated with hyperinflammation. Clinical trial registry: RPCEC00000313.

Molecular detection of Marek's disease virus in feather and blood samples from young laying hens in Colombia.

Marek's disease virus (MDV) is an immunosuppressive pathogen that can cause low production efficiency and high mortality rates in chickens. There is no current information on the MDV serotypes and pathotypes circulating in vaccinated commercial farms in Colombia where the birds are vaccinated in the incubator with Gallid herpesvirus (GaHV-2) and Meleagrid herpesvirus 1 (MeHV-1). Based on that, the main focus of this study was to understand the MDV's infection dynamics for the three known serotypes and to detect wild-virus pathogenic strains in 4-layer poultry farms in Antioquia. Samples of blood, feathers and spleens were collected from three randomly chosen animals according to age category: 1, 15, 30, 60, 90, and 120 days. Quantitative real-time PCR (qPCR) that differentiates between the three serotypes of MDV was used to assess viral loads over time, and phylogenetic analysis of the Meq oncogene was done to compare the strains of MDV with those of known pathogenicity. Meleagrid herpesvirus 1 (MeHV-1) was detected in all blood and feather follicle samples with an average number of genome copies (per 10,000 cells) of 31.44 in blood as expected as a result of vaccination. GaHV-2 was also detected in almost 100% of the blood and feather follicle samples throughout all defined age categories, with an average of 10.65 genome copies in blood samples. Gallid herpesvirus 3 (GaHV-3) was detected in 72% of blood and 84.61% of feather samples, with less than 1 copy per 10,000 cells. Based on the number of 132 bp repeats of the BamHI-H and BamHI-D regions in pooled feather samples, there were 70% (8/25) of attenuated MDV and 30% (17/25) of virulent MDV strains circulating in the farms. Virus isolation was performed successfully from every farm. In conclusion, different strains of MDV are circulating for up to 120 days in layers in Antioquia-Colombia and could be of major impact in poultry health. Keywords: Marek's disease virus (MDV); Antioquia-Colombia; qPCR; PCR; Meq gene phylogeny.

Experimental disturbances reveal group-level costs of social instability.

In group-living species, social stability is an important trait associated with the evolution of complex behaviours such as cooperation. While the drivers of stability in small groups are relatively well studied, little is known about the potential impacts of unstable states on animal societies. Temporary changes in group composition, such as a social group splitting and recombining (i.e. a disturbance event), can result in individuals having to re-establish their social relationships, thus taking time away from other tasks such as foraging or vigilance. Here, we experimentally split socially stable groups of captive zebra finches (Taeniopygia guttata), and quantified the effects of repeated disturbance events on (1) group foraging efficiency, and (2) co-feeding associations when subgroups were recombined. We found that the efficiency of groups to deplete a rich, but ephemeral, resource patch decreased after just a single short disturbance event. Automated tracking of individuals showed that repeated disturbances reduced efficiency by causing social relationships to become more differentiated and weaker, resulting in fewer individuals simultaneously accessing the patch. Our experiment highlights how short-term disturbances can severely disrupt social structure and group functionality, revealing potential costs associated with group instability that can have consequences for the evolution of animal societies.

Loss of Rearranged L-Myc Fusion (RLF) results in defects in heart development in the mouse.

Recently we reported that Rearranged L-Myc Fusion, RLF, acts as an epigenetic modifier maintaining low levels of DNA methylation at CpG island shores and enhancers across the genome. Here we focus on the phenotype of Rlf null mutant mice generated via an ENU mutagenesis screen, to identify genes required for epigenetic regulation. RLF is expressed in a range of fetal mouse tissues, including the fetal heart. Comprehensive timed-mating studies are consistent with our previously reported findings that Rlf homozygous mutant mice rarely survive to adulthood, with the majority dying shortly after birth. Histological analysis of two independent Rlf ENU mutant lines at E11.5-E14.5 showed heart defects resembling those present in humans with Left Ventricular Non-Compaction (LVNC). In situ hybridisation analysis localized expression of Rlf to the endocardium and epicardium of embryonic and postnatal hearts, and transiently to cardiomyocytes during heart looping and early chamber formation stages. RNA-seq analysis of Rlf mutant hearts highlighted defective NOTCH pathway signalling, recently describe as one cause of LVNC. This study provides the first evidence that RLF is required for normal heart development in the mouse. The heart morphological defects present at high penetrance in Rlf mutants are consistent with features of LVNC in humans, and molecular analysis identified attenuated JAGGED 1 expression and NOTCH signalling as likely contributors to these defects. Our study highlights the importance of RLF-dependent epigenetic modifications to DNA for maintaining correct gene regulatory network and intercellular signalling interactions during heart chamber and septal development. Further investigations are needed to define the biochemical role of RLF in the developing heart, and whether RLF mutations are a cause of heart defects in humans.

The role of animal reservoirs in social-environmental landscapes: remarks on the control of avian influenza and preparedness for pandemics.

Influenza viruses are well known for their ability to infect and cause disease in a broad range of hosts. Modern advances in reverse genetics have enabled scientists to probe the mutations that allow influenza viruses to perform host switching. Despite this detailed understanding of the molecular modifications that allow host switching and adaptation, there is a gap in knowledge regarding the factors external to the virus and their interactions that act as triggers leading to a pandemic. Studies on the ecology of zoonotic pathogens should be the new paradigm for understanding not only influenza viruses but any other infectious disease that can be a threat to animal and human health. The literature regarding influenza pandemics and influenza virus reservoirs was reviewed to analyse how social and economic changes can influence the appearance of new outbreaks of influenza. In addition, the importance of new research in a dynamic environment driven by the expansion of human territories and animal production systems is highlighted. A new paradigm is proposed for novel research approaches to infectious diseases such as influenza.

Les virus influenza se caractérisent par le large spectre d'hôtes qu'ils sont capables d'infecter et chez lesquels ils provoquent des maladies. Les avancées récentes de la génétique inverse ont permis aux chercheurs de suivre les mutations qui favorisent le passage des virus influenza d'un hôte à l'autre. Bien que les modifications moléculaires à l'origine du passage viral d'une espèce hôte à l'autre et de l'adaptation des virus à de nouveaux hôtes soient désormais bien comprises, d'importantes lacunes subsistent concernant les facteurs extérieurs aux virus et les interactions qui déclenchent la survenue de pandémies. L'étude de l'écologie des agents zoonotiques devrait constituer un nouveau paradigme de la recherche et permettra de mieux comprendre non seulement les virus influenza mais aussi toute maladie infectieuse présentant un danger pour la santé animale et publique. Les auteurs ont étudié la littérature consacrée aux pandémies de grippe et aux réservoirs des virus influenza et analysé l'influence des changements socio-économiques sur la survenue de nouveaux foyers de grippe. Ils soulignent également l'importance de conduire de nouveaux travaux de recherche dans un environnement dynamique transformé par l'extension des territoires utilisés par l'homme ainsi que par les systèmes de production animale. Un nouveau paradigme est ainsi proposé, qui permettra d'élaborer une méthodologie de recherche inédite dans le domaine des maladies infectieuses telles que les grippes.

Es bien conocida la capacidad que tienen los virus de la influenza de infectar y causar enfermedades a un conjunto muy heterogéneo de organismos anfitriones. Valiéndose de los últimos avances de la genética inversa, los científicos han podido utilizar sondas génicas con las mutaciones que permiten a los virus de la influenza pasar de un anfitrión a otro. Pese al detallado conocimiento que se tiene de las modificaciones moleculares que hacen posible el cambio de anfitrión y las correspondientes adaptaciones, no se sabe gran cosa de los factores externos al virus y del modo en que estos factores interaccionan para ejercer de desencadenantes de una pandemia. Los estudios sobre la ecología de patógenos zoonóticos deben ser el nuevo paradigma para comprender no solo los virus de la influenza, sino también los de otras enfermedades infecciosas que puedan constituir una amenaza sanitaria o zoosanitaria. Los autores repasan la bibliografía existente sobre pandemias de influenza y reservorios de este virus con el fin de analizar la repercusión que pueden tener los cambios sociales y económicos en la aparición de nuevos brotes de influenza. Además, se detienen a recalcar la importancia de las nuevas investigaciones en un entorno dinámico, cuya fuerza motriz es la expansión de los territorios humanos y los sistemas de producción animal. Los autores proponen un nuevo paradigma a partir del cual investigar con planteamientos novedosos enfermedades infecciosas como la influenza.

The TITAN-AMI multicenter registry evaluating the usage of Titan2 stent in patients with ST segment elevation myocardial infarction. Final result at 12-month follow-up.

AIM: Primary percutaneous coronary intervention with stent implantation is the recommended treatment for patients with ST elevation myocardial infarction (STEMI). Data from randomised trials showed good performance by a titanium-nitric-oxide coated stent in this context. The aim of this study was to confirm these data. METHODS: A multicentre registry was compiled in 23 hospitals in Spain in an all-comers population. We selected patients with STEMI from a global Titan AMI registry that included patients with acute coronary syndrome. Primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, stent thrombosis and target lesion revascularisation, at 12-month follow-up. RESULTS: The study included 893 patients with STEMI. We included all possibilities for PCI: 86.6% primary, 5% facilitated after successful fibrinolysis and 8.4% rescue PCI after failed fibrinolysis. The primary endpoint was reached in 8.4% of the patients: cardiac death 2.7%, reinfarction 3.4%, target lesion revascularisation 3.5% and definite or probable stent thrombosis 2.8%. The majority of stent thromboses presented in the first 30 days after PCI. CONCLUSION: A bioactive stent (titanium-nitric-oxide coated stent) is a possible alternative for the treatment of patients with STEMI. One-year follow-up showed better results than those presented by a regular bare-metal stent or first-generation drug-eluting stent in terms of stent thrombosis.

Minimal ureagenesis is necessary for survival in the murine model of hyperargininemia treated by AAV-based gene therapy.

Hyperammonemia is less severe in arginase 1 deficiency compared with other urea cycle defects. Affected patients manifest hyperargininemia and infrequent episodes of hyperammonemia. Patients typically suffer from neurological impairment with cortical and pyramidal tract deterioration, spasticity, loss of ambulation, seizures and intellectual disability; death is less common than with other urea cycle disorders. In a mouse model of arginase I deficiency, the onset of symptoms begins with weight loss and gait instability, which progresses toward development of tail tremor with seizure-like activity; death typically occurs at about 2 weeks of life. Adeno-associated viral vector gene replacement strategies result in long-term survival of mice with this disorder. With neonatal administration of vector, the viral copy number in the liver greatly declines with hepatocyte proliferation in the first 5 weeks of life. Although the animals do survive, it is not known from a functional standpoint how well the urea cycle is functioning in the adult animals that receive adeno-associated virus. In these studies, we administered [1-13C] acetate to both littermate controls and adeno-associated virus-treated arginase 1 knockout animals and examined flux through the urea cycle. Circulating ammonia levels were mildly elevated in treated animals. Arginine and glutamine also had perturbations. Assessment 30 min after acetate administration demonstrated that ureagenesis was present in the treated knockout liver at levels as low at 3.3% of control animals. These studies demonstrate that only minimal levels of hepatic arginase activity are necessary for survival and ureagenesis in arginase-deficient mice and that this level of activity results in control of circulating ammonia. These results may have implications for potential therapy in humans with arginase deficiency.

Actividad antioxidante y prooxidante del aceite esencial de ajo por resonancia de spin electrónica / Antioxiodant and prooxidant activity of esential oil of garic by electron spin resonance

El objetivo de este trabajo fue estudiar el comportamiento antioxidante y prooxidante del aceite esencial de ajo (AE) y su posterior adición en dosis de 0,05% (A1) y 0,4% (A2) en hamburguesas de cerdo envasadas en aerobiosis y almacenadas en refrigeración hasta 6 días. Para ello se estudió la actividad antioxidante del AE en un sistema lipídico modelo (reacción de Fenton), y en hamburguesas de cerdo por REE (resonancia de spin electrónica) mediante la formación de radicales libres durante el calentamiento a 55 oC y su posterior unión con el spin trap PBN (α-fenil-N-tert-butilnitrona) a día 0, 3 y 6 de almacenamiento. Los resultados obtenidos mostraron que el AE mostró efecto prooxidante a una concentración de fenoles totales ≥ 1.6 mg GAE/L. En hamburguesas A1 la formación de radicales tras 3 horas de calentamiento a 55 oC fue significativamente menor (P<0.05%) que en muestras control (C) y A2 durante todo el almacenamiento. En hamburguesas A2 dicha formación de radicales fue mayor (P<0.05%) que en la carne C y A1, por lo que a elevadas concentraciones de AE se ha observado un efecto prooxidante. Los resultados obtenidos indican el uso del aceite esencial de ajo en un porcentaje de 0,05% como antioxidante natural en hamburguesas de cerdo, pudiéndose plantear la incorporación de dicho aceite como una estrategia natural de conservación (AU)

The aim of this study was to study the antioxidant and prooxidant activity of the essential oil of garlic (AE) and the posterior addition at doses of 0.05% (A1) and 0.4% (A2) in pork patties packaged in aerobic conditions and stored in refrigeration during 6 days. For that, the antioxidant activity of the AE in a model system (Fenton reaction), and in burgers with REE (electron spin resonance) by free radical formation during heating at 55 °C and its binding to PBN (α-fenil-N-tert-butilnitrona) on days 0, 3 and 6 of storage was studied. The results showed that AE showed prooxidat effect at phenol concentration ≥ 1.6 mg GAE/L. In patties A1, the radical formation after 3 hours of heating at 55 °C was significantly lower (P <0.05%) than in control samples (C) and A2 throughout the storage. In contrast, burgers treated with 0.4% of AE showed that radical formation was higher (P <0.05%) than C and A1, therefore, the higher level of AE showed a prooxidant effect. The results indicate that the use of 0.05% essential oil of garlic, as a natural antioxidant in pork burgers, being a good strategy of conservation (AU)

Un "veneno" para el dolor. El ziconotide / No disponible

El ziconotide, péptido sintético análogo de la O-conotoxina de un caracol marino, ha sido introducido recientemente como un fármaco para el tratamiento del dolor rebelde a opioides. Consigue su efecto terapéutico a través de un bloqueo selectivo de los canales de calcio (Ca) tipo N dependientes de voltaje, por medio del cual reduce la liberación de neurotransmisores pronociceptivos en el asta posterior de la médula espinal, inhibiendo, de esta manera, la transmisión del impulso doloroso. Una de sus ventajas es la de no provocar tolerancia, e incluso en caso necesario, podría ser administrado conjuntamente con morfina, potenciándose la acción de ambos fármacos (AU)

The ziconotide is structurally the synthetic peptide analogue of the V-conotoxin Conus magus, a marine snail. It has recently been introduced as a drug for the treatment of pain unresponsive to opioids. Achieves its therapeutic effect via a potent selective blockade of voltage sensitive calcium channels, which in turn reduces the release of neurotransmitters pronociceptivos in the dorsal horn of the spinal cord by this action inhibits the transmission of painful stimulus.Among its advantages is to not cause tolerance. In addition, if necessary, could be co-administered with morphine, producing a synergistic effect on its action on pain (AU)

Administration of distillate thyme leaves into the diet of Segureña ewes: effect on lamb meat quality.

The effect of including thyme by-products from the distillation industry into the diet of pregnant ewes on the final quality of lamb meat was evaluated during meat storage in modified atmosphere. A total of 36 Segureña ewes were randomly assigned to three homogeneous groups. One group was fed a basal diet (BD) as control (C), whereas the diet of the other two groups was modified by substituting 10% (T 1) and 20% (T 2) of the BD with pellets made from 50% barley and 50% distilled thyme leaves (DTL). Meat spoilage (total viable, psychrotroph (PSY), moulds and yeasts, Enterobacteriaceae and lactic acid bacteria), thiobarbituric acid reactive substances (TBARS), colour (CIELab coordinates, metmyoglobin) and sensory characteristics of fresh lamb meat packed in modified atmosphere packaging (70% O2 : 30% CO2) were analysed after storage at 0, 7, 14 and 21 days. In general, the DTL-containing diet inhibited lipid and pigment oxidation in fresh lamb meat. Lower PSY counts and content of secondary oxidation product (TBARS) as a result of adding DTL to the ewe diet, whereas surface redness (a* values) was significantly higher on days 7 and 14. It can be concluded that thyme by-products from the distillation industry could be used as a source of natural antioxidant and antimicrobial in the feed for ewes.

Synthesis and characterization of PbSe nanoparticles obtained by a colloidal route using Extran as a surfactant at low temperature.

Lead selenide nanoparticles (PbSe NPs) have been obtained through an easy and low cost route using colloidal synthesis in aqueous solution. The synthesis was carried out at room temperature using Extran (Na5P3O10, NaOH and H2O) as surfactant. Hydrochloric acid (HCl) was used to eliminate the generated by-products. The size of PbSe NPs was varied by changing the Pb:Se molar concentration. The PbSe NPs were characterized by powder x-ray diffraction (XRD), scanning electron microscopy (SEM), energy dispersive x-ray analysis (EDAX), high-resolution transmission electron microscopy (HRTEM) and Raman spectroscopy. The XRD measurements showed that the PbSe NPs have the face-centered cubic phase structure. The crystal size was found to be between 14 and 20 nm as calculated from the XRD patterns and these values were corroborated with SEM and TEM. Additionally, HRTEM micrographs showed crystalline planes at (200), (220) and (111) of the PbSe NPs, in agreement with the XRD results.

[Leonine facies in carcinoid syndrome]. / Facies leonina en el síndrome carcinoide.

Carcinoid syndrome is a rare disorder caused when elevated levels of vasoactive substances secreted by a carcinoid tumor fail to be metabolized by the liver. This can occur for a variety of reasons including metastatic invasion of the organ. Carcinoid syndrome results in elevated levels of 5-hydroxyindoleacetic acid in the urine. Clinical manifestations include: flushing, diarrhea, bronchospasm, and heart failure. We describe a patient with carcinoid syndrome and hepatic metastases, in whom the key symptom of persistent facial edema resulted in conspicuous leonine facies; there was a partial response to treatment with oral isotretinoin and intramuscular lanreotide. Differential diagnosis was made with other conditions causing facial edema. A review is performed of the various skin manifestations of carcinoid syndrome, highlighting their role in the early diagnosis and treatment of the disorder.

Facies leonina en el síndrome carcinoide / Leonine Facies in Carcinoid Syndrome

El síndrome carcinoide es un proceso infrecuente que se produce por la presencia en el organismo de niveles elevados de sustancias vasoactivas secretadas por un tumor carcinoide y no metabolizadas por el hígado, debido a diversas circunstancias, entre ellas la invasión metastásica del mismo. Se traduce en una elevación del 5-hidroxi-indol-acético en orina. Clínicamente cursa con síntomas cutáneos (episodios de rubefacción-flushing), digestivos (diarrea), respiratorios (broncoespasmo) y cardiovasculares (insuficiencia cardiaca). Describimos el caso de un paciente con síndrome carcinoide con metástasis hepáticas cuyo síntoma guía fue el edema facial, que se hizo persistente otorgándole una facies leonina muy llamativa, que respondió parcialmente al tratamiento con isotretinoína por vía oral y lanreótida intramuscular. Realizamos diagnóstico diferencial con otros cuadros que cursan con edema facial y revisamos las diversas manifestaciones cutáneas que pueden surgir en el síndrome carcinoide, destacando su importancia para realizar un diagnóstico y tratamiento precoces del proceso (AU)

Carcinoid syndrome is a rare disorder caused when elevated levels of vasoactive substances secreted by a carcinoid tumor fail to be metabolized by the liver. This can occur for a variety of reasons including metastatic invasion of the organ. Carcinoid syndrome results in elevated levels of 5-hydroxyindoleacetic acid in the urine. Clinical manifestations include: flushing, diarrhea, bronchospasm, and heart failure. We describe a patient with carcinoid syndrome and hepatic metastases, in whom the key symptom of persistent facial edema resulted in conspicuous leonine facies; there was a partial response to treatment with oral isotretinoin and intramuscular lanreotide. Differential diagnosis was made with other conditions causing facial edema. A review is performed of the various skin manifestations of carcinoid syndrome, highlighting their role in the early diagnosis and treatment of the disorder (AU)

Child health in Colombia.

Colombia is a country with major problems, mainly a high degree of inequality and an unacceptably high level of violence (both armed military conflict and crime related). There are unacceptably high variations in health and health provision. Despite these difficulties, there are important steps being taken by both the government and independent organisations to try and improve child health and to achieve the Millennium Development Goals in relation to poverty, hunger and health issues. The participation of different sectors and stakeholders (including government, non-governmental organisations and other organisations of civil society) is essential to overcome Colombian history and to promote a better place for children.

Safety and immunogenicity of a combined hepatitis B virus-Haemophilus influenzae type B vaccine comprising a synthetic antigen in healthy adults.

The combined HB-Hib vaccine candidate Hebervac HB-Hib (CIGB, La Habana), comprising recombinant HBsAg and tetanus toxoid conjugate synthetic PRP antigens has shown to be highly immunogenic in animal models. A phase I open, controlled, randomized clinical trial was carried out to assess the safety and immunogenicity profile of this bivalent vaccine in 25 healthy adults who were positive for antibody to HBsAg (anti-HBs). The trial was performed according to Good Clinical Practices and Guidelines. Volunteers were randomly allocated to receive the combined vaccine or simultaneous administration of HB vaccine Heberbiovac-HB and Hib vaccine QuimiHib (CIGB, La Habana). All individuals were intramuscularly immunized with a unique dose of 10 microg HBsAg plus 10 microg conjugated synthetic PRP. Adverse events were actively recorded after vaccine administration. Total anti-HBs and IgG anti-PRP antibody titers were evaluated using commercial ELISA kits at baseline and 30 days post-vaccination. The combined vaccine candidate was safe and well tolerated. The most common adverse reactions were local pain, febricula, fever and local erythema. These reactions were all mild in intensity and resolved without medical treatment. Adverse events were mostly reported during the first 6-72 hours post-vaccination. There were no serious adverse events during the study. No severe or unexpected events were either recorded during the trial. The combined vaccine elicited an anti-HBs and anti-PRP booster response in 100% of subjects at day 30 of the immunization schedule. Anti-HBs and anti-PRP antibody levels had at least a two-fold increase compared to baseline sera. Even more, anti-HBs antibody titer showed a four-fold increase in 100% of volunteers in the study group. The results indicate that the combined HB-Hib vaccine produces increased antibody levels in healthy adults who have previously been exposed to these two antigens. To our knowledge, this is the first demonstration of safety and immunogenicity for a combined vaccine comprising recombinant HBV and synthetic Hib antigens. The present results support phase I-II clinical trial in the target population, two months old healthy infants.