Safety and Immunogenicity of Cuban Antipneumococcal Conjugate Vaccine PCV7-TT in Healthy Adults.

INTRODUCTION Pneumococcal infections are a major cause of morbidity and mortality and are associated with considerable economic burden on health systems. To prevent pneumococcal infections, 7-valent conjugate vaccines have been available for over a decade; more recently, 10- and 13-valent conjugate vaccines have been formulated, which are more immunogenic than vaccines with capsular polysaccharides only. In Cuba, a new vaccine candidate has been developed, PCV7-TT, a conjugate of tetanus toxoid with antigens of seven of the serotypes of Streptococcus pneumoniae with highest circulation in Cuba and in the world: 1, 5, 6B, 14, 18C, 19F and 23F. OBJECTIVE Assess the safety of the vaccine candidate PCV7-TT in healthy adults and conduct a preliminary assessment of its immunogenicity. METHODS A phase I, double-blind clinical trial was performed at the National Toxicology Center in Havana, Cuba. Healthy male volunteers aged 18-35 years were randomly assigned to two groups: 20 received the vaccine candidate PCV7-TT and 20 the polyvalent antipneumococcal vaccine PNEUMO-23 used as control, each in a single intramuscular dose. To assess safety, the occurrence of adverse events was monitored for 30 days following inoculation. To explore immunogenicity, concentrations of serotype-specific antibodies was quantified before and 30 days after inoculation, as well titers of opsonophagocytic antibodies. (National Clinical Trial Registry RPCEC00000133) RESULTS Local adverse events were pain, redness, induration, increased sensitivity to touch, and warmth in the injection area. Pain was registered in 70% of individuals who received PCV7-TT and in 75% of those vaccinated with PNEUMO-23. Reported systemic adverse events were general malaise, headache and drowsiness. All adverse events appeared in the first 72 hours post inoculation and lasted no longer than 3 days. One event was reported that was classified as severe in intensity and serious in consequences, but it was unrelated to vaccination appendicitis in one individual inoculated with the control vaccine. Before vaccination, all participants but one had antibody concentrations =0.20 µg/ml against the vaccine strains; after vaccination 100% of individuals were positive and the concentrations of antibodies increased in previously positive volunteers. Some individuals had opsonophagocytic antibodies against serotypes 1, 14, 19F and 23F before vaccination, with highest concentrations against serotypes 14 and 19F. After vaccination, the percent of individuals with opsonophagocytic titers >1:8 for all serotypes in the vaccine was >50% in both groups. CONCLUSIONS A single dose of candidate vaccine PCV7-TT was safe when used in healthy adults. Preliminary results showed that it was able to activate an immune response against the serotypes of Streptococcus pneumoniae used. KEYWORDS Invasive pneumococcal diseases, pneumococcal vaccines, conjugate vaccines, immunization, randomized clinical trial, safety, Cuba.

The mouse frizzy (fr) and rat 'hairless' (frCR) mutations are natural variants of protease serine S1 family member 8 (Prss8).

Please cite this paper as: The mouse frizzy (fr) and rat 'hairless' (fr(CR)) mutations are natural variants of protease serine S1 family member 8 (Prss8). Experimental Dermatology 2010; 19: 527-532. Abstract: We have previously suggested (based on genetic mapping analysis) that the allelic 'fuzzy' and 'hairless' mutations in the rat are likely orthologues of the mouse frizzy mutation (fr). Here, we analysed three large intraspecific backcross panels that segregated for mouse fr to restrict this locus to a 0.6-Mb region that includes fewer than 30 genes. DNA sequencing of one of these candidates known to be expressed in skin, protease serine S1 family member 8 (Prss8), revealed a T to A transversion associated with the fr allele that would result in a valine to aspartate substitution at residue 170 in the gene product. To test whether this missense mutation might be the molecular basis of this frizzy variant, we crossed fr/fr mice with mice that carried a recessive perinatal lethal mutation in Prss8. Hybrid offspring that inherited both fr and the Prss8 null allele displayed abnormal hair and skin, showing that these two mutations are allelic, and suggesting strongly that the T to A mutation in Prss8 is responsible for the mutant frizzy phenotype. Sequence analysis of all Prss8 coding regions in the 'hairless' rat identified a 12-bp deletion in the third exon, indicating that mouse fr and the rat 'hairless' mutations are indeed orthologues. However, this analysis failed to detect any alterations to Prss8 coding sequences in the allelic 'fuzzy' rat variant.

Comportamiento sexual en una población de embarazadas que acuden a consulta prenatal / Sexual behavior in a population of gravid women that attend a prenatal consult

Se realizó un estudio de tipo descriptivo para obsevar el comportamiento sexual de 300 mujeres embarazadas que acudieron a la consulta prenatal del Hospital Juan Pablo Pina de la ciudad de San Cristóbal durante el período mayo-julio del 1994. Se determinó que el embarazo modifica la conducta sexual de estas mujeres, altera la líbido y hace más difícil la obtención del orgasmo en la medida en que avanza el estado gestacional y que el temor al aborto o daño fetal pudiera explicar los cambios observados en el presente trabajo

Tratamiento con tintura de propóleo al 30 por ciento en la giardiasis / Treatment with tincture of propolis to the 30 percent in it giardiasis

Se realizó un estudio descriptivo, longitudinal y prospectivo en un universo de 50 pacientes comprendido entre los 6 meses y 14 años de edad con el diagnóstico de giardiasis intestinal atendidos en la consulta externa de gastroenterología del Hospital Infantil Norte"Juan de la Cruz Martínez Maceira"en el trimestre comprendido de enero a marzo de 1995, a los cuales se les aplicó tratamiento con tintura de propóleo al 30 por ciento, con el objetivo de demostrar la efectividad de éste producto,se confeccionó una planilla encuesta para el familiar siendo la información procesada por el método porcentaje; se estudiaron las variables edad,comprendido fundamentalmente de 1 a 5 años;los síntomas más frecuentes fueron el dolor abdominal seguido de las diarreas y los métodos de diágnosticos en todos los casos son el examen de heces fecales y intubación duodenal.Obteniéndose los siguientes resultados: el 64 por ciento de pacientes curados, un 18 por ciento de pacientes mejorados y un 4 por ciento de pacientes inconclusos.No se encontraron reacciones adversas, la participación de la enfermera fue detrminante en el logro y eficacia del tratmiento

Tratamiento con tintura de propóleo al 30 por ciento en la giardiasis / Treatment with tincture of propolis to the 30 percent in it giardiasis

Se realizó un estudio descriptivo, longitudinal y prospectivo en un universo de 50 pacientes comprendido entre los 6 meses y 14 años de edad con el diagnóstico de giardiasis intestinal atendidos en la consulta externa de gastroenterología del Hospital Infantil Norte"Juan de la Cruz Martínez Maceira"en el trimestre comprendido de enero a marzo de 1995, a los cuales se les aplicó tratamiento con tintura de propóleo al 30 por ciento, con el objetivo de demostrar la efectividad de éste producto,se confeccionó una planilla encuesta para el familiar siendo la información procesada por el método porcentaje; se estudiaron las variables edad,comprendido fundamentalmente de 1 a 5 años;los síntomas más frecuentes fueron el dolor abdominal seguido de las diarreas y los métodos de diágnosticos en todos los casos son el examen de heces fecales y intubación duodenal.Obteniéndose los siguientes resultados: el 64 por ciento de pacientes curados, un 18 por ciento de pacientes mejorados y un 4 por ciento de pacientes inconclusos.No se encontraron reacciones adversas, la participación de la enfermera fue detrminante en el logro y eficacia del tratmiento

Nefropatias de la anemia falciforme, en niños en el Hospital Dr. Robert Reid Cabral / Nephropathies of the sick cell anemia, en children at hospital Dr. Robert Reid Cabral

Se realizó un estudio prospectivo en 30 niños con Anemia Falciforme diagnosticados por electroforesis de hemoglobina, entre 9 meses y 15 años de edad, con una edad promedio de 7 años; 13 eran varones (43.3 por ciento ) y 17 hembras (56.7 por ciento ). La evaluación de la función renal mostró los siguientes resultados: Ninguno de los 30 casos tenía elevación de los niveles séricos de creatinina, 20 de los niños (66.7 por ciento ) mostraron la depuración endógena de la creatinina significativamente elevada, 3 de ellos (10 por ciento ) tenian proteinuria ligera, 2 (6.6 por ciento ) tenían poliuria. Ninguno presentó hematuria