Multi-residue method for the detection of 40 ß-lactam-antibiotics in vaccines by LC-MS/MS.

Antibiotics are widely used to treat bacterial infections during the process of vaccine production and storage resulting in antibiotic residues that can cause serious harm. A simple and sensitive method for residue analysis of 40 ß-lactam antibiotics was developed and validated for vaccines including inactivated enterovirus 71 vaccine (Vero cells), recombinant hepatitis B vaccine (Saccharomyces cerevisiae), and live attenuated varicella vaccine using liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI- MS/MS). Samples were prepared with acetonitrile as the protein precipitant. LC separation was performed on a C18 column. These analytes were determined by LC-MS/MS operating multiple-reaction monitoring (MRM) scans in positive mode. The ranges for limits of detection (LOD) and quantification (LOQ) were as follows: 0.02-4 ng/dose (S/N ≥ 3) and 0.04-10 ng/dose in inactivated enterovirus 71 vaccine (Vero cells) and recombinant hepatitis B vaccine (Saccharomyces cerevisiae), 0.04-16 ng/dose and 0.2-20 ng/dose in live attenuated varicella vaccine. The ranges of recoveries of all antibiotics were 84.5%-108.2% in inactivated enterovirus 71 vaccine (Vero cells), 73%-108% in recombinant hepatitis B vaccine (Saccharomyces cerevisiae), and mostly 68.2%-107.8% in live attenuated varicella vaccine. This method simultaneously offers qualitative and quantitative analysis of multi-antibiotics in vaccines, which improves vaccine safety.

Development of imaged capillary isoelectric focusing method and use of capillary zone electrophoresis in hepatitis B vaccine RECOMBIVAX HB®.

The hepatitis B virus vaccine consists of a major surface antigen called HBsAg, which is a lipid-bound protein that self-assembles into 22 nm spherical noninfectious virus-like particles (VLPs). The HBsAg VLP particles are expressed in yeast and have been well-characterized biochemically and biophysically employing various analytical techniques. In fact, a CZE method has been developed for monitoring process purification of the hepatitis B vaccine. Another CE-based method, imaged capillary IEF (icIEF) has been used extensively in the field of protein-based drug development as a tool for product identification,stability monitoring, and characterization. Here we describe the development of the icIEF method using the iCE280 instrument from ProteinSimple for measuring the pI and monitoring the profiles of HBsAg VLP particles. This method was applied to characterize the stability of the HBsAg VLP particles in three different formulation buffers. The results show that HBsAg VLP particles have a pI of 2.7 and it is one of most acidic particles that we have measured by icIEF. In addition to icIEF, we have also employed a CZE method to measure the electrophoretic mobility of HBsAg VLP particles and compared the results with icIEF and dynamic light scattering methods, showing consistent correlation among the three methods in terms of HBsAg VLP particles aggregation.

Hepatitis B vaccination of male neonates and autism diagnosis, NHIS 1997-2002.

Universal hepatitis B vaccination was recommended for U.S. newborns in 1991; however, safety findings are mixed. The association between hepatitis B vaccination of male neonates and parental report of autism diagnosis was determined. This cross-sectional study used weighted probability samples obtained from National Health Interview Survey 1997-2002 data sets. Vaccination status was determined from the vaccination record. Logistic regression was used to estimate the odds for autism diagnosis associated with neonatal hepatitis B vaccination among boys age 3-17 years, born before 1999, adjusted for race, maternal education, and two-parent household. Boys vaccinated as neonates had threefold greater odds for autism diagnosis compared to boys never vaccinated or vaccinated after the first month of life. Non-Hispanic white boys were 64% less likely to have autism diagnosis relative to nonwhite boys. Findings suggest that U.S. male neonates vaccinated with the hepatitis B vaccine prior to 1999 (from vaccination record) had a threefold higher risk for parental report of autism diagnosis compared to boys not vaccinated as neonates during that same time period. Nonwhite boys bore a greater risk.

Collaborative study on saccharide quantification of the Haemophilus influenzae type b component in liquid vaccine presentations.

Before release onto the market, it must be demonstrated that the total and free polysaccharide (poly ribosyl-ribitol-phosphate, PRP) content of Haemophilus influenzae type b (Hib) vaccine complies with requirements. However, manufacturers use different methods to assay PRP content: a national control laboratory must establish and validate the relevant manufacturer methodology before using it to determine PRP content. An international study was organised by the World Health Organization (WHO), in collaboration with the Biological Standardisation Programme (BSP) of the Council of Europe/European Directorate for the Quality of Medicines & HealthCare (EDQM) and of the European Union Commission, to verify the suitability of a single method for determining PRP content in liquid pentavalent vaccines (DTwP-HepB-Hib) containing a whole-cell pertussis component. It consists of HCl hydrolysis followed by chromatographic separation and quantification of ribitol on a CarboPac MA1 column using high-performance anion exchange chromatography coupled with pulsed amperometric detection (HPAEC-PAD). The unconjugated, free, PRP is separated from the total PRP using C4 solid-phase extraction cartridges (SPE C4). Ten quality control laboratories performed two independent analyses applying the proposed analytical test protocol to five vaccine samples, including a vaccine lot with sub-potent PRP content and very high free PRP content. Both WHO PRP standard and ribitol reference standard were included as calibrating standards. A significant bias between WHO PRP standard and ribitol reference standard was observed. Study results showed that the proposed analytical method is, in principle, suitable for the intended use provided that a validation is performed as usually expected from quality control laboratories.

Hepatitis B vaccine stored outside the cold chain setting: a pilot study in rural Lao PDR.

BACKGROUND: Hepatitis B vaccine birth dose (HepB-BD) was introduced in Lao People's Democratic Republic (Lao-PDR) to prevent perinatal hepatitis B virus transmission. HepB-BD, which is labeled for storage between 2 and 8°C, is not available at all health facilities, because of some lack of functional cold chain; however, previous studies show that HepB-BD is stable if stored outside the cold chain (OCC). A pilot study was conducted in Lao-PDR to evaluate impact of OCC policy on HepB-BD coverage. METHODS: During the six month pilot, HepB-BD was stored OCC for up to 28 days in two intervention districts and stored in cold chain in two comparison districts. In the intervention districts, healthcare workers were educated about HepB-BD and OCC storage. A post-pilot survey compared HepB-BD coverage among children born during the pilot (aged 2-8 months) and children born 1 year before (aged 14-20 months). FINDINGS: In the intervention districts, 388 children aged 2-8 months and 371 children aged 14-20 months were enrolled in the survey; in the comparison districts, 190 children aged 2-8 months and 184 children aged 14-20 months were enrolled. Compared with the pre-pilot cohort, a 27% median increase in HepB-BD (interquartile range [IQR] 58%, p<0.0001) occurred in the pilot cohort in the intervention districts, compared with a 0% median change (IQR 25%, p=0.03) in comparison districts. No adverse reactions were reported. INTERPRETATION: OCC storage improved HepB-BD coverage with no increase in adverse reactions. Findings can guide Lao-PDR on implementation and scale-up options of OCC policy.

Reversed-phase high-performance liquid chromatographic study of thimerosal stability in Cuban recombinant hepatitis B vaccine.

Non-degraded thimerosal was determined in the presence of its decomposition products by directly assaying recombinant hepatitis B vaccine using a reversed-phase liquid chromatographic method. Methanol-water-orthophosphoric acid (65:35:0.9, v/v/v) was used as the eluent. Salicylic acid was employed as an internal standard. The calibration graph was linear (r = 0.99995) up to 2.5 micrograms of thimerosal. Interference from aluminium hydroxide was eliminated by centrifugation. Good stability of thimerosal in the hepatitis B vaccine was demonstrated. The results obtained were in agreement with the recently proposed mechanism of degradation.

Establishment of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparations (BRP) batch 2 for rDNA hepatitis B vaccine (method A and B).

A collaborative study was initiated by the European Directorate for the Quality of Medicines (EDQM), to assign a potency value for candidate batch 2 of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Hepatitis B (rDNA) antigen in vitro assays, for both method A and method B by calibrating them against the Ph. Eur. BRPs, batch 1 for methods A and B respectively. The study was prompted by the observation that the first batch of BRP for method B appeared to have lost potency over time. BRP 1 for method A showed no loss in potency, however stocks of the material were nearing depletion. Eleven laboratories participated in the study and all reported results. Participants performed 3 independent assays using both method A and method B. Method A was used to assess BRPs for method A and method B was used to assess BRPs for method B. Since BRP 1B was suspected to have lost potency, an additional sample was included in the method B test in an attempt to clarify the situation. BRP 1B was also assayed in method A against BRP 1A in the hope of also attaining further information by comparing the results from this study to those obtained in the original study to establish the first batch of BRP [1]. Although it was not the primary aim of this study to correlate in vitro potency with the immunogenicity assay in mice, a number of interested parties also performed the mouse in vivo assay to obtain data on the behaviour of the candidate BRPs in this assay. For method A, potency estimates were satisfactory in terms of repeatability and reproducibility. The candidate material was therefore assigned a value of 16.6 micrograms/ml. For method B, it appeared that the observation of reduced in vitro potency of BRP1 was confirmed. Despite the attempt to clarify the situation with additional studies, it was not possible to assign a potency value with the results obtained. A small-scale collaborative study will be organised to determine an appropriate value for the candidate BRP for method B. The results from the in vivo study while highly variable showed no evidence of a shift in the in vivo potency for either BRP 1A or BRP 1B. It should be noted that the in vitro method for determination of hepatitis B vaccine potency is under revision due to the discontinuation of the Auszyme kit from Abbott, which is required to perform the current assays. Once an alternative assay has been established, the suitability of the reference preparations or establishment of new reference preparations will be required. The candidate material for method A BRP was adopted by the European Pharmacopoeia Commission at its session in November 2003, as the European Pharmacopoeia Hepatitis B vaccine (rDNA) method A, batch 2.

[The prospects for using the genetically engineered surface antigen of the hepatitis B virus (HBsAg) expressed by recombinant poxvirus strains as the basis for vaccines against hepatitis B]. / Perspektivy ispol'zovaniia genno-inzhenernogo poverkhnostnogo antigena virusa gepatitia B (HBsAg), ekspressiruemogo rekombinantnymi shtammami poksvirusov, v kachestve osnovy vaktsin protiv gepatita B.

The use of a recombinant poxvirus (RPV) strain, expressing HBsAg in the process of reproduction in different bioreactor systems under stationary and bioreactor conditions of cultivation, made it possible to obtain highly purified HBsAg. The identity and purity of HBsAg was confirmed by the analysis of its amino acid composition, SDS electrophoresis in polyacrylamide gel, electron microscopy and high-performance liquid chromatography. Good prospects of the use of RPV-expressed gene engineering HBsAg as the basis vaccines against hepatitis B was demonstrated in 10 experimental batches of vaccine. All batches of the preparation had pronounced immunogenicity and were safe and nontoxic in animal experiments. The ID50 of experimental batches did not exceed 211 ng/ml, which, according to the data of comparative experiments, was lower than, or equal to, corresponding values of analogous foreign commercial preparations, based on plasma or yeast HBsAg.

La Sentencia del TJUE de 21 de junio de 2017: nada nuevo más allá del revuelo asociado al "debate antivacunas" / The CJUE Ruling of June 21, 2017: nothing new beyond the stir associated with the "anti-vaccine debate"

La sentencia del Tribunal de Justicia de la Unión Europea de 21 de junio de 2017 fija los criterios de interpretación de la normativa de la Unión Europea (Directiva 85/374) relativa a las exigencias de prueba en un proceso de reclamación de daños imputados a una vacuna supuestamente defectuosa. En el proceso que analiza la relación de causa-efecto entre la administración de una vacuna contra la hepatitis B y el desarrollo de una enfermedad de la que no ha podido establecerse su etiología, como es la esclerosis múltiple, la prueba del defecto de una vacuna y del nexo causal entre el defecto y el daño provocado podría establecerse mediante una prueba seria, específica y consistente, analizando cada caso individualmente. Si la ciencia no sabe cómo se produce la esclerosis múltiple, no se puede practicar prueba alguna directa que conecte una causa con una consecuencia cuyo mecanismo de producción es desconocido. Un traslado de la carga de la prueba al productor es contrario a derecho. No es posible establecer un sistema en virtud del cual la ley o los tribunales fijen que, a partir de ciertos indicios, pueda considerarse que el defecto imputado a una vacuna es causa de un daño concreto cuando la investigación médica no haya demostrado la relación de causa-efecto. La sentencia no establece criterios distintos a los que venían aplicándose. Las conclusiones de los tribunales fijando los hechos no pueden establecer lo que la ciencia no ha demostrado (AU)

The European Court of Justice Ruling of 21 June 2017 lays down the criteria for interpreting the EU rules on the requirements of evidences in a procedure of claim of damages attributed to an allegedly defective vaccine, on the basis of Directive 85/374. In the process that analyzes the cause-effect relationship between the administration of a vaccine against hepatitis B and the development of a disease that has not its etiology established by medical research such as multiple sclerosis, a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence, analyzing each case individually. If science does not know how multiple sclerosis occurs, an irrefutable evidence connecting a cause with a consequence whose mechanism of production is unknown is not possible. A shift of the burden of proof from the injured party to the producer is contrary to law. It is not possible to establish a system whereby the law or the courts stipulate that, on the basis of certain types of circumstantial evidences, the defect imputed to a vaccine may be considered as causing specific damage when the medical investigation has not proved the cause-effect relationship. The Ruling does not establish different criteria to those that were being applied until now. The conclusions of the Tribunals setting the facts cannot establish what science has not demonstrated (AU)

Establishment and validation of an ELISA for the quantitation of HBsAg in recombinant hepatitis B vaccines.

Commercial enzyme-linked immunosorbent assay (ELISA) kits for the determination of the in vitro potency of recombinant hepatitis B vaccines, which detect hepatitis B surface antigen (HBsAg), have been used frequently as an alternative for traditional in vivo potency tests. With the constant need for validation procedures, an ELISA that could be employed to determine the in vitro potency of five recombinant hepatitis B vaccines simultaneously was established using two monoclonal antibodies. The use of two monoclonal antibodies produced "in house" specific for the small envelope protein S of the hepatitis B virus (HBV) resulted in the production of a highly specific, sensitive and stable ELISA. The standard ELISA parameters used in this study, considering the HBsAg content of each recombinant hepatitis B vaccine evaluated, resulted in a standard curve that could be applied for potency evaluations of different, commercial hepatitis B vaccine lots.

Infants' exposure to aluminum from vaccines and breast milk during the first 6 months.

The success of vaccination programs in reducing and eliminating infectious diseases has contributed to an ever-increasing number of vaccines given at earlier ages (newborns and infants). Exposure to low levels of environmental toxic substances (including metals) at an early age raises plausible concerns over increasingly lower neuro-cognitive rates. Current immunization schedules with vaccines containing aluminum (as adjuvant) are given to infants, but thimerosal (as preservative) is found mostly in vaccines used in non-industrialized countries. Exclusively, breastfed infants (in Brazil) receiving a full recommended schedule of immunizations showed an exceedingly high exposure of Al (225 to 1750 µg per dose) when compared with estimated levels absorbed from breast milk (2.0 µg). This study does not dispute the safety of vaccines but reinforces the need to study long-term effects of early exposure to neuro-toxic substances on the developing brain. Pragmatic vaccine safety needs to embrace conventional toxicology, addressing especial characteristics of unborn fetuses, neonates and infants exposed to low levels of aluminum, and ethylmercury traditionally considered innocuous to the central nervous system.

Interference of thiomersal in biologicals during protein estimation.

In the present report thiomersal was detected as interfering substance in hepatitis B vaccines during the total protein estimation by Lowry's protein assay. The thiomersal at different concentrations of 0.005%, 0.0075%, 0.01%, 0.02%, 0.05% and 0.1% was found to reduce the Folin Ciocalteu's phenol reagent and produce colour development between 0.024 O.D to 1.023 O.D. values. Further, the thiomersal was shown to interfere between 34.55% to 52.73% with Folin Ciocalteu's phenol reagent, when 10 batches of different hepatitis B vaccines were subjected to estimation of total protein content by Lowry's protein assay.

Impact of the Joint Statement by the American Academy of Pediatrics/US Public Health Service on thimerosal in vaccines on hospital infant hepatitis B vaccination practices.

OBJECTIVE: To determine the impact of the American Academy of Pediatrics/US Public Health Service (AAP/USPHS) joint statement on thimerosal in vaccines on hospital infant hepatitis B vaccination policies in Wisconsin. METHODS: The nurse managers of hospital newborn nurseries (n = 110) were surveyed by mail. Nonresponders were resurveyed. Twelve hospitals no longer provided obstetric services. Of the remaining 98 hospitals, 84 (86%) responded to the initial mailing and 14 (14%) responded to the second mailing. The number of hospitals that offered hepatitis B vaccine to infants before July 1999 was compared with that in March 2000. The number of hospitals that had policies in place to vaccinate infants whose mothers' hepatitis B surface antigen status (HBsAg) was positive or unknown during the thimerosal alert (July 1999 through November 1999) was compared with that in March 2000. RESULTS: Before July 1999, 81% of the hospitals representing 84% of reported Wisconsin births routinely offered hepatitis B vaccine to all infants. By March 2000, 50% of hospitals, representing 43% of births, had resumed routine infant hepatitis B vaccination. Physician decision to use a combination Haemophilus influenzae type b hepatitis B vaccine was the most frequently given reason for not reinstituting infant hepatitis B vaccination. During the thimerosal alert, 23% of hospitals did not have policies to vaccinate infants whose mothers were HBsAg-positive and 51% did not have policies to vaccinate infants whose mothers' HBsAg status was unknown. By March 2000, 6% of hospitals still did not have policies to vaccinate infants whose mothers were HBsAg-positive and 24% did not have policies to vaccinate infants whose mothers' HBsAg status was unknown. CONCLUSION: The AAP/USPHS joint statement on thimerosal in vaccines has resulted in a 38% decrease in the number of hospitals routinely offering infants hepatitis B vaccine. Although thimerosal-free hepatitis B vaccine is now available, some hospitals still do not have appropriate policies in place for vaccinating infants whose mothers' HBsAg status is positive or unknown. In the future, policymakers should include anticipated consequences that may result from changes in immunization policy in their recommendations.

Prueba cutánea retardada, IgE total y anticuerpos específicos frente a la vacuna cubana Heberbiovac-HB en asmáticos cubanos / Delayed skin test, total IgE and specific antibodies against the Cuban Heberbiovac-HB vaccine in Cuban asthmatic patients

La hipótesis higiénica intenta dar explicación coherente al incremento del asma en países desarrollados. Diversos estudios centran su atención en el papel que desempeñan las inmunizaciones sobre el sistema inmune y la influencia que ejercen sobre la atopia. El objetivo de este trabajo fue determinar las diferencias entre las concentraciones séricas de anticuerpos contra el antígeno de superficie del virus de la hepatitis B (anti-AgsHB), IgE total (IgE) y área de la prueba cutánea con el antígeno (Ag) vacunal, de la vacuna cubana contra la hepatitis B, Heberbiovac-HB, en niños asmáticos y no asmáticos. Se evaluó la influencia de la gravedad del cuadro clínico del asma sobre la respuesta inmune frente al Ag: se realizó estudio prospectivo y transversal, constituido por 103 niños asmáticos atendidos en el Hospital Infantil Docente William Soler y 37 no asmáticos de un área de salud del Centro de Atención Primaria "Julián Grimau" de la Ciudad de La Habana, Cuba. Todos los niños fueron vacunados con la vacuna Heberbiovac-HB, según esquema cubano de vacunación. Se realizó el test de ANCOVA para determinar las diferencias entre ambos grupos. En el grupo de niños asmáticos, se realizó un test de Duncan pos-hot, para establecer las diferencias, según la severidad del asma. Las diferencias significativas se centraron en las pruebas cutáneas, siendo menor el área de la prueba cutánea en asmáticos con respecto a los no asmáticos; la prueba cutánea control (PCC) y la prueba cutánea vs. antígeno vacunal de la hepatitis B (PCHB), PCC (166,5 vs. 233,6 mm2; p= 0,0077) y la PCHB (1 020,4 vs. 1 318,15 mm2; p= 0,0173). La severidad del cuadro clínico en asmáticos se relacionó de manera directa con las concentraciones de IgE e inversa con el área de la PCHB. Los niños asmáticos respondieron con menor área en la prueba cutánea retardada al compuesto vacunal, que los no asmáticos. La respuesta se deterioró a medida que se incrementó la gravedad del asma y las concentraciones de IgE.

The hygienic hypothesis tries to give a coherent explanation to the increase of asthma in the developed countries. Several studies focus their attention on the role played by immunizations in the immune system and on the influence they exert on atopy. The objective of this paper was to determine the differences among the serum concentrations of antibodies against the hepatitis B surface antigen (anti-AgsHB), the total IgE (IgE) and the area of the skin test with the vaccinal antigen (Ag) of the Cuban vaccine against hepatitis B, Heberbiovac-HB, in asthmatic and non-asthmatic children. The influence of the severity of the clinical picture of asthma on the immune response against Ag was evaluated. A prospective and cross-sectional study that included 103 asthmatic children attended at "William Soler" Children Teaching Hospital and 37 non-asthmatics from a health area of "Julián Grimau" Primary Care Center in Havana City, Cuba, was conducted. All the children were vaccinated with the Heberbiovac-HB vaccine according to the Cuban vaccination scheme. ANCOVA test was made to determine the differences between both groups. In the group of asthmatic children, Duncan's post-host test was carried out to establish the differences according to asthma severity. The significant differences were centered on the skin tests. The area of the skin test in asthmatics was lower than that of the non-asthmatics; the control skin test (CST) and the skin test against the hepatitis B vaccine antigen (STHB), CST (166,5 vs. 233,6 mm2; p=0,0077) and STHB (1 020,4 vs. 1 318,15 mm2; p=0,0173). The severity of the clinical picture in asthmatics was directly related to the IgE concentrations and inverse to the area of STHB. The asthmatic children responded with less area to the vaccinal compound in the delayed skin test. The answer deteriorated as the severity of asthma and the IgE concentrations increased.

Prueba cutánea retardada, IgE total y anticuerpos específicos frente a la vacuna cubana Heberbiovac-HB en asmáticos cubanos / Delayed skin test, total IgE and specific antibodies against the Cuban Heberbiovac-HB vaccine in Cuban asthmatic patients

La hipótesis higiénica intenta dar explicación coherente al incremento del asma en países desarrollados. Diversos estudios centran su atención en el papel que desempeñan las inmunizaciones sobre el sistema inmune y la influencia que ejercen sobre la atopia. El objetivo de este trabajo fue determinar las diferencias entre las concentraciones séricas de anticuerpos contra el antígeno de superficie del virus de la hepatitis B (anti-AgsHB), IgE total (IgE) y área de la prueba cutánea con el antígeno (Ag) vacunal, de la vacuna cubana contra la hepatitis B, Heberbiovac-HB, en niños asmáticos y no asmáticos. Se evaluó la influencia de la gravedad del cuadro clínico del asma sobre la respuesta inmune frente al Ag: se realizó estudio prospectivo y transversal, constituido por 103 niños asmáticos atendidos en el Hospital Infantil Docente William Soler y 37 no asmáticos de un área de salud del Centro de Atención Primaria "Julián Grimau" de la Ciudad de La Habana, Cuba. Todos los niños fueron vacunados con la vacuna Heberbiovac-HB, según esquema cubano de vacunación. Se realizó el test de ANCOVA para determinar las diferencias entre ambos grupos. En el grupo de niños asmáticos, se realizó un test de Duncan pos-hot, para establecer las diferencias, según la severidad del asma. Las diferencias significativas se centraron en las pruebas cutáneas, siendo menor el área de la prueba cutánea en asmáticos con respecto a los no asmáticos; la prueba cutánea control (PCC) y la prueba cutánea vs. antígeno vacunal de la hepatitis B (PCHB), PCC (166,5 vs. 233,6 mm2; p= 0,0077) y la PCHB (1 020,4 vs. 1 318,15 mm2; p= 0,0173). La severidad del cuadro clínico en asmáticos se relacionó de manera directa con las concentraciones de IgE e inversa con el área de la PCHB. Los niños asmáticos respondieron con menor área en la prueba cutánea retardada al compuesto vacunal, que los no asmáticos. La respuesta se deterioró a medida que se incrementó la gravedad del asma y las concentraciones de IgE(AU)

The hygienic hypothesis tries to give a coherent explanation to the increase of asthma in the developed countries. Several studies focus their attention on the role played by immunizations in the immune system and on the influence they exert on atopy. The objective of this paper was to determine the differences among the serum concentrations of antibodies against the hepatitis B surface antigen (anti-AgsHB), the total IgE (IgE) and the area of the skin test with the vaccinal antigen (Ag) of the Cuban vaccine against hepatitis B, Heberbiovac-HB, in asthmatic and non-asthmatic children. The influence of the severity of the clinical picture of asthma on the immune response against Ag was evaluated. A prospective and cross-sectional study that included 103 asthmatic children attended at "William Soler" Children Teaching Hospital and 37 non-asthmatics from a health area of "Julián Grimau" Primary Care Center in Havana City, Cuba, was conducted. All the children were vaccinated with the Heberbiovac-HB vaccine according to the Cuban vaccination scheme. ANCOVA test was made to determine the differences between both groups. In the group of asthmatic children, Duncan's post-host test was carried out to establish the differences according to asthma severity. The significant differences were centered on the skin tests. The area of the skin test in asthmatics was lower than that of the non-asthmatics; the control skin test (CST) and the skin test against the hepatitis B vaccine antigen (STHB), CST (166,5 vs. 233,6 mm2; p=0,0077) and STHB (1 020,4 vs. 1 318,15 mm2; p=0,0173). The severity of the clinical picture in asthmatics was directly related to the IgE concentrations and inverse to the area of STHB. The asthmatic children responded with less area to the vaccinal compound in the delayed skin test. The answer deteriorated as the severity of asthma and the IgE concentrations increased(AU)

Actualización sobre inmunización contra la hepatitis B en trabajadores sanitarios / Update on hepatitis B inmunization in health care workers

La infección por VHB en el adulto suele ser autolimitada; sólo un 5-10% de los infectados desarrollarán infección persistente o pasarán a la etapa de portadores crónicos. De estos últimos, sólo un 20% desarrollarán cirrosis hepática. Los trabajadores sanitarios poseen un importante riesgo laboral de adquirir infección por el VHB, siendo la sangre el medio más importante de transmisión en este grupo de riesgo. En este artículo se realiza una revisión de algunas publicaciones científicas importantes sobre la inmunización frente al VHB en trabajadores sanitarios, así como, su situación y normativa en España (AU)

Hepatitis B virus infection in adults is usually self-limited; only 5 to 10% of those infected people will develop a persistent infection or progress to the stage of chronic carriers, and only 20% of the last ones will develop liver cirrhosis. Health-care workers have an important occupational risk of hepatitis B infection, being blood the most important mean of transmission for this group. This article is a review about some important scientific publications about immunization against hepatitis B virus in health-care workers. It also discuss legal regulations and current situation in Spain (AU)

Vacunación frente a la hepatitis B / No disponible

No disponible

Evaluación de la respuesta serológica a la vacuna contra la hepatitis B en una población laboral hospitalaria / Evaluation of serologic response of Hepatitis B vaccine in the hospitalable group

Se evaluó la efectividad de la vacuna contra la hepatitis B (Engerix B) en 116 empleados del Hospital Nacional de Niños, San José, Costa Rica, de 120 que ingresaron voluntariamente al programa de vacunación en el período 1995-1996. La vacunación fue exitosa en el 99,13 por ciento de los individuos alcanzando éstos respuestas de seroprotección con niveles de anti HBs mayores a 10mUI/ml. Se puede corroborar que la edad y el sexo tienen influencia directa sobre los niveles de seroconversión; en general son mejores respondedores los jóvenes y las mujeres

Vacuna recombinante contra la hepatitis viral B en trabajadores de la salud del Instituto Peruano de Seguridad Social / Recombinant hepatitis B vaccine in health workers of Peruvian Social Security Institute

Se investigó la inmunogenicidad (seroconversión, seroprotección, hiperrespuesta y media geométrica) producida por la vacuna recombinante cubana contra la hepatitis viral tipo B en nuestro medio, en un estudio multicéntrico nacional, concurrente, aplicando el esquema de 0, 1, 2 meses en 211 trabajadores de la salud, susceptibles pertenecientes al Instituto Peruano de Seguridad Social. La cuantifcación del antiHBs se realizó por el método inmunoenzimático de Organon Tecknica. Se obtuvo un 97 por ciento de seroprotección en sólo 75 días de haber iniciado el esquema, observóndose una mayor inmunogenicidad en mujeres menores de 40 años. Se recomienda la aplicación de este esquema conmo parte del programa de control de la hepatitis viral tipo B por su simetría, corta latencia y grado de protección