Ensayo clínico de reto, para evaluar una cepa candidata a vacuna contra el cólera / Challenge clinical trial for evaluation of a vaccine candidate strain against cholera

INTRODUCCIÓN: la cepa atenuada 638 Vibrio cholerae O1 El Tor, Ogawa, ha demostrado ser bien tolerada e inmunogénica por vía oral en estudios realizados en voluntarios sanos. OBJETIVO: se evaluó la protección conferida contra el cólera, en un ensayo clínico de reto, para el escalado tecnológico y farmacéutico de este candidato vacunal como ingrediente activo a escala industrial. MÉTODOS: en el estudio participaron 21 voluntarios sanos, 12 de ellos recibieron el candidato vacunal, y 9 ingirieron un placebo; 28 d después, todos recibieron una dosis infectante de una cepa virulenta de V.cholerae. RESULTADOS: la diarrea se registró en 7 de los 9 placebos, mientras que ninguno de los voluntarios vacunados presentó diarrea. Los voluntarios placebos del grupo sanguíneo O, tuvieron diarreas con mayor frecuencia e intensidad. Todos los voluntarios en el grupo placebo excretaron V. cholerae mientras que solo 3 (25 por ciento) de los 12 vacunados la excretaron. CONCLUSIONES: en este modelo de ensayo de reto, la cepa 638 demostró proteger contra la diarrea producida por una cepa virulenta de V. cholerae.

INTRODUCTION: live attenuated oral Vibrio cholerae O1 El Tor, Ogawa strain 638 has demonstrated to be well tolerated and immunogenic when administrated orally in studies carried out in healthy volunteers. OBJECTIVE: to evaluate the protection against cholera infection in a challenge clinical trial, for the technological and pharmaceutical scale-up of this vaccinal candidate as active ingredient at industrial level. METHOD: a total of 21 healthy volunteers were involved in this trial; the vaccine candidate was administered to 12 of them and the remaining nine were given the placebo. Twenty eight days later, all of them received an infective dose of a V. cholerae virulent strain. RESULTS: diarrheas were observed in 7 out of 9 placebos whereas not a single vaccinated volunteer showed diarrheas. More frequent and intense loose stools were found in the placebo volunteers with O-blood group. All volunteers in he placebo group excreted V. cholerae, but only three (25 percent) out of the 12 vaccinated volunteers did so. CONCLUSION: in this challenge clinical trial model, the 638 strain proved to protect people against the diarrhea caused by a virulent V. cholerae strain.

Ensayo clínico de reto, para evaluar una cepa candidata a vacuna contra el cólera / Challenge clinical trial for evaluation of a vaccine candidate strain against cholera

INTRODUCCIÓN: la cepa atenuada 638 Vibrio cholerae O1 El Tor, Ogawa, ha demostrado ser bien tolerada e inmunogénica por vía oral en estudios realizados en voluntarios sanos. OBJETIVO: se evaluó la protección conferida contra el cólera, en un ensayo clínico de reto, para el escalado tecnológico y farmacéutico de este candidato vacunal como ingrediente activo a escala industrial. MÉTODOS: en el estudio participaron 21 voluntarios sanos, 12 de ellos recibieron el candidato vacunal, y 9 ingirieron un placebo; 28 d después, todos recibieron una dosis infectante de una cepa virulenta de V.cholerae. RESULTADOS: la diarrea se registró en 7 de los 9 placebos, mientras que ninguno de los voluntarios vacunados presentó diarrea. Los voluntarios placebos del grupo sanguíneo O, tuvieron diarreas con mayor frecuencia e intensidad. Todos los voluntarios en el grupo placebo excretaron V. cholerae mientras que solo 3 (25 por ciento) de los 12 vacunados la excretaron. CONCLUSIONES: en este modelo de ensayo de reto, la cepa 638 demostró proteger contra la diarrea producida por una cepa virulenta de V. cholerae (AU)

INTRODUCTION: live attenuated oral Vibrio cholerae O1 El Tor, Ogawa strain 638 has demonstrated to be well tolerated and immunogenic when administrated orally in studies carried out in healthy volunteers. OBJECTIVE: to evaluate the protection against cholera infection in a challenge clinical trial, for the technological and pharmaceutical scale-up of this vaccinal candidate as active ingredient at industrial level. METHOD: a total of 21 healthy volunteers were involved in this trial; the vaccine candidate was administered to 12 of them and the remaining nine were given the placebo. Twenty eight days later, all of them received an infective dose of a V. cholerae virulent strain. RESULTS: diarrheas were observed in 7 out of 9 placebos whereas not a single vaccinated volunteer showed diarrheas. More frequent and intense loose stools were found in the placebo volunteers with O-blood group. All volunteers in he placebo group excreted V. cholerae, but only three (25 percent) out of the 12 vaccinated volunteers did so. CONCLUSION: in this challenge clinical trial model, the 638 strain proved to protect people against the diarrhea caused by a virulent V. cholerae strain (AU)

Ensayo clínico de reto, para evaluar una cepa candidata a vacuna contra el cólera / Challenge clinical trial for evaluation of a vaccine candidate strain against cholera

INTRODUCCIÓN: la cepa atenuada 638 Vibrio cholerae O1 El Tor, Ogawa, ha demostrado ser bien tolerada e inmunogénica por vía oral en estudios realizados en voluntarios sanos. OBJETIVO: se evaluó la protección conferida contra el cólera, en un ensayo clínico de reto, para el escalado tecnológico y farmacéutico de este candidato vacunal como ingrediente activo a escala industrial. MÉTODOS: en el estudio participaron 21 voluntarios sanos, 12 de ellos recibieron el candidato vacunal, y 9 ingirieron un placebo; 28 d después, todos recibieron una dosis infectante de una cepa virulenta de V.cholerae. RESULTADOS: la diarrea se registró en 7 de los 9 placebos, mientras que ninguno de los voluntarios vacunados presentó diarrea. Los voluntarios placebos del grupo sanguíneo O, tuvieron diarreas con mayor frecuencia e intensidad. Todos los voluntarios en el grupo placebo excretaron V. cholerae mientras que solo 3 (25 por ciento) de los 12 vacunados la excretaron. CONCLUSIONES: en este modelo de ensayo de reto, la cepa 638 demostró proteger contra la diarrea producida por una cepa virulenta de V. cholerae (AU)

INTRODUCTION: live attenuated oral Vibrio cholerae O1 El Tor, Ogawa strain 638 has demonstrated to be well tolerated and immunogenic when administrated orally in studies carried out in healthy volunteers. OBJECTIVE: to evaluate the protection against cholera infection in a challenge clinical trial, for the technological and pharmaceutical scale-up of this vaccinal candidate as active ingredient at industrial level. METHOD: a total of 21 healthy volunteers were involved in this trial; the vaccine candidate was administered to 12 of them and the remaining nine were given the placebo. Twenty eight days later, all of them received an infective dose of a V. cholerae virulent strain. RESULTS: diarrheas were observed in 7 out of 9 placebos whereas not a single vaccinated volunteer showed diarrheas. More frequent and intense loose stools were found in the placebo volunteers with O-blood group. All volunteers in he placebo group excreted V. cholerae, but only three (25 percent) out of the 12 vaccinated volunteers did so. CONCLUSION: in this challenge clinical trial model, the 638 strain proved to protect people against the diarrhea caused by a virulent V. cholerae strain (AU)

[Challenge clinical trial for evaluation of a vaccine candidate strain against cholera]. / Ensayo clínico de reto, para evaluar una cepa candidata a vacuna contra el cólera.

INTRODUCTION: live attenuated oral Vibrio cholerae Ol El Tor, Ogawa strain 638 has demonstrated to be well tolerated and immunogenic when administrated orally in studies carried out in healthy volunteers. OBJECTIVES: to evaluate the protection against cholera infection in a challenge clinical trial, for the technological and pharmaceutical scale-up of this vaccinal candidate as active ingredient at industrial level. METHODS: a total of 21 healthy volunteers were involved in this trial; the vaccine candidate was administered to 12 of them and the remaining nine were given the placebo. Twenty eight days later, all of them received an infective dose of a V. cholerae virulent strain. RESULTS: diarrheas were observed in 7 out of 9 placebos whereas not a single vaccinated volunteer showed diarrheas. More frequent and intense loose stools were found in the placebo volunteers with O-blood group. All volunteers in he placebo group excreted V. cholerae, but only three (25%) out of the 12 vaccinated volunteers did so. CONCLUSION: in this challenge clinical trial model, the 638 strain proved to protect people against the diarrhea caused by a virulent V. cholerae strain.

Enterocolitis necrosante en un niño prematuro hijo de padres VIH+ / Necrotizing enterocolitis observed in a premature newborn with HIV+parents

En Cuba, entre el 1ero. de enero de 1986 y el 30 de abril de 2007 nacieron 280 niños hijos de madres VIH+. De ellos solo 22 (7,8 por ciento) nacieron con edad gestacional menor de 37 semanas y solo uno (4,5 por ciento) presentó una enterocolitis necrosante. En el presente artículo se describe un episodio de esta enfermedad en un niño prematuro hijo de padres VIH+, supuestamente asociado al uso profiláctico de zidovudina en las madres seropositivas por la posibilidad de producir toxicidad mitocondrial en el feto. Con el tratamiento quirúrgico empleado, la evolución del niño fue favorable. El caso presentado constituye una evidencia que el personal médico debe tener en cuenta para el cuidado y diagnóstico de estos pacientes.

In Cuba, from January 1, 1986 to April 30, 2007 were born 280 children from HIV+ mothers. Only 22 (7, 8 percent) had a gestational age under 37 weeks and only one (4, 5 percent) presented with a necrotizing enterocolitis. In present paper we describe an episode of this disease in a premature baby son of HIV+ parents, supposedly associated with prophylactic use of Zidovudine in seropositive mothers by possibility to produce mitochondria toxicity in fetus. This case is an evidence that family physician must to assess for care and diagnosis of these patients.

Enterocolitis necrosante en un niño prematuro hijo de padres VIH+ / Necrotizing enterocolitis observed in a premature newborn with HIV+parents

En Cuba, entre el 1ero. de enero de 1986 y el 30 de abril de 2007 nacieron 280 niños hijos de madres VIH+. De ellos solo 22 (7,8 por ciento) nacieron con edad gestacional menor de 37 semanas y solo uno (4,5 por ciento) presentó una enterocolitis necrosante. En el presente artículo se describe un episodio de esta enfermedad en un niño prematuro hijo de padres VIH+, supuestamente asociado al uso profiláctico de zidovudina en las madres seropositivas por la posibilidad de producir toxicidad mitocondrial en el feto. Con el tratamiento quirúrgico empleado, la evolución del niño fue favorable. El caso presentado constituye una evidencia que el personal médico debe tener en cuenta para el cuidado y diagnóstico de estos pacientes(AU)

In Cuba, from January 1, 1986 to April 30, 2007 were born 280 children from HIV+ mothers. Only 22 (7, 8 percent) had a gestational age under 37 weeks and only one (4, 5 percent) presented with a necrotizing enterocolitis. In present paper we describe an episode of this disease in a premature baby son of HIV+ parents, supposedly associated with prophylactic use of Zidovudine in seropositive mothers by possibility to produce mitochondria toxicity in fetus. This case is an evidence that family physician must to assess for care and diagnosis of these patients(AU)

[Change in the survival of Cuban AIDS patients with tuberculosis in the Highly Active Antiretroviral Therapy (HAART) era]. / Cambios en la supervivencia de enfermos con SIDA y tuberculosis en Cuba en la era del Tratamiento Antirretroviral de Alta Eficacia (TARVAE).

HIV infection affected 0.06% of the Cuban population and AIDS associated tuberculosis (TB) represented 4.4% of cases in 2004. The objective of this study was to determine the survival of AIDS patients with TB. 167 individuals of both sexes and ages between 15 and 60 years old were studied; all of them were diagnosed in the Havana's Tropical Medicine Institute "Pedro Kourí", Cuba, between January 1st 1997 and May 31st 2005. The Kaplan-Meier's method and the Long-rank test were used for the survival, and the Cox's multivariate method to identify the variables associated with mortality by means of SPSS 9.0. 78 individuals of the total died at the end of study, 71.8% belonged to the pre highly active antiretroviral therapy (HAART) era and 28.2% to the later period. From all deceased cases due to TB, 82.1% were diagnosed in the pre HAART era. The median survival was 41 months (CI=20-62). TB diagnosis in the pre HAART period, TB not being the first disease indicator of AIDS, suffering from candidiasis of esophagus before TB and a LTCD4+ count < 200 at the diagnosis of TB, were all independently associated with mortality. This study demonstrated the positive impact of HAART in the survival of Cuban AIDS patients with TB and also identified advanced immunodepression and opportunistic infections as predictors of mortality.

Cambios en la supervivencia de enfermos con SIDA y tuberculosis en Cuba en la era del tratamiento antirretroviral de alta eficacia (TARVAE) / Change in the survival of Cuban AIDS patients with tuberculosis in the highly active antiretroviral therapy (HAART) era

En Cuba el VIH infecta al 0,06% de la población y la tuberculosis (TB) asociada al SIDA representó el 4,4% de los casos en el año 2004. El objetivo de este estudio fue determinar la supervivencia de los enfermos con SIDA y TB. Se estudiaron 167 individuos de ambos sexos, con edades comprendidas entre 15 y 60 años, diagnosticados en el Instituto de Medicina Tropical “Pedro Kourí” de La Habana, Cuba, entre el 1º de enero de 1997 y el 31 de mayo del 2005. Se utilizó el método de Kaplan-Meier y la prueba de Log-rank para la supervivencia, un modelo multivariado de Cox para identificar las variables asociadas con la mortalidad mediante SPSS 9.0. De los 167 individuos 78 fallecieron, el 71,8% perteneció a la era-pre Tratamiento Antirretroviral de Alta Eficacia (TARVAE) y el 28,2% al periodo posterior. Del total de fallecidos por TB (39), el 82,1% se diagnosticó en la etapa pre-TARVAE. La mediana de supervivencia fue 41 meses (IC=20-62). Se asociaron de forma independiente con la mortalidad las categorías: diagnóstico de TB en la etapa pre-TARVAE, no ser la TB la primera enfermedad indicadora de SIDA, padecer candidiasis oroesofágica antes de la TB y menos de 200 LTCD4+ en el diagnóstico de la TB. Se demostró el impacto positivo del TARVAE en la supervivencia de los enfermos SIDA con TB en Cuba, y se identificaron la inmunodepresión avanzada y las enfermedades oportunistas como predictores de mortalidad.

[HIV mother to child transmission: report of nine Cuban fatal cases in ten years]. / Infección por VIH en Cuba por transmisión vertical: Reporte de nueve casos fatales en 10 años.

Vertical transmission of HIV infection constitutes one of the most sensitive pillars of the current pandemic of this disease. This article carries out a report of the nine Cuban children who acquired this way the infection and died between 1986 and 2006. Prophylactic management of the cases and the clinical and anatomic pathological manifestations of those in whom autopsy was performed are described. The average gestational age was of 37.6 weeks, four of the pregnancies were captured late. Six children were born by caesarean section and in all transmission were presumably intrauterine. The average birth weight was 2786 grams. Four mother-sibling binomial received prophylaxis with AZT. The autopsy was carried out only in 4 children.

Infección por VIH en Cuba por transmisión vertical: Reporte de nueve casos fatales en 10 años / HIV mother to child transmission: Report of nine Cuban fatal cases in ten years

Vertical transmission of HIV infection constitutes one of the most sensitive pillars of the current pandemic of this disease. This article carries out a report of the nine Cuban children who acquired this way the infection and died between 1986 and 2006. Prophylactic management of the cases and the clinical and anatomic pathological manifestations of those in whom autopsy was performed are described. The average gestational age was of 37.6 weeks, four of the pregnancies were captured late. Six children were born by caesarean section and in all transmission were presumably intrauterine. The average birth weight was 2786 grams. Four mother-sibling binomial received prophylaxis with AZT. The autopsy was carried out only in 4 children.

Infección por VIH en Cuba por transmisión vertical: reporte de nueve casos fatales en 10 años / HIV mother to child transmission: report of nine Cuban fatal cases in ten years

Vertical transmission of HIV infection constitutes one of the most sensitive pillars of the current pandemic of this disease. This article carries out a report of the nine Cuban children who acquired this way the infection and died between 1986 and 2006. Prophylactic management of the cases and the clinical and anatomic pathological manifestations of those in whom autopsy was performed are described. The average gestational age was of 37.6 weeks, four of the pregnancies were captured late. Six children were born by caesarean section and in all transmission were presumably intrauterine. The average birth weight was 2786 grams. Four mother-sibling binomial received prophylaxis with AZT. The autopsy was carried out only in 4 children(AU)

Transmisión vertical de la infección por el VIH constituye uno de los pilares más sensibles de la actual pandemia de esta enfermedad. En este artículo se realiza un informe de los nueve niños cubanos que adquirieron de esta manera la infección y murió entre 1986 y 2006. Profilaxis de la gestión de los casos y las historias clínicas y anatómicas manifestaciones patológicas de aquellos en quienes se realizó la autopsia se describen. La edad gestacional promedio fue de 37,6 semanas, cuatro de los embarazos fueron capturados tarde. Seis niños nacieron por cesárea y en todos los presumiblemente transmisión intrauterina. El promedio de peso al nacer fue 2.786 gramos. Cuatro hermanos binomio madre-recibieron profilaxis con AZT. La autopsia se llevó a cabo en sólo 4 niño

Supervivencia a los tres años del diagnóstico de 72 casos con tuberculosis y SIDA en la era pre-TARVAE en Cuba / Survival of patients three years after the diagnosis of tuberculosis and AIDS in Cuba during pre-HAART era

Fundamento: Hay más de 40 millones de afectados en el mundo por el VIH/SIDA; han muerto alrededor de 20 millones de personas desde los inicios de la epidemia. Hay mayores tasas de mortalidad y menor supervivencia en los enfermos con tuberculosis (TB) e infección por el VIH-I. Particularmente, en Cuba no existen estudios previos que aborden la supervivencia en individuos coinfectados por VIH/TB. Métodos: Estudio observacional de una serie de 72 casos con TB y SIDA antes de generalizada la terapia antirretroviral de alta eficacia (TARVAE). Se describen variables clínicas e inmunológicas que se relacionan con la supervivencia a los tres años del diagnóstico de la TB y con el riesgo de muerte. Utilizamos el método de Kaplan-Meier y de riesgos proporcionales de Cox. Resultados: El 69.4% de los enfermos habían fallecido a los tres años del diagnóstico de la TB. La media del recuento de LTCD4+ resultó significativamente inferior en los muertos: 126 células por mm³ (p < 0.0001). El 44.4% de los casos cumplió los criterios de muerte por TB. La mediana de supervivencia global fue de 10 meses. Tener LTCD4 + < a 200 células y padecer candidiasis profunda previo a la TB, se asoció independientemente con el riesgo de muerte. Conclusiones: En ausencia de TARVAE, las infecciones oportunistas y el deterioro inmunológico en los individuos con SIDA y TB se relacionaron con un mayor riesgo de muerte.

Background: Infection due to HIV/AIDS affects more than 40 million people worldwide; around 20 million have succumbed since the epidemy began. There are higher mortality rates and shortened survival in those affected by tuberculosis (TB) and HIV-I. In Cuba, there are no previous studies regarding the survival of patients coinfected by HIV/TB. Methods: Observational study of a series of 72 cases infected by TB and AIDS before the widespread use of highly active anti-retroviral therapy (HAART); we describe the clinical and immunological variables associated to three year survival from the diagnosis of TB/AIDS and to the risk of death. Survival analyses were done by the Kaplan-Meier method and the log-rank test to determine the survival function according to categories of the variables included. Cox's proportional hazards was used to determine the independent association of each variable with the risk of death. Results: 51.4% of patients were dead one year and 69.4%, three years after the diagnosis of TB. Mean CD4+T lymphocyte counts were significantly lower in the deceased, 126 cells/mm³ (p < 0.0001); 44.4% fulfilled the criteria of death caused by TB. Mean survival was 10 months; survival was higher in those patients with TB as the first condition indicative of AIDS, in those who were not AIDS before TB, in those not having previous deep candidiasis, when CD4 + T lymphocyte counts > 200/mm³, in those with a reactive tuberculin skin test and when smears from sputum were negative to acid fast bacilli. The risk of death was independently associated to CD4 + T lymphocyte counts < 200/mm³, and having deep candidiasis before TB. Conclusions: In the absence of HA ART, opportunistic infections and immunologic impairment in patients with AIDS and TB are related to lower survival rates and increased risk of death.

Tuberculosis y SIDA en Cuba: Estudio de dos series de casos / Tuberculosis and AIDS in Cuba: A study of two series of cases

Objetivo: Caracterizar dos grupos de enfermos con SIDA y tuberculosis (TB) diagnosticados antes y después de generalizada la terapia antirretrovirai de alta eficacia (TARVAE) en Cuba. Métodos: Diseño descriptivo y correlacional en dos series de casos en 149 enfermos con SIDA y TB: serie I, 72 casos (enero 1997-marzo 2001, antes de la TARVAE); serie II, 77 casos (mayo 2001-julio 2004, después de la TARVAE). Todos los casos fueron egresados del Instituto de Medicina Tropical "Pedro Kourí" de La Habana, Cuba. Se evaluaron variables demográficas, clínicas, microbiológicas e inmunológicas por revisión de expedientes clínicos. Resultados principales y conclusiones: Predominó el sexo masculino en ambas series; la edad media varió de los 30 a los 33 años. El 58.3% y el 57.1% de los casos de ambas series clasificaba como enfermo SIDA en el momento de la TB, ésta fue la primera enfermedad indicadora del síndrome en el 64.9% de los casos en la serie II, 48.6% en el resto. En la serie II, el 54.5% de los enfermos tuvieron un recuento de LTCD4+ < 200 células, indicando mejor estado inmunológico respecto a la serie I (76.4%). El estado clínico de la TB fue semejante en ambos grupos; en la serie II, hubo mayor frecuencia de fiebre de origen desconocido (92.2%), diaforesis nocturna (64.9%), disnea (14.3%) y linfadenopatías regionales (27.3%). La localización pulmonar fue la más frecuente en ambas series (79.2 y 75.35%); en 9 casos de la serie II se diagnosticó TB diseminada (11.7%). Las formas radiológicas más frecuentes fueron el infiltrado inflamatorio difuso de las bases, la mediastinal y la TB con radiografía negativa; en la serie II, hubo lesiones cavitarías (7.8%) y apicales (14.3%), pero menos afectación de las bases (18.2% vs 36.1%); no hubo correlación entre el recuento promedio de LTCD4+ y las formas clínicas y radiológicas de la TB. En la serie II resultó inferior la frecuencia de baciloscopías y cultivos de esputos positivos y superior la de Mantoux reactivos (32.9%) y exámenes anatomohistológicos positivos (16.9%).

Objective: Analysis of groups of patients with the acquired immunodeficiency syndrome (AIDS) and tuberculosis (TB) diagnosed before and after the use of highly active antiretroviral therapy (HAART) in Cuba. Methods: Chart analysis of 149 cases with AIDS and TB. Series I, 72 cases (January 1997-March 2001, before HAART). Series II, 77 cases (May 2001-June 2004, after HAART); all the patients were discharged from the "Instituto de Medicina Tropical 'Pedro Kourí" in Havana, Cuba. Results and conclusions: There was a predominance of young (30-33ys) males in both series; 58.3% and 57.1% of cases classified as AIDS at the appearance of TB; TB was the first indicator of AIDS in 64.9% of cases in Series II; 54.5% of cases in Series II and 36.4% in Series I had < 200 CD4 + TL cells, probably related to better immunologic status. Clinical profile was similar; fever of uknown origin, nocturnal sweats, dyspnea and regional lymphadenopathies were more frequent in Series II. Amongst TB cases, pulmonary disease was more frequent (79.2% and 75.3%, respectively); 9 cases (11.7%) of Series II had disseminated TB. Diffuse basal and mediastinal shadows and negative chest X rays were more frequent; there was no correlation between the counts of CD4+ TL cells and the clinical and radiological forms of TB. Series II had a lower invadence of positive sputum smears and positive cultures and a higher incidence of positive intradermal reaction to tuberculin and positive tissue diagnoses for TB.

[Immunological characteristic of children vertically infected with HIV: a case-control study]. / Características inmunológicas de los niños infectados por vía vertical con el VIH: estudio de casos y controles.

HIV infection in children causes a serious immunodeficiency with special characteristics that distinguish it from the adult, causing a global immune deficit. This is a case-control study between Cuban paediatric patients infected with HIV by vertical transmission and a control group of supposedly healthy children. Both groups were characterized from the clinical point of view and markers were used for evaluating the immunologic and virologycal state. Clinically 75% of patients present a pattern of precocious progression; from the total, only two stayed asymptomatic. All HIV-infected children receive antirretroviral treatment and three of them present values of viral load bigger than 100,000 cp/mL. The immune alterations found in the HIV-infected children compared with healthy children were: a cellular immune depletion with diminished counts of lymphocyte subsets T CD4+, CD16+/CD56+ and CD19+, an increase in subsets of CD3+, CD8+, CD8+/CD38+, CD3+/ CD95+ and a hypergammaglobulinemia due to prevalence of immunoglobulin gamma IgG (p < 0.05). On the other hand, there were not significantly differences in the serum levels of both C3 and C4, as well as in the haemolytic activity of the classic and alternate activation pathways of the complement system. This finding allowed better attention and treatment of paediatric HIV patients.

Características inmunológicas de los niños infectados por vía vertical con el VIH: estudio de casos y controles / Immunological characteristic of HIV infected children by vertical way: cases and controls study

HIV infection in children conditions a serious immunodeficiency with special characteristic that distinguish it from the adult, causing a global immune deficit. This constitutes a cases and controls study between Cuban paediatric patients infected with HIV by vertical transmission and a control group of supposedly healthy children. The both groups were characterized from the clinical point of view and markers were used for evaluated the immunologic and virologycal state. Clinically 75% of patients present a pattern of precocious progression, from total only two stay asymptomatic. All HIV infected children receive antirretroviral treatment and three of them present values of viral load bigger than 100,000 cp/mL. The immune alterations found in the HIV infected children compared with healthy children were: a cellular immune depletion with diminish counts of lymphocytes subsets of T CD4+, CD16+/CD56 + and CD19+, an increase in subsets of CD3+, CD8+, CD8+/CD38+, CD3+/ CD95+ and a hipergammaglobulinemia to prevalence of immunoglobulin gamma IgG (p < 0.05). On the other hand, they were not significantly differences in the serum levels of both C3 and C4, as well as in the haemolytic activity of the roads classic and it alternates of the complement system. This finding allowed us to a better attention and treatment of paediatric HIV patients.

La infección por el virus de la inmunodeficiencia humana (VIH) en niños condiciona una grave inmunodeficiencia con características especiales que la distinguen del adulto, ocasionando un déficit inmune global. Se realizó un estudio de casos y controles de los pacientes pediátricos cubanos infectados por transmisión vertical con el VIH comparado con niños supuestamente sanos. Ambos grupos se caracterizaron desde el punto de vista clínico y se emplearon marcadores que evaluaron el estado inmunológico y virológico. Clínicamente 75% de los pacientes infectados por VIH presentan un patrón de progresión precoz, y dos se mantienen asintomáticos. A todos los niños infectados se les suministró tratamiento antirretroviral y tres presentan valores de carga viral mayores de 100,000 cp/mL. Las alteraciones inmunes encontradas en los pacientes VIH+ fueron: una inmunodepresión celular con conteos de subpoblaciones linfoides T CD4+, CD16+/CD56 + y CD 19+ disminuidas significativamente con respecto al grupo control (p < 0.05). Además, se encontró un aumento de linfocitos CD3+, CD8+, CD8+/CD38+, CD3+/CD95+ y una hipergammaglobulinemia a predominio de inmunoglobulina gamma IgG en la comparación estadística (p < 0.05). Por otra parte, no se encontraron diferencias significativas en los niveles séricos de C3 y C4, así como en la actividad hemolítica de las vías clásica y alterna del sistema del complemento. Este conocimiento nos permitió sentar pautas para contribuir al manejo y tratamiento de los pacientes pediátricos infectados por VIH.

The Vaccine Candidate Vibrio cholerae 638 Is Protective against Cholera in Healthy Volunteers / s. t

Vibrio cholerae 638 is a living candidate cholera vaccine strain attenuated by deletion of the CTX prophage from C7258 (O1, El Tor Ogawa) and by insertion of the Clostridium thermocellum endoglucanase A gene into the hemagglutinin/protease coding sequence. This vaccine candidate was previously found to be well tolerated and immunogenic in volunteers...(AU)

[Factors associated with the presence of tuberculosis in patients with acquired immunodeficiency syndrome in Cuba]. / Factores asociados con la presencia de tuberculosis en pacientes con el síndrome de inmunodeficiencia adquirida en Cuba.

OBJECTIVES: To determine the factors associated with the development of tuberculosis in patients with acquired immunodeficiency syndrome (AIDS) and to identify the most frequent symptoms and signs of tuberculosis in this group of patients. METHODS: This retrospective observational case-control study was carried out with 143 patients diagnosed with AIDS who were discharged from the Pedro Kourí Institute of Tropical Medicine, which is in the city of Havana, Cuba, between January 1997 and March 2001. The cases were 72 patients with AIDS and some clinical form of tuberculosis, while the control group was made up of the first 71 AIDS patients without tuberculosis who were discharged. The following variables were evaluated: AIDS stage before the study, serious opportunistic infections suffered before the diagnosis of tuberculosis (pulmonary pneumocystosis, cerebral toxoplasmosis, systemic candidiasis, isosporiasis, and recurrent pneumonia), concentration of CD4+ T lymphocytes, and clinical symptoms and signs of tuberculosis. The primary data were taken from the clinical files of the patients. We calculated the frequency of the nominal qualitative variables and the crude odd ratios (ORs) and their 95% confidence intervals (CIs). The statistical association among the variables was determined with the chi-square test with Yates correction. The individual effect of each variable was assessed through multivariate logistic regression analysis. The level of statistical significance was 0.05. RESULTS: Tuberculosis in this group of patients showed a statistically significant association with: being ill with AIDS before the study (OR = 3.57; 95% CI: 1.78 to 7.17); a history of pulmonary pneumocystosis (OR = 4.73; 95% CI: 1.51 to 15.76), cerebral toxoplasmosis (OR = 6.22; 95% CI: 1.21 to 42.99), or systemic candidiasis (OR = 11.29; 95% CI: 1.40 to 246.5); and having CD4+ T lymphocyte concentrations lower than 200 cells/mm(3). However, the logistic regression showed a significant association only with the history of systemic candidiasis (OR = 10.47; 95% CI: 1.06 to 103.5; P = 0.0446). The symptoms associated with the clinical diagnosis of tuberculosis were hemoptysis (OR = 7.54; 95% CI: 1.88 to 170.34), fever of unknown origin (OR = 13.38; 95% CI: 5.55 to 32.96), night sweats (OR = 21.95; 95% CI: 4.66 to 142.43), and weight loss (OR = 3.52; 95% CI: 1.65 to 7.55). The associated signs were regional lymphadenopathies (OR = 10.00; 95% CI: 1.22 to 220.3), hepatomegaly (OR = 5.44; 95% CI: 1.76 to 17.95), and splenomegaly (OR = 5.08; 95% CI: 1.63 to 16.83). CONCLUSIONS: The symptoms and signs seen most frequently in the patients with AIDS and tuberculosis are the characteristics of tuberculosis in patients without AIDS. In patients with AIDS, tuberculosis can be associated with other diseases whose symptoms are similar to those of tuberculosis. Nevertheless, these results indicate that the traditional symptoms of tuberculosis can help diagnose tuberculosis in this group of patients.