Cambios en las características epidemiológicas de los pacientes pediátricos infectados por VIH en Navarra / Changes in the epidemiological characteristics of paediatric patients with HIV infection in Navarre

Introducción: los flujos migratorios, junto a las medidas de prevención de la transmisión vertical, han cambiado la epidemiología de los nuevos diagnósticos de infección por el virus de la inmunodeficiencia humana. Objetivo: conocer las características clínicas y epidemiológicas de los nuevos diagnósticos de infección por el VIH en Navarra. Material y métodos: revisión retrospectiva de las historias clínicas de los pacientes controlados durante 15 años (2000-2014) analizando variables epidemiológicas y clínicas, con tres puntos de corte quinquenales. Datos poblacionales del Instituto Nacional de Estadística. Resultados: 15 pacientes estudiados, todos por transmisión vertical. Madres de origen extranjero: globalmente el 47%. El 0% en 2004, 36% en 2009 (100% de nuevos diagnósticos) y 36% en 2014 (75% de los nuevos). No se encontraron diferencias en el estadio clínico, inmunológico, ni en la carga viral según su origen. El contagio materno fue al inicio por uso compartido de jeringuillas; posteriormente por vía heterosexual. Conclusiones: las características de los niños infectados por virus de la inmunodeficiencia humana han cambiado, siendo en la actualidad mayoritariamente hijos de inmigrantes y el contagio materno vía heterosexual

Introduction: migratory flows and the introduction of measures to prevent vertical transmission have changed the epidemiology of new cases of infection by human immunodeficiency virus (HIV). Objective: to establish the clinical and epidemiological characteristics of new cases of infection by HIV in Navarre. Materials and methods: we conducted a retrospective study by reviewing the health records of patients managed in a 15-year period (2000-2014), analysing epidemiological and clinical variables in three 5-year intervals. We obtained the data for the reference population from the Instituto Nacional de Estadística. Results: we analysed the cases of 15 patients, all of them infected by vertical transmission. Children of foreign-born mothers amounted to 47% of the total sample, corresponding to 0% of cases in 2004, 36% of cases (including 100% of newly diagnosed cases) in 2009, and 36% of cases (including 75% of newly diagnosed cases) in 2014. We did not find differences in the stage of HIV, the immune status or the viral load based on geographical origin. The leading source of infection in mothers was injectable drug use at the beginning of the study, and changed to heterosexual transmission during the analysed period. Conclusions: we found changes in the characteristics of children infected by HIV, who are now most frequently children of immigrants whose mothers became infected through heterosexual transmission

13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants.

OBJECTIVES: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants. METHODS: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine). RESULTS: Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration ≥ 0.35 µg/mL for all serotypes: >85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and >97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups. CONCLUSIONS: Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization-established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.

A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants.

BACKGROUND: Neisseria meningitidis serogroup B (MnB) is a major cause of invasive meningococcal disease in infants. A conserved, surface-exposed lipoprotein, LP2086 (a factor H-binding protein [fHBP]), is a promising MnB vaccine target. A bivalent, recombinant vaccine targeting the fHBP (rLP2086) of MnB was developed. METHODS: This phase 1/2 clinical study was designed to assess the immunogenicity, safety, and tolerability of a 4-dose series of the rLP2086 vaccine at 20-, 60-, 120-, or 200-µg dose levels in vaccine-naive infants when given with routine childhood vaccines. The study was to consist of two phases: a single-blind sentinel phase and an open-label full enrollment phase. During the sentinel phase, randomization of subjects to the next higher dose was delayed pending a 14-day safety review of dose 1 of the preceding dose cohort. The full enrollment phase was to occur after completion of the sentinel phase. RESULTS: Local reactions were generally mild and adverse events infrequent; however, after only 46 infants were randomized into the study, fever rates were 64% and 90% in subjects receiving one 20- or 60-µg rLP2086 dose, respectively. Most fevers were <39.0°C. Only 2 subjects in the 20-µg group and 1 subject in the 60-µg group experienced fevers >39.0°C; no fevers were >40.0°C. Due to these high fever rates, the study was terminated early. No immunogenicity data were collected. This report discusses the safety and acceptability of rLP2086 in infants after one 20- or 60-µg dose. CONCLUSION: Due to the high fever rate experienced in the 20- and 60-µg groups, rLP2086 in the current formulation may not be acceptable for infants.