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6 result(s) for "Carabajal, Carlos"
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Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial
The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed. This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases. Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice. www.ClinicalTrials.gov NCT00466947.
Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial
Background The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed. Methods and Findings This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases. Conclusions Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice. Trial registration www.ClinicalTrials.gov NCT00466947 Please see later in the article for the Editors' Summary
Digital Elevation Models: Terminology and Definitions
Digital elevation models (DEMs) provide fundamental depictions of the three-dimensionalshape of the Earth’s surface and are useful to a wide range of disciplines. Ideally, DEMs record theinterface between the atmosphere and the lithosphere using a discrete two-dimensional grid, withcomplexities introduced by the intervening hydrosphere, cryosphere, biosphere, and anthroposphere.The treatment of DEM surfaces, affected by these intervening spheres, depends on their intendeduse, and the characteristics of the sensors that were used to create them. DEM is a general term,and more specific terms such as digital surface model (DSM) or digital terrain model (DTM) recordthe treatment of the intermediate surfaces. Several global DEMs generated with optical (visible andnear-infrared) sensors and synthetic aperture radar (SAR), as well as single/multi-beam sonars andproducts of satellite altimetry, share the common characteristic of a georectified, gridded storagestructure. Nevertheless, not all DEMs share the same vertical datum, not all use the same conventionfor the area on the ground represented by each pixel in the DEM, and some of them have variable dataspacings depending on the latitude. This paper highlights the importance of knowing, understandingand reflecting on the sensor and DEM characteristics and consolidates terminology and definitions ofkey concepts to facilitate a common understanding among the growing community of DEM users,who do not necessarily share the same background
Successful live birth from oocytes after more than 14 years of cryopreservation
Objective To report a birth of a healthy girl after long-term oocyte cryopreservation by slow cooling in sodium depleted medium. Design Clinical application. Setting University Affiliated, Private IVF center. Patient A 38-year-old woman received embryos from IVF by intracytoplasmic sperm injection (ICSI) with her own oocytes that were cryopreserved by slow freezing in a low-sodium medium 14 years and 6 months before, when she was 24 years old. Main outcome measure(s) Survival, fertilization, cleavage, clinical pregnancy and delivery. Result(s) From six metaphase-II oocytes thawed, two survived, one was fertilized after ICSI and a cleaving embryo was transferred on day 3. A single term pregnancy was achieved, ending with the delivery of a healthy girl. Conclusion(s) Cryopreservation after slow freezing in a sodium depleted medium maintained the developmental competence of oocytes after long-term storage and resulted in a successful live birth. As far as is known, this case represents, up to date, the longest storage period of cryopreserved human oocytes resulting in a live birth.
Digital Elevation Models: Terminology and Definitions
Digital elevation models (DEMs) provide fundamental depictions of the three-dimensionalshape of the Earth’s surface and are useful to a wide range of disciplines. Ideally, DEMs record theinterface between the atmosphere and the lithosphere using a discrete two-dimensional grid, withcomplexities introduced by the intervening hydrosphere, cryosphere, biosphere, and anthroposphere.The treatment of DEM surfaces, affected by these intervening spheres, depends on their intendeduse, and the characteristics of the sensors that were used to create them. DEM is a general term,and more specific terms such as digital surface model (DSM) or digital terrain model (DTM) recordthe treatment of the intermediate surfaces. Several global DEMs generated with optical (visible andnear-infrared) sensors and synthetic aperture radar (SAR), as well as single/multi-beam sonars andproducts of satellite altimetry, share the common characteristic of a georectified, gridded storagestructure. Nevertheless, not all DEMs share the same vertical datum, not all use the same conventionfor the area on the ground represented by each pixel in the DEM, and some of them have variable dataspacings depending on the latitude. This paper highlights the importance of knowing, understandingand reflecting on the sensor and DEM characteristics and consolidates terminology and definitions ofkey concepts to facilitate a common understanding among the growing community of DEM users,who do not necessarily share the same background