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Maternal transfer of anti HPV 6 and 11 antibodies upon immunization with the 9-valent HPV vaccine / Ana María Guevara Zambrano  

Público ISBD Título : Maternal transfer of anti HPV 6 and 11 antibodies upon immunization with the 9-valent HPV vaccine Tipo de documento : documento electrónico Autores : Ana María Guevara Zambrano, Fecha de publicación : 2019 Títulos uniformes : Human Vaccines & Immunotherapeutics Idioma : Inglés (eng) Palabras clave : Human papillomavirus  9vHPV vaccine  recurrent respiratory papillomatosis  clinical trial  geometric mean titers (GMTs) Resumen : Background: This exploratory analysis was conducted to characterize the level of HPV types 6/11 antibodies in peripartum maternal blood and in cord blood of infants born to women who received 9-valent HPV (9vHPV) vaccine or quadrivalent HPV (qHPV) vaccine in a pivotal efficacy study (V503-001, NCT 00543543). Methods: A total of 21 mother-infant pairs had evaluable HPV 6/11 results available for analysis. HPV6/11 antibodies were assessed using competitive Luminex immunoassay. The distribution of the ratios of infant to mother anti-HPV antibodies (i.e., infant-anti-HPV/mother- anti-HPV) was summarized. Results: All mothers and infants were seropositive to HPV 6 and HPV 11. Anti-HPV 6/11 geometric mean titers (GMTs) in peripartum maternal blood and in cord blood of infant born to study participants were highly correlated. A 100% of infants born to seropositive mothers were also seropositive. The GMT ratios of peripartum maternal blood vs. those in cord blood were HPV 6: 1.23 [0.43, 3.49] and HPV 11: 1.29 [0.54, 3.07] in the 9vHPV vaccine group and HPV 6: 1.33 [0.41, 4.29] and HPV 11: 1.19 [0.45, 3.13] in the qHPV vaccine group, respectively. Conclusions: These results indicate that antibodies induced by the 9vHPV vaccine cross the placenta, which could potentially be beneficial against HPV6/11 infection and related disease such as recurrent respiratory papillomatosis. Mención de responsabilidad : Ana Maria Guevara, Eugenio Suarez, Alejandro Victoria, Hextan Ys Ngan, Angelica Lindén Hirschberg, Edison Fedrizzi, Oliver Bautista, Christine Shields, Amita Joshi, Alain Luxembourg Referencia : Hum Vaccin Immunother. 2019;15(1):141-145. DOI (Digital Object Identifier) : 10.1080/21645515.2018.1514227 PMID : 30261146 En línea : https://www.tandfonline.com/doi/abs/10.1080/21645515.2018.1514227?journalCode=kh [...] Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4174 Maternal transfer of anti HPV 6 and 11 antibodies upon immunization with the 9-valent HPV vaccine [documento electrónico] / Ana María Guevara Zambrano,  . - 2019. Obra : Human Vaccines & Immunotherapeutics Idioma : Inglés (eng) Palabras clave : Human papillomavirus  9vHPV vaccine  recurrent respiratory papillomatosis  clinical trial  geometric mean titers (GMTs) Resumen : Background: This exploratory analysis was conducted to characterize the level of HPV types 6/11 antibodies in peripartum maternal blood and in cord blood of infants born to women who received 9-valent HPV (9vHPV) vaccine or quadrivalent HPV (qHPV) vaccine in a pivotal efficacy study (V503-001, NCT 00543543). Methods: A total of 21 mother-infant pairs had evaluable HPV 6/11 results available for analysis. HPV6/11 antibodies were assessed using competitive Luminex immunoassay. The distribution of the ratios of infant to mother anti-HPV antibodies (i.e., infant-anti-HPV/mother- anti-HPV) was summarized. Results: All mothers and infants were seropositive to HPV 6 and HPV 11. Anti-HPV 6/11 geometric mean titers (GMTs) in peripartum maternal blood and in cord blood of infant born to study participants were highly correlated. A 100% of infants born to seropositive mothers were also seropositive. The GMT ratios of peripartum maternal blood vs. those in cord blood were HPV 6: 1.23 [0.43, 3.49] and HPV 11: 1.29 [0.54, 3.07] in the 9vHPV vaccine group and HPV 6: 1.33 [0.41, 4.29] and HPV 11: 1.19 [0.45, 3.13] in the qHPV vaccine group, respectively. Conclusions: These results indicate that antibodies induced by the 9vHPV vaccine cross the placenta, which could potentially be beneficial against HPV6/11 infection and related disease such as recurrent respiratory papillomatosis. Mención de responsabilidad : Ana Maria Guevara, Eugenio Suarez, Alejandro Victoria, Hextan Ys Ngan, Angelica Lindén Hirschberg, Edison Fedrizzi, Oliver Bautista, Christine Shields, Amita Joshi, Alain Luxembourg Referencia : Hum Vaccin Immunother. 2019;15(1):141-145. DOI (Digital Object Identifier) : 10.1080/21645515.2018.1514227 PMID : 30261146 En línea : https://www.tandfonline.com/doi/abs/10.1080/21645515.2018.1514227?journalCode=kh [...] Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4174

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Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine / Ana María Guevara Zambrano  

Público ISBD Título : Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine Tipo de documento : documento electrónico Autores : Ana María Guevara Zambrano, Fecha de publicación : 2017 Títulos uniformes : Vaccine Idioma : Inglés (eng) Palabras clave : 9vHPV vaccine  Clinical trial  Human papillomavirus  Immune memory  Immunogenicity Resumen : Background: The 9-valent HPV (9vHPV) vaccine was developed to prevent infection and disease related to 9 HPV types (HPV6/11/16/18/31/33/45/52/58) which cause approximately 90% of cervical cancers, HPV-related vulvar, vaginal and anal cancers, and genital warts worldwide. In a pivotal efficacy study, the 9vHPV vaccine prevented infection and disease due to the 9 vaccine types. Duration of protection remains to be determined. Vaccines that induce long-term protection are generally characterized by the generation of immune memory. The purpose of this report is to assess the persistence of HPV antibody response and existence of immune memory at 5 years post-vaccination. Methods:A subset of subjects (N = 150) who received 3 doses of 9vHPV vaccine at day 1, month 2 and month 6 in the pivotal efficacy study continued in a study extension and received a fourth dose of 9vHPV vaccine at month 60. Serum HPV antibody levels were measured pre-dose 4 and at 7 and 28 days post-dose 4 by competitive Luminex immunoassay. Adverse events were assessed using a vaccination report card. Results: HPV antibodies induced following the 3-dose series of 9vHPV vaccine in the base study persisted through month 60 with seropositivity rates ranging from 77.5% to 100%. Geometric mean titers at 1 week and 1 month post-dose 4 were 1.25–4.10 and 1.65–4.88-fold higher, respectively, than levels observed 1 month following the completion of the three-dose primary series. Seropositivity rates were >99% and 100% at 1 week and 1 month post-dose 4, respectively. The fourth dose of 9vHPV vaccine was generally well tolerated. Conclusions: A three-dose regimen of the 9vHPV vaccine induced persistent HPV antibody response through 5 years post-vaccination. Administration of a fourth dose resulted in a strong anamnestic response to all 9 vaccine types. These findings suggest that the efficacy of the 9vHPV vaccine will be long lasting Mención de responsabilidad : Ana Guevara, Robinson Cabello, Linn Woelber, Edson Duarte Moreira Jr, Elmar Joura, Olaf Reich, Christine Shields, Misoo C Ellison, Amita Joshi, Alain Luxembourg Referencia : Vaccine. 2017 Sep 5;35(37):5050-5057. DOI (Digital Object Identifier) : 10.1016/j.vaccine.2017.07.017 PMID : 28789851 En línea : https://linkinghub.elsevier.com/retrieve/pii/S0264410X17309131 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4034 Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine [documento electrónico] / Ana María Guevara Zambrano,  . - 2017. Obra : Vaccine Idioma : Inglés (eng) Palabras clave : 9vHPV vaccine  Clinical trial  Human papillomavirus  Immune memory  Immunogenicity Resumen : Background: The 9-valent HPV (9vHPV) vaccine was developed to prevent infection and disease related to 9 HPV types (HPV6/11/16/18/31/33/45/52/58) which cause approximately 90% of cervical cancers, HPV-related vulvar, vaginal and anal cancers, and genital warts worldwide. In a pivotal efficacy study, the 9vHPV vaccine prevented infection and disease due to the 9 vaccine types. Duration of protection remains to be determined. Vaccines that induce long-term protection are generally characterized by the generation of immune memory. The purpose of this report is to assess the persistence of HPV antibody response and existence of immune memory at 5 years post-vaccination. Methods:A subset of subjects (N = 150) who received 3 doses of 9vHPV vaccine at day 1, month 2 and month 6 in the pivotal efficacy study continued in a study extension and received a fourth dose of 9vHPV vaccine at month 60. Serum HPV antibody levels were measured pre-dose 4 and at 7 and 28 days post-dose 4 by competitive Luminex immunoassay. Adverse events were assessed using a vaccination report card. Results: HPV antibodies induced following the 3-dose series of 9vHPV vaccine in the base study persisted through month 60 with seropositivity rates ranging from 77.5% to 100%. Geometric mean titers at 1 week and 1 month post-dose 4 were 1.25–4.10 and 1.65–4.88-fold higher, respectively, than levels observed 1 month following the completion of the three-dose primary series. Seropositivity rates were >99% and 100% at 1 week and 1 month post-dose 4, respectively. The fourth dose of 9vHPV vaccine was generally well tolerated. Conclusions: A three-dose regimen of the 9vHPV vaccine induced persistent HPV antibody response through 5 years post-vaccination. Administration of a fourth dose resulted in a strong anamnestic response to all 9 vaccine types. These findings suggest that the efficacy of the 9vHPV vaccine will be long lasting Mención de responsabilidad : Ana Guevara, Robinson Cabello, Linn Woelber, Edson Duarte Moreira Jr, Elmar Joura, Olaf Reich, Christine Shields, Misoo C Ellison, Amita Joshi, Alain Luxembourg Referencia : Vaccine. 2017 Sep 5;35(37):5050-5057. DOI (Digital Object Identifier) : 10.1016/j.vaccine.2017.07.017 PMID : 28789851 En línea : https://linkinghub.elsevier.com/retrieve/pii/S0264410X17309131 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4034

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A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia / Kenny Mauricio Gálvez Cárdenas  

Público ISBD Título : A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia Tipo de documento : documento electrónico Autores : Kenny Mauricio Gálvez Cárdenas, Fecha de publicación : 2017 Títulos uniformes : Revista Brasileira de Hematologia e Hemoterapia Idioma : Inglés (eng) Palabras clave : Sickle cell disease  SANGUINATE  Safety  Clinical trial Resumen : Background: Treatment of sickle cell anemia is a challenging task and despite the well understood genetic and biochemical pathway of sickle hemoglobin, current therapy continues to be limited to the symptomatic treatment of pain, supplemental oxygen, antibiotics, red blood cell transfusions and hydroxyurea. SANGUINATE is a carbon monoxide releasing molecule and oxygen transfer agent under clinical development for the treatment of sickl cell anemia and comorbidities. Methods: An open-label randomized Phase Ib study was performed in adult sickle cell anemia patients. Two dose levels of SANGUINATE were compared to hydroxyurea in 24 homozygotes for Hb SS. Twelve subjects received either a low dose (160mg/kg) of SANGUINATE or 15 mg/kg hydroxyurea. Another 12 subjects received either a high dose (320mg/kg) of SANGUINATE or 15mg/kg hydroxyurea. The primary endpoint was the safety of SANGUINATE versus hydroxyurea in sickle cell anemia patients. Secondary endpoints included determination of the plasma pharmacokinetics and assessment of hematologic measurements. Results: Musculoskeletal related adverse events were the most common. Transient tro-ponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity; however, no clinical signs were noted. Following an assessment of vital signs, tricuspid regurgitant velocity, electrocardiogram, serum biochemistry, hematology, urinalysis, and analysis of reported adverse events, SANGUINATE was found to be safe in stable sickle cell anemia patients. Conclusions: The clinical trial met its primary objective of demonstrating an acceptable safety profile for SANGUINATE in patients with sickle cell anemia. This trial established the safety of SANGUINATE at both dose levels and permitted its advance to Phase II trials. Mención de responsabilidad : Hemant Misra, James Bainbridge, John Berryman, Abraham Abuchowski, Kenneth Mauricio Galvez, Luis Fernando Uribe, Angel Luis Hernandez, Nestor Rodolfo Sosa Referencia : Rev Bras Hematol Hemoter. 2017 Jan - Mar;39(1):20-27. DOI (Digital Object Identifier) : 10.1016/j.bjhh.2016.08.004 PMID : 28270341 En línea : https://linkinghub.elsevier.com/retrieve/pii/S1516848416300986 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4019 A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia [documento electrónico] / Kenny Mauricio Gálvez Cárdenas,  . - 2017. Obra : Revista Brasileira de Hematologia e Hemoterapia Idioma : Inglés (eng) Palabras clave : Sickle cell disease  SANGUINATE  Safety  Clinical trial Resumen : Background: Treatment of sickle cell anemia is a challenging task and despite the well understood genetic and biochemical pathway of sickle hemoglobin, current therapy continues to be limited to the symptomatic treatment of pain, supplemental oxygen, antibiotics, red blood cell transfusions and hydroxyurea. SANGUINATE is a carbon monoxide releasing molecule and oxygen transfer agent under clinical development for the treatment of sickl cell anemia and comorbidities. Methods: An open-label randomized Phase Ib study was performed in adult sickle cell anemia patients. Two dose levels of SANGUINATE were compared to hydroxyurea in 24 homozygotes for Hb SS. Twelve subjects received either a low dose (160mg/kg) of SANGUINATE or 15 mg/kg hydroxyurea. Another 12 subjects received either a high dose (320mg/kg) of SANGUINATE or 15mg/kg hydroxyurea. The primary endpoint was the safety of SANGUINATE versus hydroxyurea in sickle cell anemia patients. Secondary endpoints included determination of the plasma pharmacokinetics and assessment of hematologic measurements. Results: Musculoskeletal related adverse events were the most common. Transient tro-ponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity; however, no clinical signs were noted. Following an assessment of vital signs, tricuspid regurgitant velocity, electrocardiogram, serum biochemistry, hematology, urinalysis, and analysis of reported adverse events, SANGUINATE was found to be safe in stable sickle cell anemia patients. Conclusions: The clinical trial met its primary objective of demonstrating an acceptable safety profile for SANGUINATE in patients with sickle cell anemia. This trial established the safety of SANGUINATE at both dose levels and permitted its advance to Phase II trials. Mención de responsabilidad : Hemant Misra, James Bainbridge, John Berryman, Abraham Abuchowski, Kenneth Mauricio Galvez, Luis Fernando Uribe, Angel Luis Hernandez, Nestor Rodolfo Sosa Referencia : Rev Bras Hematol Hemoter. 2017 Jan - Mar;39(1):20-27. DOI (Digital Object Identifier) : 10.1016/j.bjhh.2016.08.004 PMID : 28270341 En línea : https://linkinghub.elsevier.com/retrieve/pii/S1516848416300986 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4019

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