The Experts below are selected from a list of 12330 Experts worldwide ranked by ideXlab platform
Daniel A. Scott - One of the best experts on this subject based on the ideXlab platform.
-
immunogenicity and safety of the 13 valent pneumococcal conjugate Vaccine compared to the 23 valent pneumococcal Polysaccharide Vaccine in elderly japanese adults
Human Vaccines & Immunotherapeutics, 2015Co-Authors: Masanari Shiramoto, William C. Gruber, Daniel A. Scott, Ryuzo Hanada, Christine Juergens, Yasuko Shoji, Mizuki Yoshida, Barry Ballan, David A Cooper, Beate SchmoelethomaAbstract:Streptococcus pneumoniae is a major cause of severe disease worldwide, particularly in the elderly population. Due to increasing life expectancy in Japan and elsewhere, an effective Vaccine which offers the possibility of prolonged protection is required. Protein conjugated pneumococcal Vaccines, which have the ability to boost immunity (immunologic memory) on natural exposure or revaccination, may meet these requirements. An unconjugated 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) has been available for decades; however data on protection against pneumonia are inconsistent. For the first time, a randomized, modified double-blind trial comparing the 13-valent pneumococcal conjugate Vaccine (PCV13) with PPSV23 was conducted in PPSV23-naive adults ≥65 years of age in Japan. This study showed that statistically significantly greater functional antibody responses as measured by opsonophagocytic assays 1 month after vaccination were elicited in the PCV13 group (n = 366) compared with the PPSV23 grou...
-
immunogenicity and safety of 13 valent pneumococcal conjugate Vaccine in hiv infected adults previously vaccinated with pneumococcal Polysaccharide Vaccine
The Journal of Infectious Diseases, 2015Co-Authors: Marshall J Glesby, Richard N. Greenberg, Alejandra Gurtman, Vani Sundaraiyer, Wendy Watson, Cynthia Brinson, Jacob Lalezari, Daniel J Skiest, Robert J Natuk, Daniel A. ScottAbstract:Background Persons with human immunodeficiency virus (HIV) infection are at increased risk of pneumococcal disease. We evaluated the safety and immunogenicity of 13-valent pneumococcal conjugate Vaccine (PCV13) in this population. Methods HIV-infected persons ≥ 18 years of age who were previously vaccinated with ≥ 1 dose of 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) and had CD4 cell counts ≥ 200 cells/mm(3) and HIV viral loads Results A total of 329 subjects received ≥ 1 dose, and 279 received 3 doses administered at 6-month intervals. Increases in anticapsular Polysaccharide immunoglobulin G concentrations and opsonophagocytic antibody titers were demonstrated 1 month after each of the 3 doses of PCV13. Antibody levels were generally similar after each dose. The responses were similar whether subjects had previously received 1 or ≥ 2 doses of PPSV23. Pain at the injection-site was the most common local reaction. Severe injection site or systemic events were uncommon. Conclusions Vaccination with PCV13 induces anticapsular immunoglobulin G and opsonophagocytic antibody responses in HIV-infected adults with prior PPSV23 vaccination and CD4 cell counts ≥ 200 cells/mm(3). The observations support the use of PCV13 in this population. Clinical trials registration NCT00963235.
-
immunogenicity safety and tolerability of 13 valent pneumococcal conjugate Vaccine followed by 23 valent pneumococcal Polysaccharide Vaccine in recipients of allogeneic hematopoietic stem cell transplant aged 2 years an open label study
Clinical Infectious Diseases, 2015Co-Authors: Catherine Cordonnier, Vani Sundaraiyer, William C. Gruber, Christine Juergens, Per Ljungman, Johan Maertens, Dominik Selleslag, Peter C Giardina, Keri Clarke, Daniel A. ScottAbstract:Background. Life-threatening Streptococcus pneumoniae infections often occur after hematopoietic stem cell transplant (HSCT); vaccination is important for prevention. Methods. In an open-label study, patients (n = 251) 3–6 months after allogeneic HSCT received 3 doses of 13-valent pneumococcal conjugate Vaccine (PCV13) at 1-month intervals, a fourth dose 6 months later, and 1 dose of 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) 1 month later. Immunogenicity at prespecified time points and Vaccine safety were assessed. Results. In the evaluable immunogenicity population (N = 216; mean age, 37.8 years), geometric mean fold rises (GMFRs) of immunoglobulin G geometric mean concentrations from baseline to postdose 3 showed significant increases in antibody levels across all PCV13 serotypes (GMFR range, 2.99–23.85; 95% confidence interval lower limit, >1); there were significant declines over the next 6 months, significant increases from predose 4 to postdose 4 (GMFR range, 3.00–6.97), and little change after PPSV23 (GMFR range, 0.86–1.12). Local and systemic reactions were more frequent after dose 4. Six patients experienced serious adverse events possibly related to PCV13 (facial diplegia, injection-site erythema and pyrexia, autoimmune hemolytic anemia, and suspected lack of Vaccine efficacy after dose 3 leading to pneumococcal infection), PCV13 and PPSV23 (Guillain-Barre syndrome), or PPSV23 (cellulitis). There were 14 deaths, none related to study Vaccines. Conclusions. A 3-dose PCV13 regimen followed by a booster dose may be required to protect against pneumococcal disease in HSCT recipients. Dose 4 was associated with increased local and systemic reactions, but the overall safety profile of a 4-dose regimen was considered acceptable. Clinical Trials Registration. {"type":"clinical-trial","attrs":{"text":"NCT00980655","term_id":"NCT00980655"}}NCT00980655.
-
safety and immunogenicity of 13 valent pneumococcal conjugate Vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23 valent pneumococcal Polysaccharide Vaccine in elderly adults a randomized open
Human Vaccines & Immunotherapeutics, 2014Co-Authors: Christine Juergens, William C. Gruber, Daniel A. Scott, Emilio A Emini, Pierre De Villiers, Keymanthri Moodley, Deepthi Jayawardene, Kathrin U Jansen, Beate SchmoelethomaAbstract:This randomized open-label trial was designed to provide preliminary immunogenicity and safety data to support development of the pediatric 13-valent pneumococcal conjugate Vaccine (PCV13) for adults. The aims were to: identify an age-appropriate PCV13 formulation, i.e., with (n = 309) or without (n = 304) aluminum phosphate (AlPO4); compare the selected PCV13 formulation (n = 309) with 23-valent pneumococcal Polysaccharide Vaccine (PPSV23; n = 301); and, together with an extension study, assess sequential use of pneumococcal Vaccines at 1-year intervals in adults aged ≥65 years (n = 105) not pre-vaccinated with PPSV23. Immune responses were measured by ELISA and opsonophagocytic activity assays 1 month postvaccination. Immunoglobulin G responses elicited by PCV13 with AlPO4 and PCV13 without AlPO4 were similar for the majority, and noninferior for all PCV13 serotypes. PCV13 with AlPO4 was generally more reactogenic, with reactions mainly mild or moderate. Thus, PCV13 with AlPO4 (hereafter PCV13) became t...
-
immunogenicity and safety of a 13 valent pneumococcal conjugate Vaccine in adults 70 years of age and older previously vaccinated with 23 valent pneumococcal Polysaccharide Vaccine
Vaccine, 2013Co-Authors: Lisa A. Jackson, Richard N. Greenberg, Alejandra Gurtman, William C. Gruber, Daniel A. Scott, Kathryn L Rice, Karlis Pauksens, Thomas R Jones, Emilio A Emini, Beate SchmoelethomaAbstract:a b s t r a c t Background: The currently recommended single dose of the 23-valent pneumococcal free Polysaccharide Vaccine (PPSV23) for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the 13-valent Polysaccharide conjugate Vaccine (PCV13). Methods: We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before study entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Anti- pneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination.
Beate Schmoelethoma - One of the best experts on this subject based on the ideXlab platform.
-
immunogenicity and safety of the 13 valent pneumococcal conjugate Vaccine compared to the 23 valent pneumococcal Polysaccharide Vaccine in elderly japanese adults
Human Vaccines & Immunotherapeutics, 2015Co-Authors: Masanari Shiramoto, William C. Gruber, Daniel A. Scott, Ryuzo Hanada, Christine Juergens, Yasuko Shoji, Mizuki Yoshida, Barry Ballan, David A Cooper, Beate SchmoelethomaAbstract:Streptococcus pneumoniae is a major cause of severe disease worldwide, particularly in the elderly population. Due to increasing life expectancy in Japan and elsewhere, an effective Vaccine which offers the possibility of prolonged protection is required. Protein conjugated pneumococcal Vaccines, which have the ability to boost immunity (immunologic memory) on natural exposure or revaccination, may meet these requirements. An unconjugated 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) has been available for decades; however data on protection against pneumonia are inconsistent. For the first time, a randomized, modified double-blind trial comparing the 13-valent pneumococcal conjugate Vaccine (PCV13) with PPSV23 was conducted in PPSV23-naive adults ≥65 years of age in Japan. This study showed that statistically significantly greater functional antibody responses as measured by opsonophagocytic assays 1 month after vaccination were elicited in the PCV13 group (n = 366) compared with the PPSV23 grou...
-
safety and immunogenicity of 13 valent pneumococcal conjugate Vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23 valent pneumococcal Polysaccharide Vaccine in elderly adults a randomized open
Human Vaccines & Immunotherapeutics, 2014Co-Authors: Christine Juergens, William C. Gruber, Daniel A. Scott, Emilio A Emini, Pierre De Villiers, Keymanthri Moodley, Deepthi Jayawardene, Kathrin U Jansen, Beate SchmoelethomaAbstract:This randomized open-label trial was designed to provide preliminary immunogenicity and safety data to support development of the pediatric 13-valent pneumococcal conjugate Vaccine (PCV13) for adults. The aims were to: identify an age-appropriate PCV13 formulation, i.e., with (n = 309) or without (n = 304) aluminum phosphate (AlPO4); compare the selected PCV13 formulation (n = 309) with 23-valent pneumococcal Polysaccharide Vaccine (PPSV23; n = 301); and, together with an extension study, assess sequential use of pneumococcal Vaccines at 1-year intervals in adults aged ≥65 years (n = 105) not pre-vaccinated with PPSV23. Immune responses were measured by ELISA and opsonophagocytic activity assays 1 month postvaccination. Immunoglobulin G responses elicited by PCV13 with AlPO4 and PCV13 without AlPO4 were similar for the majority, and noninferior for all PCV13 serotypes. PCV13 with AlPO4 was generally more reactogenic, with reactions mainly mild or moderate. Thus, PCV13 with AlPO4 (hereafter PCV13) became t...
-
immunogenicity and safety of a 13 valent pneumococcal conjugate Vaccine in adults 70 years of age and older previously vaccinated with 23 valent pneumococcal Polysaccharide Vaccine
Vaccine, 2013Co-Authors: Lisa A. Jackson, Richard N. Greenberg, Alejandra Gurtman, William C. Gruber, Daniel A. Scott, Kathryn L Rice, Karlis Pauksens, Thomas R Jones, Emilio A Emini, Beate SchmoelethomaAbstract:a b s t r a c t Background: The currently recommended single dose of the 23-valent pneumococcal free Polysaccharide Vaccine (PPSV23) for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the 13-valent Polysaccharide conjugate Vaccine (PCV13). Methods: We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before study entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Anti- pneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination.
-
immunogenicity and safety of a 13 valent pneumococcal conjugate Vaccine compared to a 23 valent pneumococcal Polysaccharide Vaccine in pneumococcal Vaccine naive adults
Vaccine, 2013Co-Authors: Lisa A. Jackson, Alejandra Gurtman, William C. Gruber, Daniel A. Scott, Emilio A Emini, Deepthi Jayawardene, Kathrin U Jansen, Martin Van Cleeff, Carmel Devlin, Beate SchmoelethomaAbstract:Background Streptococcus pneumoniae is a major cause of morbidity and mortality among adults 50 years of age and older in the United States. Pneumococcal conjugate Vaccines are efficacious against pneumococcal disease in children and may also offer advantages in adults. Methods We performed a randomized, modified double-blind trial that compared a single dose of 13-valent pneumococcal conjugate Vaccine (PCV13) with 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) in 831 pneumococcal Vaccine naive adults 60-64 years of age. An additional group of 403 adults 50-59 years of age received open-label PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured at baseline, and at 1 month and 1 year after vaccination. Results In the randomized trial, the month 1 post-vaccination OPA geometric mean titers in the PCV13 group were statistically significantly higher than in the PPSV23 group for 8 of the 12 serotypes common to both Vaccines and for serotype 6A, a serotype unique to PCV13, and were comparable for the other 4 common serotypes. The immune response to PCV13 was generally greater in adults 50-59 years of age compared to adults 60-64 years of age. OPA titers declined from 1 month to 1 year after PCV13 administration but remained higher than pre-vaccination baseline titers. Conclusions PCV13 induces a greater functional immune response than PPSV23 for the majority of serotypes covered by PCV13, suggesting that PCV13 could offer immunological advantages over PPSV23 for prevention of Vaccine-type pneumococcal infection.
-
influence of initial vaccination with 13 valent pneumococcal conjugate Vaccine or 23 valent pneumococcal Polysaccharide Vaccine on anti pneumococcal responses following subsequent pneumococcal vaccination in adults 50 years and older
Vaccine, 2013Co-Authors: Lisa A. Jackson, Alejandra Gurtman, William C. Gruber, Daniel A. Scott, Emilio A Emini, Kathrin U Jansen, Martin Van Cleeff, Robert W Frenck, John J Treanor, Beate SchmoelethomaAbstract:Abstract Background Unlike free Polysaccharide Vaccines, pneumococcal Polysaccharide conjugate Vaccines (PCVs) induce a T cell-dependent immune response and have the potential to provide an extended duration of protection with repeated vaccinations. Methods This was an extension of a previous study in pneumococcal Vaccine-naive adults aged 50–64 years in which adults 60–64 years of age were given 13-valent PCV (PCV13) or 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) and adults aged 50–59 were given PCV13. In this follow up study conducted about 4 years later, the 60–64 year olds initially given PCV13 received PCV13 or PPSV23, and those initially given PPSV23 received another PPSV23. All adults aged 50–59 years were re-vaccinated with PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after vaccination. Results A second PCV13 given about 4 years after a first vaccination induced OPA titers that were significantly higher than those following the initial vaccination for 7 of 13 serotypes in the older group, and 6 of 13 serotypes in the younger group, and responses to the remaining serotypes were largely non-inferior. In contrast, OPA titers following revaccination with PPSV23 were statistically significantly lower for 9 of the 13 serotypes, and non-inferior for the remaining serotypes, when compared to the responses to the first PPSV23. OPA titers in the older adults who received PPSV23 after initial PCV13 were significantly higher than those following a first PPSV23 for 10 of the 13 serotypes. Conclusion In adults 50 to 64 years of age, initial vaccination with PCV13 establishes an immune state that results in recall anti-pneumococcal responses upon subsequent vaccination with either conjugated or free Polysaccharide Vaccine. In contrast, initial vaccination with PPSV23 results in an immune state in which subsequent PPSV23 administration yields generally lower responses compared with the initial responses.
William C. Gruber - One of the best experts on this subject based on the ideXlab platform.
-
immunogenicity and safety of a 13 valent pneumococcal conjugate Vaccine in adults 18 49 years of age naive to 23 valent pneumococcal Polysaccharide Vaccine
Vaccine, 2015Co-Authors: Kristina A Bryant, Alejandra Gurtman, Vani Sundaraiyer, Thomas R Jones, Robert W Frenck, John J Treanor, John Rubino, Allison Thompson, L M Baxter, William C. GruberAbstract:Abstract Background Based on the success of vaccination with pneumococcal conjugate Vaccines (PCVs) in children, recent studies have focused on PCVs in adults. Data from a randomized, double-blind study comparing the immunogenicity, tolerability, and safety of the 13-valent PCV (PCV13) and the 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) in PPSV23-naive adults 60–64 years of age have been published. The same study also included a cohort of adults aged 18–49 years that received open-label PCV13. The purpose of this cohort was to examine the immunogenicity, safety, and tolerability of PCV13 in adult subjects 18–49 years of age compared with adults 60–64 years of age for whom PCV13 is approved. Methods Adults naive to PPSV23 were grouped by age into 2 cohorts: 18–49 years (n = 899; further stratified by age into 3 subgroups 18–29, 30–39, and 40–49 years) and 60–64 years (n = 417). All subjects received 1 dose of PCV13. In both age groups, immunogenicity was assessed by antipneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs) 1 month after vaccination. Safety and tolerability were evaluated. Results In adults aged 18–49 years, OPA GMTs and IgG GMCs were noninferior for all 13 serotypes and statistically significantly higher for all except 1 serotype (OPA GMT) and 5 serotypes (IgG GMCs) compared with adults 60–64 years. Immune responses were highest in the youngest age subgroup (18–29 years). Local reactions and systemic events were more common in adults 18–49 years compared with 60–64 years and were self-limited. Conclusion Immune responses to PCV13 are robust in adults ≥18 years of age, with highest responses observed in the youngest subgroup. Based on its safety and immunologic profile, PCV13 may serve an important therapeutic role in younger adults, particularly those with underlying medical conditions who have an increased risk of serious pneumococcal infections.
-
immunogenicity and safety of the 13 valent pneumococcal conjugate Vaccine compared to the 23 valent pneumococcal Polysaccharide Vaccine in elderly japanese adults
Human Vaccines & Immunotherapeutics, 2015Co-Authors: Masanari Shiramoto, William C. Gruber, Daniel A. Scott, Ryuzo Hanada, Christine Juergens, Yasuko Shoji, Mizuki Yoshida, Barry Ballan, David A Cooper, Beate SchmoelethomaAbstract:Streptococcus pneumoniae is a major cause of severe disease worldwide, particularly in the elderly population. Due to increasing life expectancy in Japan and elsewhere, an effective Vaccine which offers the possibility of prolonged protection is required. Protein conjugated pneumococcal Vaccines, which have the ability to boost immunity (immunologic memory) on natural exposure or revaccination, may meet these requirements. An unconjugated 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) has been available for decades; however data on protection against pneumonia are inconsistent. For the first time, a randomized, modified double-blind trial comparing the 13-valent pneumococcal conjugate Vaccine (PCV13) with PPSV23 was conducted in PPSV23-naive adults ≥65 years of age in Japan. This study showed that statistically significantly greater functional antibody responses as measured by opsonophagocytic assays 1 month after vaccination were elicited in the PCV13 group (n = 366) compared with the PPSV23 grou...
-
immunogenicity safety and tolerability of 13 valent pneumococcal conjugate Vaccine followed by 23 valent pneumococcal Polysaccharide Vaccine in recipients of allogeneic hematopoietic stem cell transplant aged 2 years an open label study
Clinical Infectious Diseases, 2015Co-Authors: Catherine Cordonnier, Vani Sundaraiyer, William C. Gruber, Christine Juergens, Per Ljungman, Johan Maertens, Dominik Selleslag, Peter C Giardina, Keri Clarke, Daniel A. ScottAbstract:Background. Life-threatening Streptococcus pneumoniae infections often occur after hematopoietic stem cell transplant (HSCT); vaccination is important for prevention. Methods. In an open-label study, patients (n = 251) 3–6 months after allogeneic HSCT received 3 doses of 13-valent pneumococcal conjugate Vaccine (PCV13) at 1-month intervals, a fourth dose 6 months later, and 1 dose of 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) 1 month later. Immunogenicity at prespecified time points and Vaccine safety were assessed. Results. In the evaluable immunogenicity population (N = 216; mean age, 37.8 years), geometric mean fold rises (GMFRs) of immunoglobulin G geometric mean concentrations from baseline to postdose 3 showed significant increases in antibody levels across all PCV13 serotypes (GMFR range, 2.99–23.85; 95% confidence interval lower limit, >1); there were significant declines over the next 6 months, significant increases from predose 4 to postdose 4 (GMFR range, 3.00–6.97), and little change after PPSV23 (GMFR range, 0.86–1.12). Local and systemic reactions were more frequent after dose 4. Six patients experienced serious adverse events possibly related to PCV13 (facial diplegia, injection-site erythema and pyrexia, autoimmune hemolytic anemia, and suspected lack of Vaccine efficacy after dose 3 leading to pneumococcal infection), PCV13 and PPSV23 (Guillain-Barre syndrome), or PPSV23 (cellulitis). There were 14 deaths, none related to study Vaccines. Conclusions. A 3-dose PCV13 regimen followed by a booster dose may be required to protect against pneumococcal disease in HSCT recipients. Dose 4 was associated with increased local and systemic reactions, but the overall safety profile of a 4-dose regimen was considered acceptable. Clinical Trials Registration. {"type":"clinical-trial","attrs":{"text":"NCT00980655","term_id":"NCT00980655"}}NCT00980655.
-
safety and immunogenicity of 13 valent pneumococcal conjugate Vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23 valent pneumococcal Polysaccharide Vaccine in elderly adults a randomized open
Human Vaccines & Immunotherapeutics, 2014Co-Authors: Christine Juergens, William C. Gruber, Daniel A. Scott, Emilio A Emini, Pierre De Villiers, Keymanthri Moodley, Deepthi Jayawardene, Kathrin U Jansen, Beate SchmoelethomaAbstract:This randomized open-label trial was designed to provide preliminary immunogenicity and safety data to support development of the pediatric 13-valent pneumococcal conjugate Vaccine (PCV13) for adults. The aims were to: identify an age-appropriate PCV13 formulation, i.e., with (n = 309) or without (n = 304) aluminum phosphate (AlPO4); compare the selected PCV13 formulation (n = 309) with 23-valent pneumococcal Polysaccharide Vaccine (PPSV23; n = 301); and, together with an extension study, assess sequential use of pneumococcal Vaccines at 1-year intervals in adults aged ≥65 years (n = 105) not pre-vaccinated with PPSV23. Immune responses were measured by ELISA and opsonophagocytic activity assays 1 month postvaccination. Immunoglobulin G responses elicited by PCV13 with AlPO4 and PCV13 without AlPO4 were similar for the majority, and noninferior for all PCV13 serotypes. PCV13 with AlPO4 was generally more reactogenic, with reactions mainly mild or moderate. Thus, PCV13 with AlPO4 (hereafter PCV13) became t...
-
immunogenicity and safety of a 13 valent pneumococcal conjugate Vaccine in adults 70 years of age and older previously vaccinated with 23 valent pneumococcal Polysaccharide Vaccine
Vaccine, 2013Co-Authors: Lisa A. Jackson, Richard N. Greenberg, Alejandra Gurtman, William C. Gruber, Daniel A. Scott, Kathryn L Rice, Karlis Pauksens, Thomas R Jones, Emilio A Emini, Beate SchmoelethomaAbstract:a b s t r a c t Background: The currently recommended single dose of the 23-valent pneumococcal free Polysaccharide Vaccine (PPSV23) for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the 13-valent Polysaccharide conjugate Vaccine (PCV13). Methods: We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before study entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Anti- pneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination.
Lisa A. Jackson - One of the best experts on this subject based on the ideXlab platform.
-
randomized clinical trial of a single versus a double dose of 13 valent pneumococcal conjugate Vaccine in adults 55 through 74 years of age previously vaccinated with 23 valent pneumococcal Polysaccharide Vaccine
Vaccine, 2018Co-Authors: Lisa A. Jackson, Hana El M Sahly, Sarah L George, Patricia L Winokur, Kathryn M Edwards, Rebecca C Brady, Nadine Rouphael, Wendy A Keitel, Mark J Mulligan, Robert L BurtonAbstract:Abstract Introduction In older adults, prior administration of 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) blunts the opsonophagocytic antibody (OPA) response to subsequent administration of 13-valent pneumococcal conjugate Vaccine (PCV13). To determine whether a higher dose of PCV13 could mitigate this effect in adults 55 through 74 years of age, we compared OPA responses to a double dose of PCV13 in persons previously vaccinated with PPSV23 with responses to a single dose of PCV13 in previously vaccinated persons, and with a single dose in PPSV23 naive persons. Methods Subjects previously vaccinated with PPSV23 were randomly assigned to receive either a single injection or two concurrent injections of 0.5 mL PCV13. Naive subjects received a single injection of 0.5 mL PCV13. Serotype-specific OPA responses to 12 of the PCV13 serotypes were assessed on samples collected on Day 29 and Day 181. Comparisons of the OPA titers between study groups were based on the lower bound of the 95% confidence interval of the log geometric mean ratio to define superiority (>1) and non-inferiority (>0.5). Results At Day 29, the OPA responses to one dose in previously vaccinated (n = 284) versus one dose in naive subjects (n = 311) achieved the threshold for non-inferiority for only 3 of the 12 serotypes. In previously vaccinated subjects, responses to a double dose (n = 288) versus a single dose met the threshold for superiority for 7 serotypes. The responses to a double dose in previously vaccinated subjects versus a single dose in naive subjects met the threshold for non-inferiority for 9 serotypes. Conclusions There is a dose response to PCV13 in older adults and the higher response to a double dose in previously vaccinated adults is non-inferior to that of a single dose in naive adults for 9 of the 12 PCV13 serotypes evaluated.
-
immunogenicity and safety of a 13 valent pneumococcal conjugate Vaccine in adults 70 years of age and older previously vaccinated with 23 valent pneumococcal Polysaccharide Vaccine
Vaccine, 2013Co-Authors: Lisa A. Jackson, Richard N. Greenberg, Alejandra Gurtman, William C. Gruber, Daniel A. Scott, Kathryn L Rice, Karlis Pauksens, Thomas R Jones, Emilio A Emini, Beate SchmoelethomaAbstract:a b s t r a c t Background: The currently recommended single dose of the 23-valent pneumococcal free Polysaccharide Vaccine (PPSV23) for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the 13-valent Polysaccharide conjugate Vaccine (PCV13). Methods: We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before study entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Anti- pneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination.
-
immunogenicity and safety of a 13 valent pneumococcal conjugate Vaccine compared to a 23 valent pneumococcal Polysaccharide Vaccine in pneumococcal Vaccine naive adults
Vaccine, 2013Co-Authors: Lisa A. Jackson, Alejandra Gurtman, William C. Gruber, Daniel A. Scott, Emilio A Emini, Deepthi Jayawardene, Kathrin U Jansen, Martin Van Cleeff, Carmel Devlin, Beate SchmoelethomaAbstract:Background Streptococcus pneumoniae is a major cause of morbidity and mortality among adults 50 years of age and older in the United States. Pneumococcal conjugate Vaccines are efficacious against pneumococcal disease in children and may also offer advantages in adults. Methods We performed a randomized, modified double-blind trial that compared a single dose of 13-valent pneumococcal conjugate Vaccine (PCV13) with 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) in 831 pneumococcal Vaccine naive adults 60-64 years of age. An additional group of 403 adults 50-59 years of age received open-label PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured at baseline, and at 1 month and 1 year after vaccination. Results In the randomized trial, the month 1 post-vaccination OPA geometric mean titers in the PCV13 group were statistically significantly higher than in the PPSV23 group for 8 of the 12 serotypes common to both Vaccines and for serotype 6A, a serotype unique to PCV13, and were comparable for the other 4 common serotypes. The immune response to PCV13 was generally greater in adults 50-59 years of age compared to adults 60-64 years of age. OPA titers declined from 1 month to 1 year after PCV13 administration but remained higher than pre-vaccination baseline titers. Conclusions PCV13 induces a greater functional immune response than PPSV23 for the majority of serotypes covered by PCV13, suggesting that PCV13 could offer immunological advantages over PPSV23 for prevention of Vaccine-type pneumococcal infection.
-
influence of initial vaccination with 13 valent pneumococcal conjugate Vaccine or 23 valent pneumococcal Polysaccharide Vaccine on anti pneumococcal responses following subsequent pneumococcal vaccination in adults 50 years and older
Vaccine, 2013Co-Authors: Lisa A. Jackson, Alejandra Gurtman, William C. Gruber, Daniel A. Scott, Emilio A Emini, Kathrin U Jansen, Martin Van Cleeff, Robert W Frenck, John J Treanor, Beate SchmoelethomaAbstract:Abstract Background Unlike free Polysaccharide Vaccines, pneumococcal Polysaccharide conjugate Vaccines (PCVs) induce a T cell-dependent immune response and have the potential to provide an extended duration of protection with repeated vaccinations. Methods This was an extension of a previous study in pneumococcal Vaccine-naive adults aged 50–64 years in which adults 60–64 years of age were given 13-valent PCV (PCV13) or 23-valent pneumococcal Polysaccharide Vaccine (PPSV23) and adults aged 50–59 were given PCV13. In this follow up study conducted about 4 years later, the 60–64 year olds initially given PCV13 received PCV13 or PPSV23, and those initially given PPSV23 received another PPSV23. All adults aged 50–59 years were re-vaccinated with PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after vaccination. Results A second PCV13 given about 4 years after a first vaccination induced OPA titers that were significantly higher than those following the initial vaccination for 7 of 13 serotypes in the older group, and 6 of 13 serotypes in the younger group, and responses to the remaining serotypes were largely non-inferior. In contrast, OPA titers following revaccination with PPSV23 were statistically significantly lower for 9 of the 13 serotypes, and non-inferior for the remaining serotypes, when compared to the responses to the first PPSV23. OPA titers in the older adults who received PPSV23 after initial PCV13 were significantly higher than those following a first PPSV23 for 10 of the 13 serotypes. Conclusion In adults 50 to 64 years of age, initial vaccination with PCV13 establishes an immune state that results in recall anti-pneumococcal responses upon subsequent vaccination with either conjugated or free Polysaccharide Vaccine. In contrast, initial vaccination with PPSV23 results in an immune state in which subsequent PPSV23 administration yields generally lower responses compared with the initial responses.
-
Effectiveness of pneumococcal Polysaccharide Vaccine in older adults.
The New England journal of medicine, 2003Co-Authors: Lisa A. Jackson, Patti Benson, Kathleen M. Neuzil, William E. Barlow, Annette L. Adams, Christi A. Hanson, Lisa D. Mahoney, David K. Shay, William W. ThompsonAbstract:BackgroundStreptococcus pneumoniae is the chief cause of pneumonia in older adults, but it remains unclear whether use of the pneumococcal Polysaccharide Vaccine alters the overall risk of community-acquired pneumonia. In a large population of older adults, we assessed the effectiveness of the pneumococcal Vaccine. MethodsIn this retrospective cohort study, 47,365 Group Health Cooperative members 65 years of age or older were assessed over a three-year period. The primary outcomes were hospitalization because of community-acquired pneumonia (validated by chart review), pneumonia in patients who were not hospitalized (“outpatient pneumonia,” determined from administrative data sources), and pneumococcal bacteremia. The association between pneumococcal vaccination and the risk of each outcome was evaluated by means of multivariate Cox proportional-hazards models, with adjustment for age, sex, nursing-home residence or nonresidence, smoking status, medical conditions, and receipt or nonreceipt of influenza v...
Maria C Rodriguezbarradas - One of the best experts on this subject based on the ideXlab platform.
-
response of human immunodeficiency virus infected patients receiving highly active antiretroviral therapy to vaccination with 23 valent pneumococcal Polysaccharide Vaccine
Clinical Infectious Diseases, 2003Co-Authors: Daniel M. Musher, Maria C Rodriguezbarradas, Irene Alexandraki, Tabinda Nazir, Michael Foltzer, Sheldon T BrownAbstract:Whether highly active antiretroviral therapy (HAART) impacts responses to 23-valent pneumococcal Polysaccharide Vaccine (PV) is not known. Immunoglobulin G (IgG) levels for 6 capsular Polysaccharides in human immunodeficiency virus (HIV)-infected patients who had received > or =6 months of HAART were measured either after their first dose of PV (n=46) or after revaccination (n=41); control subjects had never received HAART and had received the first dose of PV (n=38). There were no significant differences in pre- or postvaccination IgG levels among these groups but for 1 capsular Polysaccharide. The 3 groups had significant postvaccination increases in IgG levels to all capsular Polysaccharides. The control group had a greater number of 2-fold responses than did the combined HAART groups (P or =200 cells/mm3 had a greater number of 2-fold responses than did those with a CD4 cell count of <200 cells/mm3 (P<.05). For revaccinated patients, postvaccination IgG levels were correlated with the CD4 cell count at the initial vaccination. The immunogenicity of PV among patients receiving long-term HAART is modest. It seems best to immunize HIV-infected patients early in the course of disease.
-
effect of human immunodeficiency virus type 1 infection on the antibody response to a glycoprotein conjugate pneumococcal Vaccine results from a randomized trial
The Journal of Infectious Diseases, 1996Co-Authors: Faruque Ahmed, Daniel M. Musher, Maria C Rodriguezbarradas, Mark C Steinhoff, Robert G Hamilton, Kenrad E NelsonAbstract:Adults (n = 282) were randomized to receive either a pneumococcal glycoprotein conjugate Vaccine, composed of pneumococcal serotypes 6B, 14, 18C, 19F, and 23F linked to CRM197, or a 23-valent pneumococcal Polysaccharide Vaccine. Among human immunodeficiency virus (HIV)-uninfected persons, conjugate Vaccine elicited significantly higher IgG antibody geometric mean titers (GMTs) than did Polysaccharide Vaccine for serotypes 6B, 18C, and 23F: IgG GMTs were 9.0 versus 4.8, 23.2 versus 5.9, and 15.3 versus 4.4 micrograms/mL, respectively. In contrast, the two Vaccines elicited similar antibody GMTs in HIV-infected persons: GMTs ranged from 1.3 to 10.8 micrograms/mL for all serotypes. Of note, among persons receiving Polysaccharide Vaccine, antibody GMTs in HIV-uninfected and -infected persons with CD4 lymphocytes > or = 500/microL were similar. These data underscore the importance of controlled clinical evaluations of newer pneumococcal Vaccines in all high-risk groups for whom pneumococcal immunization is recommended and highlight the need for early immunization of HIV-infected persons with currently available Polysaccharide Vaccines.