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3. 1728. Immune Responses to Cross-Reactive Serotypes 6C and 15C After 20-Valent Pneumococcal Conjugate Vaccine in Infants

Author

Tamimi, Noor, primary, Kline, Mary J, additional, Center, Kimberly J, additional, Thompson, Allison, additional, Baugher, Gary, additional, Drozd, Jelena, additional, Scully, Ingrid L, additional, Giardina, Peter, additional, Trammel, James, additional, Lei, Lanyu, additional, Peng, Yahong, additional, Scott, Daniel, additional, Gruber, William C, additional, and Watson, Wendy, additional

Published
2023
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4. 1944. Tolerability and Safety of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Infants and Older Children in Global Studies

Author

Flint, Laurence, primary, McElwee, Kathleen, additional, Ouedraogo, G Laissa, additional, Tamimi, Noor, additional, Kline, Mary J, additional, Center, Kimberly J, additional, Thompson, Allison, additional, de Solom, Richard, additional, Yamaji, Masako, additional, Trammel, James, additional, Lei, Lanyu, additional, Peng, Yahong, additional, Gruber, William C, additional, Scott, Daniel, additional, and Watson, Wendy, additional

Published
2023
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10. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States

Author

Senders, Shelly, primary, Klein, Nicola P., additional, Lamberth, Erik, additional, Thompson, Allison, additional, Drozd, Jelena, additional, Trammel, James, additional, Peng, Yahong, additional, Giardina, Peter C., additional, Jansen, Kathrin U., additional, Gruber, William C., additional, Scott, Daniel A., additional, and Watson, Wendy, additional

Published
2021
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12. 1236. Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Healthy Infants in the United States

Author

Senders, Shelly, primary, Klein, Nicola P, additional, Lamberth, Erik, additional, Thompson, Allison, additional, Drozd, Jelena, additional, Trammel, James, additional, Peng, Yahong, additional, Giardina, Peter, additional, Jansen, Kathrin U, additional, Gruber, William C, additional, Scott, Daniel, additional, and Watson, Wendy, additional

Published
2020
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15. Carrier-Induced Hyporesponsiveness to Pneumococcal Conjugate Vaccines: Unraveling the Influence of Serotypes, Timing, and Previous Vaccine Dose.

Author

Dagan, Ron, Jiang, Qin, Juergens, Christine, Trammel, James, Gruber, William C, and Scott, Daniel A

Subjects
NASOPHARYNX microbiology, IMMUNOGLOBULIN analysis, DOSE-effect relationship in pharmacology, PNEUMOCOCCAL vaccines, RANDOMIZED controlled trials, BLIND experiment, SEROTYPES, DESCRIPTIVE statistics, CHILDREN
Abstract

Background Pneumococcal conjugate vaccines (PCVs) elicit lower immune response against serotypes carried before or at the time of vaccination (hyporesponsiveness) in infants. The limited studies conducted to date did not permit comprehensive insights regarding this phenomenon. This study, the largest ever conducted with both carriage and serologic endpoints, attempted to add insight on serotype-specific hyporesponsiveness in relation to the number of PCV doses administered before carriage acquisition. Methods In a double-blind randomized clinical trial (n = 1754 infants), 7-valent or 13-valent PCV was administered at ages 2, 4, 6, and 12 months. New acquisition was defined based on nasopharyngeal swabs at ages 2, 4, 6, 7, and 12 months. Serotype-specific immunoglobulin G levels were obtained 1 month after the infant series and 1 month after the toddler dose. Results A lower immune response after the infant series and the toddler dose was consistently observed for carriers of serotypes 6A, 6B, 18C, and 19F at predefined time points, with a similar trend observed in carriers of serotype 23F. In contrast, carriage of serotypes 9V, 14, and 19A did not generally affect immune responses. For some but not all serotypes, hyporesponsiveness was decreased with an increased number of vaccine doses received before acquisition. A complex interrelationship between carriage and immune response was observed between cross-reacting serotypes. Conclusions Carrier-induced hyporesponsiveness to PCVs is common, differs among serotypes, and depends on timing of carriage acquisition and prior number of administered PCV doses. Clinical Trials Registration NCT00508742. [ABSTRACT FROM AUTHOR]

Published
2021
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18. Efficacy of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Versus That of 7-Valent PCV (PCV7) Against Nasopharyngeal Colonization of Antibiotic-NonsusceptibleStreptococcus pneumoniae

Author

Dagan, Ron, primary, Juergens, Christine, additional, Trammel, James, additional, Patterson, Scott, additional, Greenberg, David, additional, Givon-Lavi, Noga, additional, Porat, Nurith, additional, Gurtman, Alejandra, additional, Gruber, William C., additional, and Scott, Daniel A., additional

Published
2014
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19. Post Hoc Analysis of a Randomized Double-Blind Trial of the Correlation of Functional and Binding Antibody Responses Elicited by 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines and Association with Nasopharyngeal Colonization

Author

Juergens, Christine, primary, Patterson, Scott, additional, Trammel, James, additional, Greenberg, David, additional, Givon-Lavi, Noga, additional, Cooper, David, additional, Gurtman, Alejandra, additional, Gruber, William C., additional, Scott, Daniel A., additional, and Dagan, Ron, additional

Published
2014
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20. 1106Modeling of nasopharyngeal acquisition as a function of anti-capsular serum antibody concentrations and of ethnicity after vaccination with pneumococcal conjugate vaccines (PCVs)

Author

Dagan, Ron, primary, Juergens, Christine, additional, Trammel, James, additional, Patterson, Scott D., additional, Greenberg, David, additional, Givon-Lavi, Noga, additional, Porat, Nurith, additional, Gruber, William C., additional, and Scott, Daniel A., additional

Published
2014
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21. 13-Valent pneumococcal conjugate vaccine (PCV13) in children partially immunized with 7-valent pneumococcal conjugate vaccine (PCV7) : A phase 3, open-label trial

Author

Silfverdal, Sven Arne, Flodmark, Carl-Erik, Rombo, Lars, Tansey, Susan P., Sidhu, Mohinder, Trammel, James, Emini, Emilio A., Gruber, William C., Scott, Daniel A., Gurtman, Alejandra, Silfverdal, Sven Arne, Flodmark, Carl-Erik, Rombo, Lars, Tansey, Susan P., Sidhu, Mohinder, Trammel, James, Emini, Emilio A., Gruber, William C., Scott, Daniel A., and Gurtman, Alejandra

Abstract

Background: As 13-valent pneumococcal conjugate vaccine (PCV13) is introduced, children who began vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) may complete their vaccination with PCV13. This open-label phase 3 study evaluated immunogenicity and safety of PCV13 in Swedish infants and toddlers previously given 1 or 2 doses of PCV7 during infancy. Methods: Healthy infants previously given PCV7 at ages 3 months (group 1; n = 118) or 3 and 5 months (group 2; n = 116) received PCV13 at ages 5 (group 1) and 12 months (both groups). IgG responses were assessed 1 month after each PCV13 dose and before the 12-month dose. Local reactions and systemic events were collected for 7 days postvaccination. Other adverse events were also collected. Results: Post-5-month dose, IgG geometric mean concentrations (GMCs) in group 1 were 1.56-4.70 mu g/ml for most PCV7 serotypes except 6B (0.40 mu g/ml) and 23F (0.57 mu g/ml) and 0.72-1.88 mu g/ml for most of the 6 additional serotypes, except 6A (0.28 mu g/ml). Post-12-month dose, IgG GMCs for the PCV7 serotypes were 2.93-9.63 mu g/ml (group 1) and 3.33-9.30 mu g/ml (group 2); and for the 6 additional serotypes, 1.85-14.65 mu g/ml (group 1) and 1.34-13.16 mu g/ml (group 2). GMCs increased by >4-fold in both groups from pre- to post-12-month dose. Proportions of subjects in group 1 with pneumococcal serotype-specific IgG concentrations >= 0.35 mu g/ml (WHO-designated postprimary reference antibody level) post-5-month dose were 92.2-99.1% for most PCV7 serotypes except 6B (53.0%) and 23F (62.6%) and 80.9-100.0% for most of the 6 additional serotypes except 6A (36.8%). Local reactions and fever were mostly mild or moderate. Conclusions: PCV13 was immunogenic and safe in infants and toddlers previously partially immunized with PCV7. Even a single dose in an infant or toddler induces an immune response to the 6 additional serotypes.

Published
2013
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22. Effectiveness of 13-valent pneumococcal conjugate vaccination for protection against acute otitis media caused by Streptococcus pneumoniaein healthy young children: a prospective observational study

Author

Pichichero, Michael, Kaur, Ravinder, Scott, Daniel A, Gruber, William C, Trammel, James, Almudevar, Anthony, and Center, Kimberly J

Abstract

With wide use of the seven-valent pneumococcal conjugate vaccine (PCV7) for protection against acute otitis media caused by Streptococcus pneumoniaeserotypes included in the vaccine, efficacy testing for the 13-valent vaccine (PCV13) was not feasible. We aimed to assess the effectiveness of PCV13 in preventing acute otitis media caused by the six serotypes in PCV13 that were not in PCV7.

Published
2018
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23. 13-Valent pneumococcal conjugate vaccine (PCV13) in children partially immunized with 7-valent pneumococcal conjugate vaccine (PCV7): A phase 3, open-label trial

Author

Silfverdal, Sven Arne, primary, Flodmark, Carl-Erik, additional, Rombo, Lars, additional, Tansey, Susan P., additional, Sidhu, Mohinder, additional, Trammel, James, additional, Emini, Emilio A., additional, Gruber, William C., additional, Scott, Daniel A., additional, and Gurtman, Alejandra, additional

Published
2013
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24. Immunogenicity and Safety of MMRV and PCV-7 Administered Concomitantly in Healthy Children

Author

Leonardi, Michael, primary, Bromberg, Kenneth, additional, Baxter, Roger, additional, Gardner, Julie L., additional, Klopfer, Stephanie, additional, Nicholson, Ouzama, additional, Brockley, Michael, additional, Trammel, James, additional, Leamy, Vicky, additional, Williams, Wendy, additional, Kuter, Barbara, additional, and Schödel, Florian, additional

Published
2011
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25. Multicenter Surveillance of Streptococcus pneumoniae Isolates From Middle Ear and Mastoid Cultures in the 13-Valent Pneumococcal Conjugate Vaccine Era.

Author

Kaplan, Sheldon L., Center, Kimberly J., Barson, William J., Ling-Lin, Philana, Romero, José R., Bradley, John S., Tan, Tina Q., Hoffman, Jill A., Peters, Timothy R., Gurtman, Alejandra, Scott, Daniel A., Trammel, James, Gruber, William C., Hulten, Kristina G., and Mason, Edward O.

Subjects
OTITIS media in children, COMBINED vaccines, STREPTOCOCCUS pneumoniae, MIDDLE ear, MASTOIDITIS, SEROTYPES
Abstract

Background. Streptococcus pneumoniae is a common cause of otitis media (OM) in children; mastoiditis remains an important complication of OM. Limited data are available on the impact of the 13-valent pneumococcal conjugate vaccine (PCV13) on pneumococcal otitis. Methods. Investigators from 8 children's hospitals in the United States prospectively collected pneumococcal isolates from middle ear or mastoid cultures from children from 2011 to 2013. Serotype and antibiotic susceptibilities were determined and PCV13 doses for children documented. Results. Over the 3-year period, the proportion of isolates included in PCV13 ( plus a related serotype) decreased significantly (P = .0006) among the middle ear/mastoid isolates (2011, 50% [74/149]; 2012, 40.5% [47/116]; 2013, 29% [34/118]). The number of serotype 19A isolates in 2013 (n = 12, 10.2% of total) decreased 76% compared with the number of 19A isolates in 2011 (n = 50, 33.6% of total). Of the children from whom serotype 19A was isolated (n = 93), 55% had previously received <3 doses of PCV13. The most common non-PCV13 serotypes for the combined years were 35B (n = 37), 21 (n = 20), 23B (n = 20), 15B (n = 18), 11 (n = 17), 23A (n = 14), 15A (n = 14), and 15C (n = 14). The proportion of isolates with a penicillin minimal inhibitory concentration >2 μg/mL decreased significantly over the 3 years (2011, 22% [35/154]; 2012, 20% [24/118]; 2013, 10% [12/120]; P < .02). Conclusions. The number of pneumococcal isolates and the percentage of isolates with high-level penicillin resistance from cultures taken from children with OM or mastoiditis for clinical indications have decreased following PCV13 use, largely related to decreases in serotype 19A isolates. [ABSTRACT FROM AUTHOR]

Published
2015
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26. Post HocAnalysis of a Randomized Double-Blind Trial of the Correlation of Functional and Binding Antibody Responses Elicited by 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines and Association with Nasopharyngeal Colonization

Author

Juergens, Christine, Patterson, Scott, Trammel, James, Greenberg, David, Givon-Lavi, Noga, Cooper, David, Gurtman, Alejandra, Gruber, William C., Scott, Daniel A., and Dagan, Ron

Abstract

ABSTRACTIn a randomized double-blind trial in healthy Israeli infants in Israel who received the 13-valent or 7-valent pneumococcal conjugate vaccine (PCV13 or PCV7, respectively) at 2, 4, 6, and 12 months, PCV13 significantly reduced nasopharyngeal (NP) colonization of serotypes 1, 6A, 7F, 19A, cross-reacting 6C, and the common PCV7 serotype 19F, from ages 7 to 24 months. No differences were observed between the vaccine groups for serotype 3 or for the remaining common PCV7 serotypes. For serotype 5, too few events were observed to draw an inference. Generally consistent with these findings, PCV13 elicited significantly higher enzyme-linked immunosorbent assay (ELISA) IgG-binding antibody responses than did PCV7 for the additional PCV13 serotypes 1, 3, 5, 6A, 7F, 19A, and for the common serotype 19F, with similar or lower responses for the remaining common serotypes. To further assess immunogenicity and colonization, we conducted a post hocanalysis of PCV13 functional antibody responses measured by opsonophagocytic activity (OPA) assays in a randomly selected subset of subjects. The pattern of functional antibody OPA responses elicited by PCV13 relative to PCV7 was similar to that of the ELISA anticapsular IgG-binding antibody responses described above. In addition, the OPA responses generally correlated positively with IgG responses for all 13 serotypes among the PCV13 recipients and for all 7 common serotypes and the additional serotype 6A but not for 19A or the other serotypes unique to PCV13 among the PCV7 recipients. This post hocanalysis supports an association between serum OPA functional and IgG-binding antibody levels, allowing for a transfer of inferred associations between IgG responses and NP colonization to OPA responses.

Published
2014
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27. Hyperfibrinogenemia and Functional Outcome From Acute Ischemic Stroke

Author

Zoppo, Gregory J. del, Levy, David E., Wasiewski, Warren W., Pancioli, Arthur M., Demchuk, Andrew M., Trammel, James, Demaerschalk, Bart M., Kaste, Markku, Albers, Gregory W., and Ringelstein, Eric B.

Abstract

Background and Purpose—Epidemiological studies have found strong correlations between elevated plasma fibrinogen levels and both ischemic stroke incidence and stroke mortality. Little is known about the influence of fibrinogen levels on functional stroke outcome.

Published
2009
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