Search

Your search keyword '"Gruber, William C."' showing total 405 results
Start Over Author "Gruber, William C." Publication Type Academic Journals
405 results on '"Gruber, William C."'

1. Serum Troponin I Assessments in 5- to 30-Year-Olds After BNT162b2 Vaccination

Author

Albertson, Timothy E., Hansen, Caitlin, Bihari, Smiti, Gayed, Juleen, Xu, Xia, Simón-Campos, J. Abraham, Dever, Michael E., Cardona, Jose F., Mitha, Essack, Baker, Jeffrey B., Keep, Georgina, Oladipupo, Islamiat, Mensa, Federico J., Feng, Ye, Ma, Hua, Koury, Kenneth, Mather, Susan, Ianos, Claudia Ana, Anderson, Annaliesa S., Türeci, Özlem, Şahin, Uǧur, Gruber, William C., Gurtman, Alejandra, Sabharwal, Charu, and Kitchin, Nicholas

Published
2024
Full Text
View/download PDF

12. Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial

Author

Absalon, Judith, Segall, Nathan, Block, Stan L, Center, Kimberly J, Scully, Ingrid L, Giardina, Peter C, Peterson, James, Watson, Wendy J, Gruber, William C, Jansen, Kathrin U, Peng, Yahong, Munson, Samantha, Pavliakova, Danka, Scott, Daniel A, and Anderson, Annaliesa S

Published
2021
Full Text
View/download PDF

13. A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds.

Author

Usdan, Lisa, Patel, Sohil, Rodriguez, Hector, Xu, Xia, Lee, Dung-Yang, Finn, Daniel, Wyper, Hayley, Lowry, Francine S, Mensa, Federico J, Lu, Claire, Cooper, David, Koury, Kenneth, Anderson, Annaliesa S, Türeci, Özlem, Şahin, Uğur, Swanson, Kena A, Gruber, William C, Kitchin, Nicholas, and Group, the C4591044 Study

Subjects
IMMUNIZATION, RESEARCH funding, COVID-19 vaccines, DESCRIPTIVE statistics, VACCINE immunogenicity, GENETIC mutation, COMPARATIVE studies, CONFIDENCE intervals, COVID-19
Abstract

Background Protection against contemporary severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants requires sequence-adapted vaccines. Methods In this ongoing phase 2/3 trial, 12–17-year-olds (n = 108), 18–55-year-olds (n = 313), and >55-year-olds (n = 306) who previously received 3 original BNT162b2 30-µg doses, received a fourth dose (second booster) of 30-µg bivalent original/Omicron-BA.4/BA.5-adapted BNT162b2 (BNT162b2-Omi.BA.4/BA.5). For comparisons with original BNT162b2, participants were selected from another phase 3 trial. Immunologic superiority 1 month after vaccination, with respect to 50% neutralizing titers (lower bound [LB] of 2-sided 95% confidence interval [CI] for geometric mean ratio [GMR], >1), and noninferiority with respect to seroresponse rates (LB of 2-sided 95% CI for rate difference, greater than −5%), for Omicron BA.4/BA.5 were assessed in >55-year-olds versus original BNT162b2 as a second booster. Noninferiority with respect to neutralizing titer level (LB of 2-sided 95% CI for GMR, > 0.67) and seroresponse rate (LB of 2-sided 95% CI for rate difference, greater than −10%) of Omicron BA.4/BA.5 immune response for BNT162b2-Omi.BA.4/BA.5 in 18–55 versus >55-year-olds was assessed. Results One month after vaccination in >55-year-olds, the model-adjusted GMR of Omicron BA.4/BA.5 neutralizing titers for the BNT162b2-Omi.BA.4/BA.5 versus BNT162b2 groups (2.91 [95% CI, 2.45–3.44]) demonstrated the superiority of BNT162b2-Omi.BA.4/BA.5. Adjusted difference in the percentages of >55-year-olds with seroresponse (26.77% [95% CI, 19.59–33.95]) showed noninferiority of BNT162b2-Omi.BA.4/BA.5 to BNT162b2. Noninferiority of BNT162b2-Omi.BA.4/BA.5 in 18–55-year-olds compared with >55-year-olds was met for model-adjusted GMR and seroresponse. Geometric mean titers in 12–17-year-olds increased from baseline to 1 month after vaccination. The BNT162b2-Omi.BA.4/BA.5 safety profile was similar to the profiles for booster doses of bivalent Omicron BA.1-modified BNT162b2 and original BNT162b2 reported in previous studies. Conclusions Based on immunogenicity and safety data up to 1 month after vaccination in participants who previously received 3 original BNT162b2 doses, a BNT162b2-Omi.BA.4/BA.5 30-µg booster has a favorable benefit-risk profile. Clinical Trials Registration NCT05472038 [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

14. Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults.

Author

Athan, Eugene, Baber, James, Quan, Karen, Scott, Robert J, Jaques, Anna, Jiang, Qin, Li, Wen, Cooper, David, Cutler, Mark W, Kalinina, Elena V, Anderson, Annaliesa S, Swanson, Kena A, Gruber, William C, Gurtman, Alejandra, Schmoele-Thoma, Beate, and Group, for the Study C3671006 Investigator

Subjects
INFLUENZA prevention, ELDER care, PATIENT safety, SEASONS, RESEARCH funding, INFLUENZA vaccines, BLIND experiment, STATISTICAL sampling, COMBINED vaccines, TREATMENT effectiveness, RANDOMIZED controlled trials, DESCRIPTIVE statistics, RESPIRATORY syncytial virus infections, INFLUENZA, HEMAGGLUTINATION tests, VIRAL vaccines, VACCINE immunogenicity, CONFIDENCE intervals, COMPARATIVE studies, DRUG tolerance, IMMUNITY, OLD age
Abstract

Background Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and influenza vaccine could be a benefit, requiring 1 rather than 2 visits to a healthcare provider for individuals receiving both vaccines. Methods The primary immunogenicity objective of this phase 3, 1:1 randomized, double-blind, placebo-controlled study in healthy adults aged ≥65 years in Australia was to demonstrate noninferiority of immune responses with coadministration of the stabilized RSV prefusion F protein–based vaccine (RSVpreF) and seasonal inactivated influenza vaccine (SIIV) versus SIIV or RSVpreF administered alone, using a 1.5-fold noninferiority margin (lower bound 95% confidence interval >.667). Safety and tolerability were evaluated by collecting reactogenicity and adverse event data. Results Of 1403 participants randomized, 1399 received vaccinations (median age, 70; range, 65‒91 years). Local reactions and systemic events were mostly mild or moderate when RSVpreF was coadministered with SIIV or administered alone. No vaccine-related serious adverse events were reported. Geometric mean ratios were 0.86 for RSV-A and 0.85 for RSV-B neutralizing titers at 1 month after RSVpreF administration and 0.77 to 0.90 for strain-specific hemagglutination inhibition assay titers at 1 month after SIIV. All comparisons achieved the prespecified 1.5-fold noninferiority margin. Conclusions The primary study objectives were met, demonstrating noninferiority of RSVpreF and SIIV immune responses when RSVpreF was coadministered with SIIV and that RSVpreF had an acceptable safety and tolerability profile when coadministered with SIIV. The results of this study support coadministration of RSVpreF and SIIV in an older-adult population. Clinical Trials Registration https://clinicaltrials.gov/study/NCT05301322. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

16. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults

Author

Mulligan, Mark J., Lyke, Kirsten E., Kitchin, Nicholas, Absalon, Judith, Gurtman, Alejandra, Lockhart, Stephen, Neuzil, Kathleen, Raabe, Vanessa, Bailey, Ruth, Swanson, Kena A., Li, Ping, Koury, Kenneth, Kalina, Warren, Cooper, David, Fontes-Garfias, Camila, Shi, Pei-Yong, Türeci, Özlem, Tompkins, Kristin R., Walsh, Edward E., Frenck, Robert, Falsey, Ann R., Dormitzer, Philip R., Gruber, William C., Şahin, Uğur, and Jansen, Kathrin U.

Published
2020
Full Text
View/download PDF

17. A Phase 2 Extension Study Evaluating the Immunogenicity, Safety, and Tolerability of 3 or 4 Doses of a Clostridioides difficile Vaccine in Healthy US Adults Aged 65 to 85 Years.

Author

Remich, Shon, Kitchin, Nicholas, Peterson, James, Li, Ping, Pride, Michael W, Brock, Linda, Anderson, Annaliesa S, Gruber, William C, Jansen, Kathrin U, Lockhart, Stephen P, and Webber, Chris

Subjects
CLOSTRIDIOIDES difficile, IMMUNE response, CLINICAL trial registries, VACCINE effectiveness, VACCINE safety
Abstract

Background This phase 2 extension explored the long-term antibody persistence of an investigational Clostridioides difficile vaccine and the safety, tolerability, and immunogenicity of dose 4 approximately 12 months post–dose 3. Methods One year post–dose 3, healthy US 65- to 85-year-olds (N = 300) were randomized to dose 4 of vaccine at previously received antigen levels (100 or 200 μg) or placebo. Assessments included safety and percentages of participants achieving neutralizing antibody titers above prespecified thresholds (≥219 and ≥2586 neutralization units/mL for toxins A and B, respectively). Results In participants previously given three 200-µg doses and placebo in the extension, toxin A and B neutralizing antibodies were above prevaccination levels 48 months post–dose 3 (36 months after placebo); 24.0% and 26.0% had toxin A and B antibodies at or above prespecified thresholds, respectively. Neutralizing antibodies increased post–dose 4 (12 months post–dose 3) and persisted to 36 months post–dose 4. Thirty days post–dose 4, all participants had toxin A and 86.5% to 100% had toxin B titers at or above prespecified thresholds. Local reactions were more frequent in vaccine recipients. Systemic and adverse event frequencies were similar across groups. Conclusions C difficile vaccine immune responses persisted 48 months post–dose 3. Dose 4 was immunogenic and well tolerated, supporting continued development. Clinical Trials Registration. ClinicalTrials.gov NCT02561195. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

22. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations

Author

Wysocki, Jacek, Center, Kimberly J., Brzostek, Jerzy, Majda-Stanislawska, Ewa, Szymanski, Henryk, Szenborn, Leszek, Czajka, Hanna, Hasiec, Barbara, Dziduch, Jerzy, Jackowska, Teresa, Witor, Anita, Kopińska, Elżbieta, Konior, Ryszard, Giardina, Peter C., Sundaraiyer, Vani, Patterson, Scott, Gruber, William C., Scott, Daniel A., and Gurtman, Alejandra

Published
2017
Full Text
View/download PDF

25. Safety, tolerability, and immunogenicity of a 4-antigen Staphylococcus aureus vaccine (SA4Ag): Results from a first-in-human randomised, placebo-controlled phase 1/2 study

Author

Frenck, Robert W., Jr, Creech, C. Buddy, Sheldon, Eric A., Seiden, David J., Kankam, Martin K., Baber, James, Zito, Edward, Hubler, Robin, Eiden, Joseph, Severs, Joseph M., Sebastian, Shite, Nanra, Jasdeep, Jansen, Kathrin U., Gruber, William C., Anderson, Annaliesa S., and Girgenti, Douglas

Published
2017
Full Text
View/download PDF

31. Publisher Correction: Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults

Author

Mulligan, Mark J., Lyke, Kirsten E., Kitchin, Nicholas, Absalon, Judith, Gurtman, Alejandra, Lockhart, Stephen, Neuzil, Kathleen, Raabe, Vanessa, Bailey, Ruth, Swanson, Kena A., Li, Ping, Koury, Kenneth, Kalina, Warren, Cooper, David, Fontes-Garfias, Camila, Shi, Pei-Yong, Türeci, Özlem, Tompkins, Kristin R., Walsh, Edward E., Frenck, Robert, Falsey, Ann R., Dormitzer, Philip R., Gruber, William C., Şahin, Uğur, and Jansen, Kathrin U.

Published
2021
Full Text
View/download PDF

37. Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.

Author

Hassanzadeh, Hamid, Baber, James, Begier, Elizabeth, Noriega, David C, Konishi, Hiroaki, Yato, Yoshiyuki, Wang, Michael Y, Huec, Jean Charles Le, Patel, Vikas, Varga, Peter, Liljenqvist, Ulf, Conly, John, Sabharwal, Charu, Munjal, Iona, Cooper, David, Radley, David, Jaques, Anna, Patton, Michael, Gruber, William C, and Jansen, Kathrin U

Subjects
PREVENTION of bloodborne infections, STAPHYLOCOCCAL disease prevention, PREVENTION of surgical complications, ELECTIVE surgery, RESEARCH, HOST-bacteria relationships, SPINE diseases, CATHETER-related infections, SPINAL fusion, INVESTIGATIONAL drugs, VACCINE immunogenicity, VACCINE effectiveness, STAPHYLOCOCCAL diseases, RANDOMIZED controlled trials, PRE-tests & post-tests, COMPARATIVE studies, SURGICAL site infections, HOSPITAL care, BLIND experiment, DESCRIPTIVE statistics, POSTOPERATIVE period, STATISTICAL sampling, PATIENT safety, BACTERIAL vaccines, EVALUATION
Abstract

Background Staphylococcus aureus is a global pathogen that is frequently responsible for healthcare-associated infections, including surgical site infections (SSIs). Current infection prevention and control approaches may be limited, with S. aureus antibiotic resistance remaining problematic. Thus, a vaccine to prevent or reduce S. aureus infection is critically needed. We evaluated the efficacy and safety of an investigational 4-antigen S. aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation. Methods In this multicenter, site-level, randomized, double-blind trial, patients aged 18–85 years received a single dose of SA4Ag or placebo 10–60 days before surgery. SA4Ag efficacy in preventing postoperative S. aureus bloodstream infection and/or deep incisional or organ/space SSIs was the primary end point. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed. Results Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria. SA4Ag showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 cases in each group through postoperative day 90), despite inducing robust functional immune responses to each antigen compared with placebo. Colonization rates across groups were similar through postoperative day 180. Local reactions and systemic events were mostly mild or moderate in severity, with AEs reported at similar frequencies across groups. Conclusions In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated but, despite eliciting substantial antibody responses that blocked key S. aureus virulence mechanisms, was not efficacious in preventing S. aureus infection. Clinical Trials Registration. NCT02388165. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

39. Circulating Antibody 1 and 2 Years After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Preterm Compared With Term Infants

Author

Martinón-Torres, Federico, Wysocki, Jacek, Center, Kimberly J., Czajka, Hanna, Majda-Stanislawska, Ewa, Omeñaca, Felix, Concheiro-Guisan, Ana, Gimenez-Sanchez, Francisco, Szenborn, Leszek, Blázquez-Gamero, Daniel, Moreno-Galarraga, Laura, Giardina, Peter C., Sun, Gang, Gruber, William C., Scott, Daniel A., and Gurtman, Alejandra

Published
2017
Full Text
View/download PDF

43. Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults.

Author

Baber, James, Arya, Mark, Moodley, Yuben, Jaques, Anna, Jiang, Qin, Swanson, Kena A, Cooper, David, Maddur, Mohan S, Loschko, Jakob, Gurtman, Alejandra, Jansen, Kathrin U, Gruber, William C, Dormitzer, Philip R, and Schmoele-Thoma, Beate

Subjects
RESPIRATORY syncytial virus, OLDER people, CLINICAL trial registries, BOOSTER vaccines, SEASONAL influenza
Abstract

Background Respiratory syncytial virus (RSV) is an important cause of disease in older adults. We evaluated the safety and immunogenicity of a stabilized RSV prefusion F subunit (RSVpreF) vaccine candidate with/without adjuvant in adults aged 65–85 years. Methods Primary cohort participants were equally randomized to 1 of 7 RSVpreF formulations: 60 µg with either Al(OH)3 or CpG/Al(OH)3, 120 µg with either Al(OH)3 or CpG/Al(OH)3, 240 µg with either Al(OH)3 or CpG/Al(OH)3, 240 µg unadjuvanted, or placebo, administered concomitantly with high-dose seasonal inactivated influenza vaccine (SIIV). Participants in the month 0,2 cohort were randomized to RSVpreF 240 µg with CpG/Al(OH)3 or placebo, administered at months 0 and 2. Results All RSVpreF vaccine candidates elicited robust and persistent serum neutralizing responses when administered alone or with SIIV. There was no notable difference in neutralizing response between the formulations, including those containing CpG. In the month 0,2 cohort, there was no booster effect of dose 2. SIIV responses were similar or slightly lower with concomitant administration of RSVpreF. Most systemic and local reactions were mild and more frequent after RSVpreF than placebo. Conclusions RSVpreF formulations were well tolerated and elicited robust neutralizing responses in older adults; however, CpG/Al(OH)3 did not further enhance responses. Clinical Trials Registration. NCT03572062. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

46. 13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6–17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study

Author

De Montalembert, Mariane, Abboud, Miguel R., Fiquet, Anne, Inati, Adlette, Lebensburger, Jeffrey D., Kaddah, Normeen, Mokhtar, Galila, Piga, Antonio, Halasa, Natasha, Inusa, Baba, Rees, David C., Heath, Paul T., Telfer, Paul, Driscoll, Catherine, Al Hajjar, Sami, Tozzi, Alberto, Jiang, Qin, Emini, Emilio A., Gruber, William C., Gurtman, Alejandra, and Scott, Daniel A.

Published
2015
Full Text
View/download PDF

48. Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults

Author

Bonten, Marc J.M., Huijts, Susanne M., Bolkenbaas, Marieke, Webber, Chris, Patterson, Scott, Gault, Samantha, van Werkhoven, Cornelis H., van Deursen, Anna M.M., Sanders, Elisabeth A.M., Verheij, Theo J.M., Patton, Michael, McDonough, Anne, Moradoghli-Haftvani, Anita, Smith, Helen, Mellelieu, Tracey, Pride, Michael W., Crowther, Graham, Schmoele-Thoma, Beate, Scott, Daniel A., Jansen, Kathrin U., Lobatto, Rita, Oosterman, Bas, Visser, Nils, Caspers, Esther, Smorenburg, Andre, Emini, Emilio A., Gruber, William C., and Grobbee, Diederick E.

Published
2015
Full Text
View/download PDF

49. Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years.

Author

Essink, Brandon, Sabharwal, Charu, Cannon, Kevin, Frenck, Robert, Lal, Himal, Xu, Xia, Sundaraiyer, Vani, Peng, Yahong, Moyer, Lisa, Pride, Michael W, Scully, Ingrid L, Jansen, Kathrin U, Gruber, William C, Scott, Daniel A, and Watson, Wendy

Subjects
SAFETY, CONFIDENCE intervals, PNEUMOCOCCAL vaccines, VACCINE effectiveness, TREATMENT effectiveness, RANDOMIZED controlled trials, PRE-tests & post-tests, COMPARATIVE studies, SEROTYPES, BLIND experiment, DESCRIPTIVE statistics, STATISTICAL sampling, PATIENT safety, PHYSIOLOGIC salines, EVALUATION
Abstract

Background Pneumococcal conjugate vaccines (PCVs) have significantly reduced pneumococcal disease, but disease from non-PCV serotypes remains. The safety, tolerability, and immunogenicity of a 20-valent PCV (PCV20) were evaluated. Methods This pivotal phase 3, randomized, double-blind study enrolled adults into 3 age groups (≥60, 50–59, and 18–49 years) at US and Swedish sites. Participants were randomized to receive 1 PCV20 or 13-valent PCV (PCV13) dose. After 1 month, participants aged ≥60 years also received 1 dose of saline or 23-valent polysaccharide vaccine (PPSV23). Safety assessments included local reactions, systemic events, adverse events, serious adverse events, and newly diagnosed chronic medical conditions. Opsonophagocytic activity geometric mean titers 1 month after PCV20 were compared with 13 matched serotypes after PCV13 and 7 additional serotypes after PPSV23 in participants aged ≥60 years; noninferiority was declared if the lower bound of the 2-sided 95% confidence interval for the opsonophagocytic activity geometric mean titer ratio (ratio of PCV20/saline to PCV13/PPSV23 group) was >0.5. PCV20-elicited immune responses in younger participants were also bridged to those in 60–64-year-olds. Results The severity and frequency of prompted local reactions and systemic events were similar after PCV20 or PCV13; no safety concerns were identified. Primary immunogenicity objectives were met, with immune responses after PCV20 noninferior to 13 matched serotypes after PCV13 and to 6 additional PPSV23 serotypes in participants aged ≥60 years; serotype 8 missed the statistical noninferiority criterion. PCV20 induced robust responses to all 20 vaccine serotypes across age groups. Conclusions PCV20 was safe and well tolerated, with immunogenicity comparable to that of PCV13 or PPSV23. PCV20 is anticipated to expand protection against pneumococcal disease in adults. Clinical Trials Registration NCT03760146. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results