Background Booster doses of meningococcal conjugate vaccines may induce long-term protection against invasive meningococcal disease. MenACYW-TT [MenQuadfi®] is a quadrivalent meningococcal conjugate vaccine, licensed for use in ages 2 years and older in USA. The vaccine is also licensed in ages 12 months and older in EU and other countries. Methods A phase IIIb study (NCT04084769) was conducted to evaluate the persistence of immune response in adults and adolescents primed 3-6 years earlier with either MenACYW-TT or MCV4-CRM (Menveo®) and, safety and immunogenicity of MenACYW-TT when administered as a booster dose with or without concomitant administration with MenB vaccines (Bexsero® and Trumenba®). Serum bactericidal assays with human complement (hSBA) and baby rabbit complement (rSBA) were used to measure antibodies against vaccine serogroups at baseline (Day 0 [D0]), D06 (in a subset) and 30 days post-vaccination (D30). Safety data were collected up to 6 months post-vaccination. Results At D0, the GMTs were higher in subjects primed with MenACYW-TT vs MCV4-CRM for serogroups C, Y and W, and were comparable for serogroup A. At D0, all hSBA GMTs were higher than those observed pre-priming dose, suggesting persistence of immunity. Sufficiency of hSBA seroresponse ( >75%) was demonstrated following administration of MenACYW-TT booster dose regardless of the priming vaccine administered 3-6 years earlier. Vaccine seroresponse in a subset of participants at D06 ranged from 77.8% (95%CI 62.9%; 88.8%) for serogroup A to 97.8% (88.5%; 99.9%) for serogroup W suggesting a quick onset of immune response post-booster. Post-vaccination (D30) hSBA GMTs were comparable for serogroups A, Y and W regardless of the nature of the priming vaccine and were higher for serogroup C in subjects primed with MenACYW-TT vaccine. The MenACYW-TT booster dose was well-tolerated and had similar safety profiles regardless of the priming vaccine. The safety profiles were comparable regardless of the MenB vaccine co-administered with MenACYW-TT vaccine. Conclusion MenACYW-TT used as priming vaccine was able to demonstrate persistence of immune response 3-6 years later. MenACYW-TT elicits robust booster responses in adults and adolescents primed with MenACYW-TT or MCV4-CRM Disclosures Betzana Zambrano, MD, Sanofi Pasteur (Employee) Germán Áñez, MD, Sanofi Pasteur (Other Financial or Material Support, Former employee) Sue Jiayuan, MSc, Sanofi Pasteur (Independent Contractor) Judy Pan, PhD, Sanofi Pasteur (Employee) Habiba Arroum, MD, Sanofi Pasteur (Employee) Kucku Varghese, PhD, Sanofi Pasteur (Employee) Emilia Jordanov, MD, Sanofi Pasteur (Employee, Shareholder) Mandeep S. Dhingra, MD, Sanofi Pasteur (Employee, Shareholder)
BackgroundPeramivir (PVR) is a potent neuraminidase inhibitor with in vitro activity against all influenza virus subtypes. Previous studies demonstrated the efficacy and safety of PVR as a single dose intravenous (IV) treatment for acute uncomplicated influenza in adults.MethodsA phase 3 study compared age-appropriate doses of single dose IV PVR to 5 days of oral oseltamivir (OSE) (4:1 randomization, stratified by age) in pediatric subjects age 0 -17 years within 48 hours of onset of acute uncomplicated influenza. Plasma concentrations of PVR were measured up to 6 hours post dose. Serial viral titers were measured from nasopharyngeal swabs. Severity of influenza signs and symptoms were recorded in a diary.Results122 subjects were enrolled up to a data cutoff of March 31, 2017 (<2 yrs, n = 7; 2-<7yrs, n = 37; 7-<13 yrs, n = 48; 13–17 yrs, n = 30). Interim results are reported for the first 108 subjects randomized, of which 101 (94%) received study drug. Influenza was confirmed by PCR in 75 (74%) subjects who received study drug (Intent-to-treat-Infected [ITTI] population). Key endpoints are summarized:PVROSEIntent to treat (ITT) population: n (all age groups)8523ITTI population: n (%)5916A/H1N122 (37%)9 (56%)A/H3N212 (20%)3 (19%)A/Ind1 (2%)0 (0%)B23 (39%)4 (25%)A + B1 (2%)0 (0%)Proportion of ITTI population shedding virus1, n (%)Baseline53/59 (90%)14/16 (88%)Day 327/59 (46%)10/16 (63%)Day 72/59 (3%)0/16 (0%)Day 140/59 (0%)0/16 (0%)Time to alleviation of symptoms, hrs275.6 (47.0, 109.2)99.8 (34.7, 133.6)Time to resolution of fever, hrs240.5 (22.1, 47.0)34.7 (13.7, 42.3) 1Determined by virus culture assay; 2ITTI population: median (95% CI).No serious adverse events were reported. AEs occurring in more than two subjects overall were:PVROSESafety population: n7823Any event17 (22%)5 (22%)Vomiting2 (3%)2 (9%)Nausea0 (0%)2 (9%)Pyrexia2 (3%)0 (0%)Tympanic membrane hyperemia2 (3%)0 (0%)ConclusionTreatment of influenza in pediatric subjects with single dose IV PVR or 5 days of oral OSE was generally safe and well tolerated. Whilst not powered for efficacy differences, trends were observed in more rapid reduction in virus shedding and symptom alleviation for PVR treated subjects compared with OSE. The study continues to enroll subjects < 7 years.Disclosures J. Vanchiere, BioCryst Pharmaceuticals: Consultant and Investigator, Consulting fee and Research support; S. Plunkett, BioCryst Pharmaceuticals: Investigator, Research support; R. Annamalai, BioCryst Pharmaceuticals: Investigator, Research support; K. Julien, BioCryst Pharmaceuticals: Investigator, Research support; J. Peterson, BioCryst Pharmaceuticals: Investigator, Research support; M. Goisse, BioCryst Pharmaceuticals: Investigator, Research support; S. Christensen, BioCryst Pharmaceuticals: Investigator, Research support; P. Mehta, BioCryst Pharmaceuticals: Investigator, Research support; S. Coleman, BioCryst Pharmaceuticals: Investigator, Research support; F. Munoz, BioCryst Pharmaceuticals: Investigator, Research support; A. Flynt, BioCryst Pharmaceuticals: ...
BackgroundSafety and immunogenicity of a new formulation of PCV-15 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F*, 23F, 33F*) was evaluated in adults ≥65 years of age previously vaccinated with PPV23.MethodsStudy subjects who received PPV23 at least 1 year prior to study entry received a single dose of either PCV-15 or PCV-13 (125/arm) and were followed for safety for 14 days postvaccination. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 30 days postvaccination. NCT02573081ResultsSafety profiles were comparable between PCV-15 and PCV-13 recipients. Following vaccination, serotype- specific antibody responses for the 13 shared serotypes were generally comparable between recipients of PCV- 15 and PCV-13 for IgG GMCs and geometric mean fold rises (GMFRs), OPA GMTs and GMFRs, and percentages of subjects with ≥4-fold-rise from baseline. Recipients of PCV-15 had numerically higher IgG GMCs and OPA GMTs than PCV-13 recipients for two serotypes unique to PCV-15 (22F, 33F).ConclusionPCV-15 was generally well tolerated when given as a single dose to adults ≥65 years of age previously vaccinated with PPV23. Following vaccination, serotype-specific IgG GMCs and OPA GMTs were comparable between recipients of PCV-15 and PCV-13 for 13 shared serotypes.*Not shared serotypes with PCV-13Disclosures U. Buchwald, Merck: Employee and Shareholder, Salary and stock options. J. Peterson, Merck: Investigator, Research grant. H. Stacey, Merckl: Investigator, Research grant. K. Julien, Merck: Investigator, Research grant. T. Sterling, Merck: Employee and Shareholder, Salary and stock options. M. Bruch, Merck: Employee and Shareholder, Salary and stock options. G. Tamms, Merck: Employee and Shareholder, Salary and stock options. J. Li, Merck: Employee and Shareholder, Salary and stock options. A. Pedley, Merck: Employee and Shareholder, Salary and stock options. K. Nolan, Merck: Employee and Shareholder, Salary and stock options. P. Benner, Merck: Employee and Shareholder, Salary and stock options. C. Abeygunawardana, Merck: Employee and Shareholder, Salary and stock options. M. Winters, Merck: Employee and Shareholder, Salary and stock options. M. Kosinski, Merck: Employee and Shareholder, Salary and stock options. J. Stek, Merck: Employee and Shareholder, Salary and stock options. L. Musey, Merck: Employee and Shareholder, Salary and stock options.
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