Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™

Leonardi, Michael; Latiolais, Thomas; Sarpong, Kwabena; Simon, Michael W.; Twiggs, Jerry; Lei, Paul; Rinderknecht, Stephen; Blatter, Mark M.; Bianco, Véronique; Baine, Yaela; Friedland, Leonard R.; Baccarini, Carmen; Miller, Jacqueline M.

doi:10.1016/j.vaccine.2014.09.064

Cited by 13 publications

(7 citation statements)

References 33 publications

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“…Systems biology approaches are increasingly being used to describe and define signatures of immunity, initially in the setting of infection but more recently in vaccine-induced responses, leading to the development of systems vaccinology (Querec et al, 2009; Olafsdottir et al, 2015). These transcriptomic analyses have primarily focused on the prediction of vaccine efficacy and immune outcome with the assessment of vaccine safety and potential reactogenicity relying on clinical reactive scores of adverse events (Bucasas et al, 2011; Furman et al, 2013; Obermoser et al, 2013; Vahey et al, 2010; Li et al, 2014; Leonardi et al, 2015; Vesikari et al, 2009). However, the transcriptome can also reveal the intricate details of the very early events after vaccination.…”

Section: Introductionmentioning

confidence: 99%

Identification of potential biomarkers of vaccine inflammation in mice

McKay

Cizmeci

Aldon

et al. 2019

eLife

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Systems vaccinology approaches have been used successfully to define early signatures of the vaccine-induced immune response. However, the possibility that transcriptomics can also identify a correlate or surrogate for vaccine inflammation has not been fully explored. We have compared four licensed vaccines with known safety profiles, as well as three agonists of Toll-like receptors (TLRs) with known inflammatory potential, to elucidate the transcriptomic profile of an acceptable response to vaccination versus that of an inflammatory reaction. In mice, we looked at the transcriptomic changes in muscle at the injection site, the lymph node that drained the muscle, and the peripheral blood mononuclear cells (PBMCs)isolated from the circulating blood from 4 hr after injection and over the next week. A detailed examination and comparative analysis of these transcriptomes revealed a set of novel biomarkers that are reflective of inflammation after vaccination. These biomarkers are readily measurable in the peripheral blood, providing useful surrogates of inflammation, and provide a way to select candidates with acceptable safety profiles.

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Section: Introductionmentioning

confidence: 99%

Identification of potential biomarkers of vaccine inflammation in mice

McKay

Cizmeci

Aldon

et al. 2019

eLife

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“…145 This important finding supported the previously observed cross-protection induced by the monovalent CPS vaccines, 146 and that suggested in the context of a recent clinical trial involving a Hib/MenC/MenY conjugate vaccine, whereby the vaccinees showed significantly higher 30 MenW-specific seroprotection than the control group. 147 Moreover, by demonstrating the partial overlap between the two CPS dynamics, the molecular simulation study also provided some insights on the superior capacity of the MenY CPS to induce crossprotection with MenW. 145 The similarity between the MenY and MenW CPS extends to their O-acetylation 35 pattern.…”

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confidence: 98%

Bacterial polysaccharides as major surface antigens: interest in O-acetyl substitutions

Mulard¹

2017

Carbohydrate Chemistry

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“…Study MET50 documented lower GMCs against some of the pertussis antigens upon concomitant administration of MenACYW-TT with Tdap [63]. However, the clinical relevance of this observation is unclear considering that there is no established immune correlate of protection for pertussis and lower anti-pertussis antibody concentrations have also been documented upon concomitant administration of MCV4-CRM and MCV4-TT with vaccines incorporating pertussis antigens [89][90][91].…”

Section: Expert Opinionmentioning

confidence: 99%

A novel vaccine to prevent meningococcal disease beyond the first year of life: an early review of MenACYW-TT

Martinón-Torres

Bertrand-Gerentes

Oster

2021

Expert Review of Vaccines

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Introduction: Although quadrivalent meningococcal conjugate vaccines have been effective in preventing invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y across age groups from infants to adults, data on their efficacy and safety in adults ≥56 years of age are lacking. Moreover, multiple available quadrivalent conjugate vaccines require reconstitution prior to administration, introducing the potential for error. A novel quadrivalent meningococcal conjugate vaccine, MenACYW-TT (MenQuadfi ® ) was approved in 2020 for use in individuals ≥12 months of age as a single dose in the European Union and some other countries and in individuals ≥2 years of age in the United States. Areas covered: The findings of Phase II/III studies that included >6600 individuals and evaluated the immunogenicity and safety of MenACYW-TT beyond the first year of life are comprehensively summarized and discussed. Expert opinion: Extensive data on immunogenicity and safety, co-administration with routine vaccines, elicitation of robust booster responses, and significantly higher Men C responses versus monovalent MenC or MenACWY standard-of-care vaccines in toddlers suggest that MenACYW-TT may be suitable for inclusion in National Immunization Programs (NIPs) globally. The authors provide their perspectives on the clinical use of MenACYW-TT across age groups from toddlers through adults.

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Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™

Cited by 13 publications

References 33 publications

Identification of potential biomarkers of vaccine inflammation in mice

Identification of potential biomarkers of vaccine inflammation in mice

Bacterial polysaccharides as major surface antigens: interest in O-acetyl substitutions

A novel vaccine to prevent meningococcal disease beyond the first year of life: an early review of MenACYW-TT

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