Randomized Trial on the Safety, Tolerability, and Immunogenicity of MenACWY-CRM, an Investigational Quadrivalent Meningococcal Glycoconjugate Vaccine, Administered Concomitantly with a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis Vaccine in Adolescents and Young Adults

ABSTRACT This study evaluated the safety, tolerability, and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine, MenACWY-CRM, when administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis (Tdap) vaccine, in subjects aged 11 to 25 years. Subjects received either MenACWY-CRM and Tdap, MenACWY-CRM and saline placebo, or Tdap and saline placebo. No significant increase in reactogenicity and no clinically significant vaccine-related adverse events (AEs) occurred when MenACWY-CRM and Tdap were administered concomitantly. Similar immunogenic responses to diphtheria, tetanus, and meningococcal (serogroups A, C, W-135, and Y) antigens were observed, regardless of concomitant vaccine administration. Antipertussis antibody responses were comparable between vaccine groups for filamentous hemagglutinin and were slightly lower, although not clinically significantly, for pertussis toxoid and pertactin when the two vaccines were administered concomitantly. These results indicate that the investigational MenACWY-CRM vaccine is well tolerated and immunogenic and that it can be coadministered with Tdap to adolescents and young adults.

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Prevalence and heritability of body dysmorphic symptoms in adolescents and young adults: a population-based nationwide twin study

Psychological Medicine ◽

10.1017/s0033291718000375 ◽

2018 ◽

Vol 48 (16) ◽

pp. 2740-2747 ◽

Cited By ~ 8

Author(s):

Jesper Enander ◽

Volen Z. Ivanov ◽

David Mataix-Cols ◽

Ralf Kuja-Halkola ◽

Brjánn Ljótsson ◽

...

Keyword(s):

Young Adults ◽

Body Dysmorphic Disorder ◽

Age Of Onset ◽

Model Fitting ◽

Population Based ◽

Adolescents And Young Adults ◽

Shared Environment ◽

Increased Risk ◽

Clinically Significant ◽

Alcohol Related Problems

AbstractBackgroundBody dysmorphic disorder (BDD) usually begins during adolescence but little is known about the prevalence, etiology, and patterns of comorbidity in this age group. We investigated the prevalence of BDD symptoms in adolescents and young adults. We also report on the relative importance of genetic and environmental influences on BDD symptoms, and the risk for co-existing psychopathology.MethodsPrevalence of BDD symptoms was determined by a validated cut-off on the Dysmorphic Concerns Questionnaire (DCQ) in three population-based twin cohorts at ages 15 (n = 6968), 18 (n = 3738), and 20–28 (n = 4671). Heritability analysis was performed using univariate model-fitting for the DCQ. The risk for co-existing psychopathology was expressed as odds ratios (OR).ResultsThe prevalence of clinically significant BDD symptoms was estimated to be between 1 and 2% in the different cohorts, with a significantly higher prevalence in females (1.3–3.3%) than in males (0.2–0.6%). The heritability of body dysmorphic concerns was estimated to be 49% (95% CI 38–54%) at age 15, 39% (95% CI 30–46) at age 18, and 37% (95% CI 29–42) at ages 20–28, with the remaining variance being due to non-shared environment. ORs for co-existing neuropsychiatric and alcohol-related problems ranged from 2.3 to 13.2.ConclusionsClinically significant BDD symptoms are relatively common in adolescence and young adulthood, particularly in females. The low occurrence of BDD symptoms in adolescent boys may indicate sex differences in age of onset and/or etiological mechanisms. BDD symptoms are moderately heritable in young people and associated with an increased risk for co-existing neuropsychiatric and alcohol-related problems.

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2724. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered in Healthy Meningococcal Vaccine-Naïve Children (2–9 Years)

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.2401 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S958-S959

Author(s):

Michael W Simon ◽

Donald Brandon ◽

Shane Christensen ◽

Carmen Baccarini ◽

Emilia Jordanov ◽

...

Keyword(s):

Adverse Events ◽

Injection Site ◽

Conjugate Vaccine ◽

Safety Data ◽

Phase Iii ◽

Meningococcal Vaccine ◽

Serious Adverse Events ◽

Double Blind ◽

Post Vaccination ◽

Quadrivalent Meningococcal Conjugate Vaccine

Abstract Background MenACYW-TT is an investigational quadrivalent meningococcal conjugate vaccine that contains tetanus toxoid as carrier protein. The vaccine is intended for global use in individuals 6 weeks of age and older. We evaluated the safety and immunogenicity of MenACYW-TT compared with a licensed quadrivalent conjugate meningococcal vaccine (MenACWY-CRM [Menveo®]) in US children 2–9 years of age. Methods In a modified double-blind Phase III study (NCT03077438), 1000 children were randomized to receive one dose of either MenACYW-TT vaccine or MenACWY-CRM vaccine. Serum bactericidal assays with human (hSBA) and baby rabbit (rSBA) complement were used to measure antibodies against representative meningococcal serogroup strains at baseline and 30 days after vaccination. Safety data were collected up to 6 months post-vaccination. Results Non-inferiority of immune responses for all four serogroups, based on percentages of participants achieving hSBA vaccine seroresponse, was demonstrated for MenACYW-TT compared with MenACWY-CRM at Day 30 compared with baseline. The proportions of individuals with hSBA titers ≥ 1:8 following MenACYW-TT administration were higher than those after MenACWY-CRM administration for all four serogroups (A: 86.4% vs 79.3%; C: 97.8% vs 67.1%; W: 94.8% vs 86.3%; Y: 98.5% vs 90.8%). Similar results were observed in two age substrata (2 to 5 years and 6 to 9 years). Percentages of participants with post-vaccination rSBA titers ≥ 1:128 were comparable between both groups. The safety profiles of MenACYW-TT and MenACWY-CRM were comparable. Reactogenicity at the MenACYW-TT injection site was lower than at the MenACWY-CRM injection site. There were no immediate adverse events (AEs), no AEs leading to study discontinuation, and no vaccine-related serious adverse events reported in the study. Conclusion MenACYW-TT vaccine was well tolerated and demonstrated a non-inferior immune response compared with that for the licensed MenACWY-CRM vaccine when administered as a single dose to meningococcal vaccine-naïve children. Disclosures All authors: No reported disclosures.

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Early intervention for impairing post-concussion symptoms in adolescents and young adults: Results from a randomized trial

Journal of Psychosomatic Research ◽

10.1016/j.jpsychores.2019.03.071 ◽

2019 ◽

Vol 121 ◽

pp. 122

Author(s):

Mille Moeller Thastum ◽

Charlotte Ulrikka Rask ◽

Erhard Trillingsgaard Naess-Schmidt ◽

Astrid Hoeg Tuborgh ◽

Jens Sondergaard Jensen ◽

...

Keyword(s):

Young Adults ◽

Early Intervention ◽

Randomized Trial ◽

Adolescents And Young Adults

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Randomized Trial of 2 Schedules of Meningococcal B Vaccine in Adolescents and Young Adults, Canada1

Emerging Infectious Diseases ◽

10.3201/eid2603.190160 ◽

2020 ◽

Vol 26 (3) ◽

pp. 454-462

Author(s):

Joanne M. Langley ◽

Soren Gantt ◽

Caroline Quach ◽

Julie A. Bettinger ◽

Scott A. Halperin ◽

...

Keyword(s):

Young Adults ◽

Randomized Trial ◽

Adolescents And Young Adults

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Evaluation of pegaspargase (PEG-ASP) adverse events among adolescents and young adults (AYAs) and younger patients with lymphoid malignancies (LM) at the Children’s Hospital of Eastern Ontario (CHEO).

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.15_suppl.10531 ◽

2018 ◽

Vol 36 (15_suppl) ◽

pp. 10531-10531

Author(s):

Nicole Mathies ◽

Isabelle Laforest ◽

Kenneth Tang ◽

Genevieve Goulet ◽

Lesleigh S. Abbott

Keyword(s):

Young Adults ◽

Adverse Events ◽

Adolescents And Young Adults ◽

Younger Patients ◽

Children's Hospital ◽

Lymphoid Malignancies ◽

Children’S Hospital ◽

Eastern Ontario

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2719. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered in Adults 18–55 Years of Age

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.2396 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S957-S957

Author(s):

James Peterson ◽

James Hedrick ◽

Judy Pan ◽

David Neveu ◽

Emilia Jordanov ◽

...

Keyword(s):

Single Dose ◽

Adverse Events ◽

Conjugate Vaccine ◽

Geometric Mean ◽

Safety Data ◽

The United States ◽

Phase Iii ◽

Meningococcal Vaccine ◽

Post Vaccination ◽

Quadrivalent Meningococcal Conjugate Vaccine

Abstract Background The MenACYW-TT conjugate vaccine is a quadrivalent meningococcal vaccine that contains tetanus toxoid as carrier protein. The vaccine is intended for global use in all age groups (i.e., individuals 6 weeks of age and older). This Phase III study evaluated the immune lot consistency, and safety and immunogenicity of the vaccine when compared with a licensed quadrivalent meningococcal conjugate vaccine in individuals 10–55 years of age. Methods A randomized, modified double-blind, multi-center study (NCT02842853) was conducted in the United States. The study evaluated 3344 meningococcal vaccine naïve adolescents and adults, who were randomly assigned to receive either a single dose of one of the three lots of MenACYW-TT conjugate vaccine or single dose of Menactra® [MenACWY-D]. Serum bactericidal assay with human complement (hSBA) and rabbit complement (rSBA) was used to measure antibodies against serogroups A, C, W, and Y at baseline before vaccination (Day 0) and 30 days post-vaccination. Safety data were collected up to 6 months post-vaccination. Herein we report the performance of MenACYW-TT in adults 18 through 55 years of age (n = 1,807). Results Immune equivalence was demonstrated across all 3 lots of MenACYW-TT conjugate vaccine based on geometric mean titers (GMTs) for all serogroups. Non-inferiority of immune responses, based on percentages of participants achieving hSBA vaccine seroresponse, was demonstrated between MenACYW-TT and MenACWY-D for all four serogroups at Day 30 compared with baseline. The proportions of individuals (18–55 years) with hSBA ≥ 1:8 following MenACYW-TT administration were higher than those after MenACWY-D administration for all four serogroups (A: 93.5% vs. 88.1%; C: 93.5% vs. 77.8%; W: 94.5% vs. 80.2%; Y: 98.6% vs. 81.2%). A similar trend was observed for post vaccination GMTs in adult participants. Reactogenicity profiles were comparable across study groups. Most unsolicited adverse events were of grade 1 or grade 2 intensity. No vaccine-related serious adverse events were reported. Conclusion MenACYW-TT vaccine was well tolerated and demonstrated a non-inferior immune response compared with the licensed MenACWY-D vaccine when administered as a single dose to meningococcal vaccine naïve adults. Disclosures All authors: No reported disclosures.

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