Immunogenicity and safety of MenACWY-TT, a quadrivalent meningococcal tetanus toxoid conjugate vaccine recently licensed in the United States for individuals ≥2 years of age

被引:1
作者
Marshall, Gary S. [1 ,2 ]
Pelton, Stephen, I [3 ]
Robertson, Corwin A. [4 ]
Oster, Philipp [5 ]
机构
[1] Norton Childrens, Div Pediat Infect Dis, Louisville, KY USA
[2] Univ Louisville, Sch Med, Louisville, KY 40292 USA
[3] Boston Univ, Sch Med, Dept Pediat, Boston, MA 02118 USA
[4] Sanofi, US Med Affairs, Discovery Dr, Swiftwater, PA USA
[5] Sanofi, Global Med Affairs, Lyon, France
关键词
Immunogenicity; invasive meningococcal disease; IMD; MenACWY-CRM; MenACWY-D; MenACWY-TT; MenACYW-TT; MenQuadfi; meningococcal conjugate vaccine; safety; vaccine recommendations; GUILLAIN-BARRE-SYNDROME; REPORTING SYSTEM VAERS; PHASE-III; GLOBAL EPIDEMIOLOGY; FULLY-LIQUID; DISEASE; CRM; ADULTS; ADOLESCENTS; IMPACT;
D O I
10.1080/21645515.2022.2099142
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
Vaccination offers the best way to prevent invasive meningococcal disease (IMD). As demonstrated in countries with national immunization programs (NIPs) against IMD, meningococcal conjugate vaccines have contributed to significant declines in incidence. Since some meningococcal vaccines are associated with modest immunogenicity in infants, possible immunological interference upon concomitant administration with some pediatric vaccines, and administration errors resulting from improper reconstitution, opportunities for improvement exist. A quadrivalent conjugate vaccine, MenQuadfi (R) (Meningococcal [Serogroups A, C, Y, and W] Conjugate Vaccine; Sanofi, Swiftwater, Pennsylvania), was approved in 2020 for the prevention of IMD caused by meningococcal serogroups A, C, W, and Y in individuals >= 2 years of age in the United States. Five pivotal studies and one ancillary study supported approval in the United States; clinical trials in infants are ongoing. Data on the immunogenicity and safety of this vaccine are presented, and its potential value in clinical practice is discussed.
引用
收藏
页数:17
相关论文
共 114 条
[1]   Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study [J].
Anez, German ;
Hedrick, James ;
Simon, Michael W. ;
Christensen, Shane ;
Jeanfreaue, Robert ;
Yau, Eddy ;
Pan, Judy ;
Jordanov, Emilia ;
Dhingra, Mandeep S. .
HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2020, 16 (06) :1292-1298
[2]  
[Anonymous], 2016, 2016 USRDS ANN DATA
[3]   Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines [J].
Arguedas, A. ;
Soley, C. ;
Loaiza, C. ;
Rincon, G. ;
Guevara, S. ;
Perez, A. ;
Porras, W. ;
Alvarado, O. ;
Aguilar, L. ;
Abdelnour, A. ;
Grunwald, U. ;
Bedell, L. ;
Anemona, A. ;
Dull, P. M. .
VACCINE, 2010, 28 (18) :3171-3179
[4]  
Aung Myat, 2019, J Intensive Care Soc, V20, P182, DOI 10.1177/1751143718794127
[5]   Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naive Children 2-9 Years of Age: A Phase III, Randomized Study [J].
Baccarini, Carmen I. ;
Simon, Michael W. ;
Brandon, Donald ;
Christensen, Shane ;
Jordanov, Emilia ;
Dhingra, Mandeep S. .
PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2020, 39 (10) :955-960
[6]   Cluster of serogroup W invasive meningococcal disease in a university campus [J].
Barret, A. S. ;
Clinard, F. ;
Taha, M. K. ;
Girard, I. ;
Hong, E. ;
Tessier, S. ;
Zurbaran, M. ;
de Bort, C. ;
Antona, D. ;
Deghmane, A. E. ;
Jestin, C. ;
Dupont, H. ;
Levy-Bruhl, D. ;
Tillier, C. .
MEDECINE ET MALADIES INFECTIEUSES, 2020, 50 (04) :335-341
[7]   Lack of Association of Guillain-Barre Syndrome With Vaccinations [J].
Baxter, Roger ;
Bakshi, Nandini ;
Fireman, Bruce ;
Lewis, Edwin ;
Ray, Paula ;
Vellozzi, Claudia ;
Klein, Nicola P. .
CLINICAL INFECTIOUS DISEASES, 2013, 57 (02) :197-204
[8]   Recurrent Guillain-Barre Syndrome Following Vaccination [J].
Baxter, Roger ;
Lewis, Ned ;
Bakshi, Nandini ;
Vellozzi, Claudia ;
Klein, Nicola P. .
CLINICAL INFECTIOUS DISEASES, 2012, 54 (06) :800-804
[9]   Recent changes in the epidemiology of Neisseria meningitidis serogroup W across the world, current vaccination policy choices and possible future strategies [J].
Booy, Robert ;
Gentile, Angela ;
Nissen, Michael ;
Whelan, Jane ;
Abitbol, Veronique .
HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2019, 15 (02) :470-480
[10]   The Global Meningococcal Initiative: global epidemiology, the impact of vaccines on meningococcal disease and the importance of herd protection [J].
Borrow, Ray ;
Alarcon, Pedro ;
Carlos, Josefina ;
Caugant, Dominique A. ;
Christensen, Hannah ;
Debbag, Roberto ;
De Wals, Philippe ;
Echaniz-Aviles, Gabriela ;
Findlow, Jamie ;
Head, Chris ;
Holt, Daphne ;
Kamiya, Hajime ;
Saha, Samir K. ;
Sidorenko, Sergey ;
Taha, Muhamed-Kheir ;
Trotter, Caroline ;
Vazquez Moreno, Julio A. ;
von Gottberg, Anne ;
Safadi, Marco A. P. .
EXPERT REVIEW OF VACCINES, 2017, 16 (04) :313-328