Effect on meningococcal serogroup W immunogenicity when Tdap was administered prior,concurrent or subsequent to the quadrivalent (ACWY) meningococcal CRM197-conjugate vaccine in adult Hajj pilgrims: A randomised controlled trial |
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| Affiliation: | 1. The Discipline of Child and Adolescent Health, Children’s Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia;2. Faculty of Medicine, University of Tripoli, Ain Zara, Tripoli, Libya;3. National Centre for Immunisation Research and Surveillance (NCIRS), The Children’s Hospital at Westmead, NSW, Australia;4. Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia;5. The Executive Administration of Research and Innovation, King Abdullah Medical City in Holy Capital (KAMC-HC), Makkah 24246, Saudi Arabia;6. Saudi Food and Drug Authority, Riyadh 13312, Saudi Arabia;7. Immunology Department, The Children’s Hospital at Westmead, Westmead 2145, NSW, Australia;8. Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Sydney, NSW 2145, Australia;9. Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK;10. WHO Collaborating Centre for Mass Gatherings and High Consequence/High Visibility Events, Flinders University, Adelaide 5001, Australia;1. Instituto de Atención Pediatrica, Apdo 607–1150 La Uruca, San Jose, Costa Rica;2. Wee Care Pediatrics, 2084N 1700W Suite A, Layton, UT, United States;3. Guanchipelin, San Rafael, Escazu, Heredia, Costa Rica;4. Centro de Investigaciones en Pediatría, Guatemala City, Guatemala;5. Department of Pediatrics, Mackay Memorial Hospital, 92, Sec. 2, Zhongshan N. Rd., Zhongshan District, Taipei City 104, Taiwan;6. Department of Pediatrics, Chang Gung Children''s Hospital, Chang Gung University College of Medicine, No.199, Tunghwa Rd., Taipei, Taiwan;7. Instituto de Investigación Nutricional, Av. La Molina 1885, Lima 12, Peru;8. Hospital Materno Infantil José Domingo de Obaldía, Ciudad de David, Chiriqui, Panama;9. Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States;1. Department of Internal and Pulmonary Medicine, Sheri Kashmir Institute of Medical Sciences, Soura, Srinagar 190011, Jammu and Kashmir, India;2. Postgraduate Department of Microbiology, Government Medical College, Srinagar, Jammu and Kashmir, India;3. Juhur-ul-Islam Medical College, Bajitpur, Bangladesh;1. National Centre for Epidemiology, Carlos III Health Institute (ISCIII-CNE), Madrid, Spain;2. Preventive Medicine and Public Health, University School of Medicine, Autónoma University, Madrid, Spain;1. Centre for Infectious Disease Control, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands;2. Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children’s Hospital, University Medical Center, Utrecht, The Netherlands;3. Department of Medical Microbiology and Infection Control, VU University Medical Center, The Netherlands |
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| Abstract: | Immune responses to the capsular polysaccharide administered in the polysaccharide-protein conjugate vaccines can be either improved or suppressed by the pre-existence of immunity to the carrier protein. Receiving multiple vaccinations is essential for travellers such as Hajj pilgrims, and the use of conjugated vaccines is recommended.We studied the immune response to meningococcal serogroup W upon prior, concurrent and sequential administration of a quadrivalent meningococcal conjugate vaccine (MCV4) conjugated to CRM197 (coadministered with 13 valent pneumococcal vaccine conjugate CRM197 [PCV13]), and tetanus-diphtheria-acellular pertussis (Tdap) vaccine in Australian adults before attending the Hajj pilgrimage in 2014.Participants were randomly assigned, by computer-generated numbers, to three study arms by 1:1:1 ratio. Group A received Tdap followed by MCV4-CRM197 (+PCV13) 3–4 weeks later. Group B received all three vaccines in a single visit. Group C received MCV4-CRM197 (+PCV13) followed by Tdap 3–4 weeks later. Blood samples obtained prior to and 3–4 weeks after immunisation with MCV4-CRM197 were tested for meningococcal serogroup W-specific serum bactericidal antibody responses using baby rabbit complement (rSBA).One hundred and seven participants aged between 18 and 64 (median 40) years completed the study. No significant difference in meningococcal serogroup W rSBA geometric mean titre (GMT) was observed between the study arms post vaccination with MCV-CRM197 but Group A tended to have a slightly lower GMT (A = 404, B = 984 and C = 1235, p = 0.15). No statistical difference was noticed between the groups in proportions of subjects achieving a ≥4-fold rise in rSBA titres or achieving rSBA titre ≥8 post vaccination.In conclusion, receipt of MCV4-CRM197 vaccine prior, concurrent or subsequent to Tdap has similar immunologic response, and hence concurrent administration is both immunogenic and practical. However, further investigation into whether carrier induced suppression is a public health issue is suggested.Clinical trial registration: ANZCTR no. ACTRN12613000536763. |
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| Keywords: | Meningococcal conjugate vaccine Carrier protein Vaccine interaction Diphtheria, tetanus, acellular pertussis vaccine Serum bactericidal antibody |
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