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

Mohamed Tashani; Al-Mamoon Badahdah; Mohammad Alfelali; Osamah Barasheed; Amani S Alqahtani; Leon Heron; Melanie Wong; Jennifer Louth; Harunor Rashid; Ray Borrow; Robert Booy

doi:10.1016/j.vaccine.2019.05.025

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

Vaccine. 2019 Jun 12;37(27):3562-3567. doi: 10.1016/j.vaccine.2019.05.025. Epub 2019 May 23.

Authors

Affiliations

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; Faculty of Medicine, University of Tripoli, Ain Zara, Tripoli, Libya.
² The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia. Electronic address: almamoon.badahdah@health.nsw.gov.au.
³ The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia.
⁴ The Executive Administration of Research and Innovation, King Abdullah Medical City in Holy Capital (KAMC-HC), Makkah 24246, Saudi Arabia.
⁵ Saudi Food and Drug Authority, Riyadh 13312, Saudi Arabia.
⁶ National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.
⁷ Immunology Department, The Children's Hospital at Westmead, Westmead 2145, NSW, Australia.
⁸ Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.
⁹ The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Sydney, NSW 2145, Australia.
¹⁰ The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Sydney, NSW 2145, Australia; WHO Collaborating Centre for Mass Gatherings and High Consequence/High Visibility Events, Flinders University, Adelaide 5001, Australia.

PMID: 31128875
DOI: 10.1016/j.vaccine.2019.05.025

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.

Keywords: Carrier protein; Diphtheria, tetanus, acellular pertussis vaccine; Meningococcal conjugate vaccine; Serum bactericidal antibody; Vaccine interaction.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Animals
Antibodies, Bacterial / blood
Australia
Crowding
Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage*
Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology*
Female
Humans
Immunization Schedule*
Male
Meningitis, Meningococcal / immunology
Meningitis, Meningococcal / prevention & control*
Meningococcal Vaccines / administration & dosage*
Meningococcal Vaccines / immunology*
Neisseria meningitidis, Serogroup W-135 / immunology*
Religion
Treatment Outcome
Young Adult

Substances

Antibodies, Bacterial
Diphtheria-Tetanus-acellular Pertussis Vaccines
MenACWY-CRM vaccine
Meningococcal Vaccines

Associated data

ANZCTR/ACTRN12613000536763