Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT): A review of the evidence and expert opinion

ABSTRACT

Introduction

Serogroups A, B, C, W, X, and Y of Neisseria meningitidis are responsible for almost all cases of invasive meningococcal disease. In Italy, vaccination against serogroup B is recommended at 3–13 months, C at 13–15 months, and A, C, Y and W in adolescents (12–18 years). Four quadrivalent meningococcal conjugate vaccines are available. This review describes the available data on a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT; MenQuadfi®; Sanofi).

Areas covered

We identified articles on quadrivalent meningococcal conjugate vaccines indexed on PubMed since 2000. Of the 524 studies identified, 10 human studies investigating the immunogenicity and safety of MenACYW-TT in toddlers, children aged 2–9 years, and individuals 10–55 or ≥56 years are described in detail.

Expert opinion

In Italy, pediatric and public health groups recommend amending the current vaccination schedule to include a booster dose between 6 and 9 years and quadrivalent vaccine in young adults (≥19 years), targeting waning protection after childhood vaccination and the age cohort with the highest carrier prevalence (adolescents and young adults). MenACYW-TT is a suitable meningococcal vaccine for current and pending recommendations based on high seroprotection rates and a low incidence of adverse events in these age groups. Moreover, it does not require reconstitution.

KEYWORDS:

• Invasive meningococcal disease
• immunogenicity
• vaccine
• MenACYW-TT
• Neisseria meningitidis

Article highlights

• This paper reviews the available data on the immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT MenQuadfi®, Sanofi) and provides perspectives on its use for the prevention of invasive meningococcal disease.

• Overall, MenACYW-TT has shown high rates of seroprotection in all age groups (toddlers [12–24 months], children [2–9 years], ages 10–55 years, and ages ≥56 years), and no safety issues have been observed in clinical trials. In addition, MenACYW-TT demonstrates superior immune response against serogroup C versus existing monovalent and quadrivalent vaccines.

• A quadrivalent vaccine that does not require reconstitution, such as MenACYW-TT, and has the advantage of providing broad protection against multiple serogroups can help in meeting new vaccination targets.

Acknowledgments

The authors would like to thank Patrick Moore and Ray Hill who provided medical writing assistance on behalf of Springer Healthcare Communications prior to submission and Catherine Rees who provided medical writing assistance post-submission, also on behalf of Springer Healthcare Communications. Editorial assistance and manuscript coordination support were provided by Anirban Sanyal, PhD (Sanofi). This medical writing assistance was funded by Sanofi.

Declaration of interest

S Ricci received a contribution from Sanofi to create a database (meningococcal carriage), payment for an Interview ‘Vaccines during Covid Pandemia’ from MSD, and financial support for attending meetings from Behring. E Amodio participated in Advisory Boards for Janssen Italia, AstraZeneca, MSD, Pfizer, and GSK. P Castiglia participated in Advisory Boards for AstraZeneca, GSK, Janssen Italia, Moderna, MSD, Pfizer, and Sanofi. C Azzari received grants from Sanofi, Merck, MSD, and GSK, consulting fees from Sanofi, Merck, MSD, and GSK, payment for lectures from Sanofi, Merck, MSD, and GSK and participated in Advisory Board for Sanofi, Merck, MSD, and GSK. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or material discussed in the manuscript.

Reviewer disclosures

A reviewer of this manuscript has participated in Advisory Boards for meningococcal vaccines for Sanofi Pasteur, GSK, and Pfizer. Peer reviewers of this manuscript have no other relevant financial or other relationships to disclose.

Author contributions

All listed authors made substantial contributions to the conception and design of the review, drafting the article and revising it critically for important intellectual content. All authors provided final approval of the version submitted. All authors attest that they meet the ICMJE criteria for authorship.

Data availability statement

Data sharing is not applicable to this article, as no new data were created or analyzed in this study.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

The project and the development of the manuscript were funded by Sanofi. None of the authors received financial support for the writing of the article.