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ABSTRACT
Invasive meningococcal disease is a serious infection that is most often vaccine-preventable. Long-term protection relies on antibody persistence. Here we report the persistence of the immune response 2 y post-vaccination with a quadrivalent meningococcal serogroups A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT) compared with a MenACWY polysaccharide vaccine (Men-PS), in Asian adolescents aged 11–17 y. We also report a re-analysis of data from the primary vaccination study. This persistence study (NCT00974363) conducted in India and the Philippines included subjects who previously (study NCT00464815) received a single dose of MenACWY-TT or Men-PS. Persistence of functional antibodies was measured in 407 MenACWY-TT recipients and 132 Men-PS recipients (according-to-protocol cohort) using a rabbit complement serum bactericidal assay (rSBA, cut-off 1:8). Vaccine-related serious adverse events (SAEs) occurring since the end of the initial vaccination study were retrospectively recorded. Two y post-vaccination ≥99.3% of adolescents who received MenACWY-TT had persisting antibody titers ≥1:8 against each vaccine serogroup. Antibody persistence was higher (exploratory analysis) in the MenACWY-TT group than the Men-PS group in terms of rSBA titers ≥1:8 for serogroups W and Y; rSBA titers ≥1:128 for serogroups A, W and Y; and rSBA GMTs for serogroups A, W and Y; and was lower in the MenACWY-TT group for rSBA GMTs for serogroup C. No vaccine-related SAEs were reported. The results of this study indicated that antibodies persisted for at least 2 y in the majority of adolescents after vaccination with a single dose of MenACWY-TT.
Trademarks
MENVEO and BEXSERO are registered trademarks of the GSK group of companies. MENCEVAX and TRUMENBA are registered trademarks of Pfizer. MENACTRA is registered trademark of Sanofi Pasteur. NIMENRIX is a registered trademark of the GSK group of companies, licensed to Pfizer.
Abbreviations
| CI | = | confidence interval |
| GCP | = | Good Clinical Practice guidelines |
| GMT | = | geometric mean antibody titer |
| MenACWY-TT | = | quadrivalent meningococcal serogroups A, C, W and Y vaccine conjugated to tetanus toxoid |
| Men-PS | = | Quadrivalent meningococcal serogroups A, C, W and Y polysaccharide vaccine |
| rSBA | = | serum bactericidal assay using rabbit complement |
| TT | = | tetanus toxoid |
Disclosure of potential conflicts of interest
BPQ declares personal consulting fees, support for meetings, travel or accommodation expenses for the study from GSK group of companies; BPQ reports also personal consulting fees from Sanofi Pasteur for speaker's bureau.
APD and AB declare personal support for traveling to investigator meetings from GSK group of companies; AB declares personal support for congress, travel or accommodation expenses from GSK group of companies.
The institutions of BPQ, AB and APD received grants for conducting the present study from GSK group of companies. HJ declares no conflict of interest.
DK, VB, MVdW and JMM are employees of GSK group of companies. MVdW and JMM declare stock ownership in GSK group of companies.
Acknowledgments
The authors thank the individuals who participated in the study, and all investigators involved in conducting the study. We would also like to thank the following employees of GSK Vaccines for their valuable contributions: Shailesh Mehta and Seona Macgregor for assistance in coordination of the study; Emmanuel Aris for input into statistical analyses and Pascal Lestrate and Nathalie de Schrevel, for conducting the laboratory assays.
Writing services were provided by Joanne Wolter (on behalf of GSK Vaccines) and coordination and editorial assistance by Virginie Durbecq (XPE Pharma & Science on behalf of GSK Vaccines).
Authors' contributions
BPQ, APD, AB and HJ were investigators involved in the supervision of the study, administrative, logistic and technical supports, the recruitment and the medical evaluation of subjects, the evaluation of any reported AEs/SAEs for severity and causality, the collection and interpretation of the data, and the drafting and approval of the manuscript. JMM, MVW (clinical development scientists) and VB (biostatistician) were involved in all stages of the study (study design, data analyses and interpretations, drafting and approval of the manuscript). DK (biostatistician) was involved in re-analysis of the data excluding all subjects with improper consent, data interpretation, drafting and approval of the manuscript.
Funding
This work was supported by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analysis. GlaxoSmithKline Biologicals SA also funded all costs associated with the development and the publishing of the present manuscript. All authors had full access to the data and the corresponding author was responsible for submission of the publication.