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ABSTRACT
Long-term protection against meningococcal disease relies on antibody persistence after vaccination. We report antibody persistence up to 5 y after vaccination in adolescents who received a single dose of either meningococcal serogroups A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT, Pfizer) or MenACWY polysaccharide vaccine (MenPS, GSK Vaccines) at the age of 11–17 y in the randomized controlled primary study NCT00464815. In this phase III, open, controlled, multi-center persistence follow-up study conducted in India and the Philippines (NCT00974363), antibody persistence was evaluated by a serum bactericidal antibody assay using rabbit complement (rSBA) yearly, up to year 5 after vaccination. Serious adverse events (SAEs) related to study participation were recorded. Five years after a single dose of MenACWY-TT, the percentage of participants (N = 236) with rSBA titers ≥1:8 was 97.5% for serogroup A, 88.6% for serogroup C, 86.0% for serogroup W and 96.6% for serogroup Y. The percentages in the MenPS group (N = 86) were 93.0%, 87.1%, 34.9% and 66.3%, respectively. Exploratory analysis indicated a higher percentage of subjects with rSBA titers ≥1:8 for serogroups W and Y, and higher rSBA geometric mean antibody titers for serogroups A, W and Y in the MenACWY-TT group than the MenPS group at each time point (years 3, 4 and 5). No differences between groups were observed for serogroup C. No SAEs related to study participation were reported. In conclusion, the results of this follow-up study indicate that antibodies persisted up to 5 y after a single dose of MenACWY-TT in adolescents.
Abbreviations
| ATP | = | According–to-protocol |
| CI | = | Confidence interval |
| CRM | = | cross-reactive material |
| DT | = | Diphtheria toxoid |
| GMT | = | Geometric mean antibody titer |
| IMD | = | Invasive meningococcal disease |
| rSBA | = | Serum bactericidal antibody assay using rabbit complement |
| MenACWY-TT | = | Pfizer's quadrivalent meningococcal serogroups A, C, W and Y vaccine conjugated to tetanus toxoid |
| MenPS | = | Quadrivalent meningococcal serogroups A, C, W and Y polysaccharide vaccine |
| PHE | = | Public Health England |
| SD | = | Standard deviation |
| TT | = | Tetanus toxoid |
| UK | = | United Kingdom |
| US | = | United States |
Disclosure of potential conflicts of interest
BPQ received research grants and consulting fee to conduct the present study and support for meetings, travel or accommodation expenses in the past 5 y from the GSK group of companies. BPQ also received payment for service on speakers' bureaus from Sanofi Pasteur. The institute of BPQ received fee for the present study from the GSK group of companies. The institute of AB received grants to conduct the present study and other clinical trials and for attending investigator meetings from the GSK group of companies. Dr AB also received support from the GSK group of companies for attending vaccinology meetings. The institution of APD received money from the GSK group of companies for Ethics Committee fees and for each subject enrolled (Payment to MAMC Society for Promotion of Medical Research). APD also received support from the GSK group of companies for travel to Investigator meeting. JH declares that he has no competing interests.
VB, DK, MVDW and JMM are employees of GSK Vaccines. MVDW declares stock ownership in the GSK group of companies. JM declares restricted share in the GSK group of companies.
Acknowledgments
The authors are indebted to the study participants, clinicians, nurses, and laboratory technicians at the study site, as well as to clinical investigators for their contribution to this study. In particular we thank Dr Sonia T. Carlos. We also thank the following employees of GSK Vaccines for their valuable contributions: Gulhan Denizer for assistance in preparation of, or contribution to, protocols and study reports; Shailesh Mehta and Salvacion Gatchalian for their assistance in coordination of the study; Emmanuel Aris, Laurence Fissette and Lisa Allamassey for their input into the statistical analysis; and Pascal R. Lestrate for conducting laboratory assays. Medical writing services were provided by Dr Joanne Wolter (independent, on behalf of GSK Vaccines). Dr Regis Azizieh (XPE Pharma & Science, on behalf of GSK Vaccines) provided coordination and editorial assistance.
Funding
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. The corresponding author had full access to the data and was responsible for submission of the publication.
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 participants, the evaluation of any reported adverse events / serious adverse events for severity and causality, the collection and interpretation of the data, and the drafting and approval of the manuscript. JMM, MVDW (clinical development scientists), VB (biostatistician) and DK (biostatistician) are employed by GSK Vaccines and were involved in all stages of the study (study design, data analyses and interpretations, drafting and approval of the manuscript).