Results of clinical trial in Russia to assess immunological efficacy and safety of meningococcal vaccine (serogroups A, C, Y, W, X) in adults

Relevance. The diverse serogroup composition of meningococcal pathogens circulating in different countries, the challenges in predicting serogroup prevalence, migration processes, and the active aerosol transmission mechanism of meningococcal infection necessitate the use of vaccines with the broadest possible serogroup coverage for effective prevention.
Aim. To evaluate the immunological efficacy and safety of the MENVAID® vaccine for the prevention of meningococcal infections caused by serogroups A, C, Y, W, and X in the Russian Federation.
Materials and Methods. The immunological efficacy and safety of the MENVAID® vaccine were assessed in a prospective, comparative, randomized, double-blind clinical trial with parallel groups involving adult volunteers aged 18 to 65 years. A total of 60 adult volunteers were randomized into two groups in a 1:1 ratio (Group I, n = 30; Group II, n = 30). The comparator vaccine was Menactra®.
Study Results. For all five serogroups included in the MENVAID® vaccine, both the primary and secondary immunogenicity endpoints in adults aged 18–60 years were met in comparison to the reference product (Difference ≤10 %, GMT ratios ≥0.5, respectively), confirming that the immunogenicity of MENVAID® is non-inferior to that of the comparator vaccine, Menactra®. Moreover, MENVAID® demonstrated significantly higher GMT levels for serogroups C, Y, and W compared to the comparator vaccine. In total, 132 adverse events (AEs) were reported during the study in adults, of which 124 were related to vaccine administration and were represented by local and systemic reactions: 66 AEs were recorded in Group I participants (220 %), and 58 AEs in Group II participants (193.3 %). No statistically significant difference in the number of AEs between the groups was observed. No serious adverse events (SAEs) were reported during the study.
Conclusion. The MENVAID® vaccine for the prevention of meningococcal infection caused by serogroups A, C, Y, W, and X demonstrated non-inferior efficacy and comparable safety to the comparator vaccine when administered to healthy individuals aged 18 to 60 years.

1. Nadel S, Ninis N. Invasive Meningococcal Disease in the Vaccine Era. Frontiers in Pediatrics. 2018; 6: 321.

2. Cabellos C, Pelegrin I, Benavent E, et al. Invasive Meningococcal Disease: What We Should Know, Before It Comes Back. Open Forum Infectious Diseases. 2019; 3 (6). Ofz059.

3. Jafri R.Z., Ali A., Messonnier N.E., et al. Global epidemiology of invasive meningococcal disease. Popul. Health Metr. 2013; (11): 17.

4. Wang B., Santoreneos R., Giles L., et al. Case fatality rates of invasive meningococcal disease by serogroup and age: a systematic review and meta-analysis. Vaccine 2019; 37: 2768–82.

5. Dretler, A. W., Rouphael, N. G., & Stephens, D. S. (2018). Progress toward the global control of Neisseria meningitidis: 21st century vaccines, current guidelines, and challenges for future vaccine development. Human vaccines & immunotherapeutics, 14(5), 1146-1160.

6. Christensen H., May M., Bowen L., et al. Meningococcal carriage by age: a systematic review and meta-analysis. Lancet Infect. Dis. 2010; (10): 853–61.

7. Cohn AC, MacNeil JR, Clark TA, et al. Prevention and control of meningococcal disease recommendations of the advisory committee on immunization practices (ACIP). MMWR Recomm Rep. 2013;62(2):1–32.

8. Villena, R., Safadi, M. A. P., Valenzuela, M. T., et al. (2018). Global epidemiology of serogroup B meningococcal disease and opportunities for prevention with novel recombinant protein vaccines. Human vaccines & immunotherapeutics, 14(5), 1042–1057.

9. Bolgiano B, Moran E, Beresford NJ, et al. Evaluation of critical quality attributes of a pentavalent (A, C, Y, W, X) meningococcal conjugate vaccine for global use. Pathogens. 2021 Jul 23;10(8):928.

10. Diallo F, Haidara FC, Tapia MD, et al. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine targeting serogroups A, C, W, Y, and X when coadministered with routine childhood vaccines at ages 9 months and 15 months in Mali: a single-centre, double-blind, randomised, controlled, phase 3, non-inferiority trial. The Lancet. 2025 Mar 29;405(10484):1069-80.

11. Haidara FC, Umesi A, Sow SO, et al. Meningococcal ACWYX conjugate vaccine in 2-to-29-year-olds in Mali and Gambia. New England Journal of Medicine. 2023 May 25;388(21):1942-55.

12. Tapia MD, Sow SO, Naficy A, et al. Meningococcal serogroup ACWYX conjugate vaccine in Malian toddlers. New England Journal of Medicine. 2021 Jun 3;384(22):2115-23.

13. Kulkarni PS, Kawade A, Kohli S, et al. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study. The Lancet Infectious Diseases. 2025 Apr 1;25(4):399-410.

14. Chen WH, Neuzil KM, Boyce CR, et al. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, Y, W, and X in healthy adults: a phase 1, single-centre, double-blind, randomised, controlled study. Lancet Infect Dis. 2018 Oct;18(10):1088-1096. doi: 10.1016/S1473-3099(18)30400-6.

15. Caugant D.A., Brynildsrud O.B. Neisseria meningitidis: using genomics to understand diversity, evolution and pathogenesis // Nature Reviews Microbiology. 2019. Vol. 18, N 2. P. 84–96.

16. Peterson M.E., Li Y., Bita A., et al. Meningococcal Surveillance Group. Meningococcal serogroups and surveillance: A systematic review and survey. J. Glob. Health. 2019;9:010409.

17. McAlpine A., Sadarangani M. Meningitis vaccines in children: What have we achieved and where next? Curr. Opin. Infect. Dis. 2019;32:510–516.

18. Giada Maria Di Pietro, Giulia Biffi, Massimo Luca Castellazzi, et al. Meningococcal Disease in Pediatric Age: A Focus on Epidemiology and Prevention// Int J Environ Res Public Health. 2022;19(7):4035-4051.

19. Purmohamad A., Abasi E., Azimi T. Global estimate of Neisseria meningitidis serogroups proportion in invasive meningococcal disease: A systematic review and metaanalysis. Microbial Pathogenesis. 2019;134:103571.

20. Brady R.C. Meningococcal Infections in Children and Adolescents: Update and Prevention. Adv. Pediatr. 2020;67:29–46.

21. McCarthy P.C., Sharyan A., Sheikhi Moghaddam L. Meningococcal vaccines: current status and emerging strategies. Vaccines (Basel). 2018;6(1):12.