Meningococcal polysaccharide A O-acetylation levels do not impact the immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate vaccine: Results from a randomized, controlled phase III study of healthy adults aged 18 to 25 years

Clinical and Vaccine Immunology

Volumn 20, Issue 10, 2013, Pages 1499-1507

  Lupisan, Socorro ^a   Limkittikul, Kriengsak ^b   Sosa, Nestor ^c   Chanthavanich, Pornthep ^b   Bianco, Véronique ^d   Baine, Yaela ^e   Van Der Wielen, Marie ^d   Miller, Jacqueline M ^e  

^a RESEARCH INSTITUTE FOR TROPICAL MEDICINE   (Philippines)

^b MAHIDOL UNIVERSITY   (Thailand)

^c Pan American Medical Research Center   (Panama)

^d GSK   (Belgium)

^e GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL POLYSACCHARIDE; MENINGOCOCCUS VACCINE;

ACETYLATION; ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; ATOPIC DERMATITIS; BLIGHTED OVUM; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE PAIN; MALE; MENINGOCOCCOSIS; MIGRAINE; MULTICENTER STUDY; NORMAL HUMAN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROTYPE; SERUM BACTERICIDAL ACTIVITY;

ACETYLATION; ADOLESCENT; ADULT; BLOOD BACTERICIDAL ACTIVITY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FATIGUE; FEMALE; HEADACHE; HEALTHY VOLUNTEERS; HUMANS; MALE; MENINGOCOCCAL VACCINES; PAIN; POLYSACCHARIDES, BACTERIAL; VACCINES, CONJUGATE; YOUNG ADULT;

EID: 84886732590     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00162-13     Document Type: Article

References (49)

1. Findlow J, Balmer P, Yero D, Niebla O, Pajon R, Borrow R. 2007. Neisseria vaccines 2007. Expert Rev. Vaccines 6:485-489.
2. Harrison LH, Trotter CL, Ramsay ME. 2009. Global epidemiology of meningococcal disease. Vaccine 27(Suppl 2):B51-B63.
3. Pollard AJ. 2004. Global epidemiology of meningococcal disease and vaccine efficacy. Pediatr. Infect. Dis. J. 23:S274-S279.
4. Rouphael NG, Stephens DS. 2012. Neisseria meningitidis: biology, microbiology, and epidemiology. Methods Mol. Biol. 799:1-20.
5. Khatami A, Pollard AJ. 2010. The epidemiology of meningococcal disease and the impact of vaccines. Expert Rev. Vaccines 9:285-298.
6. Harrison LH, Pass MA, Mendelsohn AB, Egri M, Rosenstein NE, Bustamante A, Razeq J, Roche JC. 2001. Invasive meningococcal disease in adolescents and young adults. JAMA 286:694-699.
7. Harrison LH. 2010. Epidemiological profile of meningococcal disease in the United States. Clin. Infect. Dis. 50(Suppl 2):S37-S44.
8. Stephens DS. 2007. Conquering the meningococcus. FEMS Microbiol. Rev. 31:3-14.
9. Caugant DA, Maiden MC. 2009. Meningococcal carriage and disease: population biology and evolution. Vaccine 27(Suppl 2):B64 -B70.
10. Tan LK, Carlone GM, Borrow R. 2010. Advances in the development of vaccines against Neisseria meningitidis. N. Engl. J. Med. 362:1511-1520.
11. Efron AM, Sorhouet C, Salcedo C, Abad R, Regueira M, Vázquez JA. 2009. W135 invasive meningococcal strains spreading in South America: significant increase in incidence rate in Argentina. J. Clin. Microbiol. 47:1979-1980.
12. von Gottberg A, du Plessis M, Cohen C, Prentice E, Schrag S, de Gouveia L, Coulson G, de Jong G, Klugman K, Group for Enteric Respiratory and Meningeal Disease Surveillance in South Africa. 2008. Emergence of endemic serogroup W135 meningococcal disease associated with a high mortality rate in South Africa. Clin. Infect. Dis. 46:377-386.
13. Sáfadi MAP, González-Ayala S, Jäkel A, Wieffer H, Moreno C, Vyse A. 2013. The epidemiology of meningococcal disease in Latin America 1945-2010: an unpredictable and changing landscape. Epidemiol. Infect. 141:447-458.
14. Vyse A, Wolter JM, Chen J, Ng T, Soriano-Gabarro M. 2011. Meningococcal disease in Asia: an under-recognized public health burden. Epidemiol. Infect. 139:967-985.
15. Shao PL, Chang LY, Hsieh SM, Chang SC, Pan SC, Lu CY, Hsieh YC, Lee CY, Dobbelaere K, Boutriau D, Tang H, Bock HL, Huang LM. 2009. Safety and immunogenicity of a tetravalent polysaccharide vaccine against meningococcal disease. J. Formos. Med. Assoc. 108:539-547.
16. Harrison LH. 2006. Prospects for vaccine prevention of meningococcal infection. Clin. Microbiol. Rev. 19:142-164.
17. Terranella A, Cohn A, Clark T. 2011. Meningococcal conjugate vaccines: optimizing global impact. Infect. Drug Resist. 4:161-169.
18. Borrow R, Miller E. 2006. Long-term protection in children with meningococcal C conjugate vaccination: lessons learned. Expert Rev. Vaccines 5:851-857.
19. Khatami A, Peters A, Robinson H, Williams N, Thompson A, Findlow H, Pollard AJ, Snape MD. 2011. Maintenance of immune response throughout childhood following serogroup C meningococcal conjugate vaccination in early childhood. Clin. Vaccine Immunol. 18:2038-2042.
20. Maiden MC, Ibarz-Pavon AB, Urwin R, Gray SJ, Andrews NJ, Clarke SC, Walker AM, Evans MR, Kroll JS, Neal KR, Ala'aldeen DA, Crook DW, Cann K, Harrison S, Cunningham R, Baxter D, Kaczmarski E, Maclennan J, Cameron JC, Stuart JM. 2008. Impact of meningococcal serogroup C conjugate vaccines on carriage and herd immunity. J. Infect. Dis. 197:737-743.
21. Centers for Disease Control and Prevention. 2011. Recommendation of the Advisory Committee on Immunization Practices (ACIP) for use of quadrivalent meningococcal conjugate vaccine (MenACWY-D) among children aged 9 through 23 months at increased risk for invasive meningococcal disease. MMWR Morb. Mortal. Wkly. Rep. 60:1391-1392.
22. Sanofi Pasteur. 2011. Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) prescribing information. Sanofi Pasteur, Swiftwater, PA. http://www.fda.gov/downloads/ biologicsbloodvaccines/vaccines/approvedproducts/ucm131170.pdf.
23. Australian Government Department of Health and Ageing. 2011. Australian public assessment report for groups A, C, Y and W-135 meningococcal polysaccharide diphtheria toxoid conjugate vaccine. Australian Government Department of Health and Ageing, Woden, Australia. http://www.tga.gov.au/pdf/ auspar/auspar-menactra-110929.pdf.
24. Cooper B, DeTora L, Stoddard J. 2011. MenveoR: a novel quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135 and Y. Expert Rev. Vaccines 10:21-33.
25. Deeks ED. 2010. Meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (Menveo): in adolescents and adults. BioDrugs 24:287-297.
26. Lee B. 2012. Meningococcal vaccines. Novartis Vaccines and Diagnostics, Basel, Switzerland. http://orion.pleksus.com.tr/puader/v2/files/file/pdf/sunum- 2012/PUADER-Congress-Meningococcal-Vaccines-LEE-FINAL.pdf.
27. Australian Government Department of Health and Ageing. 2010. Australian public assessment report for meningococcal conjugated vaccine. Australian Government Department of Health and Ageing, Woden, Australia. http://www.tga.gov.au/pdf/auspar/auspar-menveo.pdf.
28. Berry DS, Lynn F, Lee CH, Frasch CE, Bash MC. 2002. Effect of O acetylation of Neisseria meningitidis serogroup A capsular polysaccharide on development of functional immune responses. Infect. Immun. 70:3707-3713.
29. Andrews N, Borrow R, Miller E. 2003. Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England. Clin. Diagn. Lab. Immunol. 10:780-786.
30. Borrow R, Balmer P, Miller E. 2005. Meningococcal surrogates of protection: serum bactericidal antibody activity. Vaccine 23:2222-2227.
31. Centers for Disease Control and Prevention. 2006. Inadvertent misadministration of meningococcal conjugate vaccine: United States, June-August 2005. MMWR Morb. Mortal. Wkly. Rep. 55:1016-1017.
32. 13C-nuclear magnetic resonance spectroscopy. J. Infect. Dis. 136(Suppl 1):S78-S83.
33. 1H NMR assignment and detailed O-acetylation patterns of capsular polysaccharides from Neisseria meningitidis used in vaccine production. Carbohydr. Res. 296:83-96.
34. Dbaibo G, Van der Wielen M, Reda M, Medlej F, Tabet C, Boutriau D, Sumbul A, Anis S, Miller JM. 2012. The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine. Int. J. Infect. Dis. 16:e608-e615.
35. Ostergaard L, Lebacq E, Poolman J, Maechler G, Boutriau D. 2009. Immunogenicity, reactogenicity and persistence of meningococcal A, C, W-135 and Y-tetanus toxoid candidate conjugate (MenACWY-TT) vaccine formulations in adolescents aged 15-25 years. Vaccine 27:161-168.
36. Dbaibo G, Macalalad N, Aplasca-De Los Reyes MR, Dimaano E, Bianco V, Baine Y, Miller J. 2012. The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine: a randomized, controlled non-inferiority study. Hum. Vaccin. Immunother. 8:873-880.
37. Lechevin I, Le Bras V, Lestrate PR, Wauters D. 2012. Identification of key parameters that impact the sensitivity of the MenC-rSBA assay to natural antibodies, abstr P 145. Programme XVIIIth Int. Pathogenic Neisseria Conf., Würzburg, Germany, 9 to 14 September 2012.
38. Campbell JD, Edelman R, King JC, Jr, Papa T, Ryall R, Rennels MB. 2002. Safety, reactogenicity, and immunogenicity of a tetravalent meningococcal polysaccharide-diphtheria toxoid conjugate vaccine given to healthy adults. J. Infect. Dis. 186:1848-1851.
39. Kshirsagar N, Mur N, Thatte U, Gogtay N, Viviani S, Preziosi MP, Elie C, Findlow H, Carlone G, Borrow R, Parulekar V, Plikaytis B, Kulkarni P, Imbault N, LaForce FM. 2007. Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults. Vaccine 25(Suppl 1):A101-A107.
40. Goldschneider I, Gotschlich EC, Artenstein MS. 1969. Human immunity to the meningococcus. II. Development of natural immunity. J. Exp. Med. 129:1327-1348.
41. Ibarz-Pavón AB, Lemos AP, Gorla MC, Regueira M, SIREVA Working Group II, Gabastou JM. 2012. Laboratory-based surveillance of Neisseria meningitidis isolates from disease cases in Latin American and Caribbean countries, SIREVA II 2006-2010. PLoS One 7:e44102. doi:10.1371/journal.pone. 0044102.
42. Baxter R, Baine Y, Ensor K, Bianco V, Friedland LR, Miller JM. 2011. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age. Pediatr. Infect. Dis. J. 30:e41-e48.
43. Ostergaard L, Silfverdal SA, Berglund J, Flodmark CE, West C, Bianco V, Baine Y, Miller JM. 2012. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix® in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine 30:774-783.
44. Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. 2011. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum. Vaccin. 7:239-247.
45. Knuf M, Kieninger-Baum D, Habermehl P, Muttonen P, Maurer H, Vink P, Poolman J, Boutriau D. 2010. A dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young children. Vaccine 28:744-753.
46. Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. 2011. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr. Infect. Dis. J. 30:e56-e62.
47. Black S, Klein NP, Shah J, Bedell L, Karsten A, Dull PM. 2010. Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine 28:657-663.
48. Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A. 2005. Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch. Pediatr. Adolesc. Med. 159:907-913.
49. Wassilak SG, Roper MH, Murphy TV, Orenstein WA. 2004. Tetanus toxoid, p 766. In Plotkin SA, Orenstein WA (ed), Vaccines, 4th ed. WB Saunders Co., Philadelphia, PA.