Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults

Journal of Travel Medicine

Volumn 22, Issue 2, 2015, Pages 105-114

  Alberer, Martin ^a   Burchard, Gerd ^b   Jelinek, Tomas ^c   Reisinger, Emil C ^d   Meyer, Seetha ^e   Forleo Neto, Eduardo ^f   Dagnew, Alemnew F ^f   Arora, Ashwani Kumar ^g  

^a UNIVERSITY OF MUNICH   (Germany)

^b UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^c Berlin Center for Travel and Tropical Medicine   (Germany)

^d ROSTOCK UNIVERSITY MEDICAL CENTER   (Germany)

^e Novartis Vaccines   (Germany)

^f Novartis Vaccines Cambridge   (United States)

^g NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DIPHTHERIA TOXOID CRM197; HEPATITIS A HEPATITIS B VACCINE; HEPATITIS A VACCINE; HEPATITIS B SURFACE ANTIGEN; MENINGOCOCCUS VACCINE; RECOMBINANT HEPATITIS B VACCINE; HEPATITIS B VACCINE; VACCINE;

ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTHRALGIA; ARTICLE; CHILL; CONTROLLED STUDY; COUGHING; DIARRHEA; DRUG SAFETY; ERYTHEMA; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; GASTROENTERITIS; HEADACHE; HEPATITIS A; HEPATITIS B; HUMAN; IMMUNOGENICITY; INJECTION SITE INDURATION; INJECTION SITE PAIN; KIDNEY CANCER; MALE; MENINGOCOCCOSIS; MULTICENTER STUDY; MYALGIA; NAUSEA; NORMAL HUMAN; OPEN STUDY; OROPHARYNX PAIN; PHASE 3 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SEROTYPE; SERUM BACTERICIDAL ACTIVITY; SUICIDE; VACCINATION; VERTIGO; ADOLESCENT; ADVERSE DRUG REACTION; CLINICAL TRIAL; GERMANY; IMMUNIZATION; MENINGOCOCCAL INFECTIONS; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; GERMANY; HEPATITIS A; HEPATITIS A VACCINES; HEPATITIS B; HEPATITIS B VACCINES; HUMANS; IMMUNIZATION SCHEDULE; MALE; MENINGOCOCCAL INFECTIONS; MENINGOCOCCAL VACCINES; MIDDLE AGED; TREATMENT OUTCOME; VACCINES, CONJUGATE; YOUNG ADULT;

EID: 84924273041     PISSN: 11951982     EISSN: 17088305     Source Type: Journal    
DOI: 10.1111/jtm.12180     Document Type: Article

References (39)

1. Pace D, Pollard AJ,. Meningococcal disease: clinical presentation and sequelae. Vaccine 2012; 30: B3-B9.
2. Cohn AC, MacNeil JR, Harrison LH, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis 2010; 50: 184-191.
3. Jafri RZ, Ali A, Messonnier NE, et al. Global epidemiology of invasive meningococcal disease. Popul Health Metr 2013; 11: 17.
4. Harrison LH, Trotter CL, Ramsay ME,. Global epidemiology of meningococcal disease. Vaccine 2009; 27: B51-B63.
5. Bruce MG, Rosenstein NE, Capparella JM, et al. Risk factors for meningococcal disease in college students. JAMA 2001; 286: 688-693.
6. 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: 1-28.
7. Steffen R,. The risk of meningococcal disease in travelers and current recommendations for prevention. J Travel Med 2010; 17: 9-17.
8. Taha MK, Achtman M, Alonso JM, et al. Serogroup W135 meningococcal disease in Hajj pilgrims. Lancet 2000; 356: 2159.
9. Aguilera JF, Perrocheau A, Meffre C, Hahne S,. Outbreak of serogroup W135 meningococcal disease after the Hajj pilgrimage, Europe, 2000. Emerg Infect Dis 2002; 8: 761-767.
10. Keyserling H, Papa T, Koranyi K, et al. 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 2005; 159: 907-913.
11. Croxtall JD, Dhillon S,. Meningococcal quadrivalent (serogroups A, C, W135 and Y) tetanus toxoid conjugate vaccine (Nimenrix). Drugs 2012; 72: 2407-2430.
12. Broker M, Cooper B, Detora LM, Stoddard JJ,. Critical appraisal of a quadrivalent CRM(197) conjugate vaccine against meningococcal serogroups A, C, W-135 and Y (Menveo) in the context of treatment and prevention of invasive disease. Infect Drug Resist 2011; 4: 137-147.
13. Klein NP, Reisinger KS, Johnston W, et al. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J 2012; 31: 64-71.
14. Black S, Klein NP, Shah J, et al. Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine 2010; 28: 657-663.
15. Jackson LA, Baxter R, Reisinger K, et al. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis 2009; 49: e1-e10.
16. Nolan TM, Nissen MD, Naz A, et al. Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age. Hum Vaccin Immunother 2014; 10: 280-289.
17. Gasparini R, Conversano M, Bona G, et al. Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults. Clin Vaccine Immunol 2010; 17: 537-544.
18. Arguedas A, Soley C, Loaiza C, et al. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine 2010; 28: 3171-3179.
19. Alberer M, Burchard G, Jelinek T, et al. Co-administration of a meningococcal glycoconjugate ACWY vaccine with travel vaccines. Travel Med Infect Dis 2014; 12: 485-493.
20. World Health Organization. Vaccine-preventable diseases and vaccines 2013 update. International Travel and Health 2012 Ed. Geneva, Switzerland: WHO, 2013: 1-62.
21. Johnson DF, Leder K, Torresi J,. Hepatitis B and C infection in international travelers. J Travel Med 2013; 20: 194-202.
22. Wu D, Guo CY,. Epidemiology and prevention of hepatitis A in travelers. J Travel Med 2013; 20: 394-399.
23. Boggild AK, Castelli F, Gautret P, et al. Vaccine preventable diseases in returned international travelers: results from the Geosentinel Surveillance Network. Vaccine 2010; 28: 7389-7395.
24. Lavanchy D,. Worldwide epidemiology of HBV infection, disease burden, and vaccine prevention. J Clin Virol 2005; 34: S1-S3.
25. Keating GM, Noble S,. Recombinant hepatitis B vaccine (Engerix-B): a review of its immunogenicity and protective efficacy against hepatitis B. Drugs 2003; 63: 1021-1051.
26. Kallinowski B, Knoll A, Lindner E, et al. Can monovalent hepatitis A and B vaccines be replaced by a combined hepatitis A/B vaccine during the primary immunization course? Vaccine 2000; 19: 16-22.
27. Nothdurft HD,. Hepatitis A vaccines. Expert Rev Vaccines 2008; 7: 535-545.
28. Nothdurft HD, Dietrich M, Zuckerman JN, et al. A new accelerated vaccination schedule for rapid protection against hepatitis A and B. Vaccine 2002; 20: 1157-1162.
29. Connor BA, Blatter MM, Beran J, et al. Rapid and sustained immune response against hepatitis A and B achieved with combined vaccine using an accelerated administration schedule. J Travel Med 2007; 14: 9-15.
30. Borrow R, Balmer P, Miller E,. Meningococcal surrogates of protection-serum bactericidal antibody activity. Vaccine 2005; 23: 2222-2227.
31. Nascimento Silva JR, Camacho LA, Siqueira MM, et al. Mutual interference on the immune response to yellow fever vaccine and a combined vaccine against measles, mumps and rubella. Vaccine 2011; 29: 6327-6334.
32. Scheifele DW, Halperin SA, Smith B, et al. Assessment of the compatibility of co-administered 7-valent pneumococcal conjugate, DTaP.IPV/PRP-T Hib and hepatitis B vaccines in infants 2-7 months of age. Vaccine 2006; 24: 2057-2064.
33. Dagan R, Poolman JT, Zepp F,. Combination vaccines containing DTPa-Hib: impact of IPV and coadministration of CRM197 conjugates. Expert Rev Vaccines 2008; 7: 97-115.
34. Van Hoecke C, Lebacq E, Beran J, et al. Concomitant vaccination against hepatitis A and typhoid fever. J Travel Med 1998; 5: 116-120.
35. Ostergaard L, Silfverdal SA, Berglund J, et al. A tetravalent meningococcal serogroups A, C, W-135, and T tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix((R)) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine 2012; 30: 774-783.
36. Proell S, Maiwald H, Nothdurft HD, et al. Combined vaccination against hepatitis A, hepatitis B, and typhoid fever: safety, reactogenicity, and immunogenicity. J Travel Med 2002; 9: 122-126.
37. Hohler T, Groeger-Bicanic G, Hoet B, Stoffel M,. Antibody persistence and immune memory elicited by combined hepatitis A and B vaccination in older adults. Vaccine 2007; 25: 1503-1508.
38. Reisinger KS, Baxter R, Block SL, et al. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol 2009; 16: 1810-1815.
39. Stamboulian D, Lopardo G, Lopez P, et al. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis 2010; 14: e868-e875.