Improving the immunogenicity of pneumococcal conjugate vaccine in HIV-infected adults with a toll-like receptor 9 agonist adjuvant: A randomized, controlled trial

Clinical Infectious Diseases

Volumn 51, Issue 1, 2010, Pages 42-50

  Segaard, Ole S ^a   Lohse, Nicolai ^a   Harboe, Zitta B ^b   Offersen, Rasmus ^a   Bukh, Anne R ^a   Davis, Heather L ^c   Schønheyder, Henrik C ^a   Østergaard, Lars ^a  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b STATENS SERUM INSTITUT   (Denmark)

^c PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGATOLIMOD; IMMUNOGLOBULIN G; PLACEBO; PNEUMO NOVUM; PNEUMOCOCCUS VACCINE; UNCLASSIFIED DRUG;

ADULT; ARTHRALGIA; ARTICLE; CD4 LYMPHOCYTE COUNT; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG POTENTIATION; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FLU LIKE SYNDROME; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; IMMUNIZATION; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALAISE; MALE; MYALGIA; NAUSEA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMOCOCCAL INFECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROTYPE; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADJUVANTS, IMMUNOLOGIC; ADULT; AIDS-RELATED OPPORTUNISTIC INFECTIONS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4 LYMPHOCYTE COUNT; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HUMANS; IMMUNOGLOBULIN G; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; PNEUMOCOCCAL VACCINES; PNEUMONIA, PNEUMOCOCCAL; RNA, VIRAL; TOLL-LIKE RECEPTOR 9; VACCINES, CONJUGATE;

EID: 77952898416     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/653112     Document Type: Article

References (37)

1. Sogaard OS, Lohse N, Gerstoft J, et al. Hospitalization for pneumonia among individuals with and without HIV infection, 1995-2007: a Danish population-based, nationwide cohort study. Clin Infect Dis 2008; 47:1345-1353.
2. Nuorti JP, Butler JC, Gelling L, Kool JL, Reingold AL, Vugia DJ. Epidemiologic relation between HIV and invasive pneumococcal disease in San Francisco County, California. Ann Intern Med 2000; 132:182-190. (Pubitemid 30064917)
3. Redd SC, Rutherford GW III, Sande MA, et al. The role of human immunodeficiency virus infection in pneumococcal bacteremia in San Francisco residents. J Infect Dis 1990;162:1012-1017. (Pubitemid 20353577)
4. Barry PM, Zetola N, Keruly JC, Moore RD, Gebo KA, Lucas GM. Invasive pneumococcal disease in a cohort of HIV-infected adults: incidence and risk factors, 1990-2003. AIDS 2006;20:437-444.
5. Grau I, Pallares R, Tubau F, et al. Epidemiologic changes in bacteremic pneumococcal disease in patients with human immunodeficiency virus in the era of highly active antiretroviral therapy. Arch Intern Med 2005;165:1533-1540. (Pubitemid 41058035)
6. Nielsen H, Kvinesdal B, Benfield TL, Lundgren JD, Konradsen HB. Rapid loss of specific antibodies after pneumococcal vaccination in patients with human immunodeficiency virus-1 infection. Scand J Infect Dis 1998;30:597-601. (Pubitemid 29145749)
7. Kroon FP, van Dissel JT, Ravensbergen E, Nibbering PH, van Furth R. Antibodies against pneumococcal polysaccharides after vaccination in HIV-infected individuals: 5-year follow-up of antibody concentrations. Vaccine 1999;18:524-530. (Pubitemid 29462610)
8. Rodriguez-Barradas MC, Groover JE, Lacke CE, et. al. IgG antibody to pneumococcal capsular polysaccharide in human immunodeficiency virus-infected subjects: persistence of antibody in responders, revaccination in nonresponders, and relationship of immunoglobulin allotype to response. J Infect Dis 1996; 173:1347-1353.
9. French N, Nakiyingi J, Carpenter LM, et al. 23-valent pneumococcal polysaccharide vaccine in HIV-1-infected Ugandan adults: double-blind, randomised and placebo controlled trial. Lancet 2000;355:2106-2111. (Pubitemid 30364659)
10. Rodriguez-Barradas MC, Goulet J, Brown S, et al. Impact of pneumococcal vaccination on the incidence of pneumonia by HIV infection status among patients enrolled in the veterans aging cohort site study. Clin Infect Dis 2008;46:1093-1100. (Pubitemid 351589878)
11. Whitney CG, Farley MM, Hadler J, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med 2003;348:1737-1746. (Pubitemid 36514704)
12. Rodriguez-Barradas MC, Alexandraki I, Nazir T, et al. Response of human immunodeficiency virus-infected patients receiving highly active antiretroviral therapy to vaccination with 23-valent pneumococcal polysaccharide vaccine. Clin Infect Dis 2003; 37:438-447. (Pubitemid 36976504)
13. Kroon FP, van Dissel JT, Ravensbergen E, Nibbering PH, van Furth R. Enhanced antibody response to pneumococcal polysaccharide vaccine after prior immunization with conjugate pneumococcal vaccine in HIV-infected adults. Vaccine 2000; 19:886-894.
14. Feikin DR, Elie CM, Goetz MB, et al. Specificity of the antibody response to the pneumococcal polysaccharide and conjugate vaccines in human immunodeficiency virus-infected adults. Clin Diagn Lab Immunol 2004;11:137-141.
15. Krieg AM. Therapeutic potential of Toll-like receptor 9 activation. Nat Rev Drug Discov 2006; 5:471-484. (Pubitemid 44136959)
16. Chu RS, McCool T, Greenspan NS, Schreiber JR, Harding CV. CpG oligodeoxynucleotides act as adjuvants for pneumococcal polysaccharide-protein conjugate vaccines and enhance antipolysaccharide immunoglobulin G2a (IgG2a) and IgG3 antibodies. Infect Immun 2000; 68: 1450-1456.
17. Sen G, Chen Q, Snapper CM. Immunization of aged mice with a pneumococcal conjugate vaccine combined with an unmethylated CpG-containing oligodeoxynucleotide restores defective immunoglobulin G antipolysaccharide responses and specific CD4+-T-cell priming to young adult levels. Infect Immun 2006;74:2177-2186.
18. Kovarik J, Bozzotti P, Tougne C, et al. Adjuvant effects of CpG oli-godeoxynucleotides on responses against T-independent type 2 antigens. Immunology 2001; 102:67-76. (Pubitemid 32142516)
19. Cooper CL, Davis HL, Angel JB, et al. CPG 7909 adjuvant improves hepatitis B virus vaccine seroprotection in antiretroviral-treated HIVinfected adults. AIDS 2005; 19:1473-1479.
20. Cooper CL, Davis HL, Morris ML, et al. CPG 7909, an immunostimulatory TLR9 agonist oligodeoxynucleotide, as adjuvant to EngerixB HBV vaccine in healthy adults: a double-blind phase I/II study. J Clin Immunol 2004;24:693-701.
21. Cooper CL, Davis HL, Morris ML, et al. Safety and immunogenidty of CPG 7909 injection as an adjuvant to Fluarix influenza vaccine. Vaccine 2004;22:3136-3143.
22. Mullen GE, Ellis RD, Miura K, et al. Phase 1 trial of AMA1-C1/A1hydrogel plus CPG 7909: an asexual blood-stage vaccine for Plasmodium falciparum malaria. PLoS ONE 2008;3:e2940.
23. Abraham-Van Parijs B. Review of pneumococcal conjugate vaccine in adults: implications on clinical development. Vaccine 2004; 22:1362-1371. (Pubitemid 38446912)
24. Jackson LA, Neuzil KM, Nahm MH, et al. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine 2007; 25:4029-4037.
25. Konradsen HB, Sorensen UB, Henrichsen J. A modified enzyme-linked immunosorbent assay for measuring type-specific anti-pneumococcal capsular polysaccharide antibodies. J Immunol Methods 1993; 164: 13-20. (Pubitemid 23269918)
26. Skovsted IC, Kerrn MB, Sonne-Hansen J, et al. Purification and structure characterization of the active component in the pneumococcal 22F polysaccharide capsule used for adsorption in pneumococcal enzyme-linked immunosorbent assays. Vaccine 2007;25:6490-6500. (Pubitemid 47198920)
27. Martinez JE, Clutterbuck EA, Li H, Romero-Steiner S, Carlone GM. Evaluation of multiplex flow cytometric opsonophagocytic assays for determination of functional anticapsular antibodies to Streptococcus pneumoniae. Clin Vaccine Immunol 2006;13:459-466. (Pubitemid 44044831)
28. Trotti A, Byhardt R, Stetz J, et al. Common toxicity criteria: version 2.0. an improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys 2000;47:13-47.
29. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 2009. http://www.ich.org/cache/compo/276-254-1.html. Accessed 1 February 2010.
30. Lesprit P, Pedrono G, Molina JM, et al. Immunological efficacy of a prime-boost pneumococcal vaccination in HIV-infected adults. AIDS 2007;21:2425-2434.
31. Fletcher RWF. Clinical epidemiology: the essentials. 4th ed. Baltimore, MD: Lippincott Williams & Wilkins, 2005.
32. Higgins D, Marshall JD, Traquina P, Van Nest G, Livingston BD. Immunostimulatory DNA as a vaccine adjuvant. Expert Rev Vaccines 2007;6:747-759.
33. Aebig JA, Mullen GE, Dobrescu G, et al. Formulation of vaccines containing CpG oligonucleotides and alum. J Immunol Methods 2007; 323: 139-146.
34. Siber GR, Chang I, Baker S, et. al. Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies. Vaccine 2007;25:3816-3826.
35. Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr Infect Dis J 2000;19:187-195. (Pubitemid 30167436)
36. Cooper CL, Angel JB, Seguin I, Davis HL, Cameron DW. CPG 7909 adjuvant plus hepatitis B virus vaccination in HIV-infected adults achieves long-term seroprotection for up to 5 years. Clin Infect Dis 2008;46:1310-1314. (Pubitemid 351589919)
37. Jackson LA, Neuzil KM., Whitney CG, et al. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine 2005;23:3697-3703.