1887

Chapter 17 : Immunogenicity and Safety in Adults

MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Ebook: Choose a downloadable PDF or ePub file. Chapter is a downloadable PDF file. File must be downloaded within 48 hours of purchase

Buy this Chapter
Digital (?) $15.00

Preview this chapter:
Zoom in
Zoomout

Immunogenicity and Safety in Adults, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555815820/9781555814083_Chap17-1.gif /docserver/preview/fulltext/10.1128/9781555815820/9781555814083_Chap17-2.gif

Abstract:

During the past decade, a number of studies have evaluated the immunogenicity and safety of various pneumococcal conjugate vaccine (PCV) formulations in immunocompromised and immunocompetent adults. This chapter summarizes the findings from evaluations of PCVs in immunocompetent adults. Two early studies evaluated the immune response to monovalent PCV formulations by using radioimmunoassays, but since that time, all clinical studies of PCVs in immunocompetent adults have assessed the immunoglobulin G (IgG) antibody response by using enzyme-linked immunosorbent assays (ELISAs) and, in some cases, additional immunologic assays, such as the opsonophagocytic assay (OPA). Two studies were conducted among different populations and used different laboratories for the ELISA, which have been standardized to give similar results in different laboratories. The geometric mean concentrations (GMCs) are strikingly similar, suggesting that the administration of pneumococcal polysaccharide vaccine (PPSV) may induce hyporesponsiveness to PCV which persists for at least 5 years. This chapter defines a booster response simply as one involving significantly higher antibody levels in PCV-primed individuals than in unprimed individuals following the administration of the standard licensed dose of PPSV. PCVs are well tolerated in immunocompetent adults. The experience with PCV in adults as described in published reports is limited, and conclusions about the immunogenicity and safety of PCVs must be viewed as preliminary and subject to confirmation in larger, well controlled studies.

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17

Key Concept Ranking

Pneumococcal Conjugate Vaccine
0.61151177
Outer Membrane Proteins
0.46792212
Enzyme-Linked Immunosorbent Assay
0.4378355
0.61151177
Highlighted Text: Show | Hide
Loading full text...

Full text loading...

Figures

Image of Figure 1
Figure 1

ELISA-measured GMC of IgG antibodies following administration of a 0.5-ml dose of PCV7-CRM (7vPnC) to three groups of elderly adults defined by their previous exposure to PPSV (23vPS). The first group consisted of 110 pneumococcal-vaccine-naïve adults enrolled in the study by de Roux ( ), the second group consisted of 78 participants in the de Roux study who received the PCV 1 year after the PPSV, and the third group consisted of 44 adults in the study by Jackson et al. who received the PCV 5 or more years after the PPSV ( ). The GMCs following the PCV dose tended to be lower in the groups previously exposed to PPSV than in the pneumococcal-vaccine-naïve group.

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Permissions and Reprints Request Permissions
Download as Powerpoint
Image of Figure 2
Figure 2

ELISA-measured IgG response to PCV7-CRM at days 7, 14, 28, and 42 in 15 healthy young adults. Adapted from the ( ) with permission from the publisher.

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Permissions and Reprints Request Permissions
Download as Powerpoint
Image of Figure 3
Figure 3

Serum IgG antibody responses to capsular types 6B, 14, 18C, 19F, and 23F in older adults after immunization with an investigational 5-valent oligosaccharide CRM PCV (CV) or the 23-valent PPSV (PV). Arrows indicate times of first and second vaccine injections. Closed circles, subjects immunized with the PCV at month 0 and the PPSV at month 6; open circles, subjects immunized with the PPSV at month 0 and a placebo at month 6; asterisks, significant difference in GMC between vaccine groups ( < 0.05). Reprinted from the ( ) with permission from the publisher.

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Permissions and Reprints Request Permissions
Download as Powerpoint

References

/content/book/10.1128/9781555815820.ch17
1. Ahmed, F.,, M. C. Steinhoff,, M. C. Rodriguez-Barradas,, R. G. Hamilton,, D. M. Musher, and, K. E. Nelson. 1996. Effect of human immunodeficiency virus type 1 infection on the antibody response to a glycoprotein conjugate pneumococcal vaccine: results from a randomized trial. J. Infect. Dis. 173:8390.
2. Anderson, P., and, R. Betts. 1989. Human adult immunogenicity of protein-coupled pneumococcal capsular antigens of serotypes prevalent in otitis media. Pediatr. Infect. Dis. J. 8:S50S53.
3. Austrian, R.,, R. M. Douglas,, G. Schiffman,, A. M. Coetzee,, H. J. Koornhof,, S. Hayden-Smith, and, R. D. Reid. 1976. Prevention of pneumococcal pneumonia by vaccination. Trans. Assoc. Am. Physicians 89:184194.
4. Black, S.,, H. Shinefield,, B. Fireman,, E. Lewis,, P. Ray,, J. R. Hansen,, L. Elvin,, K. M. Ensor,, J. Hackell,, G. Siber,, F. Malinoski,, D. Madore,, I. Chang,, R. Kohberger,, W. Watson,, R. Austrian, and, K. Edwards, et al. 2000. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr. Infect. Dis. J. 19:187195.
5. Black, S. B.,, H. R. Shinefield,, S. Ling,, J. Hansen,, B. Fireman,, D. Spring,, J. Noyes,, E. Lewis,, P. Ray,, J. Lee, and, J. Hackell. 2002. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr. Infect. Dis. J. 21:810815.
6. Butler, J. C.,, R. F. Breiman,, J. F. Campbell,, H. B. Lipman,, C. V. Broome, and, R. R. Facklam. 1993. Pneumococcal polysaccharide vaccine efficacy. An evaluation of current recommendations. JAMA 270:18261831.
7. De Roux, A.,, B. Schmoele-Thoma,, G. R. Siber,, J. G. Hackell,, A. Kuhnke,, N. Ahlers,, S. A. Baker,, A. Razmpour,, E. A. Emini,, P. D. Fernsten,, W. C. Gruber,, S. Lockhart,, O. Burkhard,, T. Welte, and, H. M. Lode. Comparison of pneumococcal conjugated polysaccharide and free polysaccharide vaccines in elderly adults: conjugate vaccine elicits improved anti-bacterial immune responses and immunological memory. Clin. Infect. Dis., in press.
8. Fattom, A.,, C. Lue,, S. C. Szu,, J. Mestecky,, G. Schiffman,, D. Bryla,, W. F. Vann,, D. Watson,, L. M. Kimzey,, J. B. Robbins, et al. 1990. Serum antibody response in adult volunteers elicited by injection of Streptococcus pneumoniae type 12F polysaccharide alone or conjugated to diphtheria toxoid. Infect. Immun. 58:23092312.
9. Fry, A. M.,, E. R. Zell,, A. Schuchat,, J. C. Butler, and, C. G. Whitney. 2002. Comparing potential benefits of new pneumococcal vaccines with the current polysaccharide vaccine in the elderly. Vaccine 21:303311.
10. Honkanen, P. O.,, T. Keistinen,, L. Miettinen,, E. Herva,, U. Sankilampi,, E. Laara,, M. Leinonen,, S. L. Kivela, and, P. H. Makela. 1999. Incremental effectiveness of pneumococcal vaccine on simultaneously administered influenza vaccine in preventing pneumonia and pneumococcal pneumonia among persons aged 65 years or older. Vaccine 17:24932500.
11. Jackson, L. A.,, P. Benson,, V. P. Sneller,, J. C. Butler,, R. S. Thompson,, R. T. Chen,, L. S. Lewis,, G. Carlone,, F. De-Stefano,, P. Holder,, T. Lezhava, and, W. W. Williams. 1999. Safety of revaccination with pneumococcal polysaccharide vaccine. JAMA 281:243248.
12. Jackson, L. A.,, K. M. Neuzil,, M. H. Nahm,, C. G. Whitney,, O. Yu,, J. C. Nelson,, P. Starkovich,, M. Dunstan,, B. Carste,, D. R. Feikin,, D. K. Shay,, J. Baggs, and, G. Carlone. 2007. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine 25:40294037.
13. Jackson, L. A.,, K. M. Neuzil,, C. G. Whitney,, P. Starkovich,, M. Dunstan,, O. Yu,, J. C. Nelson,, D. R. Feikin,, D. K. Shay,, J. Baggs,, B. Carste,, M. H. Nahm, and, G. Carlone. 2005. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine 23:36973703.
14. Jackson, L. A.,, K. M. Neuzil,, O. Yu,, P. Benson,, W. E. Barlow,, A. L. Adams,, C. A. Hanson,, L. D. Mahoney,, D. K. Shay, and, W. W. Thompson. 2003. Effectiveness of pneumococcal polysaccharide vaccine in older adults. N. Engl. J. Med. 348:17471755.
15. Jonsson, S.,, G. Vidarsson,, H. Valdimarsson,, G. Schiffman,, R. Schneerson, and, I. Jonsdottir. 2002. Vaccination of COPD patients with a pneumococcus type 6B tetanus toxoid conjugate vaccine. Eur. Respir. J. 20:813818.
16. Kamboj, K. K.,, H. L. Kirchner,, R. Kimmel,, N. S. Greenspan, and, J. R. Schreiber. 2003. Significant variation in serotype-specific immunogenicity of the seven-valentStreptococcus pneumoniaecapsularpolysaccharide-CRM197 conjugate vaccine occurs despite vigorous T cell help induced by the carrier protein. J. Infect. Dis. 187:16291638.
17. Kroon, F. P.,, J. T. van Dissel,, E. Ravensbergen,, P. H. Nibbering, and, R. van Furth. 2000. Enhanced antibody response to pneumococcal polysaccharide vaccine after prior immunization with conjugate pneumococcal vaccine in HIV-infected adults. Vaccine 19:886894.
18. Kroon, F. P.,, R. Van Furth, and, S. M. Bruisten. 1996. The effects of immunization in human immunodeficiency virus type 1 infection. N. Engl. J. Med. 335:817819.
19. Kyaw, M. H.,, C. E. Rose, Jr.,, A. M. Fry,, J. A. Singleton,, Z. Moore,, E. R. Zell, and, C. G. Whitney. 2005. The influence of chronic illnesses on the incidence of invasive pneumococcal disease in adults. J. Infect. Dis. 192:377386.
20. Lode, H.,, A. Kuhnke,, A. de Roux,, N. Ahlers, and, B. Schmole-Thoma. 2004. Comparison of three different dose levels of pneumococcal conjugate vaccine (pnc) in the elderly. 42nd Annu. Meet. Infect. Dis. Soc. Am., Boston, MA, 30 September to 3 October 2004.
21. Lottenbach, K. R.,, C. M. Mink,, S. J. Barenkamp,, E. L. Anderson,, S. M. Homan, and, D. C. Powers. 1999. Age-associated differences in immunoglobulin G1 (IgG1) and IgG2 subclass antibodies to pneumococcal polysaccharides following vaccination. Infect. Immun. 67:49354938.
22. Madore, D. V.,, C. L. Johnson-Kraines,, E. P. Rothstein, and, D. H. Smith, et al. 1999. Kinetics of antibody response to Haemophilus influenzae type b vaccines. Curr. Med. Res. Opin. 15:105112.
23. Molrine, D. C.,, S. George,, N. Tarbell,, P. Mauch,, L. Diller,, D. Neuberg,, R. C. Shamberger,, E. L. Anderson,, N. R. Phillips,, K. Kinsella, and, D. M. Ambrosino. 1995. Antibody responses to polysaccharide and polysaccharide-conjugate vaccines after treatment of Hodgkin disease. Ann. Intern. Med. 123:828834.
24. Nieminen, T.,, J. Eskola, and, H. Kayhty. 1998. Pneumococcal conjugate vaccination in adults: circulating antibody secreting cell response and humoral antibody responses in saliva and in serum. Vaccine 16:630636.
25. Nieminen, T.,, H. Kayhty,, A. Virolainen, and, J. Eskola. 1998. Circulating antibody secreting cell response to parenteral pneumococcal vaccines as an indicator of a salivary IgA antibody response. Vaccine 16:313319.
26. Powers, D. C.,, E. L. Anderson,, K. Lottenbach, and, C. M. Mink. 1996. Reactogenicity and immunogenicity of a protein-conjugated pneumococcal oligosaccharide vaccine in older adults. J. Infect. Dis. 173:10141018.
27. Schneerson, R.,, J. B. Robbins,, J. C. Parke, Jr.,, C. Bell,, J. J. Schlesselman,, A. Sutton,, Z. Wang,, G. Schiffman,, A. Karpas, and, J. Shiloach. 1986. Quantitative and qualitative analyses of serum antibodies elicited in adults by Haemophilus influenzae type b and pneumococcus type 6A capsular polysaccharide-tetanus toxoid conjugates. Infect. Immun. 52:519528.
28. Scott, D. A.,, S. F. Komjathy,, B. T. Hu,, S. Baker,, L. A. Supan,, C. A. Monahan,, W. Gruber,, G. R. Siber, and, S. P. Lockhart. 2007. Phase 1 trial of a 13-valent pneumococcal conjugate vaccine in healthy adults. Vaccine 25:61646166.
29. Scott, D. A.,, S. F. Komjathy,, J. Ruckle,, L. Supan,, M. Dar,, S. Baker,, A. Razmpour,, B. Hu,, P. Fernsten,, S. Lockhart,, W. Gruber, and, G. Siber. 2006. Safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine in healthy adults. Fifth Int. Sym. Pneumococci pneumococcal Dis., Alice Springs, Australia, 3 to 6 April 2006.
30. Shapiro, E. D.,, A. T. Berg,, R. Austrian,, D. Schroeder,, V. Parcells,, A. Margolis,, R. K. Adair, and, J. D. Clemens. 1991. The protective efficacy of polyvalent pneumococcal polysaccharide vaccine. N. Engl. J. Med. 325:14531460.
31. Shelly, M. A.,, H. Jacoby,, G. J. Riley,, B. T. Graves,, M. Pichichero, and, J. J. Treanor. 1997. Comparison of pneumococcal polysaccharide and CRM197-conjugated pneumococcal oligosaccharide vaccines in young and elderly adults. Infect. Immun. 65:242247.
32. Shelly, M. A.,, M. E. Pichichero, and, J. J. Treanor. 2001. Low baseline antibody level to diphtheria is associated with poor response to conjugated pneumococcal vaccine in adults. Scand. J. Infect. Dis. 33:542544.
33. Smit, P.,, D. Oberholzer,, S. Hayden-Smith,, H. J. Koornhof, and, M. R. Hilleman. 1977. Protective efficacy of pneumococcal polysaccharide vaccines. JAMA 238:26132616.
34. Snape, M. D.,, D. F. Kelly,, P. Salt,, S. Green,, C. Snowden,, L. Diggle,, A. Borkowski,, L. M. Yu,, E. R. Moxon, and, A. J. Pollard. 2006. Serogroup C meningococcal glyco-conjugate vaccine in adolescents: persistence of bactericidal antibodies and kinetics of the immune response to a booster vaccine more than 3 years after immunization. Clin. Infect. Dis. 43:13871394.
35. Soininen, A.,, I. Seppala,, T. Nieminen,, J. Eskola, and, H. Kayhty. 1999. IgG subclass distribution of antibodies after vaccination of adults with pneumococcal conjugate vaccines. Vaccine 17:18891897.
36. Storek, J.,, P. M. Mendelman,, R. P. Witherspoon,, B. A. McGregor, and, R. Storb. 1997. IgG response to pneumococcal polysaccharide-protein conjugate appears similar to IgG response to polysaccharide in bone marrow transplant recipients and healthy adults. Clin. Infect. Dis. 25:12531255.
37. Vidarsson, G.,, S. T. Sigurdardottir,, T. Gudnason,, S. Kjartansson,, K. G. Kristinsson,, G. Ingolfsdottir,, S. Jonsson,, H. Valdimarsson,, G. Schiffman,, R. Schneerson, and, I. Jonsdottir. 1998. Isotypes and opsonophagocytosis of pneumococcus type 6B antibodies elicited in infants and adults by an experimental pneumococcus type 6B-tetanus toxoid vaccine. Infect. Immun. 66:28662870.
38. Wuorimaa, T.,, H. Kayhty,, O. Leroy, and, J. Eskola. 2001. Tolerability and immunogenicity of an 11-valent pneumococcal conjugate vaccine in adults. Vaccine 19:18631869.

Tables

Generic image for table
Table 1

Characteristics of 15 polysaccharide-protein conjugate vaccine formulations evaluated in published clinical studies that included immunocompetent adults

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Generic image for table
Table 2

Published results of clinical trials excluding dose-ranging studies comparing the ELISA-measured IgG response to PCV with the response to PPSV in immunocompetent adults

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Generic image for table
Table 3

Results of dose-ranging studies of PCV7-CRM (Prevnar) comparing the ELISA-measured IgG responses to various PCV dosages with the response to PPSV in immunocompetent elderly adults

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Generic image for table
Table 4

Results of dose-ranging studies of PCV7-CRM (Prevnar) comparing the OPA-measured responses to various PCV dosages with the response to PPSV in immunocompetent elderly adults

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Generic image for table
Table 5

Antibody response in immunocompetent adults as measured by ELISA and OPA following first and second doses of PCV

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Generic image for table
Table 6

ELISA-measured IgG response to PPSV challenge given at various intervals after PCV compared with the response to PPSV alone

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17
Generic image for table
Table 7

Prevalence of fever and local signs and symptoms in elderly subjects following administration of PCV7-CRM compared to those following administration of 23-PPSV

Citation: Jackson L, Siber G. 2008. Immunogenicity and Safety in Adults, p 245-259. In Siber G, Klugman K, Mäkelä P (ed), Pneumococcal Vaccines. ASM Press, Washington, DC. doi: 10.1128/9781555815820.ch17

This is a required field
Please enter a valid email address
Please check the format of the address you have entered.
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error