Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Elderly Adults Previously Immunized with a 23-Valent Pneumococcal Polysaccharide Vaccine: An Open-Label Trial — Oak Academic Publishing
Research ArticleOpen AccessGoogle Scholar indexed
Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Elderly Adults Previously Immunized with a 23-Valent Pneumococcal Polysaccharide Vaccine: An Open-Label Trial
Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany
,
Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Akademiska Sjukhuset, Uppsala, Sweden
,
Pfizer Pharma GmbH, Berlin, Germany
,
Pfizer Inc., Collegeville, USA
,
Pfizer Vaccine Research, Pfizer, Pearl River, USA
,
Pfizer Vaccine Research, Pfizer, Pearl River, USA
,
Pfizer Pharma GmbH, Berlin, Germany
1 Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany
2 Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Akademiska Sjukhuset, Uppsala, Sweden
3 Pfizer Pharma GmbH, Berlin, Germany
4 Pfizer Inc., Collegeville, USA
5 Pfizer Vaccine Research, Pfizer, Pearl River, USA
6 Pfizer Vaccine Research, Pfizer, Pearl River, USA
An open-label, multicenter study was conducted to describe the safety of the 13-valent pneumococcal conjugate vaccine (PCV13) in 1049 individuals aged ≥68 years, who had previously been immunized with the unconjugated 23-valent pneumococcal polysaccharide vaccine (PPSV23). In addition, the safety profile of PCV13 in this study was compared, in a post-hoc descriptive analysis, to that observed in other elderly populations, who had received PCV13 or PPSV23 as part of other completed studies. Local (56.6%) and systemic reactions (58.4%) were very common, but were mainly mild, and of short duration (mean: 1.3 - 4.6 days). There were no related serious adverse events (AEs) within 1 month after PCV13 . 123 days after PCV13 and 94 days after a nonstudy influenza vaccine, a case of transient Guillain - Barré syndrome occurred, which the investigator assessed as possibly related to the vaccination. Reactogenicity observed in this study population was generally similar to that of other elderly study populations with PPSV23-preimmunized adults, and with PPSV23-naive adults. Reactogenicity was less common in this study than that observed in PPSV23-preimmunized adults who were revaccinated with PPSV23 rather than a subsequent dose of PCV13. There were no related serious AEs reported after PCV13 and PPSV23 in these comparator studies. Conclusion: PCV13 may be administered safely to older adults previously immunized with PPSV23. (ClinicalTrials. gov Identifier: NCT00500266)
World Health Organization,“23-Valent Pneumococcal Polysaccharide Vaccine WHO Position Paper,”Weekly Epidemiological Record, Vol. 83, No. 42, 2008, pp. 373- 384. http://www.who.int/wer/2008/wer8342.pdf
K. Klugman, S. Black, R. Dagan, R. Malley and C. Whitney, “Pneumococcal Conjugate Vaccine and Pneumococcal Common Protein Vaccines,” In: S. A. Plotkin and W. A. Orenstein, Eds., Vaccines, 6th Edition, Saunders, Philadelphia, 2012, pp. 534-535.
A. Huss, P. Scott, A. E. Stuck, C. Trotter and M. Egger, “Efficacy of Pneumococcal Vaccination in Adults: A Meta-Analysis,” Canadian Medical Association Journal, Vol. 180, No. 1, 2009, pp. 48-58. http://dx.doi.org/10.1503/cmaj.080734
S. Moberley, J. Holden, D. P. Tatham and R. M. Andrews, “Vaccines for Preventing Pneumococcal Infection in Adults,” Cochrane Database of Systematic Reviews, Vol. 23, No. 1, 2008, Article ID: CD000422. http://dx.doi.org/10.1002/14651858.CD000422.pub3
Department of Health, UK, “JCVI Statement on the Routine Pneumococcal Vaccination Programme for Adults Aged 65 Years and Older (Updated 25 July 2011),” http://webarchive.nationalarchives.gov.uk/20130107105354/ http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/ dh_128704.pdf
Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices, “Updated Recommendations for Prevention of Invasive Pneumococcal Disease among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23),” Morbidity and Mortality Weekly Report (MMWR), Vol. 59, No. 34, 2010, pp. 1102-1106. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5934a3.htm
J. Torling, J. Hedlund, H. B. Konradsen and A. Ortqvist, “Revaccination with the 23-Valent Pneumococcal Polysaccharide Vaccine in Middle-Aged and Elderly Persons Previously Treated for Pneumonia,” Vaccine, Vol. 22, No. 1, 2003, pp. 96-103. http://dx.doi.org/10.1016/S0264-410X(03)00521-8
E. A. Clutterbuck, R. Lazarus, L. M. Yu, J. Bowman, E. A. Bateman, L. Diggle, et al., “Pneumococcal Conjugate and Plain Polysaccharide Vaccines Have Divergent Effects on Antigen-Specific B Cells,” Journal of Infectious Diseases, Vol. 205, No. 9, 2012, pp. 1408-1416. http://dx.doi.org/10.1093/infdis/jis212
L. A. Jackson, A. Gurtman, M. van Cleeff, R. W. Frenck, J. Treanor, K. U. Jansen, et al., “Influence of Initial Vaccination with 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Pneumococcal Polysaccharide Vaccine on Anti-Pneumococcal Responses Following Subsequent Pneumococcal Vaccination in Adults 50 Years and Older,” Vaccine, Vol. 31, No. 35, 2013, pp. 3594-3602. http://dx.doi.org/10.1016/j.vaccine.2013.04.084
G. Ada, “Vaccines and Vaccination,” New England Journal of Medicine, Vol. 345, No. 14, 2001, pp. 1042-1053. http://dx.doi.org/10.1056/NEJMra011223
L. A. Jackson, A. Gurtman, K. Rice, K. Pauksens, R. N. Greenberg, T. R. Jones, et al., “Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Adults 70 Years of Age and Older Previously Vaccinated with 23-Valent Pneumococcal Polysaccharide Vaccine,” Vaccine, Vol. 31, No. 35, 2013, pp. 3585-3593. http://dx.doi.org/10.1016/j.vaccine.2013.05.010
T. F. Schwarz, J. Flamaing, H. C. Rumke, J. Penzes, C. Juergens, A. Wenz, et al., “A Randomized, Double-Blind Trial to Evaluate Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine Given Concomitantly with Trivalent Influenza Vaccine in Adults Aged ≥ 65 Years,” Vaccine, Vol. 29, No. 32, 2011, pp. 5195- 5202. http://dx.doi.org/10.1016/j.vaccine.2011.05.031
US Food and Drug Administration, “Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials,” 2007. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformtion/ Guidances/Vaccines/ucm074775.htm
I. S. Chan and Z. Zhang, “Test-Based Exact Confidence Intervals for the Difference of Two Binomial Proportions,” Biometrics, Vol. 55, No. 4, 1999, pp. 1202-1209. http://dx.doi.org/10.1111/j.0006-341X.1999.01202.x
“Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects (Study 3000),” ClinicalTrials.gov Identifier: NCT00500266. http://clinicaltrials.gov/show/NCT00500266
“Study Evaluating Safety, Tolerability and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine (Study 3005),” ClinicalTrials.gov Identifier: NCT00546572. http://clinicaltrials.gov/ct2/show/results/NCT00546572
“Study Evaluating Safety and Immunogenicity of 13- Valent Pneumococcal Conjugate Vaccine with Influenza Vaccine in Adults (Study 3008),” ClinicalTrials.gov Identifier: NCT00492557. http://clinicaltrials.gov/ct2/show/results/NCT00492557
J. J. Sejvar, K. S. Kohl, J. Gidudu, A. Amato, N. Bakshi, R. Baxter, et al., “Guillain-Barré Syndrome and Fisher Syndrome: Case Definitions and Guidelines for Collection, Analysis, and Presentation of Immunization Safety Data,” Vaccine, Vol. 29, No. 3, 2011, pp. 599-612. http://dx.doi.org/10.1016/j.vaccine.2010.06.003
T. Lasky, G. J. Terracciano, L. Magder, C. L. Koski, M. Ballesteros, D. Nash, et al., “The Guillain-Barré Syndrome and the 1992-1993 and 1993-1994 Influenza Vaccines,” New England Journal of Medicine, Vol. 339, No. 25, 1998, pp. 1797-1802. http://dx.doi.org/10.1056/NEJM199812173392501
Centers for Disease Control and Prevention (CDC), “Update: Guillain-Barré Syndrome among Recipients of Menactra Meningococcal Conjugate Vaccine—United States, June 2005-September 2006,” Morbidity and Mortality Weekly Report (MMWR), Vol. 55, No. 41, 2006, pp. 1120- 1124. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5541a2.htm
P. De Wals, G. Deceuninck, R. M. Boucher and M. Ouakki, “Risk of Guillain-Barré Syndrome Following Serogroup C Meningococcal Conjugate Vaccine in Quebec, Canada,” Clinical Infectious Diseases, Vol. 46, No. 8, 2008, pp. E75-E77. http://dx.doi.org/10.1086/533469
R. Baxter, N. Bakshi, B. Fireman, E. Lewis, P. Ray, C. Vellozzi, et al., “Lack of Association of Guillain-Barré Syndrome with Vaccinations,” Clinical Infectious Diseases, Vol. 57, No. 2, 2013, pp. 197-204. http://dx.doi.org/10.1093/cid/cit222
L. A. Jackson, “Pneumococcal Polysaccharide Vaccines,” In: S. A. Plotkin and W. A. Orenstein, Eds., Vaccines, 6th Edition, Saunders, Philadelphia, 2012, pp. 542-572.
L. A. Jackson, A. Gurtman, M. van Cleeff, K. U. Jansen, D. Jayawardene, C. Devlin, et al., “Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Compared to a 23-Valent Pneumococcal Polysaccharide Vaccine in Pneumococcal Vaccine-Naive Adults,” Vaccine, Vol. 31, No. 35, 2013, pp. 3577-3584. http://dx.doi.org/10.1016/j.vaccine.2013.04.085