Lack of effectiveness of the 23-valent polysaccharide pneumococcal vaccine in reducing all-cause pneumonias among healthy young military recruits: A randomized, double-blind, placebo-controlled trial

Vaccine

Volumn 33, Issue 9, 2015, Pages 1182-1187

  Russell, Kevin L ^a,b   Baker, Carolyn I ^a,c   Hansen, Christian ^a   Poland, Gregory A ^d   Ryan, Margaret A K ^a,e   Merrill, Mary M ^f   Gray, Gregory C ^f  

^a NAVAL MEDICAL CENTER SAN DIEGO   (United States)

^b Armed Forces Health Surveillance Center (AFHSC)   (United States)

^c HOLOGIC INC   (United States)

^d Mayo Vaccine Research Group   (United States)

^e LAC+USC Medical Center   (United States)

^f DUKE UNIVERSITY   (United States)

Author keywords

Epidemiology; Pneumococcus; Pneumonia; Streptococcus; Vaccine

Indexed keywords

PLACEBO; PNEUMOCOCCUS VACCINE; 23-VALENT PNEUMOCOCCAL CAPSULAR POLYSACCHARIDE VACCINE;

ACUTE RESPIRATORY TRACT DISEASE; ADENOVIRUS INFECTION; ADOLESCENT; ADULT; ARMY; ARTICLE; CHLAMYDIAL PNEUMONIA; CHLAMYDOPHILA PNEUMONIAE; CONTROLLED STUDY; DEMOGRAPHY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ELECTRONIC MEDICAL RECORD; ENVIRONMENT; FEMALE; FOLLOW UP; HIGH RISK POPULATION; HUMAN; INFLUENZA A; MAJOR CLINICAL STUDY; MALE; MENINGITIS; MYCOPLASMA PNEUMONIA; MYCOPLASMA PNEUMONIAE; NORMAL HUMAN; OUTCOME ASSESSMENT; PARAINFLUENZA VIRUS INFECTION; PNEUMOCOCCAL INFECTION; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SMOKING; SOLDIER; STREPTOCOCCUS PNEUMONIA; STREPTOCOCCUS PNEUMONIAE; THROAT CULTURE; VACCINATION; YOUNG ADULT; COHORT ANALYSIS; INCIDENCE;

ADOLESCENT; ADULT; COHORT STUDIES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INCIDENCE; MALE; MILITARY PERSONNEL; PLACEBOS; PNEUMOCOCCAL VACCINES; PNEUMONIA; YOUNG ADULT;

EID: 84922886977     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.12.058     Document Type: Article

References (40)

1. Robbins J.B., Austrian R., Lee C.J., Rastogi S.C., Schiffman G., Henrichsen J., et al. Considerations for formulating the second-generation pneumococcal capsular polysaccharide vaccine with emphasis on the cross-reactive types within groups. J Infect Dis 1983, 148:1136-1159.
2. Update: pneumococcal polysaccharide vaccine usage--United States. Morb Mortal Wkly Rep 1984, 33:273-327. 81.
3. Skull S.A., Andrews R.M., Byrnes G.B., Kelly H.A., Nolan T.M., Brown G.V., et al. Prevention of community-acquired pneumonia among a cohort of hospitalized elderly: benefit due to influenza and pneumococcal vaccination not demonstrated. Vaccine 2007, 25:4631-4640.
4. Vila-Corcoles A., Ochoa-Gondar O., Hospital I., Ansa X., Vilanova A., Rodriguez T., et al. Protective effects of the 23-valent pneumococcal polysaccharide vaccine in the elderly population: the EVAN-65 study. Clin Infect Dis 2006, 43:860-868.
5. Shapiro E.D., Berg A.T., Austrian R., Schroeder D., Parcells V., Margolis A., et al. The protective efficacy of polyvalent pneumococcal polysaccharide vaccine. N Engl J Med 1991, 325:1453-1460.
6. Fiore A.E., Levine O.S., Elliott J.A., Facklam R.R., Butler J.C. Effectiveness of pneumococcal polysaccharide vaccine for preschool-age children with chronic disease. Emerg Infect Dis 1999, 5:828-831.
7. Hedlund J., Christenson B., Lundbergh P., Ortqvist A. Effects of a large-scale intervention with influenza and 23-valent pneumococcal vaccines in elderly people: a 1-year follow-up. Vaccine 2003, 21:3906-3911.
8. Vila-Corcoles A., Salsench E., Rodriguez-Blanco T., Ochoa-Gondar O., de Diego C., Valdivieso A., et al. Clinical effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumonia in middle-aged and older adults: a matched case-control study. Vaccine 2009, 27:1504-1510.
9. Vila-Corcoles A., Ochoa-Gondar O., Guzman J.A., Rodriguez-Blanco T., Salsench E., Fuentes C.M. Effectiveness of the 23-valent polysaccharide pneumococcal vaccine against invasive pneumococcal disease in people 60 years or older. BMC Infect Dis 2010, 10:73.
10. Hirsch E.F., McKinney M. An epidemic of pneumococcus bronchopneumonia. J Infect Dis 1919, 24:594-617.
11. McCullers J.A., Bartmess K.C. Role of neuraminidase in lethal synergism between influenza virus and Streptococcus pneumoniae. J Infect Dis 2003, 187:1000-1009.
12. Hakansson A., Kidd A., Wadell G., Sabharwal H., Svanborg C. Adenovirus infection enhances in vitro adherence of Streptococcus pneumoniae. Infect Immun 1994, 62:2707-2714.
13. Russell K.L., Hawksworth A.W., Ryan M.A., Strickler J., Irvine M., Hansen C.J., et al. Vaccine-preventable adenoviral respiratory illness in US military recruits, 1999-2004. Vaccine 2006, 24:2835-2842.
14. Gray G.C., Callahan J.D., Hawksworth A.W., Fisher C.A., Gaydos J.C. Respiratory diseases among U.S. military personnel: countering emerging threats. Emerg Infect Dis 1999, 5:379-385.
15. Gray G.C., Mitchell B.S., Tueller J.E., Cross E.R., Amundson D.E. Pneumonia hospitalizations in the US navy and marine corps: rates and risk factors for 6,522 admissions, 1981-1991. Am J Epidemiol 1994, 139:793-802.
16. Reichler M., Reynolds R., Schwartz B., Musher D., Pratt D., Hohenhaus G., et al. Epidemic of pneumococcal pneumonia in a military training camp [abstract no 49]. 31st Interscience Conference on Antimicrobial Agents and Chemotherapy 1991, American Society for Microbiology, Chicago.
17. Crum N.F., Wallace M.R., Lamb C.R., Conlin A.M., Amundson D.E., Olson P.E., et al. Halting a pneumococcal pneumonia outbreak among United States Marine Corps trainees. Am J Prev Med 2003, 25:107-111.
18. Sanchez J.L., Craig S.C., Kolavic S., Hastings D., Alsip B.J., Gray G.C., et al. An outbreak of pneumococcal pneumonia among military personnel at high risk: control by low-dose azithromycin postexposure chemoprophylaxis. Mil Med 2003, 168:1-6.
19. Balicer R.D., Zarka S., Levine H., Klement E., Sela T., Porat N., et al. Control of Streptococcus pneumoniae serotype 5 epidemic of severe pneumonia among young army recruits by mass antibiotic treatment and vaccination. Vaccine 2010, 28:5591-5596.
20. Vainio A., Lyytikainen O., Sihvonen R., Kaijalainen T., Teirila L., Rantala M., et al. An outbreak of pneumonia associated with S. pneumoniae at a military training facility in Finland in 2006. APMIS 2009, 117:488-491.
21. Zhogolev S.D., Mosiagin V.D., Demidovich V.U., Mel'nichenko P.I., Ogarkov P.I. Efficacy of pneumococcal vaccine in military units. Zh Mikrobiol Epidemiol Immunobiol 2003, 36-42.
22. Willems J.S., Sanders C.R., Riddiough M.A., Bell J.C. Cost effectiveness of vaccination against pneumococcal pneumonia. N Engl J Med 1980, 303:553-559.
23. Patrick K.M., Woolley F.R. A cost-benefit analysis of immunization for pneumococcal pneumonia. JAMA 1981, 245:473-477.
24. Beutels P., Postma M.J. Economic evaluations of adult pneumococcal vaccination strategies. Expert Rev Pharmacoecon Outcomes Res 2001, 1:47-58.
25. Vold Pepper P., Owens D.K. Cost-effectiveness of the pneumococcal vaccine in the United States Navy and Marine Corps. Clin Infect Dis 2000, 30:157-164.
26. Jones R.N., Sader H.S., Moet G.J., Farrell D.J. Declining antimicrobial susceptibility of Streptococcus pneumoniae in the United States: report from the SENTRY Antimicrobial Surveillance Program (1998-2009). Diagn Microbiol Infect Dis 2010, 68:334-336.
27. Barile A., Driscoll T., Harley D., Haberberger R., Wallace M. Increasing incidence of penicillin-resistant Streptococcus pneumoniae. Proceedings of the IDSA 35th Annual Meeting 1997.
28. Zhogolev S.D., Ogarkov P.I., Mel'nichenko P.I. The prophylaxis of nonhospital pneumonia using 23-valent pneumococcus vaccine in the military collectives. Voen Med Zh 2004, 325:35-43. 96.
29. Murray P.R. American society for microbiology. Manual of clinical microbiology 1995, ASM Press, Washington, DC. 6th ed.
30. Isenberg H.D. American society for microbiology. Clinical microbiology procedures handbook 1992, American Society of Microbiology, Washington, DC.
31. Kalin M., Kanclerski K., Granstrom M., Mollby R. Diagnosis of pneumococcal pneumonia by enzyme-linked immunosorbent assay of antibodies to pneumococcal hemolysin (pneumolysin). J Clin Microbiol 1987, 25:226-229.
32. Campbell L.A., Perez Melgosa M., Hamilton D.J., Kuo C.C., Grayston J.T. Detection of Chlamydia pneumoniae by polymerase chain reaction. J Clin Microbiol 1992, 30:434-439.
33. Persing D.H. Diagnostic molecular microbiology: principles and applications 1993, American Society for Microbiology, Washington, DC.
34. Abele-Horn M., Busch U., Nitschko H., Jacobs E., Bax R., Pfaff F., et al. Molecular approaches to diagnosis of pulmonary diseases due to Mycoplasma pneumoniae. J Clin Microbiol 1998, 36:548-551.
35. de Barbeyrac B., Bernet-Poggi C., Febrer F., Renaudin H., Dupon M., Bebear C. Detection of Mycoplasma pneumoniae and Mycoplasma genitalium in clinical samples by polymerase chain reaction. Clin Infect Dis 1993, 17(Suppl 1):S83-S89.
36. Ieven M., Ursi D., Van Bever H., Quint W., Niesters H.G., Goossens H. Detection of Mycoplasma pneumoniae by two polymerase chain reactions and role of M. pneumoniae in acute respiratory tract infections in pediatric patients. J Infect Dis 1996, 173:1445-1452.
37. Preventing pneumococcal disease among infants and young children Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2000, 49:1-35.
38. Whitney C.G., Farley M.M., Hadler J., Harrison L.H., Bennett N.M., Lynfield R., et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med 2003, 348:1737-1746.
39. Field investigation: fatal Pneumococcal meningitis, Fort Leonard Wood, Missouri, February 2009. MSMR 2009, 16:2-6.
40. Surveillance snapshot: immunization against and incidence of pneumococcal disease. MSMR 2009, 16:7.