Community-acquired pneumonia: 23-valent pneumococcal capsular polysaccharide vaccine had no clear effect.

Clinical bottom line (level 1b-)

  1. Patients who had been treated in hospital for community-acquired pneumonia and were given a 23-valent pneumococcal capsular polysaccharide vaccine, had no clear difference in new pneumonia than those given placebo.
  2. Patients who were given a 23-valent pneumococcal capsular polysaccharide vaccine, had no clear difference in pneumococcal pneumonia than those given placebo.
Ortqvist et al: Lancet 1998; 351: 399-403
Expires March 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: departments of infectious diseases at six tertiary-care or university hospitals, Sweden

693 patients (aged range 50 to 85 years; mean 69, 52% female) Treated in hospital for community-acquired pneumonia

Excluded if
  • <50 and >85 years old
  • immunocompromised (myeloma or other active malignancy, renal dialysis, HIV, asplenia, hypogammaglobulinemia)
  • low compliance (unlikely to follow protocol)
  • previously given pneumococcal vaccine
  • hypersensitive to vaccine components


    • Control Group: (n = 353, 352 analysed): placebo, 0.5 mL sodium chloride intramuscularly
    Experimental Group: (n = 340, 339 analysed): 23-valent pneumococcal capsular polysaccharide vaccine 0.5 mL (25 µ g each capsular type), intramuscularly

    100% followed for mean2.5 years

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNH
    (95% CI)
    new pneumonia unknown 57
    (16.2%)    		 63
    (18.6%)    		 -15.0%
    (-59.0% to 17.0%)    		 -2.39%
    (-8.04% to 3.26%)    		 42
    (NNT = 31 to infinity;
    NNH = 12 to infinity)
    pneumococcal pneumonia unknown 16
    (4.55%)    		 19
    (5.60%)    		 -23.0%
    (-136% to 36.0%)    		 -1.06%
    (-4.34% to 2.22%)    		 94
    (NNT = 45 to infinity;
    NNH = 23 to infinity)

  • The relative risk for recurrence of pneumonia at between 76 and 85 years old is 2.39 (CI 1.49 to 3.85) (estimated by Cox proportional hazard regression).

    • Comments

    1. Patients on anticoagulant treatment received the vaccine subcutaneously.
    2. It is possible that in this secondary prevention trial the native immunological response to pneumococcal infection and/or and vaccination of the patients under study may have been different from patients receiving primary or routine prophylaxis.

    Citation

    1. Ortqvist A, Hedlund J, Burman L-A, et al: Randomised trial of 23-valent pneumococcal capsular polysaccharide vaccine in prevention of pneumonia in middle-aged and elderly people. Lancet 1998; 351: 399-403
    Search Terms: pneumonia and vaccine in Medline
    Contributor: Clare Wotton and Musab Hayatli, November 1999
    Reviewer: Niteesh K Choudhry

    Clinical Question.
    Patient community-acquired pneumonia
    Intervention or Exposure 23-valent pneumococcal capsular polysaccharide vaccine
    Comparison placebo
    Outcome pneumonia