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

Kevin L. Russell, Carolyn I. Baker, Christian Hansen, Gregory A. Poland, Margaret A K Ryan, Mary M. Merrill, Gregory C. Gray

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Streptococcus pneumoniae infections have periodically caused significant morbidity and outbreaks among military personnel, especially trainees. This study evaluated the effectiveness of the 23-valent polysaccharide pneumococcal vaccine (PPV23) in reducing pneumonia in healthy military trainees. Methods: From 2000-2003, 152. 723 military trainees from 5 US training camps were enrolled in a double-blind, placebo-controlled trial of PPV23. Participants were closely monitored during basic training for radiographically confirmed pneumonia etiology and loss-of-training days. Participants were also followed using electronic medical encounter data until 1 June 2007 for three additional outcomes: any-cause pneumonia, any acute respiratory disease, and meningitis. Results: Comparison of demographic data by study arm suggested the randomization procedures were sound. During basic training, 371 study participants developed radiographically confirmed pneumonia. None had evidence of S. pneumoniae infection, but other etiologies included adenovirus (38%), Chlamydophila pneumoniae (9%), and Mycoplasma pneumoniae (8%). During the follow-up period, many study participants, in both the vaccine and placebo groups, had clinical encounters for the medical outcomes of interest. However, Cox's proportional hazard modeling revealed no evidence of a protective vaccine effect during recruit training (radiographically confirmed pneumonia) or up to 6.7 years after enrollment (any-cause pneumonia, any acute respiratory disease, or meningitis). Conclusions: Data from this large, double-blind, placebo controlled trial do not support routine use of PPV23 among healthy new military trainees. This clinical trial was registered at clinicaltrials.gov (registration number NCT02079701, http://www.clinicaltrials.gov/ct2/show/NCT02079701?term=NCT02079701&rank=1).

Original languageEnglish (US)
Pages (from-to)1182-1187
Number of pages6
JournalVaccine
Volume33
Issue number9
DOIs
StatePublished - Feb 25 2015

Fingerprint

Pneumococcal Vaccines
pneumonia
placebos
Pneumonia
polysaccharides
Placebos
vaccines
Pneumococcal Infections
Streptococcus pneumoniae
meningitis
Acute Disease
Meningitis
respiratory tract diseases
etiology
Vaccines
Mycoplasma pneumoniae
Chlamydophila pneumoniae
Medical Electronics
military personnel
Military Personnel

Keywords

  • Epidemiology
  • Pneumococcus
  • Pneumonia
  • Streptococcus
  • Vaccine

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

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. / Russell, Kevin L.; Baker, Carolyn I.; Hansen, Christian; Poland, Gregory A.; Ryan, Margaret A K; Merrill, Mary M.; Gray, Gregory C.

In: Vaccine, Vol. 33, No. 9, 25.02.2015, p. 1182-1187.

Research output: Contribution to journalArticle

Russell, Kevin L. ; Baker, Carolyn I. ; Hansen, Christian ; Poland, Gregory A. ; Ryan, Margaret A K ; Merrill, Mary M. ; Gray, Gregory C. / 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. In: Vaccine. 2015 ; Vol. 33, No. 9. pp. 1182-1187.
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abstract = "Background: Streptococcus pneumoniae infections have periodically caused significant morbidity and outbreaks among military personnel, especially trainees. This study evaluated the effectiveness of the 23-valent polysaccharide pneumococcal vaccine (PPV23) in reducing pneumonia in healthy military trainees. Methods: From 2000-2003, 152. 723 military trainees from 5 US training camps were enrolled in a double-blind, placebo-controlled trial of PPV23. Participants were closely monitored during basic training for radiographically confirmed pneumonia etiology and loss-of-training days. Participants were also followed using electronic medical encounter data until 1 June 2007 for three additional outcomes: any-cause pneumonia, any acute respiratory disease, and meningitis. Results: Comparison of demographic data by study arm suggested the randomization procedures were sound. During basic training, 371 study participants developed radiographically confirmed pneumonia. None had evidence of S. pneumoniae infection, but other etiologies included adenovirus (38{\%}), Chlamydophila pneumoniae (9{\%}), and Mycoplasma pneumoniae (8{\%}). During the follow-up period, many study participants, in both the vaccine and placebo groups, had clinical encounters for the medical outcomes of interest. However, Cox's proportional hazard modeling revealed no evidence of a protective vaccine effect during recruit training (radiographically confirmed pneumonia) or up to 6.7 years after enrollment (any-cause pneumonia, any acute respiratory disease, or meningitis). Conclusions: Data from this large, double-blind, placebo controlled trial do not support routine use of PPV23 among healthy new military trainees. This clinical trial was registered at clinicaltrials.gov (registration number NCT02079701, http://www.clinicaltrials.gov/ct2/show/NCT02079701?term=NCT02079701&rank=1).",
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