Effectiveness of the Pneumococcal Polysaccharide Vaccine in Military Recruits

Summary

The primary objective is to determine the clinical benefit of employing the 23-valent pneumococcal vaccine among US military trainees. Secondary objectives include: * determining the etiology of clinical pneumonia among U.S. military trainees; * comparing the serotype distribution of S. pneumoniae (Sp) isolates recovered from vaccinated and nonvaccinated trainees diagnosed with pneumonia; and * comparing days lost from training due to pneumonia or acute respiratory disease for vaccinated and nonvaccinated subjects.

Timeline

Start

2000-10

Primary completion

2003-06

Completion

2007-06

Outcome

Missed primary endpoint

paper Cox's proportional hazard modeling revealed no evidence of a protective vaccine effect during recruit training (radiographically confirmed pneumonia). PMID 25579777 ↗

Publications

• Background Plouffe JF, Breiman RF, Facklam RR. Bacteremia with Streptococcus pneumoniae. Implications for therapy and prevention. Franklin County Pneumonia Study Group. JAMA. 1996 Jan 17;275(3):194-8. doi: 10.1001/jama.275.3.194.
• Background Gray GC, Mitchell BS, Tueller JE, Cross ER, Amundson DE. Pneumonia hospitalizations in the US Navy and Marine Corps: rates and risk factors for 6,522 admissions, 1981-1991. Am J Epidemiol. 1994 Apr 15;139(8):793-802. doi: 10.1093/oxfordjournals.aje.a117076.
• Background McMillan A, Pattman RS. Evaluation of urethral culture for Neisseria gonorrhoeae in the routine investigation of men attending a STD clinic. Br J Vener Dis. 1979 Aug;55(4):271-3. doi: 10.1136/sti.55.4.271.
• Background Gray GC, Callahan JD, Hawksworth AW, Fisher CA, Gaydos JC. Respiratory diseases among U.S. military personnel: countering emerging threats. Emerg Infect Dis. 1999 May-Jun;5(3):379-85. doi: 10.3201/eid0503.990308.
• Background Fine MJ, Smith MA, Carson CA, Meffe F, Sankey SS, Weissfeld LA, Detsky AS, Kapoor WN. Efficacy of pneumococcal vaccination in adults. A meta-analysis of randomized controlled trials. Arch Intern Med. 1994 Dec 12-26;154(23):2666-77. doi: 10.1001/archinte.1994.00420230051007.
• Russell KL, Baker CI, Hansen C, Poland GA, Ryan MA, Merrill MM, Gray GC. 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. 2015 Feb 25;33(9):1182-7. doi: 10.1016/j.vaccine.2014.12.058. Epub 2015 Jan 8.

Drugs

Indications