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Richard P. Wenzel, Robert B. Craven, John A. Davies, J. Owen Hendley, Owen Hendley, Bruce H. Hamory, Gwaltney Gwaltney, Protective Efficacy of an Inactivated Mycoplasma pneumoniae Vaccine, The Journal of Infectious Diseases, Volume 136, Issue Supplement_1, August 1977, Pages S204–S207, https://doi.org/10.1093/infdis/136.Supplement.S204
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Abstract
The protective efficacy of a formalin-inactivated Mycoplasma pneumoniae vaccine was evaluated in a double-blind fashion in 7,861 Marine Corps recruits at Parris Island, South Carolina. Vaccine, administered in a 1-ml dose by a jet-injection device, was glass-grown and contained 264 µg of protein nitrogen/ml. Phosphate-buffered saline with formalin was injected as a control. Systemic reactions to injection were similar in both groups, but the percentage of vaccinees with erythema (51%) and induration (52%) at 24 hr was significantly greater than the percentage of controls (2%) with these reactions (P < 0.001). Twenty-one (0.5%) of 3,930 vaccinees and 43 (1.1%) of the 3,931 placebo recipients were hospitalized with pneumonia (x2 = 7.61; P < 0.01). Ten of 21 vaccinees and seven of 43 controls with pneumonia had a positive pharyngeal culture for M. pneumoniae (x2 = 1.69; P = 0.20), and fourfold rises in titer of serum antibody were noted in five of 14 vaccinees and in 15 of 28 placebo recipients with pneumonia (x2 = 7.90; P < 0.005). Therefore, vaccine efficacy for M. pneumoniae-specific pneumonia was 42% as determined by cultures and 67% by serologic tests. The vaccine showed no protective efficacy for M. pneumoniae-specific bronchitis or for M. pneumoniae pharyngeal carriage in recruits in training.