Meta-analysis of published clinical trials of a ribosomal vaccine (ribomunyl) in prevention of respiratory infections

Abstract

Objective: To perform a meta-analysis using data from all clinical trials and studies of a ribosomal vaccine (Ribomunyl((R))) in order to estimate its overall effect on the number of infections and antibacterial courses used per person.

Design and setting: Meta-analysis of studies performed between 1985 and 1999 in 7 European countries and also in Kazakhstan, Tunisia, Morocco and Argentina.

Patients and participants: Information from 14 213 adults and children.

Results: There were 9 randomised, double-blind, placebo-controlled studies, 3 randomised nonblind studies and 16 nonblind studies with no placebo arm in which the response to ribosomal vaccine was compared with historical information. The mean number of infections per person in a study period of 3 months using placebo was found to be 2.39 (standard error +/- 0.50), and in a study period of 6 months was 3.35 (+/-0.41) infections. In both study periods, ribosomal vaccine use was associated with a reduction in the number of infections per person of 1.43 (+/-0.26). In the study period, patients on placebo reported 3.02 (+/-0.44) antibacterial courses, whereas ribosomal vaccine was associated with a reduction of 1.32 (+/-0.42) antibacterial courses.

Conclusions: In spite of variability in data quality, and the small sample size in some of the studies, we conclude that in patients with recurrent respiratory infections ribosomal vaccine significantly reduces both the number of infections and the number of antibacterial courses compared with placebo. This study is a strong and objective demonstration of the efficacy of ribosomal vaccine in limiting the number of otorhinolaryngological infections in children and adults.