Bacterial vaginitis: protection against infection and secretory immunoglobulin levels in the vagina after immunization therapy with Gynatren.

In a prospective, randomized double-blind study the prophylactic effect of the immunotherapeutic agent, Gynatren, against reinfection was investigated in 192 patients with bacterial vaginitis (95 treated with the active preparation versus 97 with placebo). In 30 and 25% of the patients in the two groups, respectively, it was the third or even more frequent infection in a period of 12 months. In a further 46 and 39%, respectively, it was the second infection in the course of a year. All the patients were given local treatment with tetracycline-amphotericin B vaginal suppositories and at the same time vaccinated with Gynatren or placebo. One month after the start of treatment, 85% of the patients in the active-treatment group and 83% in the placebo group were asymptomatic and free from pathogenic bacteria. After 3 months 78% in the active-treatment group and 60% in the placebo group were free from infection. After 6 months 76 and 40%, and after 12 months 75 and 37% of the women in the active-treatment and placebo groups, respectively, were free from clinical symptoms and pathogenic bacteria. These results correlated with the concentrations of local antibodies (secretory immunoglobulin) detectable in the vaginal secretion.