Lactobacillus vaccine

Lactobacillus vaccines are used in the therapy and prophylaxis of non-specific bacterial vaginitis and trichomoniasis. The vaccines consist of specific inactivated strains of Lactobacilli, called "aberrant" strains in the relevant literature dating from the 1980s. These strains were isolated from the vaginal secretions of patients with acute colpitis. The lactobacilli in question are polymorphic, often shortened or coccoid in shape and do not produce an acidic, anti-pathogenic vaginal environment. A colonization with aberrant lactobacilli has been associated with an increased susceptibility to vaginal infections and a high rate of relapse following antimicrobial treatment. Intramuscular administration of inactivated aberrant lactobacilli provokes a humoral immune response. The production of specific antibodies both in serum and in the vaginal secretion has been demonstrated. As a result of the immune stimulation, the abnormal lactobacilli are inhibited, the population of normal, rod-shaped lactobacilli can grow and exert its defense functions against pathogenic microorganisms.

Medical uses Lactobacillus vaccines are primarily used in the therapy and prophylaxis of dysbiotic conditions of the vaginal ecosystem (bacterial vaginitis, vaginal trichomoniasis, and to a lesser extent, vaginal candidiasis). Secondarily, they are used in the prophylaxis and complementary treatment of various urogenital diseases, if vaginal dysbiosis is suspected to be the root cause of the condition. These include (chronic) upper genital tract infections, urinary tract infections and cervical dysplasias. The prophylactic use in patients with a history of late miscarriage and preterm labor is practiced preferably before conception.

Effectiveness

Bacterial vaginitis Rüttgers studied the benefit of vaccination with Gynatren in preventing bacterial vaginitis in a patient group with frequent vaginal infections. All of the 192 patients participating in the prospective, randomized, double-blind, placebo-controlled study received local treatment with a tetracycline-amphotericin B vaginal suppository. 95 patients additionally received vaccination with Gynatren, whereas 97 patients were treated with a placebo preparation of identical outward appearance. One month after the start of the treatment 85% of the patients in the active treatment group and 83% in the placebo group were cured (asymptomatic and free from pathogenic bacteria). After 3 months 78% of the verum group and 60% of the placebo group remained free from infection. After 6 months 76% and 40%, and after 12 months 75% and 37% of women in the respective groups were still free from infection. Another study by Boos and Rüttgers investigated the therapeutic effect of SolcoTrichovac when used as a sole therapeutic agent. The 182 patients enrolled into the study showed symptoms of acute vaginitis, and most of them had been treated for months with topical or oral antibiotics or antimycotics without success. For the course of the study they were advised to refrain from using such preparations. Six months after the first injection 71% of the patients showed a normal vaginal flora according to the classification of Jirovec and Peter. Further studies on the therapeutic and preventive efficacy of lactobacillus vaccines alone or in combination to antimicrobial treatment in bacterial vaginitis have produced similar results.

Vaginal trichomoniasis Litschgi has investigated the use of SolcoTrichovac both as a therapeutic and as a recurrence prophylactic measure. On the latter subject he reported enrolling 114 women with trichomoniasis into a randomized, double-blind, placebo-controlled study, 66% of whom had case histories of recurrent vulvovaginitis. All patients as well as their sexual partners received systemic and/or local nitroimidazole treatment. 61 patients were additionally vaccinated with SolcoTrichovac, 53 patients with placebo. At the first follow-up check, 6 weeks after the first injection, 3 patients in each group still had motile trichomonads. Among the patients that were pronounced cured at this visit, a total of 15 reinfections (33.3%) were recorded in the placebo group during the follow-up period from month 4 to month 12 after the first injection, whilst in the verum group there were no new infections. Harris designed a similar randomized, double-blind, placebo-controlled study with 198 participants and reported a reinfection rate of 21.6% in the placebo group, in contrast to 3.1% in the SolcoTrichovac group 8 months after completing the course of three injections. Further studies have confirmed the efficacy of lactobacillus vaccines as a powerful complementary treatment and recurrence prophylactic measure in trichomoniasis.

Vaginal candidiasis Vaginal mycoses are considered a weak indicator that the lactobacillus flora is compromised, since Candida albicans and Lactobacilli can coexist symbiotically. Consequently, immunotherapeutic modulation of the lactobacillus flora has a lesser success rate in this condition than in bacterial and trichomonal vaginitis. Verling reported vaccinating 42 patients with candida-induced chronic colpo-vaginitis with SolcoTrichovac, who had shown resistance to usual fungicidal treatment such as topical amphotericin B, nystatin and povidone-iodine. Of these, 7 patients (17%) have healed and another 18 patients (43%) showed only mild symptoms one month after the third injection.

Urinary tract infections In many women prone to recurrent urinary tract infections, the mucosal surfaces of the vaginal introitus are colonized by Escherichia coli and Enterococci, rather than Lactobacilli. Reid and Burton have postulated that the vagina may act as a reservoir for uropathogens. In the proposed scenario, the dysbiotic vaginal environment is continually seeding the bladder with infectious microbes leading to a persistent or recurrent urinary tract infection. As they suggested, by recolonizing the vagina with lactobacilli and displacing the pathogens, the infection of the bladder may resolve. No studies have been conducted on the use of lactobacillus vaccines in recurrent urinary tract infections using modern formulations of the vaccine. The inventor of lactobacillus vaccines, Újhelyi reported initial success in preventing uropoietic infections in pregnant women under therapy with experimental single-strain vaccines.

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