Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial.

OBJECTIVE: The investigational AS04-adjuvanted herpes simplex virus type 2 (HSV-2) glycoprotein D (gD2) subunit prophylactic vaccine ('HSV vaccine'; GlaxoSmithKline Vaccines) has been shown to be well tolerated in adults, but limited data exist for pre-teen and adolescent girls, a likely target population. The primary objective of this study was to compare the occurrence of serious adverse events (SAEs) over 12 months between HSV vaccine recipients and saline recipients (placebo control group) in pre-teen and adolescent girls. The immunogenicity of the HSV vaccine was also assessed. METHODS: Healthy girls aged 10-17 years, stratified by age (10-15 years; 16-17 years), were randomised 2:1:1 to receive the HSV vaccine, a hepatitis A vaccine (Havrix™; HAV control) or placebo (saline) according to a 0-, 1-, 6-month schedule. Participants and study personnel not involved in the preparation or administration of vaccines were blinded to treatment. Safety and immunogenicity analyses were performed overall and by age (10-15 years; 16-17 years) and HSV serostatus. RESULTS: No statistically significant difference in the percentage of subjects with SAEs was observed between the HSV and saline group, or between the HSV and pooled control (HAV and saline) groups. The HSV vaccine was well tolerated, although a higher incidence of solicited local symptoms was observed in the HSV group than in the control group. Neither age nor HSV serostatus at the time of study entry had an impact on the safety profile of this vaccine. The HSV vaccine was immunogenic regardless of pre-vaccination HSV serostatus. Higher anti-gD geometric mean concentrations were observed in HSV-1 seropositive participants than in HSV-1 seronegative participants. CONCLUSION: The HSV vaccine had an acceptable safety profile, and was well tolerated and immunogenic when administered to girls aged 10-17 years regardless of age or HSV pre-vaccination serostatus.

European guideline for the organization of a consultation for sexually transmitted infections, 2012.

This guideline is intended to serve as a framework for those working in any location where sexually transmitted infections (STIs) are managed. It offers recommendations which will need to be adapted depending on local facilities and policies, and is not intended to be all encompassing. This guideline should be read in conjunction with other European guidelines on the management of specific infections (see http://www.iusti.org/).

Chlamydia trachomatis infections in eastern Europe: legal aspects, epidemiology, diagnosis, and treatment.

OBJECTIVES: Knowledge concerning genital Chlamydia trachomatis infections in eastern Europe is scarce. Data on the legal aspects, epidemiology, diagnosis, and treatment of the infection have never been collected, summarised, and presented to the international scientific community. The aim of this study was to present the current situation on the main aspects of chlamydial infections in the countries of eastern Europe. METHODS: Written questionnaires concerning legal aspects, epidemiology, diagnosis, and treatment of the infection were distributed among national STI operating administrators as well as researchers who had presented papers at earlier meetings of European chlamydia or STI societies. RESULTS: Most of the countries have not legalised reporting of chlamydial infections and in those who have done so, the quality of the reporting system is poor. Contact tracing is mostly done on a voluntary basis. Reported chlamydia incidence varies from 21 to 276 per 100000 inhabitants. The most commonly used diagnostic test remains the direct immunofluorescence test; however, some tendencies towards nucleic acid amplification are in evidence. Diagnostic services are paid for by the patient himself, while treatment in many countries is partially or completely covered by public insurance. CONCLUSIONS: This is the first report summarising data concerning the situation on C trachomatis infections in eastern Europe. The reporting system and diagnosis of C trachomatis infections remain suboptimal, which allows neither control of the epidemiological situation nor optimal treatment of the patients. The most urgent work currently necessary is the education of professionals and the general population.

Sexually transmitted infections in Estonia.

Estonia, one of the Baltic countries, regained its independence in 1991, after the collapse of the USSR. This process led to great changes in every sphere of life--in politics, in the economy and in medicine. The service providing care for sexually transmitted infections (STIs) was involved in the process of these changes, too. However, freedom was followed not only by great happiness, but also by social destabilization and transformation of the old moral norms, the most evident features of which were the dramatic rise in crime, a sexual revolution and public prostitution. These 2 great simultaneous transformations in the STI care system and public mores led to the rapid increase of STIs in Estonia in the first half of the 1990s. Now some stabilization, and even a fall in incidence has occurred.