Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial.

BACKGROUND: Intradermal vaccination provides direct and potentially more efficient access to the immune system via specialised dendritic cells and draining lymphatic vessels. We investigated the immunogenicity and safety during 3 successive years of different dosages of a trivalent, inactivated, split-virion vaccine against seasonal influenza given intradermally using a microinjection system compared with an intramuscular control vaccine. METHODS: In a randomised, partially blinded, controlled study, healthy volunteers (1150 aged 18 to 57 years at enrollment) received three annual vaccinations of intradermal or intramuscular vaccine. In Year 1, subjects were randomised to one of three groups: 3 microg or 6 microg haemagglutinin/strain/dose of inactivated influenza vaccine intradermally, or a licensed inactivated influenza vaccine intramuscularly containing 15 microg/strain/dose. In Year 2 subjects were randomised again to one of two groups: 9 microg/strain/dose intradermally or 15 microg intramuscularly. In Year 3 subjects were randomised a third time to one of two groups: 9 microg intradermally or 15 microg intramuscularly. Randomisation lists in Year 1 were stratified for site. Randomisation lists in Years 2 and 3 were stratified for site and by vaccine received in previous years to ensure the inclusion of a comparable number of subjects in a vaccine group at each centre each year. Immunogenicity was assessed 21 days after each vaccination. Safety was assessed throughout the study. RESULTS: In Years 2 and 3, 9 microg intradermal was comparably immunogenic to 15 microg intramuscular for all strains, and both vaccines met European requirements for annual licensing of influenza vaccines. The 3 microg and 6 microg intradermal formulations were less immunogenic than intramuscular 15 microg. Safety of the intradermal and intramuscular vaccinations was comparable in each year of the study. Injection site erythema and swelling was more common with the intradermal route. CONCLUSION: An influenza vaccine with 9 microg of haemagglutinin/strain given using an intradermal microinjection system showed comparable immunogenic and safety profiles to a licensed intramuscular vaccine, and presents a promising alternative to intramuscular vaccination for influenza for adults younger than 60 years. TRIAL REGISTRATION: (Clinicaltrials.gov) NCT00703651.

[Acquired Immunodeficiency Syndrome and opportunistic infections]. / Igyto imunodeficito sindromas ir oportunistines infekcijos.

This article presents a clinical case of late diagnosis of cerebral toxoplasmosis and cytomegalovirus retinitis of right eye in a 32-year-old patient who was unaware of her HIV status. In addition, this article reviews the literature reflecting clinical, diagnostic, and treatment issues of some opportunistic infections in AIDS.

[Vaccine for human immunodeficiency virus (HIV)--relevance of these days]. / Skiepai nuo zmogaus imunodeficito viruso (ZIV)--siu dienu aktualija.

Since 1980 more than 25 million people have died from acquired immunodeficiency syndrome (AIDS), which results from infection with human immunodeficiency virus (HIV). Number of new cases increases very threateningly. One and the most effective method to stop the progress of epidemic is the development of the vaccine for HIV. There is the presentation of the first stage of the vaccine for HIV testing (structure, methodology), which is now on trial in St. Pierre hospital, Brussels University. HIV characteristics which inflame the process of the vaccine development, historical facts and facts about vaccines on trial in these days are reviewed in this article. More than 10,000 volunteers have been participating in various clinical trials since 1987. The development of the vaccine is a very difficult, long-terming (about 8-10 years) and costly process. The process of the vaccine testing is very difficult in developing countries where the infection spreads the most rapidly. Available data confirm that the vaccine must be multi-componential, inducing cellular, humoral immunity against various subtypes of HIV. The vaccine cannot protect fully but the changes of the natural infection course could decrease virulence, distance the stage of AIDS, and retard the spread of the epidemic.

Tickborne encephalitis in an area of high endemicity in lithuania: disease severity and long-term prognosis.

Of 250 consecutively admitted patients with central nervous system (CNS) infections who were treated during a 1-year period, all 133 patients with tickborne encephalitis (TBE) were included in a prospective follow-up study. TBE presented as mild (meningeal) in 43.6% of patients and as moderate or severe (encephalitic) in 43.6% and 12.8% of patients, respectively. Paralytic disease was observed in 3.8% of the subjects, and cranial nerve injury was observed in 5.3%. One patient died of TBE. Permanent CNS dysfunction after 1 year was found in 30.8% of patients; in 8.5% of all TBE cases, severe disabilities required adjustment of daily activities. Corticosteroid treatment did not seem to improve outcome. A progressive course of TBE was noted in 2 patients. The risk of incomplete recovery was significantly higher among patients with the encephalitic form of TBE (odds ratio, 4.066; 95% confidence interval, 1.848-8.947). In conclusion, TBE is an important pathogen in CNS infection in the Kaunas region of Lithuania, and it causes long-lasting morbidity in one-third of cases.

Rabies post-exposure prophylaxis vaccination with purified chick embryo cell vaccine (PCECV) and purified Vero cell rabies vaccine (PVRV) in a four-site intradermal schedule (4-0-2-0-1-1): an immunogenic, cost-effective and practical regimen.

Currently, two intradermal (ID) regimens for rabies post-exposure prophylaxis (PEP) are recommended by WHO and used in countries where approved by national authorities: the Thai Red Cross (TRC) two-site ID regimen and the eight-site ID regimen. Besides these WHO recommended schedules, a new economical four-site ID regimen was evaluated that reduces the cost of PEP by up to 80%, when compared with the standard intramuscular Essen regimen, reduces the number of visits required for the patients when compared with the TRC regimen, and is more convenient than the eight-site regimen. To determine the immunogenicity of the ID four-site PEP regimen (4-0-2-0-1-1), 180 healthy volunteers were randomized to receive 0.1 mL volumes of PCECV or PVRV administered ID over both left and right shoulders and both deltoid regions on day 0, both deltoid regions on day 7 and over one deltoid region on days 30 and 90. Regardless of the vaccine, every subject developed rabies virus neutralizing antibody (RVNA) titers above 0.5 IU/mL by day 14, as determined by rapid fluorescent focus inhibition test (RFFIT) using a homologous test system. Two weeks after the last dose of vaccine, RVNA titers were all above 0.5 IU/mL (day 104). Geometric mean titers were similar throughout the study period. Both vaccines were well tolerated. These results demonstrate that a new four-site ID PEP regimen is a cost-effective and convenient alternative to IM (Essen or Zagreb) or ID (TRC or eight-site) regimens, especially using a 1 mL vial of vaccine (PCECV).

[Prevalence of papillomavirus infection among patients with laryngeal papillomatosis and the effects of some risk factors on the persistence of papillomaviruses in the upper respiratory tract]. / Papilomavirusines infekcijos paplitimas tarp ligoniu, serganciu gerklu papilomatoze, ir kai kuriu rizikos veiksniu itaka papilomavirusu persistavimui virsutiniuose kvepavimo takuose.

UNLABELLED: Infection with high-risk human papillomaviruses is a significant risk factor of various benign and malignant human lesions in the upper respiratory tract, skin and the genital tract. The identification of particular human papillomaviruses types is important for identifying patients with premalignant lesions who are at risk of progression to malignancy. Our aim was to establish the prevalence of human papillomaviruses infection in the upper respiratory tract of patients with laryngeal papillomatosis, to identify viral types, to evaluate the relationship between some risk factors and persistence of human papillomaviruses in the upper respiratory tract and to determine the pattern of human papillomaviruses infection. MATERIAL AND METHODS: The group of 36 patients with laryngeal papillomatosis and control group of 108 persons without any complains of respiratory system was examined. Epidemiologic characteristics and objective data were analyzed and routine laryngological examination was performed. Pharyngeal swabs of all persons and laryngeal biopsies of 17 patients were taken and analyzed for the presence of human papillomaviruses DNA. Viral typing using the polymerase chain reaction was performed. RESULTS: Human papillomaviruses DNA was detected in all except one case of laryngeal papillomatosis; then only 23.15% of persons without complaints of respiratory system were found human papillomaviruses positive. Human papillomaviruses 6, 11 types were predominant (in 88.9% of patients and 19.4% of persons from control group). High-risk human papillomaviruses were detected in 52.78% of laryngeal papillomatosis cases and in 9.26% of control cases. Risk factors were noted statistically significantly more often in human papillomaviruses positive cases. CONCLUSIONS: The prevalence of human papillomaviruses infection in the upper respiratory tract of patients with laryngeal papillomatosis is high; human papillomaviruses 6, 11 types are predominant. High-risk human papillomaviruses were noted statistically significantly more often in the group of patients with laryngeal papillomatosis. Inclination to diseases of respiratory system, dental caries, smoking, low living standard are statistically significantly related to human papillomaviruses persistence in the upper respiratory tract.