A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis.

Forty-four adult patients with cutaneous leishmaniasis (CL) were enrolled in a randomized, double-blind, controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1+MPL-SE vaccine (consisting of 5, 10, or 20 µg recombinant Leishmania polyprotein LEISH-F1 antigen+25 µg MPL-SE adjuvant) (n=27), adjuvant alone (n=8), or saline placebo (n=9). The study injections were given subcutaneously on Days 0, 28, and 56, and the patients were followed through Day 336 for safety, immunological, and clinical evolution endpoints. All patients received chemotherapy with meglumine antimoniate starting on Day 0. The vaccine was safe and well tolerated. Nearly all vaccine recipients and no adjuvant-alone or placebo recipients demonstrated an IgG antibody response to LEISH-F1 at Day 84. Also at Day 84, 80% of vaccine recipients were clinically cured, compared to 50% and 38% of adjuvant-alone and placebo recipients. The LEISH-F1+MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy.

Evaluation of an immunochemotherapeutic protocol constituted of N-methyl meglumine antimoniate (Glucantime) and the recombinant Leish-110f + MPL-SE vaccine to treat canine visceral leishmaniasis.

The evaluation of the efficacy of an immunochemotherapy protocol to treat symptomatic dogs naturally infected with Leishmania chagasi was studied. This clinical trial had the purpose to test the combination of N-methyl meglumine antimoniate (Glucantime and the second generation recombinant vaccine Leish-110f plus the adjuvant MPL-SE to treat the canine leishmaniasis (CanL). Thirty symptomatic naturally infected mongrel dogs were divided into five groups. Animals received standard treatment with Glucantime or treatment with Glucantime Leish-110f + MPL-SEas immunochemotherapy protocol. Additional groups received Leish-110f + MPL-SE only, MPL-SE only, or placebo. Evaluation of haematological, biochemical (renal and hepatic function) and plasmatic proteins, immunological (humoral and cellular immune response) and the parasitological test revealed improvement of the clinical parameters and parasitological cure in dogs in both chemotherapy alone and immunochemotherapy cohorts. However, the immunotherapy and immunochemotherapy cohorts had reduced number of deaths, higher survival probability, and specific cellular reactivity to leishmanial antigens, in comparison with chemotherapy cohort only and control groups (adjuvant alone and placebo). These results support the notion of using well-characterized recombinant vaccine as an adjunct to improve the current chemotherapy of CanL.

Nota sobre o uso de bio-sensores "Maria" nas ações de vigilância entomológica contra a doença de Chagas ao norte de Minas Gerais / About the use of

Oitocentos e sessenta e seis bio-sensores para a detecção passiva de triatomíneos foram ensaiados em intradomicílios de treze municípios de área endêmica de Triatoma sordida (Norte de Minas Gerais, Brasil), espécie que é hoje a mais freqüentemente detectável no Brasil, especialmente naquela Região. Examinados os sensores a cada três meses, por quatro vezes em uma subárea de sete municípios (seiscentos e quarenta e dois sensores, com positividade máxima de 0,5 por cento) e por duas nos outros seis municípios (duzentos e vinte e quatro sensores, com positividade máxima de 2,7 por cento), os resultados foram, significativamente inferiores à rotina de busca direta hora-homem feita nos mesmos municípios, inclusive para as taxas de infestação intradomiciliar. Em que pese a simplicidade e boa aceitação dos sensores pela população, os mesmos não se mostraram adequados à pesquisa triatomínica na região em apreço, tanto em termos de efetividade quanto de custo-benefício.

[About the use of "Maria" bio-sensors in the activities of epidemiological surveillance against Chagas' disease in the North of Minas Gerais State]. / Nota sobre o uso de bio-sensores "Maria" nas ações de vigilância entomológica contra a doença de Chagas ao Norte de Minas Gerais.

Eight hundred and sixty six bio-sensors for the passive detection of triatomine bugs, were tried in intra-domiciles of thirteen municipalities of an endemic area of Triatoma sordida in the North of Minas Gerais State, Brazil. This species is nowadays the most captured in Brazil and mainly in the above region. The sensors were examined every three months, corresponding to four times in the first seven municipalities (six hundred and forty two sensors, with a maximum positivity of 0.5%) and two times in the other six (two hundred and twenty two sensors, with a maximum positivity of 2.7%), showing results significantly inferior in comparison with the routine man-hour research performed in the same municipalities, including in terms of intra-domestic infestation index. Despite the simplicity and good acceptance of the sensors by the population they were demonstrated to be inadequate for triatomine research under the conditions of this trial, in terms of efficacy and cost-benefit.

Importance of Lutzomyia longipalpis in the dynamics of transmission of canine visceral leishmaniasis in the endemic area of Porteirinha Municipality, Minas Gerais, Brazil.

A study of Lutzomyia longipalpis (Lutz and Neiva, 1912) (Diptera: Psychodidae), the primary vector of American visceral leishmaniasis (AVL), and the canine form of the disease, was carried out in Porteirinha. The city is situated in the northern part of the Brazilian State of Minas Gerais and is an endemic area of AVL. Systematic phlebotomine captures were performed in seven districts with previously reported cases of canine visceral leishmaniasis, during 2 years (January 2000--December 2001). A total of 2328 specimens of L. longipalpis were captured. The association between the local climate variables and the population density of L. longipalpis was evaluated and rainfall was determined to be a major factor, with increased populations during the rainy season (October--March). At the same time period, blood samples from every dog domiciled in the same seven districts, in total 14,077 animals, were analyzed for infection by viscerotropic Leishmania using indirect immunofluorescence assay (IFA). Accumulated incidence rates of canine VL per district varied from 3.40 to 14.34 for the 2-year period. A positive correlation between the population density of L. longipalpis and the canine cases of visceral leishmaniasis in Porteirinha was observed.

Epidemiology of canine visceral leishmaniosis in the endemic area of Montes Claros Municipality, Minas Gerais State, Brazil.

The Montes Claros City is located in an endemic area for visceral leishmaniosis in the Minas Gerais State, Brazil. With the implementation of a program for the control of visceral leishmaniosis in 1994, a sectional study was carried out to evaluate the infection by viscerotropic Leishmania in the population of dogs from Montes Claros, basically using indirect immunofluorescence antibody test (IFAT). Blood samples were collected on filter paper from 33,937 dogs, representing 96.1% of the canine local population. The prevalence for visceral leishmaniosis was found to be 9.7% in the municipality, being 9.9% in the urban area and 8.8% in the rural area. The annual incidence showed to be 64.3/1000 dogs. Prevalence of infection was not correlated with dogs age. The most affected breeds were: Boxer (24.6%) and Cocker (26.9%); Mongrel dogs had a prevalence of 7.8%. Short-hair animals had a prevalence of 11.9%, while long-furred animals had a prevalence of 8.9%. The isoenzymatic profile indicated that Leishmania (Leishmania) chagasi was the visceral leishmaniosis etiological agent in Montes Claros City, Minas Gerais State, Brazil. The main geographical areas for the parasite transmission were identified, and control measures were immediately started. The role of the dog as a reservoir for L. chagasi was confirmed. It was demonstrated that short-furred animals are at a higher risk of acquiring visceral leishmaniosis than the long-furred dogs.