Alum-precipitated autoclaved Leishmania major plus bacille Calmette-Guérrin, a candidate vaccine for visceral leishmaniasis: safety, skin-delayed type hypersensitivity response and dose finding in healthy volunteers.

In a previous efficacy study, autoclaved Leishmania major (ALM) + bacille Calmette-Guérrin (BCG) vaccine was shown to be safe, but not superior to BCG alone, in protecting against visceral leishmaniasis. From June 1999 to June 2000, we studied the safety and immunogenicity of different doses of alum-precipitated ALM + BCG vaccine mixture administered intradermally to evaluate whether the addition of alum improved the immunogenicity of ALM. Twenty-four healthy adult volunteers were recruited and sequentially allocated to receive either 10 microg, 100 microg, 200 microg, or 400 microg of leishmanial protein in the alum-precipitated ALM + BCG vaccine mixture. Side effects were minimal for all doses and confined to the site of injection. All volunteers in the 10 microg, 100 microg, and 400 microg groups had a leishmanin skin test (LST) reaction of > or = 5 mm by day 42 and this response was maintained when tested after 90 d. Only 1 volunteer out of 5 in the 200 microg group had a LST reaction of > or = 5 mm by day 42 and the reasons for the different LST responses in this group are unclear. This is the first time that an alum adjuvant with ALM has been in used in humans and the vaccine mixture was safe and induced a strong delayed type hypersensitivity (DTH) reaction in the study volunteers. On the basis of this study we suggest that 100 1 microg of leishmanial protein in the vaccine mixture is a suitable dose for future efficacy studies, as it induced the strongest DTH reaction following vaccination.

Patients' satisfaction with primary health care centers services in kuwait city, kuwait.

BACKGROUND: Assessment of patient satisfaction offers a way of optimizing health status and prevents waste of medical resources. The direct measurement of patient satisfaction is a new phenomenon in Kuwait. OBJECTIVE: Assess patient satisfaction with respect to primary health care services and study any patterns of association of sociodemographic variables on the patient satisfaction level. METHODS: The sample consisted of 301 patients selected systematically from five primary health care centers to represent various geographic areas in Kuwait City. Just over 56% of the sample were females, 59% were married, the great majority (70.4%) were government employees, more than 60% had a monthly income of less than 900 KD, more than 54% were intermediate and high secondary school graduates, and 37% were university graduates or had advanced degrees. The data was collected by personal interview using structured questionnaire. RESULTS: The overall mean satisfaction was 3.1 points out of five (62%). The mean satisfaction scores were 3.64, 3.29, 3.08, 3.05, 2.21 for laboratory, pharmacy, radiology, dental and physician services, respectively. The highest mean score for physician services was obtained for communication skills (2.23); for pharmacy services, the availability of medicine (4.01); for laboratory services, the availability of lab materials (3.73); for radiology services, the waiting time for x-ray (3.60); and for dental services, the adequacy of dentists (3.27). The results indicated that gender, income, marital status and occupation were the most consistent demographic predictors of satisfaction, with females, those with lower income, lower education levels and the unemployed having higher mean satisfaction scores. CONCLUSION: There is a need for corrective intervention in some service areas and for an educational program to inform patients of the objectives and limitations of primary health services.

Autoclaved Leishmania major vaccine for prevention of visceral leishmaniasis: a randomised, double-blind, BCG-controlled trial in Sudan.

BACKGROUND: Visceral leishmaniasis is a major cause of morbidity and mortality in the Sudan. Drug treatment is expensive, and drug resistance is becoming increasingly common. Safe, effective, and cheap vaccines are needed. We report the results of a vaccine trial against human visceral leishmaniasis. METHODS: We undertook a double-blind randomised trial to test the safety and efficacy of an autoclaved Leishmania major (ALM) promastigote vaccine (1 mg per dose). Of 5093 volunteers screened, 2306 had negative leishmanin skin tests and reciprocal titres of less than 6400 in the direct agglutination test. They were randomly assigned two doses of ALM mixed with BCG or BCG alone. Volunteers were followed up for 2 years. The primary endpoint was clinical visceral leishmaniasis or post-kala-azar dermal leishmaniasis. Analyses were by intention to treat. FINDINGS: Side-effects were confined to the injection site. The cumulative frequency of visceral leishmaniasis at 2 years did not differ significantly between the group assigned ALM plus BCG and that assigned BCG alone (133/1155 [11.5%] vs 141/1151 [12.3%], p=0.6). The vaccine efficacy was 6% (95% CI -18 to 25). The proportion of individuals showing leishmanin skin conversion was significantly higher in the ALM plus BCG group than in the BCG alone group throughout follow-up (303 [30%] vs 72 [7%] at 42 days). Individuals whose leishmanin test converted after vaccination (induration > or =5 mm) had a significantly lower frequency of visceral leishmaniasis than non-responders (27/375 [7.2%] vs 210/1660 [12.7%], p=0.003). INTERPRETATION: We found no evidence that two doses of ALM plus BCG offered significant protective immunity against visceral leishmaniasis compared with BCG alone. Leishmanin skin conversion with an induration of 5 mm or more in either group was associated with protection from the disease.