Attenuated Vibrio cholerae oral vaccineCVD 103-HgR was welltolerated by 324 Thai soldiers and civilians. Most receiveda single 5 X 10 8 cfu dose, while 40 each receivedone or two 5 X 10 9 cfu doses. Vibriocidal antibody (the best correlate of immunity) seroconversion was lower in soldiers than civilians (P < .001). Increasing the vaccinedose to 5 X 10 9 cfu raised the geometric mean titer (P < .001). A second 5 X 10 9 cfu dose one week later did not notably increase seroconversions. Likelihood of seroconversion was inverselycorrelated with baseline vibriocidal titer (P < .001). CVD 103-HgR caused seroconversion in most subjects with baseline titers .;;1:40, including 100% of civilians after one 5 X 10 8 cfu dose, 79% of soldiers after one 5 X 10 9 cfu dose, and 45% of soldiers after one 5 X 10 8 cfu dose. In persons with elevatedbaseline titers, vibriocidal antibody seroconversion is not a sensitive measure of whether vaccine has boosted intestinal immunity; for such subjects,other measurements must be used. Study regimens in endemic areas should use a single 5 X 10 9 cfu dose.Cholera remains an important public health problem in less-developed countries, spreading readily where sanitation is compromised and often appearing in explosive epidemics. The World Health Organization has targeted the development of an improved cholera vaccine as a priority [I, 2] because the parenteral inactivated whole cell vaccine, which provides only limited, short-lived protection, can play no practical role in cholera control [3]. An ideal new cholera vaccine would be well tolerated and rapidly stimulate a high level of long-term protection among all age groups after administration ofjust one oral dose. Such a vaccine would constitute a welcome addition to the public health intervention measures available to control epidemic and endemic cholera.An important advance in immunization against cholera was documented several years ago in a field trial in BanglaReceived 6 November 1991; revised 14 January 1992. The clinical protocol followed the guidelines of the Department of Health and Human Services and was reviewed by ethical committees at the University of Maryland at Baltimore. Mahidol University. and the US Department of the Army. The studies were explained in detail, and written informed consent was obtained.Grant desh when two related inactivated oral cholera vaccines (one consisting of inactivated Vibrio cholerae 0 I organisms and the other of inactivated organisms plus the B subunit ofcholera toxin) were each shown to confer 50% protection for 3 years [4]. That experience illustrates that oral vaccines can elicit relatively long-lived protection against cholera. However, the field trial in Bangladesh also exposed notable deficiencies of those oral inactivated vaccines: Multiple, spaced doses were required to elicit protection, young children (the population with the highest incidence ofcholera in that area) were least protected, and despite administration of three spaced doses, the level of efficacy was only 50%-52% [4].With a...
A randomized, double-blind study was performed comparing ciprofloxacin in a 500-mg single dose with 1,000 mg (500-mg doses given 12 h apart) for the treatment of chancroid in Thailand. Haemophilus ducreyi was isolated from 87 (48%) of 180 men with a clinical diagnosis of chancroid. For men with ulcers that were culture positive for H. ducreyi, rates of cure were 100% in the 500-mg group and 98% in the 1,000-mg group. For men with ulcers that were culture negative for H. ducreyi, rates of cure were 93% in the 500-mg group and 96% in the 1,000-mg group. The MIC of ciprofloxacin for 50% of isolates among 85 isolates of H. ducreyi was 0.007 ,ug/ml (range, 0.002 to 0.03 ,ig/ml). No significant adverse effects were detected in either group. These data indicate that both of these treatment regimens are equally effective therapies for chancroid in Thailand.Chancroid, caused by Haemophilus ducreyi, is the major cause of genital ulcer disease in developing countries and is becoming an increasingly important sexually transmitted disease in the United States (9). In Thailand, chancroid infections account for nearly 20% of the venereal disease in men (11). At present the only drug that can be given orally is erythromycin, but erythromycin must be given at least for 7 days, a regimen that is associated with poor therapeutic compliance (2,4,8). Trimethoprim-sulfamethoxazole even when given in a standard 7-day regimen is frequently not an effective treatment for chancroid in Thailand (12). A single 250-mg dose of ceftriaxone is also effective, but it must be given parenterally (12). Thus, there is a need for a shortcourse or single-dose oral regimen for the treatment of chancroid. Ciprofloxacin, a new quinolone antimicrobial agent, is very effective against H. ducreyi in vitro (10), and a single oral dose is also effective for the treatment of gonorrhea. Ciprofloxacin was an efficacious and well-tolerated treatment of chancroid with a single dose (500 mg) and a 3-day regimen (500 mg twice daily) in Africa (6, 7). In the current study, we compared two regimens of ciprofloxacin, 500 mg (one tablet) and 1,000 mg (two tablets), for the treatment of chancroid in Thailand. MATERIALS AND METHODSPatients and study design. From August 1986 to January 1987, 200 men who came to the Bangrak Hospital, Venereal Disease Clinic, Bangkok, Thailand, with genital ulcers that were suspected clinically to be chancroid and were negative by dark-field examination for Treponema pallidum were enrolled in the study. All patients were otherwise healthy, between the ages of 18 and 60 years, and willing to return for follow-up evaluation. After informed consent was obtained, demographic and historical data were recorded, ulcers were measured, and tenderness, purulence, and induration were assessed. Ulcers were cultured for H. ducreyi and herpes simplex virus (HSV), and a blood specimen was obtained for a serological test for syphilis, complete blood count, creatinine and liver function tests, and total bilirubin, alkaline phosphatase, and asparate transfer...
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