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Biomedical subjects

P E Fine

Publications and source records attributed to P E Fine.

At least 19 recordsLinked to original sources
PubMed1992

Controlling leprosy.

Explore the source record for details and available documents.

Drug Therapy, Combination↗
PubMed1992

Confounding in studies of adverse reactions to vaccines.

Several social and medical attributes are associated with both avoidance or delay of vaccination and an increased risk of adverse events such as sudden infant death syndrome or childhood encephalopathy. Studies that fail to control adequately for such confounding factors are likely to underestimate the risks of adverse events attributable to vaccination. This paper reviews the literature on studies of severe adverse events after the administration of pertussis antigen-containing vaccines, with particular attention to the measures taken by different investigators to avoid this problem. Most published studies have reported a deficit of sudden infant death syndrome among vaccinees, which may reflect confounding in their study designs. An expression is derived to explore the extent of underestimation that may be introduced in such studies, under different sets of conditions. Confounding of this sort is a general problem for studies of adverse reactions to prophylactic interventions, as they may be withheld from some individuals precisely because they are already at high risk of the adverse event.

Adverse Drug Reaction Reporting Systems↗
PubMed1992

Efficacy of BCG vaccine against leprosy and tuberculosis in northern Malawi.

Protection afforded by BCG (bacillus Calmette-Guérin) vaccines against tuberculosis and leprosy varies widely between different populations. In the only controlled trial which assessed protective efficacy of BCG (Danish and Pasteur strains) against both diseases, there was slightly more protection against leprosy than against tuberculosis. We have studied the protective efficacy of BCG (Glaxo, freeze dried) vaccine against these two diseases in Karonga District, northern Malawi. BCG vaccination was introduced into this population in 1974. Prior information about BCG scar status was available for 83,455 individuals followed up between 1979 and 1989. 414 new cases of leprosy and 180 new cases of tuberculosis were found in this population over that period. Protection was estimated at 50% or greater against leprosy, and there was no evidence for lower protection against multibacillary (84%; 95% confidence interval 26% to 97%) than against paucibacillary (51%; 30% to 66%) disease. There was no statistically significant protection by BCG against tuberculosis in this population. These findings add to the evidence that BCG vaccines afford greater protection against leprosy than against tuberculosis.

Adolescent↗
PubMed1991

Mumps outbreak in a highly vaccinated population.

From October 1988 to April 1989, a large mumps outbreak occurred in Douglas County, Kansas. Of the 269 cases, 208 (77.3%) occurred among primary and secondary school students, of whom 203 (97.6%) had documentation of mumps vaccination. Attack rates were highest for students attending junior high school (8.0%), followed by high school (2.0%) and elementary school (0.7%). A retrospective cohort study conducted at one junior high school with an attack rate of 12.9% did not find age at vaccination or type of vaccine received (single or combined antigen) to be risk factors for vaccine failure. Students vaccinated more than 4 years before the outbreak appeared to have a higher attack rate than those vaccinated more recently (relative risk (RR) = 4.3; 95% confidence interval (CI) = 0.6, 30.0); however, this association did not exist when risk was evaluated based on number of vaccine doses received. Students who had documentation of receiving only one dose of vaccine were at greater risk than those who had received two doses (RR = 5.2; 95% CI = 1.0, 206.2). Overall, vaccine effectiveness among Douglas County junior high school students was estimated to be 83% (95% CI = 57%, 94%). These data suggest that mumps vaccine failure and the failure to vaccinate have contributed to the relative resurgence of mumps observed in the United States since 1986. The recent change in immunization policy to recommend a two-dose schedule of measles-mumps-rubella vaccine should help reduce the occurrence of mumps outbreaks in highly vaccinated populations.

Age Factors↗
PubMed1991

Setting up HIV serology for the Karonga leprosy vaccine trial in Malaŵi.

As part of the leprosy vaccine trial taking place in Karonga District, Northern Malaŵi, it is essential to establish whether the presence of HIV infection in the population is affecting the incidence rate or clinical presentation of leprosy or the effectiveness of the trial vaccines. To obtain the appropriate information, a rapid and economical HIV testing protocol, which could be performed in a rural laboratory and would be robust under variable environmental conditions, had to be developed. This paper reports on the development/evaluation phase of a multitest protocol based on commercially available particle agglutination and ELISA anti-HIV antibody detection kits. The protocol was devised by first evaluating a range of kits in London using a battery of African and non-African sera and then field testing 1455 sera in Malaŵi, which included 184 sera from leprosy patients and 60 sera from syphilis patients to check for cross-reactivity. According to the protocol developed, all sera are screened initially both by indirect ELISA (Organon) and using a rapid and economical modification of the Serodia particle agglutination test. Positives are retested using both a competitive ELISA (Wellcome or Behring) and the standard Serodia particle agglutination test. The validity of this multitest protocol was confirmed by Western blotting a large sample of the positive and negative Malaŵian sera in London. Factors affecting kit selection, and problems associated with individual kits, are discussed. While the specific multitest protocol developed for Malaŵi might not be suitable for every project, the principle of developing economical alternatives to Western blotting is an important consideration for any field investigation of HIV.

AIDS Serodiagnosis↗
PubMed1991

Is HIV infection a risk factor for leprosy?

A case control study was undertaken during 1988 and 1989 within the framework of the LEPRA Evaluation Project (LEP)/Karonga Prevention Trail (KPT) in Karonga District, northern Malawi, to investigate whether HIV infection is a risk factor for clinical leprosy. Cases were newly ascertained, biopsy-confirmed, incident leprosy patients older than 14 years of age. Controls were selected from the computer data base on over 170,000 people who form the basis of LEP/KPT. They were matched for sex, age, and area of residence. HIV seropositivity rates were 1.8% (2/112) for incident leprosy cases and 2.4% (24/1011) for controls. The Mantel Haenszel odds ratio is 0.6 (95% confidence interval 0.1-3.3). Thus, no evidence for an association between HIV infection and leprosy incidence has been observed in this population. In a parallel investigation, an odds ratio of 7.4% (95% confidence interval 3.3-16.7) was found for 102 microscopy- and/or culture-confirmed, incident pulmonary tuberculosis cases in the same population during 1989, a result similar to those obtained elsewhere in Africa. Among leprosy relapses, 16.7% (2/12) were HIV positive.

Adult↗
PubMed1991

Four-year follow-up results of a WHO-recommended multiple-drug regimen in paucibacillary leprosy patients in Malawi.

An evaluation of a World Health Organization-recommended multidrug therapy (WHO/MDT) in 499 paucibacillary leprosy patients is described. Patients were followed for 48 months after completion of treatment. Overall relapse rates after treatment were found to be 6.5 per 1000 person years (95% confidence interval 3.4-11.4). There were 12 relapses. A relative lack of cell-mediated immunity, as suggested by number of lesions, clinical classification and lepromin test results, and poor compliance with the dapsone component of WHO/MDT, appeared to be associated with a marginally increased risk of relapse. Severe type 1 reactions after completion of treatment occurred in 17 (3.5%) patients, 15/17 during the first 12 months of follow-up. Overall, 12 (2.5%) patients developed new disabilities during or after WHO/MDT.

Adolescent↗
PubMed1990

The anatomical distribution of single leprosy lesions in an African population, and its implications for the pathogenesis of leprosy.

Data on the anatomical sites of single leprosy lesions found in 635 newly diagnosed and biopsy-confirmed leprosy patients are presented. These patients were found during total population surveys carried out by the Lepra Evaluation Project, a prospective longitudinal study of the epidemiology of leprosy in Karonga District, Northern Malaŵi. There was a striking excess of single lesions on the face and the back of the arms, compared to the distribution of skin surface area, and a deficit on the legs, regardless of age. There is some evidence for a sex difference in lesion distribution among adults, with facial and arm lesions being relatively more common in females and back lesions being more common in males. The excess of lesions on the face compared to the lower limbs is similar to data from Uganda, but very unlike data from Burma and elsewhere in Asia. Overall, the distribution of lesions does not suggest a pattern reflecting entry of Mycobacterium leprae, nor does it suggest an association with anatomical distribution of the nervous or vascular system. It is argued that the distribution reflects the influence of some 'local' environmental or behavioural factors.

Age Factors↗
PubMed1990

Disabilities in leprosy patients ascertained in a total population survey in Karonga District, northern Malaŵi.

This paper describes the pattern of disability among 1654 leprosy patients ascertained between 1973 and 1987 in Karonga District, Northern Malaŵi. Approximately 20% of patients identified prior to 1980 had some disability at registration, but this percentage fell to approximately 10% with the introduction of total population surveys in the Lepra Evaluation Project. The proportion of patients with disabilities at registration increased with age, was higher among males than females, was higher among borderline and lepromatous than tuberculoid patients, and was higher for passively than for actively detected patients. The risk of developing disabilities among patients without any disabilities at registration was approximately 5 per 1000 person years, and appeared to be slightly higher after the completion of treatment than during treatment.

Adolescent↗
PubMed1989

A comparison of sensory loss tests and histopathology in the diagnosis of leprosy.

Three different sensory loss tests, for anaesthesia to light touch, for diminished pain sensation and for loss of thermosensation, were compared with histopathological examination results in the diagnosis of suspected tuberculoid leprosy in 120 individuals with 126 lesions. Though none of the 3 tests used in this study was found to be strikingly superior to any of the others, the results indicate potentially important differences in their usefulness in different subgroups of suspected patients. The methodological problems inherent in such studies are discussed.

Adult↗
PubMed1989

Failure of Mycobacterium leprae soluble antigens to suppress delayed-type hypersensitivity reaction to tuberculin.

In order to test a published claim that the inclusion of Mycobacterium leprae antigens with a tuberculin skin test reagent can suppress delayed-type hypersensitivity (DTH) to tuberculin in both paucibacillary and multibacillary leprosy cases, 109 leprosy cases and 104 non-leprosy controls were skin-tested simultaneously with tuberculin with and without M. leprae soluble antigens. Tests were randomized between arms and carried out double-blind. There was a clear tendency for larger DTH responses with the combined tuberculin plus M. leprae antigen than with tuberculin alone in paucibacillary leprosy cases and in non-leprosy controls. No evidence for M. leprae antigen-mediated suppression of DTH was observed in any group. It is unclear whether the difference between the results reported here, which were obtained in Malawi, and those in the published literature which were obtained in India, is attributable to geographic differences in important biological variables or to differences in the experimental protocols. The need for methodological rigour in skin-test studies is stressed.

Antigens, Bacterial↗