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  • Title: [Randomization of a population for a clinical trial of immunization against the human immunodeficiency virus (HIV)].
    Author: Dechazal L, Goussard B, Salaun JJ, Bernard J, Zagury D.
    Journal: Med Trop (Mars); 1988; 48(4):413-6. PubMed ID: 3065586.
    Abstract:
    Serum HIV antibodies has been investigated in different subpopulation from four different regions in Zäire by Elisa (Elavia Pasteur) and Western Blot. Seropositive prevalence differed from 2.4% (rural population) to 12.5% (urban population) according to the regions. When the group with 2.4% migrated to the area with 12.5% positives, after 8-12 months the number of seropositives in this group raised to 8%, showing an increase of 5.6% within one year. Such population is suitable for a large scale clinical trial (with anti-AIDS vaccine) to be performed on individuals with high risk of natural infection. Major obstacles to development of a vaccine against the HIV infection have apparently been resolved by utilizing viral signals not directly from the virus or its products, but from membranes of infected cells. Evaluation of the level of protection provided by the vaccine requires a large scale clinical trial in a population with a high rate of infection. Screening studies have been conducted in different areas and in different subgroups in Zaire in order to identify such a group. A population living or working at a site some 30 km east of Kinshasa was studied between December 1986-March 1988, and a parallel study was conducted of persons residing in Kinshasa. Groups from 2 rural regions were also studied. The 1554 persons screened were divided into 8 groups based on their residence histories. Serum HIV antibodies were assessed by ELISA and Western Blot. The 4 groups composed of men living and working in Kinshasa or within a suburban radius of 30 km had a seroprevalence rate of 12.67%, with no significant difference by residence. A population of 136 pregnant women in the same locations had a seroprevalence rate of 12.5%, for a sex ratio of 1.1. A group of 71 persons studied in a provincial city of southern Zaire who had spent time in Kinshasa several years previously had a seroprevalence of 4.23%. A group of new arrivals to the Kinshasa vicinity from the provinces who had never previously resided in Kinshasa had a seroprevalence of 2.45%. The final group was also composed of new arrivals from the same provinces with no previous urban experience. Screening after 8-12 months in the city showed that their seropositive rate had increased from 2.45% to 8.00%. This increase of 5.6% within 1 year indicates that this group would be appropriate for a large scale clinical trial on individuals with high risk of natural infection.
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