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Adverse events monitoring as a routine component of vaccine clinical trials: evidence from the WHO Vaccine Trial Registry.
Bulletin of the World Health Organization. 2000; 78(9):1167.This article assesses whether and how investigators are monitoring adverse events following immunization (AEFI) in vaccine trials, using evidence from the WHO Vaccine Trial Registry. It is noted that the Registry includes all vaccine trials sponsored since 1987 by the WHO Expanded Programme on Immunization, Global Programme for Vaccines and Immunization, and Department of Vaccines and Biologicals. For each trial, records include internal documents, reports of visits to trial sites, and publications. Based on the records from 68 trials, completed or in progress, analysis indicates that only few investigators included detailed AEFI monitoring in their study reports and publications. However, an increasing trend to include AEFI monitoring in vaccine clinical trials was noted. Since many vaccine trials are conducted by independent investigators, and AEFI monitoring methods and results deserve to be included in any publication, along with vaccine efficacy methods and results, it should be the responsibility of the study investigators, rather than of the vaccine manufacturer and the national control authority, as suggested. Several practical points for monitoring AEFIs in vaccine clinical trials are cited.
Chennai, India, Voluntary Health Services, AIDS Prevention and Control Project, . 43 p.In Tamil Nadu, India, there are no research studies undertaken to establish the prevalence of HIV among women in prostitution. However, the clinical data from various sources reveal that a significant proportion of them are infected with HIV. The situational assessment conducted by the nongovernmental organization (NGO) partners facilitated by AIDS and Prevention and Control (APAC) revealed various factors, which made women more prone to the infection. It was mainly due to the inconsistent usage of condoms; various myths and misconceptions; lower empowerment; lower social status and educational level. To this effect, the APAC project adopted the implementation of holistic, participatory gender specific and culture sensitive prevention programs among women in prostitution. It provides relevant information to risk population groups, promotion of quality condoms, enhancement of sexually transmitted disease and counseling services, and explorative research for increasing the effectiveness of the project. It is noted that APAC supports six NGOs in six towns in Tamil Nadu to implement the targeted intervention among women in prostitution.
[Bangkok, Thailand], United Nations Development Programme [UNDP], South East Asia HIV and Development Project, 2000 Jul. , 19 p.One of the greatest challenges for workers in HIV prevention is the establishment of programmes that result in primary prevention of the spread of HIV. Such programmes must target the temporal and spatial factors that create environments that are fertile for transmission, rather than simply reacting post facto to local trends in HIV prevalence and incidence. Recently, the role of development in affecting the vulnerability leading to possible HIV infection in communities has become increasingly clear. Development efforts can sometimes de-stabilize a community by moving people in or out of it, or by affecting people’s economic or cultural environment. For example, the construction of a dam can at once force people to leave their homes near the construction and find work elsewhere, and recruit new people into the area to work on the dam. Such social and cultural flux changes the way people behave and the populations with whom they are in contact. To be effective, HIV preventive efforts must be closely synchronized with exactly those development factors that acutely increase a population’s vulnerability. The proposed Early Warning Rapid Response System (EWRRS) has been conceived to establish this synchronization. By linking information about development activities with information about effective prevention for the populations affected, an EWRRS would have a critical role in HIV prevention. Knowing which development activities can trigger population movements, which populations are moving, where they will be, and what languages they speak can foster public- and private-sectoral coordination of immediate actions to educate and support these populations to reduce their vulnerability. Such knowledge can also lead to retooling development activities in order to achieve both the development objectives and HIV prevention. In May of 2000, representatives from the Greater Mekong Sub-region and international HIV specialists met in Bangkok for a Think Tank Consultation on the EWRRS. The work of that meeting is summarized here. While the EWRRS is an unconventional idea, the efficacy of which may be difficult to show at this point in its conception, its potential to promote well-informed and coordinated actions to significantly reduce HIV spread is compelling. (excerpt)
Indian Journal of Tuberculosis. 2000; 47(1):27-33.Surveillance of drug resistance was carried out at State level to obtain data which are standardised and compaiable using guidelines prescribed by the WHO/IUATLD Working Group on Anti-tuberculosis Drug Resistance Surveillance. The objective was to determine the proportion of initial and acquired drug resistance in cases of pulmonary tuberculosis in Tamil Nadu, m order to use the level of drug resistance as a performance indicator of the National Tuberculosis Programme. Two specimens of sputum from each of a total of 713 patients attending 145 participating centres all over the state were tested by smear and culture examination and drug susceptibility tests of Isoniazid, Rifampicin, Ethambutol and Streptomycin. Out of 400 patients for whom drug susceptibility results were available, 384 (96%) had no history of previous anti-tuberculosis treatment. Of these, 312 (81%) were susceptible to all the drugs tested. Resistance to Isoniazid was seen in 15.4% of patients and to Rifampicin in 4.4%, including resistance to Isoniazid and Rifampicin in 3.4%. There has been a gradual increase in initial drug resistance over the years in this part of the country. (author's)