The clinical studies of anti-HIV/AIDS vaccines: the sociological assessment of formation of cohorts of volunteers


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The clinical studies are one of the most important directions in developing safe and effective vaccine against HIV-infection/AIDS. The significant components of process of clinical tests of candidate vaccines against HIV-infection/AIDS are medical sociological and ethical issues related to formation of volunteers’ cohorts, getting their informed consent, safety and security of volunteers and their counseling about decreasing the risk of HIV-infection. The article discusses the characteristics of medical sociological and ethical aspects of clinical studies of vaccines against HIV-infection/AIDS.

作者简介

A. Reshetnikov

The research institute of sociology of medicine, health economics and medical insurance of the I.M. Sechenov first Moscow medical university

Email: socmed-lmgmu@mail.ru
акад. РАМН, д-р мед. наук, д-р соци-ол. наук, проф., дир. Moscow

R. Khaitov

The institute of immunology of the Federal medical biological agency of Russia

Email: rkhaitov@mail.ru
акад. РАН и РАМН, д-р мед. наук, проф., дир. Moscow

S. Efimenko

The research institute of sociology of medicine, health economics and medical insurance of the I.M. Sechenov first Moscow medical university

Email: socmed-lmgmu@mail.ru
д-р социол. наук, проф., зам. дир. по науке Moscow

G. Gudima

The institute of immunology of the Federal medical biological agency of Russia

Email: goudima@gmail.ru
д-р биол. наук, зав. лаб. Moscow

I. Sidorovitch

The institute of immunology of the Federal medical biological agency of Russia

Email: sidorovich@neumail.ru
д-р мед. наук, проф., зав. отд. Moscow

E. Karamov

The D.I. Ivanovsky research institute of virology of Minzdrav of Russia

Email: karamov2004@yandex.ru
д-р биол. наук, проф., зав. лаб. Moscow

N. Bogatchanskaya

The research institute of sociology of medicine, health economics and medical insurance of the I.M. Sechenov first Moscow medical university

Email: bogachanskaya@mail.ru
ст. науч. сотр. Moscow

S. Pavlov

The research institute of sociology of medicine, health economics and medical insurance of the I.M. Sechenov first Moscow medical university

Email: pavlov-sv@list.ru
ст. науч. сотр. Moscow

参考

  1. Гудима Г. О., Сидорович И. Г., Карамов Э. В. и др. // Иммунология. 2008. Т. 29, № 5. С. 252-263.
  2. Карамов Э. В., Сидорович И. Г., Хаитов Р. М. Новая вакцинология. Вакцины против ВИЧ/СПИДа. М., 2008.
  3. Национальный стандарт Российской Федерации "Надлежащая клиническая практика (Good Clinical Practice GCP)". ГОСТ Р 52379-2005, утв. приказом Федерального агентства по техническому регулированию и метрологии № 232-ст от 27 сент. 2005 г., дата введения 1 апр. 2006 г. М., 2005.
  4. Решетников А. В., Хаитов Р. М., Ефименко С. А. и др. // Социол. мед. 2011. № 2. С. 37-40.
  5. Федеральный закон "Об обращении лекарственных средств" (№ 61-ФЗ, 12 апр. 2010 г.). М., 2010.
  6. Хаитов Р. М., Решетников А. В., Сидорович И. Г. и др. // Иммунология. 2008. Т. 29, № 2. С. 68-79.
  7. Клинические испытания первой отечественной анти-ВИЧ/ СПИД-вакцины / Хаитов Р. М., Решетников А. В., Сидорович И. Г. и др. М., 2009.
  8. Ackers M.-L., Parekh B., Evans T. G. et al. // J. Infect. Dis. - 2003. Vol. 187. P. 879-886.
  9. AIDS Vaccine Blueprint 2006. Global HIV Vaccine Enterprize-IAVI. N. Y., 2006.
  10. Allen M., Israel H., Rybczyk K. et al. // AIDS Res. Hum. Petrovir. 2001. Vol. 17. P. 667-674.
  11. Berkley S. // Lancet. 2003. Vol. 362. P. 992.
  12. Bishai D., Lin M. K., Kiyonga C.W.B. Algorithms for Purchasing AIDS Vaccines, World Bank Policy Research Working Paper 2321. Washington, 2000.
  13. Buchbinder S. P., Metch B., Holte S. E. et al. // Acquir. Immune Defic. Syndr. 2004. Vol. 36, N 1. P. 604-612.
  14. Celentano D. D., Beyrer C., Natpratan C. et al. // AIDS. - 1995. Vol. 9, N 9. P. 1079 -1783.
  15. Colfax G., Buchbinder S., Vamshidar G. et al. // J. Acquir. Immune Defic. Syndr. 2005. Vol. 39, N 3. P. 359 -364.
  16. Esparza J., Chang M.-L., Widdus R. et al. // Vaccine. 2003. - Vol. 21. P. 2032 -2041.
  17. Gilbert P. B., Chiu Y. L., Allen M. et al. // Vaccine. 2003. - Vol. 21, N 21-22. P. 2933-2947.
  18. IAVI List of Ongoing Preventive AIDS Vaccine Trials. Cape Toun, 2012.
  19. Jenkins R. A., Temoshok L. R., Virochsiri K. // J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 1995. Vol. 9, N 1. P. 36-42.
  20. Jenkins R. A., Thapinta D., Morgan P. A. et al. // J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 2005. Vol. 40, N 5. P. 592-599.
  21. Kaufmann S. H., McMichael A. J. // Nature Med. 2005. - Vol. 11, Suppl. 4. P. S33-S44.
  22. Mills E., Cooper C., Guyatt G. et al. // AIDS. 2004. Vol. 18, N 17. P. 2235-2242.
  23. Moodley K., Barnes J., van Rensburg E. J., Myer L. // S. Afr. Med. J. 2002. Vol. 92, N 11. P. 904-906.
  24. Newman P. A., Duan N., Rudy E. T., Anton P. A. // AIDS Patient Care STDS. 2004. Vol. 18, N 12. P. 691-701.
  25. Newman P. A., Duan N., Rudy E. T., Johnston-Roberts K. // Vaccine. 2004. Vol. 22, N 15-16. P. 1954-1963.
  26. Newman P. A., Duan N., Lee S.-J. et al. // Vaccine. 2006. - Vol. 24, N 12. P. 2094-2101.
  27. Newman P. A., Duan N., Roberts K. J. et al. // J. Acquir. Immune Defic. Syndr. 2006. Vol. 41, N 2. P. 210-217.
  28. Newman P. A., Duan N., Lee S. J. et al. // Prev. Med. 2007. - Vol. 44, N 6. P. 554 -557.
  29. Nyamathi A. M., Suhadev M., Swaminathan S., Fahey J. L. // AIDS Behav. 2007. Vol. 11, N 4. P. 619-627.
  30. O’Connell J. M., Hogg R. S., Chan K. et al. // J. Acquir. Immune Defic. Syndr. 2002. Vol. 31, N 5. P. 521-528.
  31. Ongoing Trials of Preventive AIDS Vaccines, 2005 // IAVI Rep. 2005. Vol. 3, N 1.
  32. Rerks-Ngarm S., Pitisuttithum P., Nitayaphan S. et al. // N. Engl. J. Med. 2009. Vol. 361. P. 2209-2220.
  33. Shapiro R. S., Stein R. E. // Hum. Rights, Fall Hum. Rights Magaz. 2004. Vol. 31, N 4. P. 20-22.
  34. Sheon A. R., Wagner L., McElrath M. J. et al. // J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 1998. Vol. 19, N 5. P. 519-526.
  35. Starace F., Wagner T. M., Luzi A. M. et al. // AIDS Care. - 2006. Vol. 18, N 1. P. 66-72.
  36. Strauss R. P., Sengupta S., Kegeles S. // J. Acquir. Immune Defic. Syndr. 2001. Vol. 26. P. 63-71.
  37. Suraratdecha C., Ainsworth M., Tangcharoensathien V., Whittington D. // Hlth Policy. 2005. Vol. 71, N 3. P. 271-287.
  38. Suraratdecha C., Hecht R. Demand for a Preventive HIV Vaccine. Policy Research Working Paper. New York, 2005.
  39. Thapinta D., Jenkins R. A., Morgan P. A. et al. // J. Acquir. Immune Defic. Syndr. 2002. Vol. 30, N 5. P. 503-513.
  40. Thapinta D., Jenkins R. A. // Contemp. Clin. Trials. 2007. - Vol. 28, N 4. P. 409-422.
  41. UK vaccine test cautiously welcomed. HIV vaccine. AIDS Wkly Plus, 1999. P. 9-10.
  42. Van De Ven P., Bartholow B., Rawstorne P. et al. // AIDS Res. Hum. Retrovir. 2002. Vol. 18, N 18. P. 1333-1337.
  43. Walker S., Rowley J., Hecht R. Speeding the Manufacture of an HIV Vaccine: Policy Issues and Options. New York, 2005.
  44. Young K. R., Ross T. M. // Curr. Drug Targets Infect. Disord. - 2003. Vol. 3. P. 151-169.

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