Discussion Questions

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Clinical Trial

Between  2004 and 2007, the National Institutes of Health conducted a STEP  vaccine clinical trial—Phase IIB “test-ofconcept” study.

The  STEP study is the name of a clinical trial to test an experimental  human immunodeficiency virus (HIV) vaccine. The STEP study enrolled  3,000 participants at sites in Australia, Brazil, Canada, the Dominican  Republic, Haiti, Jamaica, Peru, Puerto Rico, and the United States. The  study was designed to test an HIV vaccine, which aimed to stimulate  production of immune system T-cells that can kill HIV-infected cells.

Based  on its first evaluation of vaccine efficacy, the findings showed there  were 24 cases of HIV infection among the 741 volunteers who received at  least one dose of the investigational vaccine compared with 21 cases of  HIV infection among the 762 volunteers who were vaccinated with the  placebo. In volunteers who received at least two vaccinations, there  were 19 cases of HIV infection among the 672 volunteers who received the  investigational vaccine and 11 instances of HIV infection among the 691  volunteers who received placebo. The study investigators of the vaccine  trials have decided to cease immunizations and are contacting study  volunteers to inform them of the developments.

Reference:

National  Institutes of Health (2007). National Institute of Allergy and  Infectious Diseases: Immunizations are discontinued in two HIV vaccine  trials. Retrieved from National Institute of Allergy and Infectious Diseases Pages/step_statement.aspx.

Using  the South University Online Library or the Internet, research further  on the STEP study, the STEP vaccine clinical trials, and their  parameters.

Based on your research, understanding, and above information, answer the following questions:

 

  • Prior to beginning this study, how would you have described the risks and benefits of the study to participants?
  • What are the ethical issues surrounding this study at the beginning and when the decision was made to terminate the study?

Submission Details:

 

  • Post your response to the Discussion Area by the due date assigned. Respond to at least two posts by the end of the week.