Question

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?

Answer 1

The STEP study was conducted to test a vaccine against HIV that would reduce the chances of infection and would also reduce the amount of virus in blood stream. Prior to the beginning of the study, the partcipants should have been explained the risk and benefits of the study.

BENEFITS OF THE STUDY:

• This vaccine if successful will be a boon in medical field as the mortality due to HIV infection is high.
• The test is conducted on vulnerable group, who is living at risk of developing HIV infection. The success of this test would have added to their relieve.
• It was promised that the test will not result in new infection with HIV as the researchers are using the synthetic portion of HIV genome.

RISKS:

• Risk of failure of test may result in development of new HIV infection.
• Although tested the vaccine may not reduce the amount of virus in bloodstream.
• It may make the participant vulnerable to infection.

HIV in our society has always created many ethical issues since beginning when the disease came into existence. The unawareness about the disease process create lots of chaos among people. But with the passage of time, this issue was resolve to a great extend. But still stigma behind the disease persist among various group of people.The various ethical issues that merged before and after the trial were:

• Presence of such stigma would make the participants prone to social and psychological harm.
• Ethical issue was created with use of term developed and developing countries.
• Such test will take time to finish. This will develop issues to safeguard the rights and welfare of the communities and individual participating in the study. Therefore, the vaccine needs to be developed immediately.
• Self determination to participate in the test
• Expenditure for the treatment of HIV will be provided or not to those who develop HIV during the test.
• People also doubted the accessibility of the proven vaccine.
• In post trial interviews the participants expressed ambivalence about the clarity and transparency of the consent process of the trial.
• The integrity of the trial based on the unforeseen outcome was questioned.