Dana L. Holmes Jr.
South University
Epidemiology
Professor Hoban
Through the years 2004 and 2007, there was a clinical trial conducted by the National Institutes of Health to test an experimental HIV vaccine. This test-of concept study was the STEP vaccine trail-Phase IIB (National Institutes of Health, 2007). The STEP trial was created to clinically study the effectiveness of a new HIV vaccine that was supposed to engage the immune system to create T-cells which can damage cells infected with the HIV virus. This trial was designed to compare the scientific results of those who received the experimental vaccine in either one dose or two, against those who received a placebo.
Prior to beginning this study, the risks and benefits of the study would need to be explained to the participants of this experimental human trial. Due to the nature of the infectious diseased involved with this trial, and according to an article titled Understanding Differences in Enrollment Outcomes Among High-Risk Populations Recruited to a Phase IIb HIV Vaccine Trial, Our study recruitment approach featured a key message on the urgent need for an HIV vaccine, and the campaign advertising included diverse and recognizable community members (Frew, & del Rio, et al., 2009, Methods Study Sample/para. 1). Study participants would have been selected due to their eligibility for the specific study which was requiring volunteers to be in the age range of 18-45, currently be HIV negative, and have a lifestyle that put them at a higher chance of potential HIV infection.
The main risk of this study would be high for those participants who received the placebo, meaning they did not receive the actual experimental vaccine that could potentially be effective in developing immunity against the HIV virus. However, those who did actually receive the vaccine were also at great risk, because the effectiveness of this vaccine had not yet been proven, and if the vaccine was not successful, those who received it were at just as at risk to contract the life threatening virus as those who received the placebo. Basically, regardless of which side of the study the participant fell on, there was no actual guarantee that anyone in the study would be protected against HIV contraction.
The benefit of the study would have been the possible confirmation that the vaccine was successful in providing people with protection against HIV, which would have been a scientific and medical breakthrough that would have had an incredibly giant impact on the entire world. If the study could provide any progress towards achieving an effective preventative measure to combat HIV infections to those who were at risk, that would be a benefit of the study. As stated by Frew, & del Rio, et al., Many reported altruism (n = 75, 22.1%) and scientific or medical contribution (n = 59, 17.4%) as their motivation for participating in an HIV vaccine clinical trial (2009,Characteristics of the Study Population/para. 2).
There were ethical issues that were involved in the beginning of this study, and also ethical issues surrounding the decision to terminate the study later. It is the responsibility of the medical and scientific community to consciously conduct their studies with proper ethics when it comes to Public Health practices. When it comes to the field of study in public health, values and principles are imperative to understand in order to make the proper decisions when weighing the justification of testing and conducting studies like this experimental HIV vaccine trial. According to the CDC on the topic of Public Health Ethics, In applying an ethics framework, public health ethics inquiry carries out three core functions, namely 1) identifying and clarifying the ethical dilemma posed, 2) analyzing it in terms of alternative courses of action and their consequences, and 3) resolving the dilemma by deciding which course of action best incorporates and balances the guiding principles and values. (CDC, 2017, What is public health ethics/para. 1)
In this study, the potential contraction of HIV had to be justified by the potential benefit that could result from the testing of this vaccine. It seemed as though researchers deemed it ethically acceptable to conduct this study utilizing placebo and unproven vaccine in order to determine the effectiveness of this experimental vaccine that was designed to produce T-cells that were to destroy cells infected with the HIV virus. Their decision to begin the STEP trial showed that the potential of a life-saving vaccine to combat HIV outweighed the potential contraction of the disease by the participants.
As the study continued, the decision was made to terminate the study. This conclusion was made due to the scientific evidence that not only was the vaccine proving to not prevent HIV infection, the study numbers actually showed that those who received the vaccine were at a greater risk of contracting the virus. These numbers clearly raised the red flag of ethics as the potential benefit was false, and the study was putting participants at a greater risk than was acceptable.
References
Center for Disease Control and Prevention. (2017). Public Health Ethics. Retrieved from:
National Institutes of Health (2007). National Institute of Allergy and Infectious Diseases: Immunizations are discontinued in two HIV vaccine trials. Retrieved from Pages/step_statement.aspx.
Frew, P. M., del Rio, C., Lu, L., Clifton, S., & Mulligan, M. J. (2009). Understanding differences in enrollment outcomes among high-risk populations recruited to a phase IIb HIV vaccine trial. Journal of Acquired Immune Deficiency Syndromes (1999), 50(3), 314319.
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Waheeda ALI BOCAS posted Apr 22, 2021 7:57 PM SubscribeThis page automatically marks posts as read as you scroll.Adjust automatic marking as read setting
Epidemiology of Disease Control
Waheeda Maxwell
SUO
Professor Carol Hoban
W5DQ
Prior to beginning this study, I would consider it to be high risk because the participants are being expose to an untreatable disease that eventually can cost them their lives. This is way they cease the immunization process and contact the volunteers to advise them of the risk factors of the study because it was deemed unethical medical trials.
The clinical trial with the combination of the poxvirus vector ALVAC and the HIV gp120 protein has taught us that a vaccine against HIV/AIDS is possible but further improvements are still needed. Although the HIV protective effect of RV144 was modest, these encouraging results reinforce the use of poxvirus vectors as HIV/AIDS vaccine candidates. The focus on prophylactic clinical studies thus far performed with an ALVAC, MVA, NYVAC and fowlpox expressing HIV antigens. The characteristic describes each vector administered either alone or in combination with other vectors, with and emphasis on the immune parameters evaluated in healthy volunteers, a percentage of responders and triggering the humoral and T cell responses. This also includes a broad polyfunctional and long lasting CD4 and CD8 T cell responses to HIV-1 antigen in most volunteers. There will be improvements in immunogenicity of the poxvirus vectors by the selective deletion of viral immunomodulatory genes and insertion of host range genes in the poxvirus genome (Elena, 2012).
The ethical issues are valid in ending the clinical trial because it was not a 100% safe for the volunteers to continue be to further exposure. The goal is to save live and prevent illness due to a deadly virus such as HIV. Even though the clinical trial of HIV began ten years ago and increasing number of trials are now being conducted in other countries, including several that are considered developing countries. Safeguarding the rights and welfare of individuals participating as research subjects in developing countries is a priority. In 1997 the United Nations Programme on HIV/AIDS (UNAIDS)
Embarked on a process of international consultation to further to define the important ethical issues ad to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts (Guenter, 2000).
Reference:
National Institutes of Health (2007). National Institute of Allergy and Infectious Diseases: Immunizations are discontinued in two HIV vaccine trials. Retrieved from Pages/step_statement.aspx.
Elena Gomez, C., Perdiguero, B., Garca-Arriaza, J., & Esteban, M. (2012). Poxvirus vectors as HIV/AIDS vaccines in humans. Human vaccines & immunotherapeutics, 8(9), 1192-1207.
Guenter, D., Esparza, J., & Macklin, R. (2000). Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS). Journal of medical ethics, 26(1), 37-43.
CAN YOU TELL ME OR ANSWER THIS QUESTION FOR ME.
What are some ethical guidelines to ensure that your participants in your study are treated appropriately?
