HIV Vaccine Trials: Safe for All

April 1, 2012

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-04-01-2012, Volume 21, Issue 4

Researchers who work on HIV vaccines face a major challenge: convincing members of at-risk communities to volunteer for these trials.

World AIDS Day 2011 (December 1) was observed in many countries around the globe. The theme of the event was "Getting to Zero"—specifically, zero new HIV infections, zero discrimination, and zero AIDS-related deaths.

A key tool in achieving such goals is the conducting of vaccine trials. Yet researchers who work on HIV vaccines face a major challenge: convincing members of at-risk communities to volunteer for these trials. To determine why participation rates in these communities are so low, University of Toronto researchers recently surveyed nine focus groups comprising at-risk individuals, and found they held a set of misconceptions.

Robert McNally

TheBody.com reported that many of these individuals falsely believe that vaccine trials expose them to the risk of getting AIDS. The surveys also uncovered a general distrust of doctors and medical researchers, as well as confusion over why HIV vaccine trials specifically target people in at-risk communities.

In addition to the concerns raised by this report, many infected individuals may feel satisfied with current drug regimes that are working—a feeling that can dampen the desire to experiment with novel treatments. Despite the issues with attracting volunteers, the clinical trial pathway is the only method for promising products to make it to the market. Those of us who are involved in the quest for an HIV vaccine recognize the paramount importance of engendering trust within the communities we are trying to help.

What can be done? Investigative sites could hire a communications firm to produce flyers detailing the safety of clinical trials, and distribute them within the community—perhaps at local doctors' offices and healthcare facilities. If budgets allow, short radio spots on local stations could stress the importance and safety of trials.

Whichever steps are taken, it is vital that members of at-risk communities understand the importance of taking part in vaccine trials. These individuals owe it to themselves—and to the HIV-positive population—to get educated on why trials are important, and the HIV research community must take the initiative to facilitate their ability to learn about them.

Vaccine trials are a vital tool at GeoVax Labs, which is testing AIDS vaccine candidates for preventative and therapeutic purposes. The therapeutic vaccine is designed to treat individuals already infected with the HIV virus and is intended to prevent these cases from progressing to full-blown AIDS. Therapeutic vaccines, when used in combination with existing oral medications, have the potential to eventually cure someone of the disease. The preventative vaccine is designed to prevent infection by the virus and reduce its transmission. Vaccines for polio, smallpox, flu, and a multitude of other diseases have proven many times that this route for protection is the only one that is practical and effective.

In February 2011, GeoVax Labs announced the results of a Phase I clinical trial testing its vaccine products involving three trial regimens. The vaccines showed excellent safety characteristics in each, with all the regimens inducing both antibody and T cell responses. A Phase I therapeutic clinical trial for the vaccine is being conducted at two sites, with a third on the way.

In order to maximize the effectiveness of vaccine trials in the development of HIV/AIDS vaccines, the population of potential subjects must be made aware of their safety and importance.

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