Q&A - What's up with the new vaccine trial in Chicago?

We really need the public to engage with us and be in this fight for the long haul... It took over 45 years to find the vaccine for polio!

An exclusive LifeLube interview with Sanford E. Gaylord, 
Community Educator, Project WISH

LifeLube - What HIV vaccine is being tested in the new study just launched in Chicago?

Sanford - At the University of Illinois at Chicago - Project WISH (We’re Invested In Stopping HIV), we launched HVTN 505, September 2009. HVTN stands for the HIV Vaccine Trials Network (www.hvtn.org). There are two types of vaccines that will be used in the study: DNA and Adenovirus vectored vaccines. The DNA vaccine is a synthetic replication of pieces of the HIV virus. It’s made in a laboratory and cannot give anyone HIV infection. Adenovirus vector is a common cold virus that is used to carry synthetic pieces of the HIV virus. This combination of vaccines has been used previously to stimulate the immune system in other studies and has been shown to be well tolerated.

Project WISH has been affiliated with the HVTN since 2001 and we’ve conducted clinical trials in partnership with them since 2004.

-What will the trial tell us?

The purpose of HVTN 505 is to teach us more about how a vaccine can stimulate production of T-cells to help the immune system respond to HIV if a person is exposed. We hope to learn if this vaccine can decrease the viral load of people who become infected with HIV. The lower the viral load, the longer it may take before a person develops symptoms of AIDS. An HIV vaccine that lowers viral load may delay the onset of illness, even if it doesn’t prevent HIV. A lower viral load may also reduce transmission of the virus to others. If the 505 vaccine does lower viral loads, scientists will know they are on the right track with vaccines which stimulate cellular (T-Cell) immunity. 

-Where else is the trial taking place? 

There are a total of 14 sites across the nation. In addition to Project WISH, trial is taking place simultaneously in the following cities: Atlanta, GA, Boston, MA; Birmingham, AL; Los Angeles, CA; Nashville, TN; New York, NY; Philadelphia, PA; Rochester, NY; San Francisco, CA; Seattle WA; and Washington, D.C. Check out www.hopetakesaction.org for a complete listing of sites.

-Who is being recruited for this study and why? How many people are you looking for in Chicago, and nationally?

Men who have sex with men (MSM) and Male to Female Transgender individuals 18-45 years of age who are fully circumcised are being recruited. The MSM population within the U.S. still bears the burden of HIV within our country.

We’re looking to recruit 80 people at Project WISH; nationally, we’re looking to recruit 1,350 people to participate in HVTN 505. 675 study participants will get vaccine and 675 will get a placebo.

- If I were to participate, how much time would it take, and what could I expect?

We’re looking for a 5 year commitment from study volunteers. The DNA vaccine will be given on 3 separate visits and the adenovirus vaccine at month 6. Then we continue to follow people for safety and we continue to provide HIV risk reduction counseling and HIV testing every three months. We’re also looking to see how their body is responding to the vaccine. There will also be physical exams and behavioral risk questionnaires. Each volunteer will receive a stipend of $ 40-95 per visit, depending on the type of visit.

-What are some of the benefits for me to participate in this trial?

This study may help in the search for a preventive HIV vaccine. At this point in the epidemic, we all must do our part so we can create a difference, especially for the generations that follow us all.

Being in this study might be beneficial to some of the study volunteers. The counseling that volunteers receive as part of the study may help them avoid getting HIV infection. The lab tests and physical exams may detect unknown health problems.

-Will this trial find a cure for HIV?

No, but it will advance our prevention efforts. Scientists believe that an effective preventive HIV vaccine is possible and are working to speed up the research process. Developing safe, effective and affordable vaccines are the best hope for controlling and/or ending the AIDS epidemic.

-Why does vaccine research take so long? Shouldn't we have something by now?

Research always requires multiple trials to find the right answer. For example, most of us wouldn’t think twice about taking Tylenol for a headache. Many may not have any idea how many trials it took to find a new pain reliever. Similarly, vaccine research has taken many years for other diseases as well. It took over 45 years to find the vaccine for polio!

I think what is important to remember is that even in trials where the product didn’t work as well as we hoped, we have still learned a great deal. Each trial is helping us to refine and retool our strategies so that we can move forward in our search. We really need the public to engage with us and be in this fight for the long haul.

-What are some of the risks to me as a trial participant?

Most common side effects from the vaccine are mild and include headache, tiredness, injection site pain or a small bump and/or scab at the injection site.

-Can I get HIV from being in this trial?

It is impossible to get HIV infection or develop AIDS from experimental vaccines. They are not made from live HIV, killed HIV, weakened HIV, or HIV-infected cells; they are synthetic replications. The investigational vaccines in this trial cannot cause HIV infection.

-I heard that some people test "false positive" in vaccine trials. What does that mean? How do you know if the positive result is truly false, or if in fact the person has seroconverted?

If you received the vaccine you might appear positive on the most common HIV tests. These tests are designed to look for the presence of antibodies to HIV and not the virus itself. We actually hope that the study vaccines will cause people to create antibodies; that is one indication that the vaccine is stimulating the immune system. This is what people may be referring to as a “false positive.” We encourage our study volunteers to only get their HIV testing done at our clinic during the trial because we can use tests that are able to tell the difference between vaccine-induced antibodies and a true HIV infection.

At the end of the study, volunteers who are showing antibodies from the vaccine will be provided HIV testing for free as long as they test “false positive.” Previous vaccine studies have shown this “false positive” may remain for years or may go away after some time.

-Would you encourage your best friend, or a close relative, to participate in this trial?

That’s a good question! I believe that this trial is well designed and well monitored but each person really needs to decide for themselves. I would encourage people I know to call or go to the website www.hopetakesaction.org and learn more about the study and meet with one of the study staff to get all of their questions answered.

Being in a study isn’t always the best decision for each individual or they may not be eligible for this particular trial, so its important to have all the facts and consider whether this seems like the right thing for you.

Even if people decide not to join the study, they can still help support our efforts in other ways. They can help educate others about vaccine research and help us to break down myths and misinformation that are out there. They may also want to join our Community Advisory Board.

-If I am interested in participating, what are my next steps?

Interested individuals can check out www.hopetakesaction.org for details. If you’re in the Chicago area, contact Project WISH toll free at 800-575-5758 or email us at wish@uic.edu. You can speak with our study staff for more information and see if you are eligible to participate, and learn how you can join us in the effort to stop HIV.