Participating in HIV vaccine trial

[kazoo]

Hi everyone,

I wanted to start a thread on HIV vaccine trials. I was given permission by Ann to start this thread given interest in the topic.

That said, I am participating in the HVTN-505 trial in San Francisco. The trial is also taking place in several other cities across the United States. Trial participants are HIV-negative gay men. The setup of the trial is to give half the participants a HIV vaccine and the other half a placebo; volunteers are not told which group they are in until the study is over. There are four vaccinations total over a six month period. The purpose is to measure the body's immune response to these vaccines (they take quite a bit of blood). Also, it goes without saying that some trial members, unfortunately, will contract HIV during the study (NOT from the vaccine, but from another HIV-infected person). Researchers will also then investigate the number of HIV-infections in the vaccine and placebo groups.

While there are no physical side effects for vaccine participants (other than typical symptoms after receiving any vaccine), there are other issues. One concern is testing study members for HIV, because the HIV vaccine may cause participants to produce HIV antibodies, enough that they result in false-positive HIV tests using the traditional antibody tests. Study members are told to test only at the study site, where different testing methods are used. It is unclear how long after the study a participant will continue to test positive on standard HIV tests.

I don't have any specific questions on this topic, but I wanted to open it for discussion. I am simply a volunteer in the study, not a HIV researcher. If I have any incorrect information, please correct me.

Thanks,
Kazoo

[veritas]

Kazoo,

I want to give you a "BRAVO !" for participating in this study.

 From what little I understand about this trial, the information to be derived from this study will give researchers much needed information to launch further vaccine research as well as perhaps a way to  keep viral load down (therapeutic possibilities). The potential to keep viral load under control  is very important to all of us living with HIV, who are looking for a kinder and gentler way to treat the virus.

Let me provide you with some links that I came across concerning the HVTN-505.  I'm sure you were given all this information, however, they may help others reading your thread to understand what a wonderful and unselfish act your doing by participating:

http://www3.niaid.nih.gov/news/QA/HVTN505qa.htm
http://www.hvtn.org/media/news.html
http://clinicaltrials.gov/ct2/show/NCT00865566
http://www.aidsaction.org/about-aids-action-mainmenu-187/hivaids-vaccine/464?task=vi

Your helping to make the dream of an aids vaccine, one step closer and I look forward to your updates !

v

[kazoo]

Thanks veritas for your response. I am happy I can help with this important study.

I have to admit that joining this kind of research study was a difficult decision. I have only received the first of four vaccinations thus far, without any noticeable symptoms. But, I still have concerns with my personal involvement in the study.

The first is any negative emotional side effects I may receive from other people (i.e. others assuming I am HIV positive). While I do not anticipate any major issues with this, it is certainly possible, considering that much of the general population is relatively uninformed about HIV research. Second, I have concern about possibly continuing to test positive on standard HIV tests well after the study is completed (unless I am in the placebo group). And third, to get the most useful information from this study on HIV treatment and management, some participants have to acquire HIV. Obviously, no one wants this to happen, but it is the best way to investigate the effectiveness of the vaccine.

I am curious if there are others who have participated in vaccine trials who have had similar considerations when participating in a study.

[Pepino2]

Thanks veritas for your response. I am happy I can help with this important study.

I have to admit that joining this kind of research study was a difficult decision. I have only received the first of four vaccinations thus far, without any noticeable symptoms. But, I still have concerns with my personal involvement in the study.

The first is any negative emotional side effects I may receive from other people (i.e. others assuming I am HIV positive). While I do not anticipate any major issues with this, it is certainly possible, considering that much of the general population is relatively uninformed about HIV research. Second, I have concern about possibly continuing to test positive on standard HIV tests well after the study is completed (unless I am in the placebo group). And third, to get the most useful information from this study on HIV treatment and management, some participants have to acquire HIV. Obviously, no one wants this to happen, but it is the best way to investigate the effectiveness of the vaccine.

I am curious if there are others who have participated in vaccine trials who have had similar considerations when participating in a study.

Thanks Kazoo for sharing this and having made the decision to get involved on this.  It must have been a tough decision.  I mean, for those of us reading this - a question of ethics comes blindly to mind.  I mean, what if such vacine studies have a direct impact on the sero-converison of its participants.  For example, what if cohort members take on more risky sexual behaviours as a result (superman effect).

In regards to the possibility of testing "false positive" forever, I'm really curious at this point to know what kind of physcological support (and pre enrollement phsycological assessments) the  research group has proposed to members of this study (and for how long - assuming you continue to test "false positive" for say - euh ...your entire life).

I can just see the confusion insurance companies would have with this

Most importantly Kazoo, it's about you and your health.  You are negative and by all means keep protecting yourself.  That is the greatest gift you can make to yourself and to us all on these boards.


Wishing you very Happy Holidays

Pepino2

[veritas]

Kazoo,

As far as testing false positive is concerned, a new HIV - Select Test EIA and Rapid test has been developed to distinguish between those who are truly infected by HIV and those who have antibodies based on vaccine trials. This test should become standard for situations such as yours. Hopefully, this should happen soon. I started a thread for this in this forum but here is the link:

http://www.ncbi.nlm.nih.gov/pubmed/19906903?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=4

Also, perhaps the co-ordinators can give you some type of document explaining your status until the rapid test becomes status quo.

I'll seccond Pepino2's comment concerning your health. Keep yourself safe. This vaccine is for research
only, with no intention of pursuing an IND for this particular vaccine. The work is very important to the Global Aids Iniitiative, thus ,the strict entry requirements for participation.

Discuss your concerns with your co-ordinator because others might have those same concerns as participants in the trial.

Please keep us up-dated!

v

[kazoo]

Thanks for your responses!

I wholeheartedly agree that the health of study participants is first and foremost. Fortunately, the study does provide safe-sex counseling at each appointment and free HIV testing whenever participants request. As for myself, I intend to practice the same sex practices which have kept my HIV status negative.

I think there is definitely some concern about volunteers taking on a "superman" mindset. I thought that in my case, the counselors made it very clear that participants should have no expectations that this vaccine would be effective.

Before entering the study, there is a screening process which involves a very thorough physical exam. In my experience, there wasn't much of a psychological assessment however, other than asking if we have experienced any psychological disorders in the past.

The study also works with participants if an issue with a false-positive test arises, such as speaking with insurance companies, physicians, employers, etc. While it is anticipated that volunteers receiving the vaccine will no longer test false-positive after some time, there have been occurrences of people from studies who test false-positive even 10 years after a trial. After this amount of time, who knows if the study sites will even be available for testing, and if participants are even living in the same area. I am hopeful for this reason that these new testing methods (like the Select Test) become commonplace. I think this would be a great step, considering the ever-growing number of people who are or have been in vaccine trials.

[kazoo]

I was able to get additional information on this HIV vaccine test through the researchers at my testing site, specifically concerning the issue of false-positives.

Fortunately, there have been very few major problems arising from participants testing false positive. It is, however, expected that the vast majority of volunteers in the vaccine group will develop HIV antibodies detectable by today's standard testing. After the last vaccine injection (there are four total), a participant is tested every three months (at a minimum) using a barrage of HIV testing methods. This allows researchers to determine which types of tests will return a false-positive. This monitoring also thus indicates when a volunteer is no longer producing HIV antibodies, and can return to standard HIV testing. I was told that there is no way to really know how long this false-positive period can last. Again, it has still been an issue for some even 10 years after a vaccine trial, but most of the time it is far less a period.

The vaccine study I am in is not using the recently-unveiled Rapid HIV Select Test, which can distinguish between vaccine and virus induced antibodies. That test does not yet have FDA approval. The researchers at my site did not have information on how quickly this test would become available, or whether it will eventually become widely available. In my discussion with the study personnel, I got the impression that virus-based testing (tests looking for the virus itself, and not antibodies) will be increasingly used. I was also told that work is in progress on a rapid version of these virus tests.

Kazoo

[veritas]

kazoo,

Thanks for the up-date !

Would the researchers be able to explain to you how this particular phase of vaccine study fits within the broard range of vaccine development for the global vaccine initiative? (might be difficult to get an answer).

Good to hear that those antibodies might be eliminated from the body eventually. However testing for the virus itself should be able to get the appropriate answers with respect to virus based vs vaccine based antibodies.

Fascinating study !

Thanks again,

v