Guinea pig for AIDS vaccine clinicals

[eschaton88]

Alrighty, so like any broke college kid at a research-heavy school I've been a volunteer control for clinical research of one variety or another. However, I just found one that will pay almost $800 over a year for once a month visits. The problem is it's an HIV vaccine, and while the PI assured me they won't be shooting me up with HIV, they will be giving me the antigens in the hopes I produce antibodies.

My problem is this would cause me to likely come up positive on an HIV test, even though I wouldn't be infected. Do you guys think this could cause a problem in the future? For instance would I be denied admittance to a school or a residency if I was falsely HIV+? I don't think a school would admit to something like that, but decisions can be influenced subconsciously. I think this is a pretty cool research topic and let's face it, I could use the money, but I don't want to cause a problem later down the line. Any input?

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[Raryn]

Erm, how on earth would they find out?

 

[EatParsley]

Alrighty, so like any broke college kid at a research-heavy school I've been a volunteer control for clinical research of one variety or another. However, I just found one that will pay almost $800 over a year for once a month visits. The problem is it's an HIV vaccine, and while the PI assured me they won't be shooting me up with HIV, they will be giving me the antigens in the hopes I produce antibodies.

My problem is this would cause me to likely come up positive on an HIV test, even though I wouldn't be infected. Do you guys think this could cause a problem in the future? For instance would I be denied admittance to a school or a residency if I was falsely HIV+? I don't think a school would admit to something like that, but decisions can be influenced subconsciously. I think this is a pretty cool research topic and let's face it, I could use the money, but I don't want to cause a problem later down the line. Any input?

I've been a clinical research coordinator for the last two years and while I don't specifically works on AIDS vaccine trials, I do work with a couple of vaccine trials for cancer research. You need to get the question about antibiodies answered before you receive your first injection. This information will come from either a nurse working on the trial, or the principal investigator - their information should be listed on the consent form. If this is a Phase I trial they will likely not have any human data, but you can ask them to check the investigator's brochure for preclinical information about antibodies in animals. If this is a trial later than Phase I, they should have this information available for you. However, not all adverse experiences can be known. If they are not able to provide you with this information, you can contact the IRB listed on the consent form for more information.

From hivtest.org "In most cases the EIA (enzyme immunoassay), used on blood drawn from a vein, is the most common screening test used to look for antibodies to HIV." So yes, this would show as a positive result if you developed these antibodies.

If the schools don't do an HIV test, all of the trial information should be kept absolutely confidential and will likely not be shared with any outside agencies, but **** does happen.
I had no idea that medical schools did HIV tests, is this school by school?

 

[Myuu]

Erm, how on earth would they find out?

Current HIV tests check for the presence of antibodies. If he goes through a trial designed to generated antibodies, he'll have 'em.

I can see that producing all sorts of school/insurance/godknowswhatelse problems and would not do it.

 

[Davydude7]

I don't know if it is something that you have ever considered, but military HPSP programs will require you to have an HIV test as part of their physical screening process. If it is possible that this would cause a false positive on an HIV test and HPSP is something that you were considering, it might not be worth it for $800.

 

[Dirt]

Well I can tell you one thing, you will never be able to donate blood again.

 

[Depakote]

\
I can see that producing all sorts of school/insurance/godknowswhatelse problems and would not do it.

I don't know about medical school, but I imagine it would be quite difficult to get health/life insurance... there would be a lot of red tape and they'd probably deny you rather than put up with the hassle.

 

[Raryn]

Current HIV tests check for the presence of antibodies. If he goes through a trial designed to generated antibodies, he'll have 'em.

I can see that producing all sorts of school/insurance/godknowswhatelse problems and would not do it.

No, I meant how on earth would any admissions committees find out?

 

[Myuu]

No, I meant how on earth would any admissions committees find out?

Ahh, gotcha.

 

[NSDQ]

After almost entering a HIV trial as a volunteer myself, I was given some info that may help you. First, the Med school I was going to volunteer at would provide me with a card that said that I was a volunteer with an HIV trial and due to this I may test positive in a std. HIV test (antibody test). However, the school said that after completing the trial they would provide me (free of charge when ever I needed one) with a HIV test that tested for actual HIV virus and not just the antibodies. If I wasn't in the area then they would reimburse me for the charge of the more expensive test. So if you want to volunteer, don't let the potential positive test stand in your way.

 

[StPlayrXtreme]

I received the medical clearance forms from a medical school, the school requires a blood count, but clearly states that HIV status is NOT to be reported. (It does however say that if the student wishes to reveal their HIV status, the information would be kept in a locked box).

I think there are so many confidentiality laws surrounding HIV testing, that I don't think developing antibodies would affect medical school. I don't think it would be an issue.

That said...i would never submit myself to that study for $800. If I'm otherwise healthy, I don't want to inject myself with something with unknown effects...but that's entirely my personal stance.

 

[NotAndrew]

No one is injecting me with HIV for under $100,000,000. So no don't do it for $800. I don't care if it is not the actual virus, I don't and you don't need $800 that badly. This being said if you test positive for HIV and some school/residency program rejected you for that you would be able to sue them for millions.

Edit: when I clicked on this thread I thought it was about testing an AIDS vaccine on actual guinea pigs.

 

[teucer]

This sort of thing is always dicey. In the end, $800.00 is a fleeting and minute reward for the possible consequences that you'll have to deal with. Cost/benefit analysis tells me my economics teacher would disapprove. All economics jokes aside, there are always possible unseen consequences involved with everything experimental. My (possibly unfounded) fear would be that it would trigger some sort of malfunction, aka cancer, in the body. Whenever you tinker with the immune system, noone can tell what the consequences will be. What would I be passing on to my children? Who knows...if none of this is a concern to you, I would go ahead. Though, considering you have a very meaningful life ahead of you that will influence others' well being as well as yourself, I would guard life and limb with far more jealousy than your current mindset seems to be dictating.

 

[WildlifeSaver]

$800.00 is nothing. It isn't the virus, but....I would not do it. Who knows what could happen. Just from that, you are going to have to deal with a lot if you go though with it like others said.

 

[drizzt3117]

If you're that hard up for money go to Covance, you'll get paid more and won't be HIV positive.

 

[mcattitude]

I just took a very intensive course on the Biological and Sociological aspects of HIV/AIDS and could not advise more strongly AGAINST participating in the experiment. There is an incredible stigma faced by people who test HIV+.

Though it would be wonderful to help the effort to find a cure or vaccine, and make some money, this could have horrible repercussions later in life.

 

[phospho]

Well I can tell you one thing, you will never be able to donate blood again.

this is probably the most important thing you should know...

for 800 bucks?

 

[WannaBePreMed]

I'm broke as fu*k but I wouldn't do one of these trials. Don't do it

 

[Upgrayedd]

There are three types of tests for HIV:

1) ELISA for antibodies - you would test positive if the vaccine works

2) Antigen test - you would most likely test positive, this might vary if your body clears the antigens at a certain rate

3) PCR test - You would test negative to either the DNA or RNA amplifications. (If you don't, then something must have gone really, really wrong with the vaccine). This is also the most expensive and likely what the sponsors would be paying for.

I don't really understand SDN sometimes. I know there is that whole "do no harm" bit of the oath, but this is one of those grey area's where it has to be interpreted/pracitced. I bet a fair amount of people in this forum would have no problem enrolling their own patients some day in a clinical trial with a similar risk/benifit profile. If you can't recommend something like this with what should be such a low risk (presumably based on the concept that somehow the sponsors may have overlooked a potentially catastrophic catch...), how can you trust and practice the rest of medicine at all???

 

[NotAndrew]

I don't really understand SDN sometimes. I know there is that whole "do no harm" bit of the oath, but this is one of those grey area's where it has to be interpreted/pracitced. I bet a fair amount of people in this forum would have no problem enrolling their own patients some day in a clinical trial with a similar risk/benifit profile. If you can't recommend something like this with what should be such a low risk (presumably based on the concept that somehow the sponsors may have overlooked a potentially catastrophic catch...), how can you trust and practice the rest of medicine at all???

The thing is people catch diseases from vaccines all the time, and these are vaccines that have been tested and worked successfully for decades. Don't get me wrong I am pro vaccines but not a vaccine that is still in the trial period, is for a disease that is not airborne, and the disease is very easily not contracted. Sorry if my not wanting to be injected with any part of the HIV virus offends you. As for recommending patients to trials with similar risk benefit ratios, in the end it is the patents choice as a doctor you explain the risks to them, not determine if they enter the trial or not. I guess what I am trying to say is people saying this guy should not volunteer for this trial in no way effects/predicts/determines if or how well you will be able to practice medicine.

 

[Upgrayedd]

The thing is people catch diseases from vaccines all the time

Oh really? How about a source on that one there... People are known to (albiet rarely) have massive immune reactions to vaccines which can be fatal, but that is different from catching the very disease that the vaccine is designed to protect you from. The only feasible way that your statement even makes sense is if you were using inactivated or heat killed innoculums. This HIV/AIDS vaccine is different. There is no genetic material even being introduced into the subjects system, so explain to me how there is any chance of HIV infecting or reproducing?

... but not a vaccine that is still in the trial period, is for a disease that is not airborne, and the disease is very easily not contracted. Sorry if my not wanting to be injected with any part of the HIV virus offends you.

I don't think the fear of an incurable and highly plastic disease is irrational at all; but the amount of fear you are expressing leads to a dangerous paralysis of action. I ask, who should we test the vaccine on then? How do we have distributive justice where those who stand to benefit from the development of a successful vaccine also need to share in the risks of development?

As for recommending patients to trials with similar risk benefit ratios, in the end it is the patents choice as a doctor you explain the risks to them, not determine if they enter the trial or not. I guess what I am trying to say is people saying this guy should not volunteer for this trial in no way effects/predicts/determines if or how well you will be able to practice medicine.

I never said that ones opinion on this matter is of suspect, but what I did imply is that there was definitely a lack of critical thinking behind many of the previous posts, and I wanted to point out the fact that there are risks in the space that we will all work in, and how you manage them DOES determine how well one practices the art of medicine. There is a time for inaction as well as action, but unsuported annecdotes and knee-jerk reactions do not make for good medicine or science.

Would I recommend this vaccine in the end to this patient? Probably not, since, as you said, he already stands a low chance of aquiring HIV, so besides the financial aspects, he stands to have very little benifit from the vaccine, and also takes on an added (although extrordinarily small) risk. Also, good luck getting waivers from the DoD if you ever decide to join the military, the posative ELISA test might disqualify one even with a negative PCR test...

Would I recommend this to a high-risk individual? Absolutely.

 

[NotAndrew]

Some reasons why upgrayedd is wrong

1. Unknown risk/little to know benefit: upgrayedd will claim that this trail brings little to no risk. However(correct me if I am wrong) our knowledge about what this trial involves is extremely limited. This vaccine may be new in which case the short term, long term, and imitate side effects are unknown. On the other hand maybe this vaccine has no side effects and you are $800 richer and you have an effective HIV vaccine. The facts are you don't know the side effects of this drug and $800 is not a lot of money. It is simply not worth it.

2. "but the amount of fear you are expressing leads to a dangerous paralysis of action": What does this mean? How is not participating in this trial dangerous to anyone?

3. "I ask, who should we test the vaccine on then?": No one. It is unnecessary.

4. You can't read minds: what I mean by that is this by saying "I did imply is that there was definitely a lack of critical thinking behind many of the previous posts" you also imply you know the thought process of me and everyone else who posted in this thread. That is just silly. Just because you don't like the outcome of thinking does not mean it did not happen.

5. Funding for HIV/AIDS clinical trials should go to programs with a benefit: sure this vaccine will help IV drug users and dudes that just hate condoms, but a far easier way exists to help the public not contract HIV. Education. Funding should go to trials that will help people living with HIV/AIDS.

 

[virusgirl]

Some reasons why upgrayedd is wrong

3. "I ask, who should we test the vaccine on then?": No one. It is unnecessary.

...

5. Funding for HIV/AIDS clinical trials should go to programs with a benefit: sure this vaccine will help IV drug users and dudes that just hate condoms, but a far easier way exists to help the public not contract HIV. Education. Funding should go to trials that will help people living with HIV/AIDS.

First of all, thumbs up to those folks who have pointed out that not all AIDS tests are antibody-based. Many of my friends participated in an HIV vaccine trial (we were starving grad students!) and none of them have had a problem. Those who have needed HIV tests, for whatever reason, were able to obtain PCR-based testing and it wasn't an issue.

NotAndrew, I have to disagree with you on the above points. It seems to me that you don't think there should be an HIV vaccine at all. It would, of course, be ideal if we could just prevent HIV infection in the first place, but that is unlikely to happen. And sadly, I think education is not going to solve the problem. I have read some studies (can't remember the citations, but they shouldn't be too hard to find for those who are interested) that indicate that even in the presence of good education about HIV and its transmission, people still continue to engage in risky behaviors. My best friend from high school, who went to the same health classes I did and knew all about the dangers of unprotected sex, still had a lot of sex without a condom, and he is HIV+ now. The problem seems to be a disconnect between intellectually acknowledging the risk and understanding that you personally are at risk. My professor used to call this the "someone else" phenomenon (as in, HIV always happens to someone else... never YOU).

I also can't overstate the importance of gender roles in the spread of HIV, particularly outside of the US. I read an interesting piece about AIDS in sub-Saharan Africa, and it included testimonials from a number of women whose husbands were migrant workers who travelled frequently to find employment. These men would go to the cities for work, have sex with prostitutes, and then come home to their wives -- and the women simply were not empowered, according to the customs of their community, to ask their husbands about their extramarital sex, or even ask them to use a condom. I realize of course that there is significant variation in local customs, and I don't mean to generalize, but I do want to point out that there are cultures were stigmas about sex/protection, and sexual communication, make it difficult for people to protect themselves against HIV even if they want to.

There is a lot of sociology and psychology behind the spread of HIV -- it is much more complicated than simply attributing the epidemic to a lack of education. For this reason, I think it is imperative that we adopt a two pronged approach: prevention through education/social support, and prevention through vaccination.

 

[squrlgrl007]

For instance would I be denied admittance to a school or a residency if I was falsely HIV+? I don't think a school would admit to something like that, but decisions can be influenced subconsciously. I think this is a pretty cool research topic and let's face it, I could use the money, but I don't want to cause a problem later down the line. Any input?

I did one of these trials at the NIH in Bethesda. It was a 1 year, stage II clinical trial. Long story short, the vaccine ended up not being effective. I have had 5 HIV tests durring/since the trial, all administered by the NIH, at their cost, due to the nature of the trial. They emphasized that if I ever needed an HIV test in the future, IT WAS POSSIBLE for a standard antibody test to come up positive, so I was required to use them for future testing. They do a PCR test, rather than an antibody titer. I have not yet had a single positive antibody test and it has been a year since the trial ended. I have been able to give blood through the red cross, ect.

On the same note, if the vaccine was successful, I would have antibodies. They stressed repeatedly that any future HIV tests I needed would be done by the NIH should I have need of it. I would look closely at the disclosure forms and the study information. If you don't feel comfortable, don't do it.

 

[Aladdin]

Alrighty, so like any broke college kid at a research-heavy school I've been a volunteer control for clinical research of one variety or another. However, I just found one that will pay almost $800 over a year for once a month visits. The problem is it's an HIV vaccine, and while the PI assured me they won't be shooting me up with HIV, they will be giving me the antigens in the hopes I produce antibodies.

My problem is this would cause me to likely come up positive on an HIV test, even though I wouldn't be infected. Do you guys think this could cause a problem in the future? For instance would I be denied admittance to a school or a residency if I was falsely HIV+? I don't think a school would admit to something like that, but decisions can be influenced subconsciously. I think this is a pretty cool research topic and let's face it, I could use the money, but I don't want to cause a problem later down the line. Any input?

Dude, it's really not worth $800 to face a lifetime of hassle or problems. Don't do it.

 

[Upgrayedd]

Some reasons why upgrayedd is wrong

1. Unknown risk/little to know benefit: upgrayedd will claim that this trail brings little to no risk. However(correct me if I am wrong) our knowledge about what this trial involves is extremely limited. This vaccine may be new in which case the short term, long term, and imitate side effects are unknown. On the other hand maybe this vaccine has no side effects and you are $800 richer and you have an effective HIV vaccine. The facts are you don't know the side effects of this drug and $800 is not a lot of money. It is simply not worth it.

2. "but the amount of fear you are expressing leads to a dangerous paralysis of action": What does this mean? How is not participating in this trial dangerous to anyone?

3. "I ask, who should we test the vaccine on then?": No one. It is unnecessary.

4. You can't read minds: what I mean by that is this by saying "I did imply is that there was definitely a lack of critical thinking behind many of the previous posts" you also imply you know the thought process of me and everyone else who posted in this thread. That is just silly. Just because you don't like the outcome of thinking does not mean it did not happen.

5. Funding for HIV/AIDS clinical trials should go to programs with a benefit: sure this vaccine will help IV drug users and dudes that just hate condoms, but a far easier way exists to help the public not contract HIV. Education. Funding should go to trials that will help people living with HIV/AIDS.

1. I agree with you on this, and if you read my post, it is what I say in the end.

2. It means if doctors never enrolled their patients in clinical trials with some risk, we would all still be dying of polio and measles.

3. This point is actually valid, but your presentation of information could stand to be better. Give background when you post an opinion, at least a sentance, otherwise just dropping bombs and bailing does little good, and what is the point of even getting in a discusion. Something like "x million dollars wasted, no chance of success, have effective anti-retrovirals, etc."

4. In your first post you say that the vaccine is the equivalent of injecting yourself with the virus, which is wrong any way you look at it. Other people were talking about anything that modifies the immune system giving them cancer (reads: any vaccine). There are plenty of reasons that this vaccine could be a bad choice from a public health/epidemiological/and personal standpoint to the OP, but lets try to keep it to real science when we talk about the actual mechanism, ok? Otherwise we're no better than the Hollywood celebrates who refuse to vaccinate their children.

5. Hard to disagree with the whole education thing, I won't go all into it, but yeah, you have to support AIDS/HIV patients if you want to limit the spread. In the end, why I feel so stronly about being PRO-vaccine is I feel a dual pronged approach though outreach and vaccination is the only way to stop the disease WORLDWIDE. Because so many of the infected don't know they have it, and they will remain a migrating disease resovoirs for the forseeable future even IF we could get everyone on AIDS cocktails.

 

[beachblonde]

Alrighty, so like any broke college kid at a research-heavy school I've been a volunteer control for clinical research of one variety or another. However, I just found one that will pay almost $800 over a year for once a month visits. The problem is it's an HIV vaccine, and while the PI assured me they won't be shooting me up with HIV, they will be giving me the antigens in the hopes I produce antibodies.

My problem is this would cause me to likely come up positive on an HIV test, even though I wouldn't be infected. Do you guys think this could cause a problem in the future? For instance would I be denied admittance to a school or a residency if I was falsely HIV+? I don't think a school would admit to something like that, but decisions can be influenced subconsciously. I think this is a pretty cool research topic and let's face it, I could use the money, but I don't want to cause a problem later down the line. Any input?

Assuming that the vaccine structure is envelope proteins and not the whole killed virus, the vaccine probably is relatively safe. People who say that people "catch diseases all the time" from vaccines need to study up on the facts (ahem, NotAndrew) because that is a very much incorrect statement. So with regards to the safety of the vaccine, it's probably harmless (and likely to be completely ineffective, based upon prior lack of success with HIV vaccines).

The issue of being seropostive for anti-HIV antibodies would be similar to people who are TB carriers. Yes, TB skin prick test is positive for those folks, but they go one step further and get a chest X-ray to prove that they are not actively infected. Similarly, people who have been vaccinated against TB outside the US have positive skin prick tests but aren't actually infected. I would think that should you develop antibodies, showing that your viral load is 0 and any PCR or RT-PCR for viral proteins would be negative would be sufficient to show that you are in fact not infected with HIV.

Ultimately, it's up to you, OP, as to whether or not the extra hassle-should you develop antibodies-is worth it. If you did, that would be cool that you were part of one of the few HIV vaccine trials that shows some promise. Certinaly developing a vaccine against HIV is a important public health initiaive, despite what certian other SDN-ers might imply. Good for you for even contemplating participating.

 

[eschaton88]

Ok, so the vaccine is at least in Phase II - the PI told me most of the people that produce antibodies do so only for a year or two after, but one guy has been for 8 years and counting. It's a statistically small chance of developing antibodies at all, assuming I ended up on the vaccine and not the placebo. Unfortunately the way this study is set up they are not testing on high-risk individuals who might stand to benefit, but only on very low-risk people with basically no medical history. I even have to be under a certain number of alcoholic drinks per week or I'm considered too high of a risk.

I did one of these trials at the NIH in Bethesda. It was a 1 year, stage II clinical trial. Long story short, the vaccine ended up not being effective. I have had 5 HIV tests durring/since the trial, all administered by the NIH, at their cost, due to the nature of the trial. They emphasized that if I ever needed an HIV test in the future, IT WAS POSSIBLE for a standard antibody test to come up positive, so I was required to use them for future testing. They do a PCR test, rather than an antibody titer. I have not yet had a single positive antibody test and it has been a year since the trial ended. I have been able to give blood through the red cross, ect.

My understanding was the results were a lot like this, and like some people have mentioned, the lab will provide an ID card explaining you might show up positive for an antibody test, and they will pay for the alternate. My understanding is you can donate blood if/when you no longer have antibodies, if you did in the first place.

I guess my real dilemma is I've seen enough clinical research from the research side of things to really appreciate the value of human volunteers, and frankly I feel somewhat hypocritical if I am working in a field that is using research volunteers but I'm not willing to consider it myself. Yeah, I know this one is a little extreme, but I've seen some of the places were AIDS is pandemic and while education is a HUGE component of changing things, I really think that the strictly medical side of things needs to be addressed as well.

Basically, emotionally I have a drive to do this as I would love to be a part of an AIDS vaccine if it would have a real impact and there is only so many ways you can do that as an undergrad. (Yes I’m looking into research as well.) Logically though, injecting oneself with antigens from a deadly virus just sounds all kinds of stupid. But I know how desperate they are for volunteers that fit the stringent requirements.

I think what I'm going to do is postpone my appointment until I make a firm decisions either way...thanks for all your help everybody!


EDIT: I'm writing this on 2 hours of sleep so if it's disjointed I apologize.

 

[LizzyM]

Look towards the end of the consent form for the section covering "research related injury". Who will pay your medical expenses if you are injured in the trial? This varies depending on the sponsor but in some (many) cases, YOU will be responsible for the cost of care. Given that a severe reaction could land you in the IUC on a vent, you might want to give some consideration to the rare but catastrophic situation you may find yourself in.

See http://www.rsihata.com/pdf/04.21.06.pdf for more information