HIV vaccine trial appears to have led to higher HIV rates

Since the end of the last century, there have been a number of HIV vaccines developed and tested.

Over 30 clinical trials of these vaccines have been done to see if they conferred immunity to HIV to those volunteers who agreed to participate in the trials.

To date, none of the trials have shown that any of the vaccines can produce significant immunity in a number of people against infection with HIV.

A study published in The Lancet, a distinguished British medical journal, shows that one of the failed vaccines may have had an unintended consequence.

This paper is a follow-up study to some trials done on a vaccine (Merck Ad5 gag/pol/nef subtype B HIV-1 preventive) performed a few years ago. The trials of this vaccine were stopped when the data showed that it was ineffective. At about the same time, a different trial using the same vaccine, showed that those vaccinated seemed to be contracting HIV at a higher rate than those in the study who were given a placebo.

One trial was done in South Africa, the Phambili (or HTVN 503) study. The other study enrolled volunteers from the Caribbean, the Americas and Australia (the HTVN 502 Step study.)

HIV virus attacking cell. 3D render, via Shutterstock.

HIV virus attacking cell. 3D render, via Shutterstock.

The vaccine made use of a recombinant (genetically-engineered) adenovirus. Adenoviruses can cause infections of the respiratory system, eyes and gastrointestinal tract in humans. Many cause symptoms of the common cold. The adenovirus was added to the vaccine to make the vaccine more effective in producing immunity in those subjects who were vaccinated. Other adenoviruses have been used in the past and haven’t caused similar problems with increased infections. In this vaccine, rAd5 (recombinant adenovirus type 5) was used.

The Phambili study primarily enrolled heterosexual males and females. In the HTVN 502 Step study, there was a preponderance of men who have sex with men (MSMs) and women at high risk for contracting HIV. Each participant was to receive three injections of the vaccine (or injections of placebo for the controls) spaced several weeks apart. Because the trials were stopped early, very few participants actually got all three injections.

The data from the Step study showed that there was an increased chance for vaccinated participants to contract HIV.

This occurred primarily in the MSM group. The vaccinated MSMs who got infected acquired their infections fairly rapidly after the study began. In the Phambili study, heterosexual men also had a greater risk of getting HIV, but those vaccinated males who got HIV tended to get it later than the Step group, sometimes years later. The men who became infected with HIV, in both groups, had similar risk behaviors (multiple partners, failure to use condoms regularly, etc.) Circumcision status didn’t make a difference. Number of vaccine injections made no difference. In short, there seems to be no good reason that one group of men got HIV later than men in the other group.

And why did the vaccine seem to make those vaccinated more prone to infection with HIV?

The researchers think that somehow the adenovirus that was used as a part of the vaccine somehow made those vaccinated less able to resist infection with HIV. The investigators propose some theories about why this is so, but they are only theories at this point. They feel strongly enough about it that they strongly recommend that this adenovirus not be used again in making any other HIV vaccines.

The outcomes here were definitely unforeseen and unintended. Even with decades of vaccine research, testing in non-human species, carefully designed protocols and safeguards, sometimes things like this happen. It is a major reason why prospective participants in research studies have possible risks explained to them. Institutional review boards (IRBs), akin to ethics committees, need to approve the research before it can be carried out on humans. The IRB looks at how much risk to the subjects might be experience and weighs that against the possible benefits of the research. The IRB acts to minimize harm to and to protect the volunteers who may be enrolled in the trial. The IRB requires that those participating in the study be fully informed about the research. At least as fully informed as they can be.

As seen in this instance, even with good preparation and planning, something terrible and unpredictable happened. Unfortunately, things like this happen, rarely, but they do happen. It’s a reminder that research doesn’t always have a good outcome.

Even from this negative result, we may get some benefit. For example, did the rAd5 virus allow the infections to occur? If so, what is the mechanism? If the method that the virus uses to facilitate infection can be identified, that could be an important point. Perhaps we could use that information in reverse and thereby strengthen the cell to make it much more resistant to infection by HIV.

Of course, that would require more research – and risks.


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Mark Thoma, MD, is a physician who did his residency in internal medicine. Mark has a long history of social activism, and was an early technogeek, and science junkie, after evolving through his nerd phase. Favorite quote: “The most exciting phrase to hear in science... is not 'Eureka!' (I found it!) but 'That's funny.'” - Isaac Asimov

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  • Helen Tolbert

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  • Helen Tolbert

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  • Karen Carrera

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  • AndyinChicago

    Thanks! (Me too).

  • 4th Turning

    This day got me to wondering how our gay vets are doing… Especially
    those returning from Afghanistan and Iraq. Watched the segment on 60 Mins.
    last night-very heart-rending. I’m assuming there are relevant blogs/vlogs
    for each of our alphabet soup crowd. But it would be kind of reassuring to
    know how the readjustment process was going and whether there was
    anything virtual friends could do by way of support, listening, etc.

  • docsterx

    Oh, that’s too bad. I hope biology starts to do a better job of cooperating and quickly, too.

  • AndyinChicago

    Ha! Yeah. I’m wrapping up my fifth year in a six year program. My project looked like it might be able to wrap up early, but turns out, no, more work has to get done. But hopefully, one more year (Although that’s the mantra of a number of 8th year grad students). Biology can sometimes be so uncooperative.

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  • docsterx

    I think posting on a site like this helps with that problem. If someone isn’t clear, he can ask questions and get information from other users, the authors, internet links, etc.

  • 4th Turning

    My concern is, especially now that we seem to be getting down to the wire on a
    number of life and death issues, that information be presented in such a way that
    readers can get their imaginations around it as well as their intellects, educational levels, etc. The lost art of tribal story-telling in which vital points were passed onto the
    young might ought to be revived now if the “glut” of bewildering new knowledge
    is going to make a dent on hard-wired in our brains behavior(s)…

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  • docsterx

    Andy, aren’t you ready to graduate now? Thought you were finishing up this year.

  • docsterx

    Andy’s right. And the authors also specifically looked if any members of either group performed more risky behaviors than members of the other group. Their conclusion was that men in both groups indulged in risky acts, didn’t follow safer-sex guidelines, etc. at about the same rate.

  • docsterx

    Patients who are on PrEP are strongly advised to wear condoms as well as take Truvada as prescribed.

    I think the “penumbra” is about how gays present themselves to straights. I know lots of gay guys who will talk about virtually anything, with anybody, even someone they just met – as long as the new acquaintance is gay. But take the same person and put him in with a mostly straight crowd and he’ll self-censors his own speech. He’s not going to talk about anal penetration, rimming, bath houses, etc. Seems to be especially true of those who are still closeted.

  • docsterx

    I read it previously. The author did a good job.

  • Thom Allen

    Thanks. Those spam bots are clever. But their ENGLISH is awful. And who would want to go to Ghana or wherever to get this panacea that they’re offering?
    Wonder if we wrote “HIV” as “aich eye vee” if we could fool them?

  • Yes, thank you, it is banished.
    We get these every time a post mentions HIV, and the Disqus spam filter does not always catch them.

  • 4th Turning

    At least it got two of us thinking. I had a young friend from back east son of doctors
    who died from a one-off in sf. Quiet, gentle, intelligent, creative, introverted. His very
    words said several times to no one in particular- who would’ve thought.
    I hope those have been a very happy 28 yrs.

  • Thom Allen

    Spam

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  • Mike_in_the_Tundra

    I’m not sure how to react to that article. I went back and forth between saying “yeah” or “nope.” Most guys I know have little problem dealing with anal sex. Although, I would think dealing with it with your partner(s) and your doctor is of upmost importance. I also have no problem with PrEP, but I would use a condom with it. Of course, I’m sort of the type who would wear a belt and suspenders. I’m terrible inexperienced for my age. I met a man when I was 22 and spent the next 28 years with him. I just have a problem with “a penumbra of silence around gay life.” The people I know aren’t very silent.

  • Rambie

    Hopefully someday we’ll find a vaccine or better yet, a cure for HIV. There are, and still will, be other STD’s out there so it’s best to keep getting tested and –as much as possible– practice safe sex.

  • 4th Turning

    I can’t imagine anyone taking a pass on this link or not sharing with others…

    “And so, in 2014, in the developed world, HIV infections continue unabated at crushing expense to society because of HIV of the mind. I do not mean to imply the existence of a scarlet H unique to gay male psychology. No, I mean the incredible complexity around being gay in 2014 – when HIV is treatable and preventable, but profound vulnerability to infection remains. I refer to the whole welter of confusing feelings and polarised messages that gay men still shoulder, often invisibly, and that the straight world still struggles with, too. Silence equals death. That was the brilliant mantra coined by the original AIDS activists, the ones who mobilised all of us to action. But there is still a penumbra of silence around gay life, even in the most ‘out’ gay man’s heart.”

    http://aeon.co/magazine/being-human/hiv-is-preventable-why-arent-infection-rates-falling/

  • Indigo

    Good point, I understand that.

  • AndyinChicago

    They wouldn’t have known versus the placebo that they had the vaccine in question, so if it was recklessness, it would have been constant in the control group.

  • Indigo

    Less resistant or more reckless?

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