Australian COVID vaccine cancelled after Phase I trials produced false positive HIV test results!

[thewayne]

Not exactly something you want to see in a vaccine!

From the article:
"The (vaccine's) molecular clamp is made from a HIV protein, which on its own is harmless. The molecular clamp stabilizes the coronavirus spike protein and presents it to the body in a way that promotes a good immune response. This is why the clamp technology is so vital," Taylor said.

He added that the clamp model vaccine had shown "good safety and immune response" against the coronavirus in early clinical trials, and the possibility for generating an HIV positive result had been thought to be low.

Yeah. Apparently not as low as they'd thought!

https://www.cnn.com/2020/12/10/australia/australia-vaccine-hiv-intl-hnk/index.html

Comments

[lxe]

I'd rather worry about a false negative (even if I were in the risk category and Australia at the same time). Why worry about a false positive?

[kathmandu]

Could give people heart attacks...

[lxe]

Not if the person (+ their PCP) has been informed.

[thewayne]

It definitely could easily be part of the consent process, but people would still freak.  Then there's the follow-on question is how long would you get false-positive results?  If we have to get COVID A/V shots on an on-going basis, as many are expecting, then this will be a never-ending problem.

[lxe]

Then there's the follow-on question is how long would you get false-positive results?

Until a different HIV test is used (I can fairly easily imagine a setup that's 100% specific to the actual virus if, instead of detecting trace quantities of (any) chemicals, it lets the HIV virus grow in vitro on a cell sample).

[thewayne]

Indeed!  Interesting point.

My grandma and my sister had to be tested for HIV back in the '80s because they received transfusions when the blood supply was tainted.

[thewayne]

I agree.  I think the concern is you're going to be mass-vaccinating millions of people, and a lot of those are going to be wanting follow-up testing to make sure they're negative, which is going to cause additional pressure. Now, for Australia, that's not a big problem since they're not having huge issues with COVID at the moment.  But that can change, and it would be a HUGE problem if they wanted to sell that vaccine in the USA!

[lxe]

I am in the US and I'd buy it, other factors being favorable.
Exposure to COVID is a daily real issue while exposure to AIDS depends on unusual circumstances and/or lifestyle.

[silveradept]

Would you define "unusual", please? Because, intentionally or no, it sounds like you're saying "you only have HIV risk if you're queer, kinky, polyamorous, or you are in a situation where someone is bleeding profusely on you", and that's not at all true.

COVID is a much more immediate and constant risk, yes, but a false positive for HIV would carry significant mental health damage, since HIV infection and positivity is still highly stigmatized, even if treatment options are better now than they were before.

[lxe]

1/ "Queer" is redundant here (compare: "you only pay a lot of income tax if you are a business owner or have a lot of income"; not all business owners are rich, and vice versa; the inference is itself a misleading stereotype).

Other than that, I'd love to know how much relevant exchange of bodily fluids with other people is neither emergency circumstances (rape victim, blood transfusion, etc.) nor a behavioral risk. When I was young, learning (*) that HIV doesn't transmit e.g. via air/droplets or brief indirect skin contact was a part of destereotyping and destigmatizing AIDS ("you won't be at risk of infection just because you get in the same room; it's safe to be in the same room").

Was (*) wrong?

2/ "Some technology might mistakenly assume A or B about you" is exactly a stereotype away from "our, or someone else's, technology will make you A or B".

I-131 radiosurgery produces false positive alarms at airports. The solution, for
all the "air terrorist" stigma, is giving affected people proper warning and documentation.

[lxe]

P.S. Compared to "queer", the contribution of "poliamory" to the risk is technically nonzero, but still both qualitatively misleading and quantitatively exponentially lower than the contribution of frequency of *changing* partners.

A stable polyamorous relationship (e.g. a polygamous traditional Muslim family) is only marginally at a greater risk than a stable 1-1 relationship.

Again, would be curious to hear counter-evidence; until then it's the CDC AIDS fact sheet + basic arithmetic and statistics.

[silveradept]

Thank you for the additional context. My workplace wants us to treat fluid incidents and accidental needle stick as being potential bloodborne pathogen carriers, neither of which necessarily are behavior risks nor things that happen only in emergency contexts, and depending on the location and the surrounding community, may or may not be more likely. So no, the starred bit isn't wrong at all, and documentation and information is very helpful to people who might be affected by a false positive. All the same, people's biases, judgments, and behaviors change based on what they believe to be true, so it would be better to avoid unnecessary suffering from a false positive if possible.

I disagree with you about queerness being redundant, but I'm satisfied that you're not coming from a place of categorizing anything that's not cis-het as "unusual," which was my primary concern about the statement as it was.

[lxe]

Yes, absolutely, firefighters are at a greater risk of fire harm.
It's not exactly lifestyle, so I stand amended.
I would, at the same time, expect that judgments about fire are more evidence-based among firefighters than among the general public.

PPPS. Informed consent, I still believe, solves all of the above (not just the post, but the entire discussion), provided vaccine administration is voluntary.

[dewline]

Okay, that's still a little disturbing.

[thewayne]

Just a wee bit.  Come for the vaccine, come back for an HIV assay!  Even if you don't need it!

[foreverdawning]

If I were an official, I'd probably still distribute the vaccine if it's as safe as they say.

[thewayne]

One of the problems is it greatly reduces marketability outside of AU, which means harder to recover costs.

[silveradept]

That is definitely an issue that needs overcoming before distribution. People do not need the additional panic of possibly facing contracted HIV from a vaccine dose. That would be catnip for the anti-vax crowd, even if they're all false positives.

[thewayne]

Excellent point.

[graydon]

Remember that it's not the only vaccine; even counting only the "Western" ones, there are close to a dozen candidates in the pipeline.

This isn't something that means it doesn't work as a vaccine, but it's a very significant drawback other candidate vaccines don't have.

[thewayne]

I was reading more about it today, they were saying that it was proving effective, but it would take a year and more testing to remove the bug causing the false positives. An interesting vaccine development, excuse the pun: the Brits are engaging in a trial in Russia combining their Oxford vaccine with the Russian Sputnik vaccine!  Curious stuff.

[graydon]

It's a novel and interesting approach -- stick a molecular clamp on the virus' spike protein to prevent it from binding -- but REALLY new, even newer than the MRNA approaches.

The traditional inactive-virus vaccines are having trouble being effective enough; the Oxford trail has a huge spread of effectivenesses for the 95% confidence interval. They're trying for a mix, or a sequence of shots, to get a sufficient overall effect. It's going to take several really big trails, because it's pretty likely dosage and order and spacing all matter.

[armiphlage]

TB vaccines causes false positives for tests that check if you have active TB infections. Some countries still give them, on the grounds that preventing many people from a disease is worth not being able to reliably detect the presence of a disease, until more severe symptoms arise.

If no other COVID vaccine was available, it might be worth giving this one to those at high risk of dying of COVID in the short term, with the tradeoff that they wouldn't be able to swiftly detect future HIV infections. And if you currently are HIV+, it'd be a no-brainer.

[thewayne]

Excellent points.  I have no idea how many people are living with HIV/AIDS these days, I know it's not a small number, but would it be enough to make finishing development and distributing a vaccine profitable?  BUT, we have a proverbial plethora of vaccines in development, so there's not a problem with some failing - which some have.  As I said in another post, I was reading more about this particular vaccine's problem, and they estimated it would take a year to edit out this bug, and I don't know if that would require restarting trials at that point.

I knew about the TB vaccine issue.  I fired a doc because she used a test that we told her would return a false positive.  We thought I might have mono, she wanted to run a basic antibody test.  We told her I get antibodies from 10,000 people every week.  Guess what: the test showed that I had mono in the past.  You have to use PCR tests on me.