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Moderna’s HIV vaccine has officially begun human trials

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Re: Moderna’s HIV vaccine has officially begun human trials

#81

Post by onlyrealcuzzo »

f6v wrote: post #56
spamizbad wrote: post #17

Earlier quoted context omitted.

One reason is that mRNA vaccines can be developed much faster than traditional vaccines. So the idea is you have a better chance of "outrunning" a strain.

I think slowly will come the realization that mRNA vaccines aren’t as fast to develop as people thought. Sputnik/AstraZeneca vaccines were released almost at the same time as Moderna/Pfizer. Yes, the latter were first commercial mRNA vaccines, but the technology is nevertheless rather mature. I watched a lecture by the people credited with creating mRNA vaccines and it turns out people have been working on the techno…

> Sputnik/AstraZeneca vaccines were released almost at the same time as Moderna/Pfizer

Most of the time and cost is associated with the trials - not the actual development AFAIK.

What would be more promising is if MRNA proves to be much more likely to pass trials. I think we need a lot more attempts at different viruses to have an idea here.

Certainly - if this HIV vaccine /does/ work - that's a huge win for MRNA.

> If mRNA vaccine was as magical as it was marketed, we wouldn’t be getting 3-4(and soon 5?) doses of the same vaccine with the emergence of new variants. Rather, there would be delta- and omicron-specific vaccine.

This is nonsense. The traditional vaccines don't work any better. They're worse. This is evidence MRNA is better than traditional vaccines.

Re: Moderna’s HIV vaccine has officially begun human trials

#82

Post by kettleballroll »

Pooge wrote: post #37

From my understanding, the effectiveness of the vaccine is measured by monitoring - in the real world - how many vaccinated people of a group catches the virus compared with how many unvaccinated did: how would it work in this case? I guess it would just take a lot of years to come up with a good approximation.

This will be Phase 1 clinical trials, ie they're mostly about side effects (and potentially dosage): ie they'll mostly check whether this will kill you / which dosage van be considered mostly safe. But at later trial stages, this will be one method to do this. Another and mich simpler one: you check whether the vaccinated people develop the antibodies you're looking for.

Re: Moderna’s HIV vaccine has officially begun human trials

#83

Post by mlyle »

abletonlive wrote: post #69
epgui wrote: post #59

Earlier quoted context omitted.

Exactly this. I would rather take the "most unsafe" vaccine of the last 30 years than take an Advil. (I am a biochemist)

Could you elaborate on why you wouldn't take advil?

Not the poster. Advil is pretty safe, but sometimes has horrific effects (e.g. Stevens Johnson Syndrome, catastrophic stomach bleeding, etc.)

Also, NSAIDs are shown to slow healing from injury in most cases.

Ibuprofen is terrifically useful but also a little scary for something we use so routinely.

e.g. some parents gave their 7 year old a motrin, and all her skin sloughed off her body and she had brain damage and lost 80% of her lung function.

https://www.cbsnews.com/news/jury-awards-63m-to-samantha-rec....

Re: Moderna’s HIV vaccine has officially begun human trials

#84

Post by Pooge »

TameAntelope wrote: post #41
Pooge wrote: post #37

From my understanding, the effectiveness of the vaccine is measured by monitoring - in the real world - how many vaccinated people of a group catches the virus compared with how many unvaccinated did: how would it work in this case? I guess it would just take a lot of years to come up with a good approximation.

https://www.hiv.gov/hiv-basics/overview/data-and-trends/stat... This info should give you a better idea of how one might compose a set of trial groups for something like this.

Thank you, this is a good resource!

But in order to have a good approximation of the effectiveness, we would need people to get infected. If I simplify, I would get vaccinated and stop using protection (i.e. condoms) during intercourse, but then I may catch it and end up living for life with HIV (contrast to COVID where you still have fairly reasonable chances to recover from). How would trials work for things like this?

Please correct me if I'm wrong, but I hope you see where I'm going with this.

Re: Moderna’s HIV vaccine has officially begun human trials

#85

Post by aleks224 »

mlyle wrote: post #21
hn_throwaway_99 wrote: post #10

As I understand it, the reason an HIV vaccine has been so difficult to create is that HIV mutates so easily. I understand the basics behind how mRNA vaccines are generated, but I don't understand why this approach would be expected to have any more success in evading the high mutation potential of HIV than other vaccine types. After all, it was even a concern with new coronavirus variants that the original Moderna va…

There's some known HIV "bnAbs", or broadly neutralizing antibodies. The thing is, these are not the antibodies most humans develop in response to HIV. Previous HIV vaccine attempts have only done a fair job at eliciting these broadly neutralizing responses. e.g. SAV001, a "whole killed" HIV vaccine, only produces broadly neutralizing antibodies in about a third of recipients (and less broadly neutralizing response in…

>An "elite controller" is a person living with HIV who is able to maintain undetectable viral loads for at least 12 months despite not having started antiretroviral therapy (ART) . Elite controllers are rare: for every two hundred people living with HIV, approximately one may be an elite controller (0.5%).

> It is not entirely understood why some patients are able to achieve undetectable viral loads without ART.

https://www.aidsmap.com/about-hiv/faq/what-elite-controller

Re: Moderna’s HIV vaccine has officially begun human trials

#86

Post by RcouF1uZ4gsC »

I think that this might be a follow-on benefit of Operation Warp Speed which had a post a few days ago.

From that post, it seems like one of the benefits to Moderna (apart from a big cash infusion) was that Moderna had the science, but did not actually have the experience and pipelines of actually bringing a drug to a broad market. They did not have the experience and infrastructure for large scale human trials and for the large scale manufacturing.

Experience with creating, testing, manufacturing, and rolling out the Covid vaccines, were I am sure invaluable in helping Moderna become a "full-stack" drug company.

Very excited by this development and looking forward to (hopefully promising) results.

It will be wonderful if we can make HIV/AIDS something future generations will only know from history books.

Re: Moderna’s HIV vaccine has officially begun human trials

#87

Post by arcticbull »

Vrondi wrote: post #27
spamizbad wrote: post #17

Earlier quoted context omitted.

One reason is that mRNA vaccines can be developed much faster than traditional vaccines. So the idea is you have a better chance of "outrunning" a strain.

Quoted post unavailable.

Generally the long pole in vaccine approval is showing that it works - not that it's safe. If there's only a handful of cases worldwide, say for Ebola, then you have to vaccinate a few thousand people and wait for a period where a statistically significant portion would have caught the disease and then didn't. This can be years. There's only a few cases per year, you can't just give a bunch of people Ebola to see if the vaccine works. They're not waiting for 'long-term side effects' to show up, they know they don't exist.

However, with HIV as with COVID, there's a pretty significant installed base around the country so showing that it works isn't really a challenge.

Usually only a few thousand or tens of thousands of folks participate in basically any drug trial, btw. We very well understand the risk profile of mRNA vaccines at this point, having deployed billions of them and studied the technology for 40+ years. And having studied vaccines for upwards of 300 years.

Re: Moderna’s HIV vaccine has officially begun human trials

#88

Post by tacLog »

ipnon wrote: post #61
tacLog wrote: post #53

Earlier quoted context omitted.

It's important to remember that any community can spread it. Needle sharing among intravenous drug users comes to mind. However, you can't deny that HIV has struck a generational blow upon the LGBTQ+ community. If this works it will be the end to an era of fear. Many will remember those that where lost and wish this only happened sooner. A new reason to celebrate is underselling the impact this will have.

It seems to me like lumping lesbians and the queer into this calculus is a little insensitive because it was almost exclusively gay men and trans women who bore the brunt. I'm sure this press release ran by a publicist who said, "we have to use all the letters or else we'll get torn to shreds on Twitter."

I get what your saying.

But on the other hand we are just talking about celebrating this. I feel like those sub-communities are probably more aware of the impact HIV than the average cis straight person and are probably going to celebrate this as well.

I don't get what's insensitive about it at all so maybe I am missing your point.

Re: Moderna’s HIV vaccine has officially begun human trials

#89

Post by tialaramex »

f6v wrote: post #56
spamizbad wrote: post #17

Earlier quoted context omitted.

One reason is that mRNA vaccines can be developed much faster than traditional vaccines. So the idea is you have a better chance of "outrunning" a strain.

I think slowly will come the realization that mRNA vaccines aren’t as fast to develop as people thought. Sputnik/AstraZeneca vaccines were released almost at the same time as Moderna/Pfizer. Yes, the latter were first commercial mRNA vaccines, but the technology is nevertheless rather mature. I watched a lecture by the people credited with creating mRNA vaccines and it turns out people have been working on the techno…

Both the Oxford-AstraZeneca vaccine and Sputnik are using a pretty similar trick that gives them the speed-up. They still get to pick an arbitrary sequence, but they're smuggling it inside a virus instead of as mRNA.

That's why the codename for the AstraZeneca vaccine is ChAdOx1, it's a Chimp Adenovirus as host for the sequence. Take this mild uninteresting chimpanzee virus, but tweak it to tell human cells to produce your arbitrary sequence instead of itself. The humans become immune to whatever your sequence was (and maybe to Chimp Adenoviruses?).

I'm sure there are reasons this might be better in some cases, and it involved less bleeding edge technology which made it a safer bet in a pandemic, but the mRNA approach seems obviously more general and even perhaps more re-usable.

Re: Moderna’s HIV vaccine has officially begun human trials

#90

Post by jldugger »

ineedasername wrote: post #48

How are human trials on high-risk low-incidence diseases like this conducted?

> high-risk low-incidence diseases like this conducted

If you're asking 'how do we test the vaccine without _trying_ to give people HIV", one option is to give it to a lot of people, and record their outcomes over time.

But first you need to prove the vaccine isnt like, super toxic in humans. So you do animal analog tests, then a limited test on humans, aka "Phase 1 trials". A previous article summarizes:

> Moderna’s vaccines passed Phase I testing earlier this year, which involves testing for safety using only a handful of human volunteers. Phase II tests for a vaccine’s overall effectiveness, and with the move into Phase III, Moderna will be looking at its efficacy versus other prevention treatments currently on the market, such as pre-exposure prophylaxis, also known as PreP.

- https://www.them.us/story/moderna-begins-hiv-vaccine-trials-...

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