You forgot the most important question: how do you verify that it works? The answer is that you don’t. You definitely cannot do a usual clinical trial with tens of thousands people. The challenge trial doesn’t make much sense if you are only going to use it for yourself and you friend. So probably you just say “ok, it is almost pure safe and there is a chance that it works, so I better make it and take it”. If a lot of people take it, you can have observational data. If people who take are high risk (e.g. doctors) and they don’t get sick compared to their colleagues, then you have some evidence.
I guess you could also test for antibodys, that should give you some evidence.
Oh yeah, I was wondering about that. If someone gets the RADVAC, would they pass existing COVID immunity assays (including antibody tests)? What different ways are there to test immunity, and which would we expect a vaccinated person to pass?
Unfortunately, this is a complex issue and there isn’t a simple answer. The most common measurement of immunity is an antibody test performed on blood. However, an intranasal vaccine is able to elicit immune responses of various kinds, and even though it might produce a robust and highly protective mucosal immune response, the blood antibody response might not be as pronounced. [more info at the FAQ]
My bad, I forgot about testing for immunity. There are 2 testable types of immunity mentioned in the paper: antibodies and T-cells. They explicitly suggest testing for antibodies before and after. However, they say that it is going to be essentially tricky with their vaccine. Firstly, the biggest effect is expected to come via cellular immunity, not via antibodies, and testing for it is not as easy as for antibodies. Secondly, the biggest effect is expected via mucosal immune system, so even the antibodies testing should be done on a nasal wash and not on a blood sample and this is a bit tricky and less reliable. Thirdly, I guess that detection of antibodies by standard antibody assays strongly depends on a specific assay and it is hard to know if the commercial test that you have access to would detect the RaDVaC-induced antibodies. I think they mention that some of the people who took the vaccine had positive antibody tests and some had negative tests.
If you are willing to spend a bit more resources on it, you can actually test for both antibodies and T-cell response. You can create a custom ELISA assay targeted specifically at response to RaDVaC antigens. I think ordering it in a lab is a bit more difficult than peptides, but still possible as a standard service. As for the T-cells, there is ELISpot or smth like that, but it is not so easy as ELISA and much more costly as it involves collection and processing of specific T-cells.
In my case, I’ve prepared the vaccine only for a few people and verification looked too costly and unreliable to be justifiable, so I decided not to do it. I hope that RaDVaC guys did it and received antibody and T-cell immune response at least in some people, but they cannot publish the positive results, because this would be tricky on the legal side. If they did it, received negative results and still recommend the vaccine, well, then they are bad guys.
I guess you could also test for antibodys, that should give you some evidence.
Oh yeah, I was wondering about that. If someone gets the RADVAC, would they pass existing COVID immunity assays (including antibody tests)? What different ways are there to test immunity, and which would we expect a vaccinated person to pass?
The RaDVaC FAQ talks about this:
My bad, I forgot about testing for immunity. There are 2 testable types of immunity mentioned in the paper: antibodies and T-cells. They explicitly suggest testing for antibodies before and after. However, they say that it is going to be essentially tricky with their vaccine. Firstly, the biggest effect is expected to come via cellular immunity, not via antibodies, and testing for it is not as easy as for antibodies. Secondly, the biggest effect is expected via mucosal immune system, so even the antibodies testing should be done on a nasal wash and not on a blood sample and this is a bit tricky and less reliable. Thirdly, I guess that detection of antibodies by standard antibody assays strongly depends on a specific assay and it is hard to know if the commercial test that you have access to would detect the RaDVaC-induced antibodies. I think they mention that some of the people who took the vaccine had positive antibody tests and some had negative tests.
If you are willing to spend a bit more resources on it, you can actually test for both antibodies and T-cell response. You can create a custom ELISA assay targeted specifically at response to RaDVaC antigens. I think ordering it in a lab is a bit more difficult than peptides, but still possible as a standard service. As for the T-cells, there is ELISpot or smth like that, but it is not so easy as ELISA and much more costly as it involves collection and processing of specific T-cells.
In my case, I’ve prepared the vaccine only for a few people and verification looked too costly and unreliable to be justifiable, so I decided not to do it. I hope that RaDVaC guys did it and received antibody and T-cell immune response at least in some people, but they cannot publish the positive results, because this would be tricky on the legal side. If they did it, received negative results and still recommend the vaccine, well, then they are bad guys.