3 ms·

This was a Phase 3 clinical trial published today in the New England Journal of Medicine: http://www.nejm.org/doi/full/10.1056/NEJMoa1102287 http://www.nejm.org

This was a Phase 3 clinical trial published today in the New England Journal of Medicine: http://www.nejm.org/doi/full/10.1056/NEJMoa1102287 http://www.nejm.org/doi/full/10.1056/NEJMoa1102287 Not home yet or I'd likely have more to say. Home now. Reading the article. First thoughts: * This is a vaccine for P. falciparum, which is the nasty form that you really don't want. Good. * Funding comes from GSK and the Bill and Melinda Gates Foundation * These are interim results, looking at the older kids (5mo and up) in a 2-prong study (the younger kids haven't all hit the 12mo-duration milestone needed per protocol so this largely ignores them so far with more to come later). Caution. (Because there was no clear rationale given for why this is being reported now, in pieces.) * Treated kids had higher incidence of meningitis. Caution. * Treated kids had higher risk of febrile seizures. Caution. * Generally, few deaths, so these kids seem to be well looked-after in this trial. Appropriate. So far, so good. Interested to see the final Phase 3 results and to see how this holds up in Phase 4/postmarketing.

Thrymr 15y ago
From my reading of the results, efficacy is only 35-55%. Does that seem low? Or is that good at this stage of a trial?
- jballanc 15y ago
  I am not an epidemiologist, so I cannot answer your question directly. However, I do know that most vaccines are not 100% protection. The goal is to reach herd immunity. This is also the reason why the recent anti-vax movement is so dangerous. Even if your kid gets vaccinated, if the rest of his/her classmates do not there is still a risk of him/her catching the disease in question.
- carbocation 15y ago
  Phase 3 is basically the definitive clinical trial. Phase 4 is essentially keeping track of what happens after your drug comes onto market. Once all of the results are in, that paper will likely become the definitive paper on this particular drug (again, it's a bit weird that they did this prelim analysis without a clearly stated reason). So Phase 3 is the real deal in terms of winning approval to market the drug. Regarding efficacy, it is definitely low compared to many modern vaccines which are in the 90+ range. But my understanding is that this is much higher than previous malaria vaccines. If the numbers are really true, then they could possibly save hundreds of thousands of lives per year despite the relatively low efficacy. And it should be a first foothold in terms of making immunologic progress against Plasmodium.

Thrymr 15y ago

From my reading of the results, efficacy is only 35-55%. Does that seem low? Or is that good at this stage of a trial?

jballanc 15y ago
I am not an epidemiologist, so I cannot answer your question directly. However, I do know that most vaccines are not 100% protection. The goal is to reach herd immunity. This is also the reason why the recent anti-vax movement is so dangerous. Even if your kid gets vaccinated, if the rest of his/her classmates do not there is still a risk of him/her catching the disease in question.
carbocation 15y ago
Phase 3 is basically the definitive clinical trial. Phase 4 is essentially keeping track of what happens after your drug comes onto market. Once all of the results are in, that paper will likely become the definitive paper on this particular drug (again, it's a bit weird that they did this prelim analysis without a clearly stated reason). So Phase 3 is the real deal in terms of winning approval to market the drug. Regarding efficacy, it is definitely low compared to many modern vaccines which are in the 90+ range. But my understanding is that this is much higher than previous malaria vaccines. If the numbers are really true, then they could possibly save hundreds of thousands of lives per year despite the relatively low efficacy. And it should be a first foothold in terms of making immunologic progress against Plasmodium.