In this episode, I’ll discuss why the quadrivalent meningococcal vaccine was used as a control for a COVID-19 vaccine.
Earlier this year a phase 1 and 2, randomized controlled trial of a COVID-19 vaccine was published in the Lancet and the quadrivalent meningococcal vaccine was used as a control rather than saline placebo. This seems like an odd choice for a control therapy, but it is not the first time something like this was done. A phase 2 Ebola vaccine trial, also published in the Lancet this year used the quadrivalent meningococcal vaccine as a control.
What both of these vaccines (the COVID-19 and Ebola ones) have in common is that they are adenovirus-vectored vaccines. They work by taking a weakened version of an adenovirus (the same type of virus that causes a common cold) to deliver the spike protein found on the surface of the virus that causes COVID-19 or Ebola. The delivery of this spike protein then causes the immunogenicity to the virus to develop.
Some known side effects of these adenovirus vector vaccines are elevated temperature, sore arm, and headache.
If a patient in the trial were to develop one of these side effects, it could unblind the treatment the patient was receiving if the control group got saline, as none of these side effects would be attributed to a saline injection.
The quadrivalent meningococcal vaccine has a high rate of side effects such as fever, injection site pain/soreness, and headache, making it an ideal candidate for an active control against an adenovirus-vectored vaccine, preserving the blinding between groups.
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