Shigella vaccin eng

Shigella is a bacterium that can cause severe diarrhea. In places with little access to clean drinking water, epidemics of Shigella infections occur. Yearly, a large number of children die from Shigella infections, especially in low-income-countries. An effective vaccine could prevent a large part of these deaths.

A new vaccine against Shigella has been developed in the United States. In the SUNSHINE study, we will investigate what the right dose of this new vaccine is, what side-effects is has and if the vaccine stimulates the immune system well. We will also add an adjuvant (additive) to improve the effectiveness of the vaccine. Both the vaccine and the adjuvant have been administered to people before in scientific studies. In all of these studies, there were no severe side effects and the vaccine and the adjuvant were safe. The vaccine and the adjuvant have not been administered simultaneously to people before. The combination of the vaccine and adjuvant is something that we will investigate in the SUNSHINE study.

During the study, participants will receive three vaccinations (with or without the adjuvant) or a placebo (a fake vaccine). There is a 4-week interval between the vaccinations. One week after each vaccination, there will be a follow-up visit were a blood sample will be taken. After the third (and last) vaccine, there will be a total of three control visits. During the study, participants will keep a diary to register side effects and other symptoms.