What are we hoping to learn?
Does the Moderna COVID-19 vaccine prevent infection and spreading the virus to others?We already know that the vaccine can prevent serious COVID-19 disease, but we still have more to learn about how the vaccine works! Now, we want to know if the Moderna COVID-19 vaccine:
— protects people from getting infected with SARS-CoV-2 (which causes COVID-19 disease)
— changes the amount of virus that is in the nose if people do get infected
— prevents transmitting SARS-CoV-2 to others.
What do you need to do?
If you decide to join the study:
— be randomized into a group that gets vaccinated immediately or a group that follows the Standard of Care. If you do not want to get a COVID-19 vaccine, you can also join the study and be part of the observation group.
— be asked to answer daily questionnaires in an eDiary app.
— be asked to take daily swabs of your nose and return them to the study staff for approximately four months.
— be asked to provide blood samples.
— be asked to follow additional procedures if you test positive for SARS-CoV-2 during the study.
— be asked to identify close contacts who will be invited to join the study. These close contacts will help researchers find out if the vaccine prevents transmission of the SARS-CoV-2 virus to others.
— be compensated for your participation.
FAQ'S About this study
No. We do expect that some people will be exposed to the virus in their everyday lives, and may become sick, but we are not intentionally infecting study participants. The Moderna vaccine does not include live, weakened or whole virus.
Yes, people who join the study get compensated. The details about compensation will be explained in the informed consent process at clinic sites.
Because testing the vaccine’s effectiveness to reduce and/or prevent transmission requires measuring spread of the virus to others. About 25,500 individuals identified as “close contacts” will also be invited to take part in the study. Close contacts who agree to participate will be asked to answer weekly questionnaires. They may also be asked to provide two blood samples and take daily swabs of their nose for two weeks.