What is it like to participate in a vaccine study?

Vaccine viles and pills imagery

You may first hear about a vaccine study from a friend, family, member, or colleague, through an announcement on social media, or directly from a clinical research coordinator who is enrolling participants. Most vaccine studies are done to test how well a vaccine works and to look at vaccine side effects. Some vaccine studies are testing new vaccines not already approved by the US Food and Drug Administration (FDA), while others are testing already approved vaccines. It is important to note that your participation in any study is completely voluntary.

If you express an interest in participating in a vaccine study, the research staff will generally ask you several questions, often over the phone, to make sure you are eligible to participate. The clinical research coordinator will also briefly discuss the details of the study, including the schedule of visits, and the risks and benefits of participating. At this point, if you are still interested in participating, the research staff will set up an in-person screening appointment for you to come either to our research clinic or to another designated study site.

The first thing that will happen at your in-person screening visit is that the clinical research staff will get your written consent or permission to participate in the study. This consent will include a detailed discussion of the specifics of the study including the schedule of study visits (either in-person or over the telephone) for the trial including dates for vaccination and any required study procedures such as blood draws. The consent will also review the risks and benefits of participating in the study and outline any compensation you may receive for participating in the trial. You will be given plenty of time to ask questions and get answers to those questions. Again, your participation is completely voluntary, so you may decide not to continue at any time.

If you consent to study participation, the clinical research staff will collect information regarding your medical history and any medications you may be taking. They will also review an eligibility checklist to make sure that you meet the requirements to be included in the study before proceeding. In some studies, you will see a medical provider (a physician, nurse practitioner or physician’s assistant) who will also review your medical history, medications, and the eligibility checklist in further detail. You may also have a physical exam, much like you would at your medical provider’s office when you have your yearly physical. Many vaccine studies also require that you have your blood drawn.

For some studies, particularly for those of new vaccines that are not FDA approved, we will check your blood counts and blood chemistries to make sure you are healthy to receive the test vaccine. If you are a woman of childbearing potential, we may also test your blood or urine to make sure that you are not currently pregnant. It may take several days to receive the results of those tests.

Once the results of the blood or urine tests are receive, and you are found to be eligible, you will be scheduled for a vaccination visit. If these tests are not required, you may receive the study vaccine on the same day as the screening visit. A registered nurse will administer the study vaccine. You will be closely monitored at the clinic by medical professionals for a specified period of time (on average 15 to 30 minutes) after being vaccinated.

While you are being monitored in the clinic, you will be given detailed instructions by the clinical research staff as to how to track any symptoms you may have, at home, after vaccination. In some cases, this may be through an electronic diary, on your smart phone, that asks you to record your temperature and other symptoms, on a daily basis, for one to two weeks after vaccination. For other studies, you will record this information on a paper diary or memory aid. You will also be scheduled to return to the clinic for your next appointment. Some studies also require more than a single dose of study vaccine to be given at a future study appointment.

At future appointments there may also be additional blood draws and study procedures. The blood draws are able to tell us if your body develops protection following the study vaccine. Studies of new vaccines that are not already approved may recheck your blood counts and blood chemistries. The study may also require that the research staff continue to monitor you for a period of time after vaccination to make sure that you remain healthy. Frequently, we monitor research participants for 6 to 12 months after receiving a study vaccine.

Lastly, before you leave the study clinic, you will be given contact information.This includes a contact number for the research staff and the study principal investigator to answer any additional study related questions that may arise. Again, your participation is completely voluntary, and you may withdraw at any time throughout the study, if you choose to do so.