Every modern vaccine we have today, including the COVID-19 vaccine, was first tested in a series of clinical trials before becoming available to the public. The millions of people who are already vaccinated have made an important difference in the fight against COVID-19, but our understanding of this virus remains far from complete. As Omicron spreads around the world, we are looking for additional volunteers to ensure we are prepared with an effective vaccine for this new variant, if it is needed.
By choosing to volunteer, you will represent others like you - in age, gender, race, ethnicity, and from communities like yours. Involving people from all backgrounds will help us to develop an Omicron-based COVID-19 vaccine that is effective for everyone.
Joining a clinical trial is an important and personal decision. Thank you for considering this study.
About The Study
This study is evaluating the safety and immune response of an investigational (study) COVID-19 Omicron vaccine in both unvaccinated and vaccinated adults.
The study is divided into 3 cohorts:
- Cohort 1 - Participants must have received 2 prior doses of the Pfizer & BioNTech COVID-19 vaccine and will be randomly assigned to receive 1 or 2 doses of the Omicron-based COVID-19 study vaccine.
- Cohort 2 - Participants must have received 3 prior doses of the Pfizer & BioNTech COVID-19 vaccine and will be randomly assigned to receive a 1st dose of the Omicron-based COVID-19 study vaccine or a 4th dose of the Pfizer & BioNTech COVID-19 vaccine. Please Note: This cohort is now full and no longer accepting new participants.
- Cohort 3 - Participants must not have received any prior COVID-19 vaccine and all participants will receive 3 doses of the Omicron-based COVID-19 study vaccine.
Participants will be enrolled in the study for about 1 year and will need to attend at least 6 office visits during this time.
Participants will be reimbursed for expenses and time related to completing study activities.
In November 2021, the COVID-19 Omicron variant was identified in South Africa. It has since spread around the world. Omicron is considered a variant of concern due to a number of genetic mutations. There is still a lot to learn about how Omicron spreads and whether current COVID-19 vaccines will provide a long-term immune response against this variant.
Doctors are currently studying a potential vaccine for Omicron in case it is needed in the future. At this time, a booster dose of the COVID-19 vaccine is still recommended as the best protection against all variants of concern, including Omicron.