The purpose of the study is to see how the body reacts to 2 booster doses of a protein-based vaccine candidate designed against the Omicron variant and to gather information on the efficacy and safety of this new vaccine candidate compared to a previously developed vaccine.
Who is eligible to participate in this study?
- Men and non-pregnant women 18 to 64 years of age
- Are in good general health, as determined by medical history, physical exam, and vital signs
- Have previously received 2 or 3 doses of the Moderna and/or Pfizer vaccines
- Have no current autoimmune or immunodeficiency disease/condition
- Have not had previous allergic reactions to vaccines
- Will not participate in any other COVID-19 prevention or treatment trials for the duration of the study
There are other requirements for taking part in this study. The study team will review all of the study criteria with patients who express interest in study participation.
What happens during the study?
Participants will enter the screening period (up to 2 weeks) to confirm if they are eligible. Once the criteria is met, the participant will be assigned to a treatment group.
Each participant will be assigned by chance (like the flip of a coin) to one of the 2 booster vaccines. Each participant will receive 2 booster injections of the same variant. Injections will be performed 90 days apart, in the upper arm muscle (called the deltoid muscle).
Participation in this study will involve 10 site visits over approximately 10 months. The study visits will include a screening visit to make sure interested patients are eligible to participate, 2 vaccination visits (Day 0 and Day 90), and a final follow-up visit at the end of the study (Day 270) to evaluate effectiveness of the vaccine.
Why should individuals consider participating in this study?
If a person is eligible to participate, his/her data may help the research team in learning more to advance the development of a COVID-19 vaccine that may protect against disease caused by the COVID-19 virus and variants, including Omicron. This opportunity will contribute to research that may increase the number of vaccine options available to fight the pandemic. Participation in this study is completely voluntary, and any participant can decide to withdraw at any time.
For further information please contact Clinical Trial Coordinator, Subaat Khan +61 7 567 80359 or email [email protected]