COVID-19 Booster Study in Healthy Adults in Australia

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Dec 19, 2022

Keywords

ClinConnect Summary

This is a blinded, two-arm randomised study to determine the safety, reactogenicity and immunogenicity of a fourth dose of SARS-CoV-2 vaccines in Australia in adults 18 years or older who have received their third dose of COVID-19 vaccine at least six months previously. Participants will be randomised to receive either bivalent Moderna (mRNA-1273.214) or Novavax. A separate non-randomised control arm (no vaccine given), frequency matched by age to the vaccine groups will also be enrolled for comparison. A total of 200 participants per group will be recruited.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have received three doses of COVID-19 vaccines at least 6 months earlier.
• • 2. No confirmed SARS-CoV-2 infection on PCR or RAT within the last 3 months.
• • 3. Willing and able to give written informed consent.
• • 4. Aged 18 years or above.
• • 5. Willing to complete the follow-up requirements of the study.
• Exclusion Criteria:
• • 1. Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
• • 2. Known HIV infection.
• • 3. Congenital immune deficiency syndrome.
• • 4. Received immunoglobulin or other blood products in the three months prior to potential study booster vaccination.
• • 5. Study staff and their relatives.
• • 6. Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exemption to receiving further COVID-19 vaccines.
• • 7. Cannot read or understand English.

Trial Officials