None listed
Conditions
Brief summary
This study is a randomised open-label trial of the Moderna Omicron-containing bivalent booster candidate mRNA-1273.214 (mRNA-1273.214) vaccine. Participants who have received 2-3 prior doses of the any COVID-19 vaccine will be randomised into two arms: to receive a 3rd dose of the Moderna Bivalent Omicron vaccine on enrolment or 3 months later. Both groups will be followed-up for six months after enrolment.. We hypothesise that there will be a difference in measurable SARS-CoV-2 antibody responses in people who receive a Moderna Bivalent Omicron COVID vaccine booster immediately on enrolment in the study compared to those who wait an additional three months before receiving a booster dose. A booster dose of the Moderna Bivalent Omicron r vaccine will be administered intramuscularly. One dose (0.5 mL) contains 50 micrograms of mRNA-1273.214 (25-µg each ancestral Wuhan-Hu-1 and omicron B.1.1.529 spike SARS-CoV-2 mRNAs) (embedded in lipid nanoparticles). This is a single-site study with interested potential participants attending the Royal Melbourne Hospital for recruitment, the consenting process and study visits. A total of 64 participants will be recruited (32 per arm).
Interventions
A booster dose of the Moderna Bivalent Omicron vaccine delivered intramuscularly on enrolment
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Aged 18-65 years • Healthy with no significant immunosuppressive illnesses. These include but are not limited to: - cancer or treatment of cancer or organ transplantation - treatment of auto-immune or inflammatory conditions such as inflammatory arthritis or inflammatory bowel disease - use of corticosteroid, TNF inhibitor, interleukins, interferons, cyclosporine or other immunosuppressive medications - significant renal or liver disease • Two or 3 prior doses of a COVID-19 vaccine, the last dose at least 4 months prior to recruitment • No previous significant adverse events to 2-3 prior doses of COVID-19 vaccine, according to the criteria below. Severe grading indicates the event prevented daily activity, temperature >40.0°C or >10.0 cm in diameter for redness and swelling at the site of injection - severe systemic events (fatigue, headache, fever, muscle or joint pain) - severe local events (pain at injection site, redness and swelling - any event requiring emergency department visit or hospitalisation • No prior anaphylaxis to any cause, including to prior CIVID-19 vaccines • No prior cardiac inflammatory condition (myocarditis, pericarditis), including to prior COVID-19 vaccines • Willing and available to have regular blood and saliva samples taken per the schedule of events • Willing to be randomly assigned to receive a booster dose of Moderna Bivalent Omicron vaccine either upon enrolment or 3 months later • Willing to provide a signed and dated informed consent form.
Exclusion criteria
• Prior COVID-19 infection • Pregnant or breastfeeding women and women planning to become pregnant • Unwilling to use reliable contraception around the timing of the vaccine (one month before and one month after) • Receiving medication that might reduce immune responses. These include but are not limited to: - systemic corticosteroids - interleukins - interferons - cyclosporine - systemic chemotherapy
Outcome results
None listed