Clinical trial NCT05658523: COVID-19 Booster Study in Healthy Adults in Australia
Official title: A Randomised Controlled Trial to Assess the Immunogenicity, Safety and Reactogenicity of a Bivalent mRNA Moderna COVID-19 Vaccine or a Protein-based Novavax COVID-19 Vaccine Given as a Fourth Dose in Healthy Adults in Australia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: COVID-19
Keywords: Booster dose Moderna and Novavax
control group
monovalent, bivalent
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Coalition for Epidemic Preparedness Innovations
name: The Peter Doherty Institute for Infection and Immunity
First posted: 2022-12-20
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants who have previously received 3 COVID-19 vaccines will be either randomised into one of two vaccine groups or be part of a self-selected control group. Randomised participants will receive a standard dose of either the bivalent Moderna or the protein-based Novavax vaccine. 200 non-randomised participants will be part of a control group and will not receive any COVID-19 vaccine.
Primary purpose: PREVENTION

Brief summary: This is a double-blinded, randomised study to determine the safety, reactogenicity, and immunogenicity of a bivalent mRNA Moderna COVID-19 vaccine or a protein-based Novavax COVID-19 vaccine given as a fourth dose in healthy adults in Australia.

Detailed description: 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.

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.

Primary outcomes:
measure: SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination
timeFrame: 28-days post booster vaccination
measure: Total incidence of solicited reactions (systemic and local)
timeFrame: Total incidence of solicited reactions will be measured for 7 days post booster vaccination
Secondary outcomes:
measure: SARS-CoV-2 specific IgG antibodies at baseline (pre booster), and 6- and 12-months post booster vaccination
timeFrame: Baseline (pre booster), 6-months and 12-months post booster vaccination
measure: SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days, 6- and 12-months post booster vaccination measured by surrogate virus neutralization test (sVNT)
timeFrame: Baseline (pre booster), 6-months and 12-months post booster vaccination
measure: SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days and 6- months post booster vaccination measured by SARS-CoV-2 microneutralisation assay
timeFrame: Baseline (pre booster), 6-months and 12-months post booster vaccination
measure: Interferon gamma (IFNγ) concentrations in International Units (IU)/mL
timeFrame: Baseline (pre booster), 6-months and 12-months post booster vaccination
measure: Number of IFNγ producing cells/million PBMCs
timeFrame: Baseline (pre booster), 6-months and 12-months post booster vaccination
measure: Frequency of cytokine-expressing T cells
timeFrame: Baseline (pre booster), 6-months and 12-months post booster vaccination
measure: Cytokine concentrations following PBMCs stimulation
timeFrame: Baseline (pre booster), 6-months and 12-months post booster vaccination
measure: Incidence of unsolicited adverse events (AE)
timeFrame: 28 days-post booster vaccination
measure: Incidence of medically attended adverse events (AE)
timeFrame: 3 months post booster vaccination
measure: Incidence of serious adverse events (SAE)
timeFrame: 12 months post booster vaccination
Other outcomes:
measure: SARS-CoV-2 breakthrough infections
timeFrame: 12 months post booster vaccination
Locations:
city: Melbourne
country: Australia
facility: Royal Children's Hospital, Murdoch Children's Research Institute
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Kim Mulholland, MD/Prof
role: PRINCIPAL_INVESTIGATOR
References: