Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination |
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units/mL and presented as geometric mean concentration and 95% confidence intervals |
28-days post booster vaccination |
|
Primary |
Total incidence of solicited reactions (systemic and local) |
Questionnaire to document solicited reactions is developed specifically for this study. Data will be reported as the proportion of participants who report by each intervention arm. Solicited reactions such as pain, tenderness, erythema/redness, induration/swelling, fever, nausea/vomiting, headache, fatigue/malaise, myalgia, arthralgia will be collected from the participants 7 days post-vaccination. |
Total incidence of solicited reactions will be measured for 7 days post booster vaccination |
|
Secondary |
SARS-CoV-2 specific IgG antibodies at baseline (pre booster), and 6-months post booster vaccination |
Serum samples collected at baseline (pre booster), and 6-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA . Data will be reported as binding antibody units/mL and presented as geometric mean concentration and 95% confidence intervals |
Baseline (pre booster), and 6-months post booster vaccination |
|
Secondary |
SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days and 6-months post booster vaccination measured by surrogate virus neutralization test (sVNT) |
Serum samples collected at baseline (pre booster), 28 days- and 6-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific neutralising antibodies using the GenScript® cPass surrogate virus neutralization test (sVNT) for both wild-type and Omicron variant. Neutralising antibody response will be reported as percentage (%) inhibition of receptor binding domain-angiotensin-converting enzyme 2 (RBD-ACE2) binding relative to a positive control. |
Baseline (pre booster), 28 days and 6 months post booster vaccination |
|
Secondary |
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 |
A subset of samples from all timepoints will be assessed using a SARS-CoV-2 microneutralisation assay to both the wild type (vaccine) strain and for two SARS-CoV-2 Variants of concern. Neutralizing antibody will be reported as endpoint titre. |
Baseline (pre booster), 28 days-, and 6-months post booster vaccination |
|
Secondary |
Interferon gamma (IFN?) concentrations in International Units (IU)/mL |
Interferon gamma (IFN?) concentrations as a measurement of cellular immunity will be assessed on a subset (40%) of the participants from each group. QuantiFERON Human IFN-? SARS-CoV-2 (Qiagen) will be used to stimulate IFN-? production in peripheral blood mononuclear cells (PBMCs) and then IFN-? production will be measured using ELISA. Data will be presented as geometric mean concentration (GMC) and 95% confidence intervals (CI). |
Baseline (pre booster), 28 days-, and 6-months post booster vaccination |
|
Secondary |
Number of IFN? producing cells/million PBMCs |
IFN? producing cells as a measurement of cellular immunity will be assessed on a subset (40%) of the participants from each group. IFN-? Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFN? producing cells/million and presented using means and 95% confidence intervals. |
Baseline (pre booster), 28 days-, and 6-months post booster vaccination |
|
Secondary |
Frequency of cytokine-expressing T cells |
Frequency of cytokine-expressing T cells will be assessed on a subset (40%) of participants using Flow cytometry (intracellular staining) on PBMCs samples. Data will be reported as frequency (%) of cytokine-expressing T cells presented as means and 95% CI. |
Baseline (pre booster), 28 days-, and 6-months post booster vaccination |
|
Secondary |
Cytokine concentrations following PBMCs stimulation |
Cytokine concentrations following PBMCs stimulation will be assessed on a subset (40%) of participants using multiplex cytokine assays.Data will be reported as cytokine concentrations in pg/ml and presented as GMC and 95% CI. |
Baseline (pre booster), 28 days and 6-months post booster vaccination |
|
Secondary |
Incidence of unsolicited adverse events (AE) |
All unsolicited AE will be collected for 28 days post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE. |
28 days-post booster vaccination |
|
Secondary |
Incidence of medically attended adverse events (AE) |
Participants with medically attended AE will be collected for 3 months post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE. |
3 months post booster vaccination |
|
Secondary |
Incidence of serious adverse events (SAE) |
SAE will be collected throughout the follow-up period of 6 months post booster vaccination. Data will be presented as a proportion of participants who report unsolicited SAE. |
6 months post booster vaccination |
|