Relapsing Multiple Sclerosis
Conditions
Keywords
COVID-19, SARS-CoV-2 mRNA vaccine, immune response, Ofatumumab, Relapsing Multiple Sclerosis, RMS, adult, MS
Brief summary
This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.
Detailed description
This was a four cohort, multicenter, open-label, prospective study of 34 (optionally up to 60) patients who had relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA vaccination (initial vaccinations or booster vaccines) as part of clinical routine. The maximal duration of the study for an individual patient was 22 months. * The first cohort was RMS patients receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine prior to starting ofatumumab treatment. * The second cohort was participants receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine while already stable on ofatumumab treatment for at least 4 weeks (since first dose). Cohort 1a - Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment. Cohort 1b - Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment. Cohort 2a - Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). Cohort 2b - Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). Development of SARS-CoV-2 specific T-cells and functional anti-SARS-CoV-2 antibodies were investigated for up to 18 months after the participants' vaccination.
Interventions
DRUGOfatumumab
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Relapsing Multiple Sclerosis (RMS) diagnosis * eligible for ofatumumab treatment * willing and eligible to receive SARS-CoV-2 mRNA vaccine
Exclusion criteria
* known prior or current COVID-19 infection * previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab * no previous vaccination with a non-modRNA SARS-CoV-2 vaccine. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine | 1 month after second dose of vaccine or booster vaccine | Participants who established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either 1 month after second dose of vaccine or 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | At Week 1, Months 6, 12 and 18 after second dose of vaccine or 1 Month after 1st booster, 1 Month after 2nd booster | Participants who maintained detectable SARS-CoV-2 reactive T-cells (measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix) after second dose of vaccine or 6 and 12 months after booster vaccine in participants who received the vaccine before or after starting ofatumumab treatment. First booster vaccination was optional for cohorts 1a and 2a. In cohorts 1b and 2b the time points Month 1 after Vacc and 1 Month after booster are identical. |
| Increase in Specific T-cells After Receiving an modRNA Booster Vaccine | Last value before booster to 1 month after booster | Patients having established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment. The fold change of SI from last value before booster to Month 1 is the ratio of SI at Month 1 divided by SI at last value before booster. |
| Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Baseline, Week 1 after Vacc, Month 1, 6, 12 after Vacc, 1 month after 1st booster, 1 month after 2nd booster | Level of SARS-CoV-2 serum functional antibodies were measured by a central laboratory using a neutralizing antibody detection kit. |
| SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Baseline, Months 1 ,6, 12 and 18 after vaccinationse of vaccine or 1,6 and 12 months after booster vaccine | Phenotypic description of the cellular immune response was performed at the central laboratory. T-cells were stimulated with SARS-CoV-2 peptide mix and analyzed for IFNg- and IL4 secretion using FACS analysis. |
Countries
Germany
Participant flow
Pre-assignment details
Thirty-seven participants were screened and 34 participants met the criteria for entry into the trial.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1a Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment. | 6 |
| Cohort 1b Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment. | 8 |
| Cohort 2a Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). | 5 |
| Cohort 2b Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). | 15 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Wish to have children. | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1a | Cohort 1b | Cohort 2a | Cohort 2b | Total |
|---|---|---|---|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 8.1 | 47.1 years STANDARD_DEVIATION 14.1 | 32.4 years STANDARD_DEVIATION 7.7 | 45.5 years STANDARD_DEVIATION 12.4 | 41.6 years STANDARD_DEVIATION 12.9 |
| Race/Ethnicity, Customized Caucasian | 6 Participants | 8 Participants | 5 Participants | 13 Participants | 32 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 4 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 1 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 | 0 / 5 | 0 / 15 |
| other Total, other adverse events | 6 / 6 | 6 / 8 | 5 / 5 | 15 / 15 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 | 1 / 5 | 1 / 15 |
Outcome results
Primary
Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine
Participants who established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either 1 month after second dose of vaccine or 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment.
Time frame: 1 month after second dose of vaccine or booster vaccine
Population: Efficacy and safety analysis sets
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1a | Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine | 80.0 percentage of participants |
| Cohort 1b | Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine | 87.5 percentage of participants |
| Cohort 2a | Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine | 100.0 percentage of participants |
| Cohort 2b | Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine | 46.7 percentage of participants |
| Total | Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine | 68.8 percentage of participants |
Secondary
Increase in Specific T-cells After Receiving an modRNA Booster Vaccine
Patients having established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment. The fold change of SI from last value before booster to Month 1 is the ratio of SI at Month 1 divided by SI at last value before booster.
Time frame: Last value before booster to 1 month after booster
Population: All patients in the efficacy analysis set, for whom ELISpot data for the time points last visit before booster and month 1 after booster were available, were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1a | Increase in Specific T-cells After Receiving an modRNA Booster Vaccine | 0.8 fold change | Standard Deviation 0.9 |
| Cohort 1b | Increase in Specific T-cells After Receiving an modRNA Booster Vaccine | 12.6 fold change | Standard Deviation 25.5 |
| Cohort 2a | Increase in Specific T-cells After Receiving an modRNA Booster Vaccine | 2.0 fold change | Standard Deviation 2.1 |
| Cohort 2b | Increase in Specific T-cells After Receiving an modRNA Booster Vaccine | 3.6 fold change | Standard Deviation 4.4 |
| Total | Increase in Specific T-cells After Receiving an modRNA Booster Vaccine | 5.3 fold change | Standard Deviation 13.2 |
Secondary
Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine
Participants who maintained detectable SARS-CoV-2 reactive T-cells (measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix) after second dose of vaccine or 6 and 12 months after booster vaccine in participants who received the vaccine before or after starting ofatumumab treatment. First booster vaccination was optional for cohorts 1a and 2a. In cohorts 1b and 2b the time points Month 1 after Vacc and 1 Month after booster are identical.
Time frame: At Week 1, Months 6, 12 and 18 after second dose of vaccine or 1 Month after 1st booster, 1 Month after 2nd booster
Population: Efficacy and safety analysis sets
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 1st booster n=4,8,3,15,30 | 75.0 percentage of participants |
| Cohort 1a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 2nd booster n=2,4,0,10,16 | 100.0 percentage of participants |
| Cohort 1a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 12 after vacc n=5,5,5,15,30 | 100.0 percentage of participants |
| Cohort 1a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 18 after vacc n=4,0,4,0,8 | 50.0 percentage of participants |
| Cohort 1a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 6 after vacc n=4,8,5,14,31 | 100 percentage of participants |
| Cohort 1a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Week 1 after vacc n=4,0,5,0,9 | 100.0 percentage of participants |
| Cohort 1b | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 12 after vacc n=5,5,5,15,30 | 100.0 percentage of participants |
| Cohort 1b | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 6 after vacc n=4,8,5,14,31 | 62.5 percentage of participants |
| Cohort 1b | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 1st booster n=4,8,3,15,30 | 87.5 percentage of participants |
| Cohort 1b | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 2nd booster n=2,4,0,10,16 | 75.0 percentage of participants |
| Cohort 2a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 1st booster n=4,8,3,15,30 | 66.7 percentage of participants |
| Cohort 2a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 6 after vacc n=4,8,5,14,31 | 60.0 percentage of participants |
| Cohort 2a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Week 1 after vacc n=4,0,5,0,9 | 100.0 percentage of participants |
| Cohort 2a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 12 after vacc n=5,5,5,15,30 | 80.0 percentage of participants |
| Cohort 2a | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 18 after vacc n=4,0,4,0,8 | 100.0 percentage of participants |
| Cohort 2b | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 12 after vacc n=5,5,5,15,30 | 93.3 percentage of participants |
| Cohort 2b | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 6 after vacc n=4,8,5,14,31 | 57.1 percentage of participants |
| Cohort 2b | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 2nd booster n=2,4,0,10,16 | 80.0 percentage of participants |
| Cohort 2b | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 1st booster n=4,8,3,15,30 | 46.7 percentage of participants |
| Total | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 2nd booster n=2,4,0,10,16 | 81.3 percentage of participants |
| Total | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Week 1 after vacc n=4,0,5,0,9 | 100.0 percentage of participants |
| Total | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 6 after vacc n=4,8,5,14,31 | 64.5 percentage of participants |
| Total | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 12 after vacc n=5,5,5,15,30 | 93.3 percentage of participants |
| Total | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 18 after vacc n=4,0,4,0,8 | 93.3 percentage of participants |
| Total | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Month 1 after 1st booster n=4,8,3,15,30 | 63.3 percentage of participants |
Secondary
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Level of SARS-CoV-2 serum functional antibodies were measured by a central laboratory using a neutralizing antibody detection kit.
Time frame: Baseline, Week 1 after Vacc, Month 1, 6, 12 after Vacc, 1 month after 1st booster, 1 month after 2nd booster
Population: Efficacy analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Baseline0 positive n=6,8, 5,14 | 0 percentage of participants |
| Cohort 1a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 12 after Vacc positive n=5,7,5,14 | 100.0 percentage of participants |
| Cohort 1a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Week 1 after Vacc positive n=5,0,5,0 | 100.0 percentage of participants |
| Cohort 1a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after 1st booster postive n=5,8,5,15 | 100.0 percentage of participants |
| Cohort 1a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after Vacc positive n=5,8,4,15 | 100.0 percentage of participants |
| Cohort 1a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after 2nd booster positive n=2,4,0,10 | 100.0 percentage of participants |
| Cohort 1a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 6 after Vacc positive n=5,8,5,15 | 100.0 percentage of participants |
| Cohort 1b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after Vacc positive n=5,8,4,15 | 100.0 percentage of participants |
| Cohort 1b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 12 after Vacc positive n=5,7,5,14 | 100.0 percentage of participants |
| Cohort 1b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after 2nd booster positive n=2,4,0,10 | 100.0 percentage of participants |
| Cohort 1b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 6 after Vacc positive n=5,8,5,15 | 100.0 percentage of participants |
| Cohort 1b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Baseline0 positive n=6,8, 5,14 | 100.0 percentage of participants |
| Cohort 1b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after 1st booster postive n=5,8,5,15 | 100.0 percentage of participants |
| Cohort 2a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 6 after Vacc positive n=5,8,5,15 | 40.0 percentage of participants |
| Cohort 2a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Baseline0 positive n=6,8, 5,14 | 0 percentage of participants |
| Cohort 2a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Week 1 after Vacc positive n=5,0,5,0 | 40.0 percentage of participants |
| Cohort 2a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after Vacc positive n=5,8,4,15 | 25.0 percentage of participants |
| Cohort 2a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 12 after Vacc positive n=5,7,5,14 | 40.0 percentage of participants |
| Cohort 2a | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after 1st booster postive n=5,8,5,15 | 66.7 percentage of participants |
| Cohort 2b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 6 after Vacc positive n=5,8,5,15 | 73.3 percentage of participants |
| Cohort 2b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after 2nd booster positive n=2,4,0,10 | 90.0 percentage of participants |
| Cohort 2b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after 1st booster postive n=5,8,5,15 | 93.3 percentage of participants |
| Cohort 2b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 1 after Vacc positive n=5,8,4,15 | 93.3 percentage of participants |
| Cohort 2b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Baseline0 positive n=6,8, 5,14 | 71.4 percentage of participants |
| Cohort 2b | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Month 12 after Vacc positive n=5,7,5,14 | 92.9 percentage of participants |
Secondary
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Phenotypic description of the cellular immune response was performed at the central laboratory. T-cells were stimulated with SARS-CoV-2 peptide mix and analyzed for IFNg- and IL4 secretion using FACS analysis.
Time frame: Baseline, Months 1 ,6, 12 and 18 after vaccinationse of vaccine or 1,6 and 12 months after booster vaccine
Population: Full analysis set -available participant data varied across time points. In alignment with the secondary study objectives of the protocol and the corresponding statistical analysis plan, the phenotypical parameters were assessed by cohort. Therefore, participants in the subcohorts 1a/1b and 2a/2b were combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | BL before initial Vacc IL4 basal n=4,5 | 2.458 % of CD4+/CD8+ cells | Standard Deviation 4.915 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | BL before initial Vacc IL4 stim.n=4,5 | 2.583 % of CD4+/CD8+ cells | Standard Deviation 5.165 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | BL before initial Vacc INFg basal n=4,5 | 0.555 % of CD4+/CD8+ cells | Standard Deviation 0.549 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | BL before initial Vacc INGg stim n=4,5 | 0.235 % of CD4+/CD8+ cells | Standard Deviation 0.191 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 1 after Vacc Il4 basal n=12,19 | 0.396 % of CD4+/CD8+ cells | Standard Deviation 2.318 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 1 after Vacc IL4 stim. n=12,19 | 0.719 % of CD4+/CD8+ cells | Standard Deviation 0.62 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 1 after Vacc INFg basal n=12,19 | 0.258 % of CD4+/CD8+ cells | Standard Deviation 2.165 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 1 after Vacc INFg stim. n=12,19 | 0.947 % of CD4+/CD8+ cells | Standard Deviation 2.165 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 6 after Vacc Il4 basal n=12,20 | 0.662 % of CD4+/CD8+ cells | Standard Deviation 1.44 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | 0Month 6 after Vacc IL4 stim.n=12,20 | 0.93 % of CD4+/CD8+ cells | Standard Deviation 2.043 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 6 after Vacc INFg basal n=12,20 | 0.236 % of CD4+/CD8+ cells | Standard Deviation 0.344 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 6 after Vacc INFg stim.n=12,20 | 0.305 % of CD4+/CD8+ cells | Standard Deviation 0.352 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 12 after Vacc Il4 basal n=10,17 | 0.361 % of CD4+/CD8+ cells | Standard Deviation 1.142 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 12 after Vacc IL4 stim.n=10,17 | 0.174 % of CD4+/CD8+ cells | Standard Deviation 0.55 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 12 after Vacc INFg basal n=10,17 | 0.132 % of CD4+/CD8+ cells | Standard Deviation 0.192 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month12 after Vacc INFg stim. n=10,17 | 0.122 % of CD4+/CD8+ cells | Standard Deviation 0.26 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 18 after Vacc IL4 basal n=4,5 | 2.368 % of CD4+/CD8+ cells | Standard Deviation 4.735 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 18 after Vacc IL4 stim.l n=4,5 | 1.833 % of CD4+/CD8+ cells | Standard Deviation 3.665 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 18 after Vacc INFg basal l n=4,5 | 0.148 % of CD4+/CD8+ cells | Standard Deviation 0.295 |
| Cohort 1a | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 18 after Vacc INFg stim.l n=4,5 | 0.138 % of CD4+/CD8+ cells | Standard Deviation 0.159 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 18 after Vacc IL4 stim.l n=4,5 | 0.176 % of CD4+/CD8+ cells | Standard Deviation 0.394 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | BL before initial Vacc IL4 basal n=4,5 | 0.262 % of CD4+/CD8+ cells | Standard Deviation 5.86 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 6 after Vacc INFg basal n=12,20 | 0.123 % of CD4+/CD8+ cells | Standard Deviation 0.205 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | BL before initial Vacc IL4 stim.n=4,5 | 0.264 % of CD4+/CD8+ cells | Standard Deviation 0.59 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month12 after Vacc INFg stim. n=10,17 | 0.757 % of CD4+/CD8+ cells | Standard Deviation 2.332 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | BL before initial Vacc INFg basal n=4,5 | 0.03 % of CD4+/CD8+ cells | Standard Deviation 0.067 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 6 after Vacc INFg stim.n=12,20 | 0.342 % of CD4+/CD8+ cells | Standard Deviation 0.644 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | BL before initial Vacc INGg stim n=4,5 | 0.146 % of CD4+/CD8+ cells | Standard Deviation 0.326 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 18 after Vacc INFg stim.l n=4,5 | 0.12 % of CD4+/CD8+ cells | Standard Deviation 0.268 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 1 after Vacc Il4 basal n=12,19 | 1.209 % of CD4+/CD8+ cells | Standard Deviation 6.919 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 12 after Vacc Il4 basal n=10,17 | 1.078 % of CD4+/CD8+ cells | Standard Deviation 2.468 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 1 after Vacc IL4 stim. n=12,19 | 2.449 % of CD4+/CD8+ cells | Standard Deviation 0.283 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 18 after Vacc IL4 basal n=4,5 | 0.118 % of CD4+/CD8+ cells | Standard Deviation 0.264 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 1 after Vacc INFg basal n=12,19 | 0.171 % of CD4+/CD8+ cells | Standard Deviation 0.917 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 12 after Vacc IL4 stim.n=10,17 | 1.031 % of CD4+/CD8+ cells | Standard Deviation 2.491 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 1 after Vacc INFg stim. n=12,19 | 0.381 % of CD4+/CD8+ cells | Standard Deviation 0.917 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 18 after Vacc INFg basal l n=4,5 | 0.11 % of CD4+/CD8+ cells | Standard Deviation 0.246 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 6 after Vacc Il4 basal n=12,20 | 0.061 % of CD4+/CD8+ cells | Standard Deviation 0.273 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Month 12 after Vacc INFg basal n=10,17 | 0.226 % of CD4+/CD8+ cells | Standard Deviation 0.478 |
| Cohort 1b | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | 0Month 6 after Vacc IL4 stim.n=12,20 | 0.44 % of CD4+/CD8+ cells | Standard Deviation 0.197 |