Relapsing Multiple Sclerosis (RMS)
Conditions
Keywords
Multiple Sclerosis, Relapsing Multiple Sclerosis, COVID, COVID-19, Vaccine, Coronavirus, adult, OMB157
Brief summary
This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.
Detailed description
This was a six-cohort, multicenter, prospective study planned for up to 88 relapsing multiple sclerosis (MS) participants. The study was intended to address two questions: 1) Can participants treated with ofatumumab develop an immune response if receiving a COVID-19 mRNA vaccine two weeks prior to ofatumumab start? 2) If receiving COVID-19 mRNA vaccine after introduction of ofatumumab treatment, can participants develop an immune response? Cohort 1: participants received an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. Cohort 2: participants received an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. Cohort 3: participants on an interferon or glatiramer acetate who received COVID-19 mRNA vaccine. Cohort 4: participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start. Cohort 5: participants vaccinated with an RNA COVID-19 vaccine, with or without a booster dose, and on interferon or glatiramer acetate. Cohort 6: participants fully vaccinated with an RNA COVID-19 vaccine who received a booster dose at least four weeks after ofatumumab start. Participants obtained the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program. Participants in Cohort 1 received loading doses of ofatumumab and subsequent dosing was 20 mg s.c. administered monthly. All other cohorts continued current dosing schedule of either ofatumumab, glatiramer acetate or interferon. Participation in trial was maximum of 421 days which was dependent on the Cohort.
Interventions
DRUGOfatumumab
3 loading doses followed by monthly administrations
BIOLOGICALmRNA COVID-19 vaccine
Pfizer or Moderna mRNA Vaccine
DRUGinterferon or glatiramer acetate
iDMT
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent must be obtained prior to participation in the study * Diagnosis of relapsing MS by 2017 revised McDonald criteria * Were willing to comply with the study schedule * Cohort 1: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab * Cohort 2: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks * Cohort 3: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on interferon or glatiramer acetate for at least 4 weeks * Cohort 4: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks * Cohort 5: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine), with or without a booster, and on interferon or glatiramer acetate for at least 4 weeks * Cohort 6: Fully vaccinated with a non-live COVID mRNA vaccine, (Pfizer or Moderna vaccine), with a booster, and on ofatumumab for at least 4 weeks
Exclusion criteria
* Received the J&J vaccine. * Had a contraindication to receiving an mRNA COVID-19 vaccine * Had an immediate allergic reaction to past vaccine or injection * Experienced a major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1 | An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Vaccination up to 70, 180, 270 and 360 days | An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders). |
| Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1 | Immune conversion was defined as (i) pre-vaccination absence of SARS-CoV-2 qualitative IgG antibody with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 1-3 only); or (ii) pre vaccination presence of SARS-CoV-2 quantitative IgG antibody (i.e., pre vaccination value ≥0.80 U/mL) with any post-vaccination ≥4-fold increase in SARS-CoV-2 quantitative IgG antibody titer (Cohorts 1-3 only); or (iii) initial negative SARS-CoV-2 nucleocapsid antibody assay with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 4 and 5 only). There was no baseline for Cohort 6 because there was no blood collection prior to vaccination. |
Countries
United States
Participant flow
Pre-assignment details
There were 24 participants screened. Cohort = C
Participants by arm
| Arm | Count |
|---|---|
| C1: VN - Plan to Start OMB157 Vaccine naive, planning to start ofatumumab | 5 |
| C2: VN - on OMB157 >=4 WKs Vaccine naive, currently on ofatumumab for ≥ 4 weeks | 2 |
| C3: VN - INFy or GA >=4 WKs Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks | 0 |
| C4: FV - OMB157 >=4 WKs Fully vaccinated, currently on ofatumumab for ≥ 4 weeks | 1 |
| C5: FV - INFy or GA >=4 WKs Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks | 11 |
| C6: FV - on OMB157 >=4 WKs + Booster Fully vaccinated, currently on ofatumumab for ≥ 4 weeks,
\+ booster | 5 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Protocol deviation | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Study terminated by sponsor | 0 | 0 | 0 | 0 | 9 | 4 |
| Overall Study | Subject decision | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | C1: VN - Plan to Start OMB157 | C2: VN - on OMB157 >=4 WKs | C3: VN - INFy or GA >=4 WKs | C4: FV - OMB157 >=4 WKs | C5: FV - INFy or GA >=4 WKs | C6: FV - on OMB157 >=4 WKs + Booster | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 2 Participants | 0 Participants | 1 Participants | 11 Participants | 5 Participants | 24 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | — | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 2 Participants | — | 1 Participants | 10 Participants | 4 Participants | 20 Participants |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 0 Participants | 0 Participants | 8 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 2 | 0 / 0 | 0 / 1 | 0 / 11 | 0 / 5 |
| other Total, other adverse events | 5 / 5 | 1 / 2 | 0 / 0 | 0 / 1 | 2 / 11 | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 | 0 / 0 | 0 / 1 | 1 / 11 | 1 / 5 |
Outcome results
Primary
Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
Time frame: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1
Population: Safety analysis set (excluding 2 participants diagnosed with COVID-19 prior to study entry. Overall number analyzed included participants who received full course of vaccine (2 doses. n =number of participants with a positive result (responders). M = number of participants in the safety analysis set who received full course (2 doses) of a COVID 19 vaccine, including a COVID-19 booster for Cohort 6 participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C1: VN - Plan to Start OMB157 | Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 100.0 Percentage of participants |
| C2: VN - on OMB157 >=4 WKs | Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 100.0 Percentage of participants |
| C4: FV - OMB157 >=4 WKs | Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 0.0 Percentage of participants |
| C5: FV - INFy or GA >=4 WKs | Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 100.0 Percentage of participants |
| C6: FV - on OMB157 >=4 WKs + Booster | Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 50.0 Percentage of participants |
| Overall | Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 86.4 Percentage of participants |
Secondary
Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
Immune conversion was defined as (i) pre-vaccination absence of SARS-CoV-2 qualitative IgG antibody with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 1-3 only); or (ii) pre vaccination presence of SARS-CoV-2 quantitative IgG antibody (i.e., pre vaccination value ≥0.80 U/mL) with any post-vaccination ≥4-fold increase in SARS-CoV-2 quantitative IgG antibody titer (Cohorts 1-3 only); or (iii) initial negative SARS-CoV-2 nucleocapsid antibody assay with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 4 and 5 only). There was no baseline for Cohort 6 because there was no blood collection prior to vaccination.
Time frame: Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C1: VN - Plan to Start OMB157 | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Immune conversion n=5,2,0,1,1,9 | 80.0 Percentage of participants |
| C1: VN - Plan to Start OMB157 | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Pre-vac presence and post vac ≥4-fold increase n=5,2,0,0,0,7 | 0 Percentage of participants |
| C1: VN - Plan to Start OMB157 | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Pre-vac absence and post vac positive n=5,2, 0,0,0,7 | 80.0 Percentage of participants |
| C2: VN - on OMB157 >=4 WKs | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Pre-vac presence and post vac ≥4-fold increase n=5,2,0,0,0,7 | 0.0 Percentage of participants |
| C2: VN - on OMB157 >=4 WKs | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Immune conversion n=5,2,0,1,1,9 | 50.0 Percentage of participants |
| C2: VN - on OMB157 >=4 WKs | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Pre-vac absence and post vac positive n=5,2, 0,0,0,7 | 50.0 Percentage of participants |
| C4: FV - OMB157 >=4 WKs | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Initial negative SARS nucleocapsid with post-vac positive SARS n=0,0,0,1,1,2 | 0.0 Percentage of participants |
| C4: FV - OMB157 >=4 WKs | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Immune conversion n=5,2,0,1,1,9 | 0.0 Percentage of participants |
| C5: FV - INFy or GA >=4 WKs | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Initial negative SARS nucleocapsid with post-vac positive SARS n=0,0,0,1,1,2 | 0.0 Percentage of participants |
| C5: FV - INFy or GA >=4 WKs | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Immune conversion n=5,2,0,1,1,9 | 0.0 Percentage of participants |
| C6: FV - on OMB157 >=4 WKs + Booster | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Pre-vac presence and post vac ≥4-fold increase n=5,2,0,0,0,7 | 0.0 Percentage of participants |
| C6: FV - on OMB157 >=4 WKs + Booster | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Pre-vac absence and post vac positive n=5,2, 0,0,0,7 | 71.4 Percentage of participants |
| C6: FV - on OMB157 >=4 WKs + Booster | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Immune conversion n=5,2,0,1,1,9 | 55.6 Percentage of participants |
| C6: FV - on OMB157 >=4 WKs + Booster | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Initial negative SARS nucleocapsid with post-vac positive SARS n=0,0,0,1,1,2 | 0.0 Percentage of participants |
Secondary
Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set)
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
Time frame: Vaccination up to 70, 180, 270 and 360 days
Population: Safety analysis set (excluding 2 participants diagnosed with COVID-19 prior to study entry)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C1: VN - Plan to Start OMB157 | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 180 days post-vaccination, n=5,2,0,1,10,4,22 | 80.0 Percentage of participants |
| C1: VN - Plan to Start OMB157 | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 360 days post-vaccination n=5,2,0,1, 10, 4,22 | 60.0 Percentage of participants |
| C1: VN - Plan to Start OMB157 | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 70 days post-vaccination n=5,0,0,0,0,0,5 | 100.0 Percentage of participants |
| C1: VN - Plan to Start OMB157 | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 270 days post-vaccination n=5,2,0,1,10,4,22 | 60.0 Percentage of participants |
| C2: VN - on OMB157 >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 180 days post-vaccination, n=5,2,0,1,10,4,22 | 0.0 Percentage of participants |
| C2: VN - on OMB157 >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 270 days post-vaccination n=5,2,0,1,10,4,22 | 0.0 Percentage of participants |
| C2: VN - on OMB157 >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 360 days post-vaccination n=5,2,0,1, 10, 4,22 | 0.0 Percentage of participants |
| C4: FV - OMB157 >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 270 days post-vaccination n=5,2,0,1,10,4,22 | 0.0 Percentage of participants |
| C4: FV - OMB157 >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 180 days post-vaccination, n=5,2,0,1,10,4,22 | 100.0 Percentage of participants |
| C4: FV - OMB157 >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 360 days post-vaccination n=5,2,0,1, 10, 4,22 | 0.0 Percentage of participants |
| C5: FV - INFy or GA >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 270 days post-vaccination n=5,2,0,1,10,4,22 | 60.0 Percentage of participants |
| C5: FV - INFy or GA >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 360 days post-vaccination n=5,2,0,1, 10, 4,22 | 10.0 Percentage of participants |
| C5: FV - INFy or GA >=4 WKs | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 180 days post-vaccination, n=5,2,0,1,10,4,22 | 90.0 Percentage of participants |
| C6: FV - on OMB157 >=4 WKs + Booster | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 360 days post-vaccination n=5,2,0,1, 10, 4,22 | 0.0 Percentage of participants |
| C6: FV - on OMB157 >=4 WKs + Booster | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 180 days post-vaccination, n=5,2,0,1,10,4,22 | 25.0 Percentage of participants |
| C6: FV - on OMB157 >=4 WKs + Booster | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 270 days post-vaccination n=5,2,0,1,10,4,22 | 50.0 Percentage of participants |
| Overall | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 180 days post-vaccination, n=5,2,0,1,10,4,22 | 68.2 Percentage of participants |
| Overall | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 270 days post-vaccination n=5,2,0,1,10,4,22 | 50.0 Percentage of participants |
| Overall | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 70 days post-vaccination n=5,0,0,0,0,0,5 | 100.0 Percentage of participants |
| Overall | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | 360 days post-vaccination n=5,2,0,1, 10, 4,22 | 18.2 Percentage of participants |