Coronavirus, Covid19, SARS-CoV-2, Severe Acute Respiratory Syndrome
Conditions
Keywords
Covid19, CVnCoV, SARS-CoV-2 mRNA vaccine, Vaccine, SARS, COVID, Safety, Reactogenicity, Immunogenicity
Brief summary
The primary objectives of this study are to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine CVnCoV, and to evaluate the humoral immune responses 14 days after 2 dose administrations of CVnCoV.
Detailed description
Study participants with the following mild to moderate per protocol defined co-morbidities will be recruited: chronic kidney disease (CKD); cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), type-2-diabetes. After safety data review, recruitment for severe cases will be opened. No severity classification will be done for study participants with chronic human immunodeficiency virus (HIV) infection with stable aviremia 12 months prior enrollment, for renal transplant patients if stable under medication for at least 6 months prior enrollment, and for study participants with a body mass index \> 32 kg/m\^2. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Interventions
BIOLOGICALCVnCoV Vaccine
Intramuscular (IM) injection in the deltoid area, preferably in the non-dominant arm.
Sponsors
CureVac
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female participants ≥18 years of age with 1 or more co-morbidities. 2. For the co-morbidities chronic kidney disease, chronic obstructive pulmonary disease (COPD), chronic cardiovascular disease and diabetes mellitus, the first 25 participants per co-morbidity should include only mild to moderate cases. Thereafter, more severe conditions may be recruited following Internal Safety Review Committee (iSRC) and Data Safety Monitoring Board (DSMB) Chair approval. 3. Participant has no overt clinical signs or symptoms of COVID-19. 4. Participant has to sign the informed consent form (ICF) before any trial procedures. 5. Participants with a life expectancy of at least 1 year as per the Investigator's assessment. 6. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. 7. Physical examination without acute clinically significant findings according to the Investigator's assessment. 8. Female participants: At the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre vaccination): negative urine pregnancy test (hCG) (only required if serum pregnancy test was performed more than 3 days before). Note: Women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause) or permanently sterilized will be considered as not having reproductive potential. 9. Female participants of childbearing potential must use highly effective methods of birth control from 2 weeks before the first administration of the trial vaccine until 3 months following the last administration.
Exclusion criteria
1. A previous clinical and laboratory-confirmed diagnosis of COVID-19 within the last six months prior to screening. 2. Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. 3. Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. Planned vaccination with an inactivated influenza vaccine is permitted. 4. Receipt of any investigational, authorized or licensed SARS-CoV-2, other coronavirus vaccine or any other lipid nanoparticles (LNP)-containing messenger ribonucleic acid vaccine prior to the administration of the trial vaccine. For authorized or licensed SARS-CoV-2: planned administration during the trial up to 6 weeks after the foreseen date of second dose administration of CVnCoV. 5. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) for \>14 days in total within 6 months prior to the administration of the trial vaccine or planned use during the trial. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. The use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted. Note: This exclusion does not apply to the renal transplant cases and is at the Investigator's discretion for participants with other co-morbidities (e.g., COPD). 6. Participants with chronic human immunodeficiency virus (HIV) infection with controlled Hepatitis B infection with therapy or aviremic Hepatitis C may be eligible for the trial, based on the Investigator's judgment. 7. History of immune-mediated or autoimmune disease. 8. History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics. 9. History of or current alcohol and/or drug abuse. 10. History of confirmed severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) disease. 11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine. 12. Presence or evidence of significant uncontrolled acute or chronic medical or psychiatric illness, excluding the co-morbidities specified in the protocol. Significant medical or psychiatric illnesses include but are not limited to: * Uncontrolled respiratory disease. * Uncontrolled neurological disorders or Guillain-Barré syndrome or history of seizure, except for febrile seizures during childhood. * Current or past malignancy, unless completely resolved without sequelae for \>5 years 13. Foreseeable non-compliance with protocol, as judged by the Investigator. 14. For female participants: pregnancy or lactation. 15. Participants with impaired coagulation or any bleeding disorder in whom an IM injection or a blood draw is contraindicated. This includes participants on treatment with anticoagulants (e.g., vitamin K antagonists, novel oral anticoagulants, and heparin). Use of platelet aggregation inhibitors is not exclusionary. However, use of anticoagulants is accepted in certain co-morbidities according to the clinical Investigator's judgment and if the international normalized ratio (INR) remains ≤3. 16. Participants employed by the Sponsor, Investigator, or trial site, or relatives of research staff working on this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 | Day 43 | The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Up to Day 57 | AESIs included: * AEs with a suspected immune-mediated etiology including potential immune-mediated diseases. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. * Non-serious intercurrent medical conditions that may affect the immune response to vaccination was collected throughout the trial. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
| Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 | Baseline and Day 43 | Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine. |
| Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 | Day 43 | The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 | Baseline and Day 43 | Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
| Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome. |
| Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36) | Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 were included. |
| Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) | Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
| Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) | Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities. |
| Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Up to Day 57 | An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Days 29, 120, 211 and 393 | The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Baseline and Days 29 and 120 | Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Days 29 and 120 | The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Baseline and Days 29, 120, 211 and 393 | Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine. |
Countries
Belgium
Participant flow
Recruitment details
This trial was performed in Belgium between 22 April 2021 and 21 September 2021.
Pre-assignment details
Of the 172 participants who were screened, 129 participants with co-morbidities known to increase the risk for (severe) COVID-19 were enrolled. Participants received investigational severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccine (CVnCoV) 12 µg on Day 1 and Day 29.
Participants by arm
| Arm | Count |
|---|---|
| Chronic Kidney Disease Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m². | 1 |
| COPD Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis. | 1 |
| Obesity Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m². | 52 |
| Chronic Cardiovascular Disease Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension. | 33 |
| Chronic HIV Infection Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed. | 33 |
| Type 2 Diabetes Mellitus Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\]. | 7 |
| Renal Transplant Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection. | 2 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 4 | 1 | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | Chronic Kidney Disease | COPD | Obesity | Chronic Cardiovascular Disease | Chronic HIV Infection | Type 2 Diabetes Mellitus | Renal Transplant | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 54.0 years | 73.0 years | 42.7 years STANDARD_DEVIATION 10.77 | 52.3 years STANDARD_DEVIATION 12.36 | 43.7 years STANDARD_DEVIATION 11.69 | 58.3 years STANDARD_DEVIATION 9.21 | 39.0 years STANDARD_DEVIATION 2.83 | 46.5 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 49 Participants | 33 Participants | 32 Participants | 7 Participants | 2 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 48 Participants | 30 Participants | 25 Participants | 7 Participants | 2 Participants | 114 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 23 Participants | 7 Participants | 4 Participants | 3 Participants | 0 Participants | 37 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 29 Participants | 26 Participants | 29 Participants | 4 Participants | 2 Participants | 92 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 | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 52 | 0 / 33 | 0 / 33 | 0 / 7 | 0 / 2 |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 50 / 52 | 32 / 33 | 33 / 33 | 7 / 7 | 2 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 52 | 0 / 33 | 0 / 33 | 1 / 7 | 0 / 2 |
Outcome results
Primary
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 were included.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: The SAS including only participants who experienced solicited local and systemic AEs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 1.0 days | — |
| Chronic Kidney Disease | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 1.0 days | — |
| Obesity | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 4.4 days | Standard Deviation 5.06 |
| Obesity | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 2.2 days | Standard Deviation 1.11 |
| Chronic Cardiovascular Disease | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 4.1 days | Standard Deviation 2.58 |
| Chronic Cardiovascular Disease | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 2.1 days | Standard Deviation 1.21 |
| Chronic HIV Infection | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 4.3 days | Standard Deviation 3.1 |
| Chronic HIV Infection | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 2.4 days | Standard Deviation 0.7 |
| Type 2 Diabetes Mellitus | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 1.8 days | Standard Deviation 0.75 |
| Type 2 Diabetes Mellitus | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 5.4 days | Standard Deviation 4.83 |
| Renal Transplant | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 1.0 days | Standard Deviation 0 |
| Renal Transplant | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 3.0 days | Standard Deviation 1.41 |
Primary
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43
The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Day 43
Population: The PPI included all participants who received both doses within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, had not received medical treatments (such as blood products, immunoglobulin therapy) that may interfere with any of the immunogenicity measurements and had at least 1 blood sample collected starting at 14 days (Day 43) post-second vaccination available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Chronic Kidney Disease | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 | 518.410 titers | — |
| COPD | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 | 50.000 titers | — |
| Obesity | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 | 1576.121 titers | Standard Deviation 7.5115 |
| Chronic Cardiovascular Disease | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 | 1385.663 titers | Standard Deviation 5.8935 |
| Chronic HIV Infection | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 | 968.795 titers | Standard Deviation 4.7759 |
| Type 2 Diabetes Mellitus | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 | 183.523 titers | Standard Deviation 2.4423 |
| Renal Transplant | Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43 | 416.051 titers | Standard Deviation 20.0136 |
Primary
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: The SAS including only participants who experienced solicited local and systemic AEs.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Chronic Kidney Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 2 | 0 Participants |
| Chronic Kidney Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 1 | 1 Participants |
| Chronic Kidney Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 1 | 1 Participants |
| Chronic Kidney Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 3 | 0 Participants |
| Chronic Kidney Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 2 | 0 Participants |
| Chronic Kidney Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 3 | 0 Participants |
| COPD | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 2 | 0 Participants |
| COPD | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 1 | 0 Participants |
| COPD | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 2 | 0 Participants |
| COPD | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 1 | 0 Participants |
| COPD | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 3 | 0 Participants |
| COPD | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 3 | 0 Participants |
| Obesity | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 1 | 30 Participants |
| Obesity | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 2 | 9 Participants |
| Obesity | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 3 | 1 Participants |
| Obesity | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 1 | 8 Participants |
| Obesity | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 2 | 19 Participants |
| Obesity | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 3 | 19 Participants |
| Chronic Cardiovascular Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 1 | 23 Participants |
| Chronic Cardiovascular Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 3 | 1 Participants |
| Chronic Cardiovascular Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 3 | 9 Participants |
| Chronic Cardiovascular Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 1 | 8 Participants |
| Chronic Cardiovascular Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 2 | 4 Participants |
| Chronic Cardiovascular Disease | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 2 | 12 Participants |
| Chronic HIV Infection | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 1 | 8 Participants |
| Chronic HIV Infection | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 3 | 0 Participants |
| Chronic HIV Infection | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 1 | 20 Participants |
| Chronic HIV Infection | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 3 | 9 Participants |
| Chronic HIV Infection | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 2 | 14 Participants |
| Chronic HIV Infection | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 2 | 6 Participants |
| Type 2 Diabetes Mellitus | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 1 | 6 Participants |
| Type 2 Diabetes Mellitus | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 3 | 2 Participants |
| Type 2 Diabetes Mellitus | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 2 | 3 Participants |
| Type 2 Diabetes Mellitus | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 1 | 2 Participants |
| Type 2 Diabetes Mellitus | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 3 | 0 Participants |
| Type 2 Diabetes Mellitus | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 2 | 0 Participants |
| Renal Transplant | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 1 | 2 Participants |
| Renal Transplant | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 3 | 0 Participants |
| Renal Transplant | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 3 | 0 Participants |
| Renal Transplant | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | Grade 2 | 0 Participants |
| Renal Transplant | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 2 | 2 Participants |
| Renal Transplant | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | Grade 1 | 0 Participants |
Primary
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities.
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Population: The SAS including only participants who experienced unsolicited AEs.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chronic Kidney Disease | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Moderate | 0 Participants |
| Chronic Kidney Disease | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Severe | 0 Participants |
| Chronic Kidney Disease | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Mild | 1 Participants |
| COPD | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Mild | 0 Participants |
| COPD | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Moderate | 1 Participants |
| COPD | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Severe | 0 Participants |
| Obesity | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Severe | 4 Participants |
| Obesity | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Mild | 6 Participants |
| Obesity | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Moderate | 17 Participants |
| Chronic Cardiovascular Disease | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Mild | 4 Participants |
| Chronic Cardiovascular Disease | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Severe | 3 Participants |
| Chronic Cardiovascular Disease | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Moderate | 7 Participants |
| Chronic HIV Infection | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Mild | 8 Participants |
| Chronic HIV Infection | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Moderate | 10 Participants |
| Chronic HIV Infection | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Severe | 1 Participants |
| Type 2 Diabetes Mellitus | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Severe | 1 Participants |
| Type 2 Diabetes Mellitus | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Moderate | 1 Participants |
| Type 2 Diabetes Mellitus | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Mild | 2 Participants |
| Renal Transplant | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Mild | 1 Participants |
| Renal Transplant | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Severe | 0 Participants |
| Renal Transplant | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Moderate | 0 Participants |
Primary
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43
Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Time frame: Baseline and Day 43
Population: The Per Protocol Immunogenicity subset (PPI) included all participants who received both doses within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, had not received medical treatments (such as blood products, immunoglobulin therapy) that may interfere with any of the immunogenicity measurements and had at least 1 blood sample collected starting at 14 days (Day 43) post-second vaccination available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chronic Kidney Disease | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 | 1 count of seroconverted participants |
| COPD | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 | 0 count of seroconverted participants |
| Obesity | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 | 34 count of seroconverted participants |
| Chronic Cardiovascular Disease | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 | 19 count of seroconverted participants |
| Chronic HIV Infection | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 | 16 count of seroconverted participants |
| Type 2 Diabetes Mellitus | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 | 4 count of seroconverted participants |
| Renal Transplant | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43 | 1 count of seroconverted participants |
Primary
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial
AESIs included: * AEs with a suspected immune-mediated etiology including potential immune-mediated diseases. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. * Non-serious intercurrent medical conditions that may affect the immune response to vaccination was collected throughout the trial. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to Day 57
Population: The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chronic Kidney Disease | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 0 Participants |
| Chronic Kidney Disease | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any Related AESIs | 0 Participants |
| COPD | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any Related AESIs | 0 Participants |
| COPD | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 0 Participants |
| Obesity | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any Related AESIs | 0 Participants |
| Obesity | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 2 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any Related AESIs | 0 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 1 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any Related AESIs | 0 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 1 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 0 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any Related AESIs | 0 Participants |
| Renal Transplant | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 0 Participants |
| Renal Transplant | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any Related AESIs | 0 Participants |
Primary
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Population: The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chronic Kidney Disease | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any related unsolicited AEs | 1 Participants |
| Chronic Kidney Disease | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any unsolicited AEs | 1 Participants |
| COPD | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any unsolicited AEs | 1 Participants |
| COPD | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any related unsolicited AEs | 1 Participants |
| Obesity | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any related unsolicited AEs | 12 Participants |
| Obesity | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any unsolicited AEs | 27 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any related unsolicited AEs | 5 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any unsolicited AEs | 14 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any related unsolicited AEs | 7 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any unsolicited AEs | 19 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any unsolicited AEs | 4 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any related unsolicited AEs | 1 Participants |
| Renal Transplant | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any related unsolicited AEs | 1 Participants |
| Renal Transplant | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | Any unsolicited AEs | 1 Participants |
Primary
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to Day 57
Population: The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chronic Kidney Disease | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| Chronic Kidney Disease | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 0 Participants |
| COPD | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| COPD | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 0 Participants |
| Obesity | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 0 Participants |
| Obesity | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 0 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 0 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 1 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| Renal Transplant | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| Renal Transplant | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 0 Participants |
Primary
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Population: The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chronic Kidney Disease | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any related solicited systemic AEs | 0 Participants |
| Chronic Kidney Disease | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 1 Participants |
| Chronic Kidney Disease | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 1 Participants |
| COPD | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 0 Participants |
| COPD | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 0 Participants |
| COPD | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any related solicited systemic AEs | 0 Participants |
| Obesity | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any related solicited systemic AEs | 44 Participants |
| Obesity | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 40 Participants |
| Obesity | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 46 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 29 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 28 Participants |
| Chronic Cardiovascular Disease | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any related solicited systemic AEs | 26 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 31 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 26 Participants |
| Chronic HIV Infection | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any related solicited systemic AEs | 28 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 6 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any related solicited systemic AEs | 6 Participants |
| Type 2 Diabetes Mellitus | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 7 Participants |
| Renal Transplant | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any related solicited systemic AEs | 2 Participants |
| Renal Transplant | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited systemic AEs | 2 Participants |
| Renal Transplant | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose | Any solicited local AEs | 2 Participants |
Primary
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Day 43
Population: A subset of the PPI population was included in the measurement of neutralizing activity.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Chronic Kidney Disease | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 | 14.140 titers | — |
| COPD | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 | 5.000 titers | — |
| Obesity | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 | 57.426 titers | Standard Deviation 9.1427 |
| Chronic Cardiovascular Disease | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 | 16.042 titers | Standard Deviation 4.079 |
| Chronic HIV Infection | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 | 18.778 titers | Standard Deviation 3.9937 |
| Type 2 Diabetes Mellitus | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 | 5.000 titers | Standard Deviation 1 |
| Renal Transplant | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43 | 10.000 titers | Standard Deviation 2.6651 |
Primary
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43
Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Baseline and Day 43
Population: A subset of the PPI population was included in the measurement of neutralizing activity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chronic Kidney Disease | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 | 1 count of seroconverted participants |
| COPD | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 | 0 count of seroconverted participants |
| Obesity | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 | 16 count of seroconverted participants |
| Chronic Cardiovascular Disease | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 | 6 count of seroconverted participants |
| Chronic HIV Infection | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 | 7 count of seroconverted participants |
| Type 2 Diabetes Mellitus | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 | 0 count of seroconverted participants |
| Renal Transplant | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43 | 1 count of seroconverted participants |
Secondary
GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Days 29, 120, 211 and 393
Population: The PPI. No data was collected for Days 211 and 393 due to early study termination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 50.000 titers | — |
| COPD | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 50.000 titers | — |
| COPD | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 50.000 titers | — |
| Obesity | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 1861.522 titers | Standard Deviation 7.3966 |
| Obesity | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 234.464 titers | Standard Deviation 9.4598 |
| Chronic Cardiovascular Disease | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 153.351 titers | Standard Deviation 5.6201 |
| Chronic Cardiovascular Disease | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 179.992 titers | Standard Deviation 6.1193 |
| Chronic HIV Infection | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 174.749 titers | Standard Deviation 1.1589 |
| Chronic HIV Infection | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 104.230 titers | Standard Deviation 5.4583 |
| Type 2 Diabetes Mellitus | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 90.306 titers | Standard Deviation 3.7506 |
| Type 2 Diabetes Mellitus | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 554.010 titers | — |
| Renal Transplant | GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 50.000 titers | Standard Deviation 1 |
Secondary
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Time frame: Baseline and Days 29, 120, 211 and 393
Population: The PPI. No data was collected for Days 211 and 393 due to early study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 0 count of seroconverted participants |
| COPD | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 0 count of seroconverted participants |
| COPD | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 0 count of seroconverted participants |
| Obesity | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 13 count of seroconverted participants |
| Obesity | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 6 count of seroconverted participants |
| Chronic Cardiovascular Disease | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 1 count of seroconverted participants |
| Chronic Cardiovascular Disease | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 7 count of seroconverted participants |
| Chronic HIV Infection | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 3 count of seroconverted participants |
| Chronic HIV Infection | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 2 count of seroconverted participants |
| Type 2 Diabetes Mellitus | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 120 | 1 count of seroconverted participants |
| Type 2 Diabetes Mellitus | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 1 count of seroconverted participants |
| Renal Transplant | Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393 | Day 29 | 0 count of seroconverted participants |
Secondary
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Days 29 and 120
Population: A subset of the PPI population was included in the measurement of neutralizing activity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 5.000 titers | — |
| COPD | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 5.000 titers | — |
| COPD | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 5.000 titers | — |
| Obesity | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 26.389 titers | Standard Deviation 7.038 |
| Obesity | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 17.311 titers | Standard Deviation 7.4073 |
| Chronic Cardiovascular Disease | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 5.000 titers | — |
| Chronic Cardiovascular Disease | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 7.297 titers | Standard Deviation 2.3521 |
| Chronic HIV Infection | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 6.234 titers | Standard Deviation 2.0782 |
| Chronic HIV Infection | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 7.071 titers | Standard Deviation 1.6325 |
| Type 2 Diabetes Mellitus | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 5.000 titers | Standard Deviation 1 |
| Type 2 Diabetes Mellitus | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 5.000 titers | — |
| Renal Transplant | Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 5.000 titers | Standard Deviation 1 |
Secondary
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Baseline and Days 29 and 120
Population: A subset of the PPI population was included in the measurement of neutralizing activity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 0 count of seroconverted participants |
| COPD | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 0 count of seroconverted participants |
| COPD | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 0 count of seroconverted participants |
| Obesity | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 2 count of seroconverted participants |
| Obesity | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 7 count of seroconverted participants |
| Chronic Cardiovascular Disease | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 2 count of seroconverted participants |
| Chronic Cardiovascular Disease | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 0 count of seroconverted participants |
| Chronic HIV Infection | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 1 count of seroconverted participants |
| Chronic HIV Infection | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 1 count of seroconverted participants |
| Type 2 Diabetes Mellitus | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 0 count of seroconverted participants |
| Type 2 Diabetes Mellitus | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 120 | 0 count of seroconverted participants |
| Renal Transplant | Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120 | Day 29 | 0 count of seroconverted participants |