COVID-19, SARS-CoV-2
Conditions
Keywords
COVID-19, Pandemic, Booster vaccination
Brief summary
Prevention of COVID-19 caused by SARS-CoV-2.
Interventions
BIOLOGICALCV0501 (3 μg)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0501 (6 μg)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0501 (12 μg)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0501 (25 μg)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0501 (50 μg)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0501 (100 μg)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0501 (200 μg)
Study vaccine was administered as a single intramuscular injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Must provide documented informed consent prior to any study procedures being performed 2. Is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits 3. Has received at least 2 doses of Comirnaty or Moderna COVID-19 Vaccine (Spikevax®\\), with the last dose of vaccine received at least 6 months prior to screening 4. Negative for SARS-CoV-2 infection by RT-PCR test at screening 5. Is a male or nonpregnant female \>= 18 years old 6. If the participant is a woman of childbearing potential, the participant agrees to use at least 1 highly effective form of contraception for at least 30 days prior to the study vaccination up to 3 months after study vaccination. 7. Agrees to refrain from blood or plasma donation from the first study vaccination through end of study. 8. Has a body mass index of 18 to 40 kg/m\^2, inclusive, at screening. 9. Is healthy or medically stable as determined by investigator judgment based on medical history, clinical laboratory tests, vital sign measurements, and physical examination findings
Exclusion criteria
1. Participant is female and has a positive pregnancy test result at screening. 2. Participant is female and is breastfeeding or will (re)start breastfeeding from the study vaccination to 3 months after vaccination. 3. Has an acute febrile illness with temperature \>=38.0°C or \>=100.4°F within 72 hours before study vaccination. Individuals with suspected COVID-19 symptoms should be excluded and referred for medical care. 4. Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before screening. 5. Has a documented medical history of HIV, hepatitis B or hepatitis C infection prior to screening, or a positive test for these conditions at screening. 6. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (eg, malignancy) or immunosuppressive/cytotoxic therapy (eg, medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy immunotherapy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of the first study vaccination. Inclusion of persons who use low dose topical, ophthalmic, inhaled, or intranasal steroid preparations is permitted. 7. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (eg, due to enterovirus or adenovirus), and celiac disease. 8. Has a new onset, clinically significant, abnormal biochemistry or hematology finding (defined as \>= Grade 1) at screening (adults with Grade 1 laboratory abnormalities that have been stable for at least 6 months before enrollment may be included in the study). 9. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain- Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), Takayasu arteritis, granulomatosis with polyangiitis, psoriasis, and insulin-dependent diabetes mellitus (Type 1). 10. Has an unstable chronic medical condition. This refers to a condition requiring a new medication or increase in dose of current medication(s) or a condition requiring hospitalization within 6 months prior to screening. 11. Has a history of hypersensitivity or severe allergic reaction, including anaphylaxis, generalized urticaria, angioedema, and other significant reactions, to vaccines or to any component of the investigational product. 12. Has received or plans to receive any licensed vaccine, within 4 weeks before or 4 weeks after study vaccination. Inactivated vaccines for influenza are permitted during the study if they are administered at least 14 days before or after study vaccination. 13. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study vaccination. Rescreening of these participants permitted after quarantine period is complete. 14. Has participated or plans to participate in another investigational study involving any investigational product or device within 6 months or 5 half-lives, whichever is longer, before the study vaccination through end of study. 15. Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before the first study vaccination through end of study. 16. Has a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 17. Has a history of alcohol abuse or other recreational drug use (excluding cannabis) within 6 months before study vaccination. 18. Has any abnormal skin condition or permanent body art (eg, tattoo) that would interfere with the ability to observe local reactions at the injection site. 19. Has a medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the individual at an unacceptable risk of injury, render the individual unable to meet the requirements of the protocol or interfere with the individual's successful completion of the trial. 20. Participant is an employee or family member of the investigator or study site personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | 8 days from vaccination at Day 1 | An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10\^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10\^6/uL; Male: 4.63-6.08x 10\^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10\^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10\^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10\^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10\^3/uL; Platelets: 163-375 x 10\^3/uL; Urea Nitrogen: 5-20 mg/dL. |
| Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study | From Day 1 up to Day 180 (including Day 180) | An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death. |
| Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study | From Day 1 up to Day 180 (including Day 180) | An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate. |
| Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study | From Day 1 up to Day 180 (including Day 180) | An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. |
| Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | From Day 1 to Day 7 (including Day 7) | Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy. |
| Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | From Day 1 to Day 7 (including Day 7) | Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills. |
| Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination | From Day 1 to day 28 (including day 28) | An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | At Day 15, Day 29, Day 91, and Day 181 | — |
| Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | At day 29 (28 days after the booster dose) | Seroresponse was defined as post-boost titers \>= 4 times pre-boost (baseline) titers for participants with titer \>= LLOQ at pre-vaccination and as post-booster titer \>= 4 times LLOQ for participants with titer \< LLOQ at pre vaccination. |
| Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | At Day 1, Day 15, Day 29, Day 91, and Day 181 | — |
Countries
Australia, Philippines, United States
Participant flow
Recruitment details
The study was conducted at 20 centers in Australia, Philippines and United States.
Pre-assignment details
Escalation to the next higher dose cohorts was based on the Safety Review Team (SRT) review of safety data from the same age group.
Participants by arm
| Arm | Count |
|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1. | 15 |
| Part B: CV0501 Dose Cohort 7 (6 μg) Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1. | 17 |
| Part A: CV0501 Dose Cohort 1 (12 μg) Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1. | 31 |
| Part A: CV0501 Dose Cohort 2 (25 μg) Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1. | 30 |
| Part A: CV0501 Dose Cohort 3 (50 μg) Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1. | 31 |
| Part A: CV0501 Dose Cohort 4 (100 μg) Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1. | 31 |
| Part A: CV0501 Dose Cohort 5 (200 μg) Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1. | 30 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 1 | 1 | 0 | 2 |
| Overall Study | Vaccine not administered | 0 | 2 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Part B: CV0501 Dose Cohort 6 (3 μg) | Part B: CV0501 Dose Cohort 7 (6 μg) | Part A: CV0501 Dose Cohort 1 (12 μg) | Part A: CV0501 Dose Cohort 2 (25 μg) | Part A: CV0501 Dose Cohort 3 (50 μg) | Part A: CV0501 Dose Cohort 4 (100 μg) | Part A: CV0501 Dose Cohort 5 (200 μg) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.8 Years STANDARD_DEVIATION 12.18 | 35.8 Years STANDARD_DEVIATION 12.66 | 50.9 Years STANDARD_DEVIATION 16.43 | 48.9 Years STANDARD_DEVIATION 17.99 | 54.5 Years STANDARD_DEVIATION 15.69 | 55.2 Years STANDARD_DEVIATION 16.15 | 49.8 Years STANDARD_DEVIATION 19.23 | 49.2 Years STANDARD_DEVIATION 17.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 10 Participants | 7 Participants | 7 Participants | 6 Participants | 3 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 15 Participants | 21 Participants | 23 Participants | 24 Participants | 25 Participants | 27 Participants | 147 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 4 Participants | 10 Participants | 24 Participants | 19 Participants | 18 Participants | 20 Participants | 12 Participants | 107 Participants |
| Sex/Gender, Customized Male | 11 Participants | 7 Participants | 7 Participants | 11 Participants | 13 Participants | 11 Participants | 18 Participants | 78 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 / 15 | 0 / 15 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 11 / 15 | 10 / 15 | 18 / 30 | 22 / 30 | 19 / 30 | 22 / 30 | 24 / 30 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 30 | 0 / 30 | 1 / 30 | 2 / 30 | 0 / 30 |
Outcome results
Primary
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Time frame: From Day 1 up to Day 180 (including Day 180)
Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study | 2 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study | 3 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study | 2 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study | 4 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study | 3 Participants |
Primary
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10\^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10\^6/uL; Male: 4.63-6.08x 10\^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10\^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10\^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10\^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10\^3/uL; Platelets: 163-375 x 10\^3/uL; Urea Nitrogen: 5-20 mg/dL.
Time frame: 8 days from vaccination at Day 1
Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Bilirubin (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes (High) | 2 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils/Leukocytes (High) | 2 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (High) | 3 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils (High) | 1 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Creatinine (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Urea Nitrogen (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (Low) | 1 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Monocytes/Leukocytes (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (Low) | 1 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alkaline Phosphatase (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Aspartate Aminotransferase (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (High) | 1 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (Low) | 4 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes/Leukocytes (High) | 2 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes/Leukocytes (High) | 2 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Monocytes/Leukocytes (High) | 1 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Aspartate Aminotransferase (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Bilirubin (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Creatinine (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (High) | 5 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils/Leukocytes (High) | 1 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Urea Nitrogen (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (High) | 2 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (Low) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alkaline Phosphatase (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (High) | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (Low) | 1 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Aspartate Aminotransferase (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (Low) | 2 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes/Leukocytes (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Creatinine (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (Low) | 4 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Urea Nitrogen (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alkaline Phosphatase (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Bilirubin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Monocytes/Leukocytes (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils/Leukocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Urea Nitrogen (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Aspartate Aminotransferase (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (Low) | 3 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Monocytes/Leukocytes (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes/Leukocytes (High) | 3 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (Low) | 2 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alkaline Phosphatase (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils/Leukocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Creatinine (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (Low) | 2 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Bilirubin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes/Leukocytes (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alkaline Phosphatase (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Aspartate Aminotransferase (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Bilirubin (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Creatinine (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils/Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (Low) | 8 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (Low) | 3 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (High) | 6 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Monocytes/Leukocytes (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (Low) | 3 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Urea Nitrogen (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Aspartate Aminotransferase (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Monocytes/Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (Low) | 5 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils/Leukocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Creatinine (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Urea Nitrogen (High) | 3 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Bilirubin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes/Leukocytes (High) | 3 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alkaline Phosphatase (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alkaline Phosphatase (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (Low) | 2 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Urea Nitrogen (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Monocytes/Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Creatinine (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Hemoglobin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Bilirubin (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (Low) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (Low) | 8 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes/Leukocytes (High) | 3 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Erythrocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Alanine Aminotransferase (High) | 3 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Platelets (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Neutrophils/Leukocytes (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Leukocytes (Low) | 1 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils/Leukocytes (High) | 1 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Aspartate Aminotransferase (High) | 2 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Eosinophils (High) | 0 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination | Lymphocytes (High) | 1 Participants |
Primary
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
Time frame: From Day 1 up to Day 180 (including Day 180)
Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study | 2 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study | 2 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study | 9 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study | 2 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study | 5 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study | 6 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study | 4 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Time frame: From Day 1 up to Day 180 (including Day 180)
Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study | 0 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study | 2 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study | 0 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Time frame: From Day 1 to Day 7 (including Day 7)
Population: Analysis was performed on the Safety set who received 1 dose of investigational product. Only participants in the Safety Set with at least one day of eDiary entry within each dose group and at each level of summarization were included in this analysis; one participant in the 25 μg group did not complete the eDiary and was excluded from the summary.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Redness | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Overall | 5 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Lymphadenopathy | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Injection site pain | 5 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Swelling | 1 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Redness | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Injection site pain | 9 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Swelling | 1 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Overall | 9 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Lymphadenopathy | 2 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Lymphadenopathy | 4 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Injection site pain | 14 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Overall | 16 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Redness | 1 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Swelling | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Redness | 2 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Overall | 19 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Injection site pain | 19 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Swelling | 1 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Lymphadenopathy | 2 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Swelling | 3 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Injection site pain | 15 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Lymphadenopathy | 5 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Overall | 16 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Redness | 2 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Redness | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Injection site pain | 19 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Lymphadenopathy | 4 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Swelling | 1 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Overall | 19 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Overall | 22 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Lymphadenopathy | 6 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Swelling | 6 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Redness | 9 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination | Injection site pain | 22 Participants |
Primary
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.
Time frame: From Day 1 to Day 7 (including Day 7)
Population: Analysis was performed on the Safety set who received 1 dose of investigational product. Only participants in the Safety Set with at least one day of eDiary entry within each dose group and at each level of summarization were included in this analysis; one participant in the 25 μg group did not complete the eDiary and was excluded from the summary.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fatigue | 1 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Overall | 4 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Chills | 1 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fever | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Arthralgia | 0 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Headache | 3 Participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Myalgia | 2 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Overall | 4 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fever | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Arthralgia | 1 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Myalgia | 3 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fatigue | 0 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Headache | 4 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Chills | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Headache | 5 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Chills | 3 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fever | 0 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Overall | 11 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Arthralgia | 2 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fatigue | 5 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Myalgia | 8 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fatigue | 14 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Overall | 17 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fever | 0 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Headache | 9 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Myalgia | 10 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Arthralgia | 5 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Chills | 5 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Chills | 3 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Overall | 15 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fatigue | 10 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Headache | 9 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fever | 2 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Arthralgia | 3 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Myalgia | 10 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Chills | 11 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Overall | 18 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fever | 3 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Myalgia | 16 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Arthralgia | 6 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fatigue | 15 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Headache | 13 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fatigue | 14 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Myalgia | 17 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Fever | 2 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Arthralgia | 3 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Overall | 21 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Chills | 11 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Solicited Systemic AE During 7 Days After Vaccination | Headache | 13 Participants |
Primary
Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
Time frame: From Day 1 to day 28 (including day 28)
Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination | 4 Participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination | 1 Participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination | 2 Participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination | 2 Participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination | 4 Participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination | 5 Participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination | 8 Participants |
Secondary
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Time frame: At Day 15, Day 29, Day 91, and Day 181
Population: The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 91 | 1.26 Fold increase | Standard Deviation 1.717 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 181 | 1.02 Fold increase | Standard Deviation 2.201 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 181 | 1.39 Fold increase | Standard Deviation 2.863 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 15 | 3.72 Fold increase | Standard Deviation 3.328 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 181 | 1.25 Fold increase | Standard Deviation 2.678 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 29 | 2.12 Fold increase | Standard Deviation 2.002 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 91 | 1.93 Fold increase | Standard Deviation 3.136 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 91 | 1.06 Fold increase | Standard Deviation 1.938 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 29 | 1.89 Fold increase | Standard Deviation 2.337 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 29 | 3.30 Fold increase | Standard Deviation 3.031 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 15 | 3.64 Fold increase | Standard Deviation 3.177 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 15 | 3.64 Fold increase | Standard Deviation 3.37 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 29 | 2.30 Fold increase | Standard Deviation 3.466 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 29 | 3.66 Fold increase | Standard Deviation 2.794 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 15 | 2.32 Fold increase | Standard Deviation 2.1 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 181 | 0.97 Fold increase | Standard Deviation 2.131 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 181 | 1.30 Fold increase | Standard Deviation 2.624 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Wild Type (WT), Day 15 | 2.14 Fold increase | Standard Deviation 2.5 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 91 | 1.81 Fold increase | Standard Deviation 2.668 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 91 | 2.37 Fold increase | Standard Deviation 2.675 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 29 | 4.27 Fold increase | Standard Deviation 5.859 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 91 | 4.64 Fold increase | Standard Deviation 7.041 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 15 | 5.31 Fold increase | Standard Deviation 5.736 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 181 | 3.81 Fold increase | Standard Deviation 6.801 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 29 | 2.48 Fold increase | Standard Deviation 2.934 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Wild Type (WT), Day 15 | 3.16 Fold increase | Standard Deviation 2.765 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 91 | 2.45 Fold increase | Standard Deviation 3.973 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 29 | 3.31 Fold increase | Standard Deviation 3.919 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 91 | 2.25 Fold increase | Standard Deviation 2.948 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 15 | 5.00 Fold increase | Standard Deviation 5.923 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 15 | 3.86 Fold increase | Standard Deviation 3.575 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 181 | 2.42 Fold increase | Standard Deviation 6.001 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 181 | 1.83 Fold increase | Standard Deviation 2.917 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 91 | 2.87 Fold increase | Standard Deviation 6.515 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 29 | 3.63 Fold increase | Standard Deviation 5.877 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 181 | 2.15 Fold increase | Standard Deviation 3.829 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 15 | 3.85 Fold increase | Standard Deviation 6.017 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 181 | 2.73 Fold increase | Standard Deviation 5.862 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 29 | 4.17 Fold increase | Standard Deviation 6.567 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 91 | 3.17 Fold increase | Standard Deviation 6.083 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 181 | 3.14 Fold increase | Standard Deviation 3.293 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Wild Type (WT), Day 15 | 4.10 Fold increase | Standard Deviation 2.687 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 29 | 3.47 Fold increase | Standard Deviation 2.557 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 91 | 3.28 Fold increase | Standard Deviation 2.709 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 181 | 1.82 Fold increase | Standard Deviation 3 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 15 | 8.64 Fold increase | Standard Deviation 3.575 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 29 | 7.71 Fold increase | Standard Deviation 3.348 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 91 | 5.31 Fold increase | Standard Deviation 3.18 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 181 | 3.40 Fold increase | Standard Deviation 3.165 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 15 | 9.50 Fold increase | Standard Deviation 3.567 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 29 | 8.16 Fold increase | Standard Deviation 3.503 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 91 | 4.52 Fold increase | Standard Deviation 3.098 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 181 | 2.57 Fold increase | Standard Deviation 4.061 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 15 | 6.94 Fold increase | Standard Deviation 3.677 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 29 | 5.64 Fold increase | Standard Deviation 3.458 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 91 | 3.78 Fold increase | Standard Deviation 3.451 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 15 | 5.50 Fold increase | Standard Deviation 3.041 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 29 | 5.16 Fold increase | Standard Deviation 2.783 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 91 | 3.26 Fold increase | Standard Deviation 2.973 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 181 | 2.16 Fold increase | Standard Deviation 3.188 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 91 | 6.88 Fold increase | Standard Deviation 3.823 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 91 | 5.27 Fold increase | Standard Deviation 2.817 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 91 | 8.94 Fold increase | Standard Deviation 3.448 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 181 | 4.16 Fold increase | Standard Deviation 2.728 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Wild Type (WT), Day 15 | 5.25 Fold increase | Standard Deviation 3.292 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 15 | 10.16 Fold increase | Standard Deviation 3.21 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 91 | 4.83 Fold increase | Standard Deviation 2.721 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 15 | 11.63 Fold increase | Standard Deviation 3.182 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 15 | 8.28 Fold increase | Standard Deviation 2.837 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 15 | 11.56 Fold increase | Standard Deviation 3.789 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 29 | 7.16 Fold increase | Standard Deviation 2.456 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 181 | 4.14 Fold increase | Standard Deviation 2.414 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 29 | 8.72 Fold increase | Standard Deviation 3.011 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 181 | 6.30 Fold increase | Standard Deviation 3.695 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 29 | 10.54 Fold increase | Standard Deviation 3.314 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 181 | 2.79 Fold increase | Standard Deviation 2.204 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 29 | 10.80 Fold increase | Standard Deviation 3.391 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 181 | 4.96 Fold increase | Standard Deviation 2.984 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 29 | 7.76 Fold increase | Standard Deviation 2.982 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 91 | 5.94 Fold increase | Standard Deviation 2.791 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 29 | 10.59 Fold increase | Standard Deviation 3.758 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 181 | 3.22 Fold increase | Standard Deviation 3.122 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 29 | 6.73 Fold increase | Standard Deviation 3.424 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 181 | 2.75 Fold increase | Standard Deviation 3.822 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 91 | 5.44 Fold increase | Standard Deviation 3.831 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 15 | 7.23 Fold increase | Standard Deviation 3.225 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 91 | 4.42 Fold increase | Standard Deviation 2.883 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 91 | 4.12 Fold increase | Standard Deviation 3.235 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 181 | 2.77 Fold increase | Standard Deviation 3.565 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 91 | 4.55 Fold increase | Standard Deviation 3.842 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 15 | 12.04 Fold increase | Standard Deviation 3.518 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 15 | 9.57 Fold increase | Standard Deviation 3.709 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 91 | 7.76 Fold increase | Standard Deviation 3.798 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Wild Type (WT), Day 15 | 4.89 Fold increase | Standard Deviation 3.329 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 29 | 8.99 Fold increase | Standard Deviation 3.658 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 15 | 10.51 Fold increase | Standard Deviation 3.586 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 29 | 7.20 Fold increase | Standard Deviation 3.118 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 29 | 11.12 Fold increase | Standard Deviation 3.793 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 181 | 1.86 Fold increase | Standard Deviation 2.586 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 181 | 1.96 Fold increase | Standard Deviation 3.087 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 15 | 9.77 Fold increase | Standard Deviation 4.246 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 29 | 8.00 Fold increase | Standard Deviation 5.258 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 29 | 11.05 Fold increase | Standard Deviation 3.888 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 91 | 4.76 Fold increase | Standard Deviation 4.024 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Wild Type (WT), Day 15 | 8.10 Fold increase | Standard Deviation 3.171 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 181 | 2.90 Fold increase | Standard Deviation 3.669 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 15 | 11.09 Fold increase | Standard Deviation 4.294 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 15 | 7.86 Fold increase | Standard Deviation 3.871 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 29 | 5.93 Fold increase | Standard Deviation 3.645 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 181 | 1.98 Fold increase | Standard Deviation 2.636 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 91 | 4.03 Fold increase | Standard Deviation 2.932 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 91 | 3.61 Fold increase | Standard Deviation 2.792 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 181 | 2.13 Fold increase | Standard Deviation 2.808 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 181 | 2.10 Fold increase | Standard Deviation 2.982 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 15 | 6.27 Fold increase | Standard Deviation 3.502 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 29 | 6.86 Fold increase | Standard Deviation 3.792 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 29 | 7.12 Fold increase | Standard Deviation 3.677 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 181 | 4.27 Fold increase | Standard Deviation 3.411 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 91 | 6.55 Fold increase | Standard Deviation 3.411 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 91 | 4.16 Fold increase | Standard Deviation 3.198 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 91 | 4.14 Fold increase | Standard Deviation 2.928 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 91 | 4.60 Fold increase | Standard Deviation 2.654 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 15 | 13.44 Fold increase | Standard Deviation 6.178 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 29 | 13.62 Fold increase | Standard Deviation 4.023 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 29 | 12.69 Fold increase | Standard Deviation 3.418 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 181 | 1.83 Fold increase | Standard Deviation 3.615 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 15 | 15.67 Fold increase | Standard Deviation 3.821 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 181 | 3.06 Fold increase | Standard Deviation 4.172 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 91 | 7.39 Fold increase | Standard Deviation 3.46 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 15 | 23.51 Fold increase | Standard Deviation 4.705 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 91 | 5.48 Fold increase | Standard Deviation 3.018 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Wild Type (WT), Day 15 | 13.31 Fold increase | Standard Deviation 4.397 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 91 | 4.41 Fold increase | Standard Deviation 3.02 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 181 | 4.38 Fold increase | Standard Deviation 4.698 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.5, Day 181 | 2.62 Fold increase | Standard Deviation 3.846 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.1, Day 29 | 20.89 Fold increase | Standard Deviation 4.123 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 15 | 18.44 Fold increase | Standard Deviation 5.067 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | WT, Day 29 | 11.74 Fold increase | Standard Deviation 3.453 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Omicron BA.2, Day 29 | 16.01 Fold increase | Standard Deviation 4.056 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point | Delta, Day 181 | 2.37 Fold increase | Standard Deviation 3.394 |
Secondary
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Time frame: At Day 1, Day 15, Day 29, Day 91, and Day 181
Population: The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 15 | 1584.4 Titers | Standard Deviation 2.84 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 29 | 3065.6 Titers | Standard Deviation 2.66 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 1 | 496.3 Titers | Standard Deviation 5.55 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 181 | 2662.1 Titers | Standard Deviation 2.42 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 29 | 1426.0 Titers | Standard Deviation 3.24 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 1 | 435.6 Titers | Standard Deviation 7.06 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 91 | 2207.8 Titers | Standard Deviation 2.56 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 181 | 928.1 Titers | Standard Deviation 4.27 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 91 | 1200.2 Titers | Standard Deviation 2.58 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 91 | 1024.5 Titers | Standard Deviation 2.63 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 1 | 399.6 Titers | Standard Deviation 8.15 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 15 | 2262.6 Titers | Standard Deviation 3.03 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 181 | 1568.7 Titers | Standard Deviation 2.96 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 29 | 1449.8 Titers | Standard Deviation 2.7 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 15 | 1336.7 Titers | Standard Deviation 2.87 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 91 | 2233.9 Titers | Standard Deviation 2.38 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 1 | 263.2 Titers | Standard Deviation 7.74 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 15 | 2357.5 Titers | Standard Deviation 2.88 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 181 | 1210.5 Titers | Standard Deviation 2.84 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 15 | 3478.1 Titers | Standard Deviation 2.67 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 29 | 1213.4 Titers | Standard Deviation 3.28 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 181 | 1525.3 Titers | Standard Deviation 3.56 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Wild Type (WT), Day 1 | 1311.5 Titers | Standard Deviation 5.36 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 91 | 1672.7 Titers | Standard Deviation 2.43 |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 29 | 2317.0 Titers | Standard Deviation 3.16 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 181 | 908.0 Titers | Standard Deviation 2.05 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 15 | 3663.7 Titers | Standard Deviation 2.04 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 29 | 2128.8 Titers | Standard Deviation 2.16 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 15 | 2643.6 Titers | Standard Deviation 2.14 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 91 | 2536.0 Titers | Standard Deviation 3.11 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Wild Type (WT), Day 1 | 1154.5 Titers | Standard Deviation 3.01 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 1 | 497.7 Titers | Standard Deviation 4.14 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 181 | 1064.9 Titers | Standard Deviation 2.99 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 29 | 2865.2 Titers | Standard Deviation 2.59 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 29 | 1364.1 Titers | Standard Deviation 1.97 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 91 | 1212.4 Titers | Standard Deviation 3.33 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 29 | 1641.1 Titers | Standard Deviation 2.74 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 91 | 2606.6 Titers | Standard Deviation 2.43 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 15 | 1907.8 Titers | Standard Deviation 2.38 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 1 | 494.9 Titers | Standard Deviation 3.73 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 181 | 2105.0 Titers | Standard Deviation 2.39 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 181 | 2070.4 Titers | Standard Deviation 2.78 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 29 | 2270.5 Titers | Standard Deviation 2.62 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 91 | 1072.0 Titers | Standard Deviation 2.21 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 1 | 545.1 Titers | Standard Deviation 4.46 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 15 | 1442.8 Titers | Standard Deviation 2.04 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 1 | 374.9 Titers | Standard Deviation 5.04 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 15 | 2723.1 Titers | Standard Deviation 2.28 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 181 | 1359.2 Titers | Standard Deviation 2.45 |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 91 | 1580.6 Titers | Standard Deviation 2.49 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 91 | 2020.3 Titers | Standard Deviation 3.87 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Wild Type (WT), Day 1 | 1678.3 Titers | Standard Deviation 3.81 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 15 | 7344.4 Titers | Standard Deviation 2.22 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 29 | 6188.1 Titers | Standard Deviation 2.25 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 91 | 5793.7 Titers | Standard Deviation 2.76 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 181 | 3138.8 Titers | Standard Deviation 2.68 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 1 | 500.0 Titers | Standard Deviation 4.83 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 15 | 4770.9 Titers | Standard Deviation 3.28 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 29 | 4263.8 Titers | Standard Deviation 3.37 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 91 | 2864.4 Titers | Standard Deviation 3.58 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 1 | 503.5 Titers | Standard Deviation 5.36 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 15 | 5348.4 Titers | Standard Deviation 3.24 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 29 | 4590.7 Titers | Standard Deviation 3.15 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 91 | 2430.5 Titers | Standard Deviation 3.25 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 181 | 1362.4 Titers | Standard Deviation 4.18 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 1 | 254.4 Titers | Standard Deviation 6.17 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 15 | 1985.9 Titers | Standard Deviation 3.05 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 29 | 1613.8 Titers | Standard Deviation 3.47 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 91 | 1027.9 Titers | Standard Deviation 4.06 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 181 | 822.1 Titers | Standard Deviation 4.54 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 1 | 587.7 Titers | Standard Deviation 4.46 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 15 | 3478.6 Titers | Standard Deviation 2.59 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 29 | 3253.1 Titers | Standard Deviation 2.75 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 181 | 1300.1 Titers | Standard Deviation 3.16 |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 181 | 1832.4 Titers | Standard Deviation 3.63 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Wild Type (WT), Day 1 | 884.4 Titers | Standard Deviation 3.67 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 181 | 383.7 Titers | Standard Deviation 4.74 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 1 | 100.0 Titers | Standard Deviation 5.24 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 91 | 3917.9 Titers | Standard Deviation 2.55 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 15 | 2383.0 Titers | Standard Deviation 2.77 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 181 | 1004.8 Titers | Standard Deviation 4.54 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 1 | 249.4 Titers | Standard Deviation 3.78 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 1 | 188.7 Titers | Standard Deviation 5.86 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 15 | 4651.9 Titers | Standard Deviation 2.44 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 15 | 1017.1 Titers | Standard Deviation 3.13 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 15 | 2180.5 Titers | Standard Deviation 3.27 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 181 | 896.5 Titers | Standard Deviation 2.93 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 1 | 205.4 Titers | Standard Deviation 5.13 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 181 | 903.8 Titers | Standard Deviation 3.81 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 29 | 832.2 Titers | Standard Deviation 3.01 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 181 | 2088.1 Titers | Standard Deviation 3.33 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 91 | 1619.9 Titers | Standard Deviation 3.6 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 91 | 1249.9 Titers | Standard Deviation 2.94 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 29 | 5869.7 Titers | Standard Deviation 2.64 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 29 | 2134.2 Titers | Standard Deviation 2.84 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 29 | 1876.5 Titers | Standard Deviation 3.48 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 91 | 618.5 Titers | Standard Deviation 3.37 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 15 | 2066.0 Titers | Standard Deviation 2.28 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 91 | 1399.4 Titers | Standard Deviation 3.06 |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 29 | 1865.1 Titers | Standard Deviation 2.49 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 29 | 12148.6 Titers | Standard Deviation 2.42 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 15 | 4606.8 Titers | Standard Deviation 2.32 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 181 | 957.2 Titers | Standard Deviation 3.49 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 91 | 2931.6 Titers | Standard Deviation 3.16 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 29 | 3810.1 Titers | Standard Deviation 2.33 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 181 | 1482.6 Titers | Standard Deviation 2.2 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 1 | 591.6 Titers | Standard Deviation 3.53 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 1 | 513.1 Titers | Standard Deviation 5.14 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 91 | 8607.5 Titers | Standard Deviation 2.42 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Wild Type (WT), Day 1 | 1752.1 Titers | Standard Deviation 3.25 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 15 | 4997.7 Titers | Standard Deviation 2.76 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 181 | 1801.2 Titers | Standard Deviation 2.74 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 91 | 3244.6 Titers | Standard Deviation 3.7 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 29 | 5148.6 Titers | Standard Deviation 3.02 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 15 | 5587.0 Titers | Standard Deviation 2.89 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 1 | 276.8 Titers | Standard Deviation 5.69 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 181 | 1647.4 Titers | Standard Deviation 2.59 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 1 | 410.2 Titers | Standard Deviation 4.91 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 15 | 2756.7 Titers | Standard Deviation 3.26 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 15 | 9679.4 Titers | Standard Deviation 2.19 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 91 | 2627.1 Titers | Standard Deviation 2.72 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 29 | 2304.2 Titers | Standard Deviation 3.27 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 29 | 4395.3 Titers | Standard Deviation 2.54 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 91 | 1341.2 Titers | Standard Deviation 3.93 |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 181 | 4413.8 Titers | Standard Deviation 1.98 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 181 | 1401.6 Titers | Standard Deviation 3.35 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 15 | 5046.6 Titers | Standard Deviation 2.01 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 29 | 3364.4 Titers | Standard Deviation 2.55 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 15 | 4767.7 Titers | Standard Deviation 2.05 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 181 | 841.7 Titers | Standard Deviation 2.93 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 91 | 1723.1 Titers | Standard Deviation 2.68 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 181 | 1151.5 Titers | Standard Deviation 3.23 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 1 | 366.8 Titers | Standard Deviation 5.77 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 1 | 253.6 Titers | Standard Deviation 5.89 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 15 | 2354.2 Titers | Standard Deviation 2.79 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 29 | 1532.3 Titers | Standard Deviation 2.91 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 181 | 2126.5 Titers | Standard Deviation 2.64 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Wild Type (WT), Day 1 | 1248.6 Titers | Standard Deviation 4.14 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 91 | 1002.9 Titers | Standard Deviation 3.58 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 181 | 483.9 Titers | Standard Deviation 4.56 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 91 | 4050.6 Titers | Standard Deviation 2.41 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 1 | 474.0 Titers | Standard Deviation 5.12 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 15 | 3455.8 Titers | Standard Deviation 2.24 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 29 | 8356.7 Titers | Standard Deviation 2.36 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 29 | 3295.5 Titers | Standard Deviation 2.36 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 91 | 1685.9 Titers | Standard Deviation 2.87 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 15 | 11321.4 Titers | Standard Deviation 2.01 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 91 | 2009.2 Titers | Standard Deviation 2.79 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 1 | 432.5 Titers | Standard Deviation 6.49 |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 29 | 3859.4 Titers | Standard Deviation 2.43 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 29 | 5906.9 Titers | Standard Deviation 2.66 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 91 | 1923.5 Titers | Standard Deviation 3.17 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 181 | 3018.1 Titers | Standard Deviation 3.28 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 15 | 20966.2 Titers | Standard Deviation 2.49 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 29 | 4310.4 Titers | Standard Deviation 3.37 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Wild Type (WT), Day 1 | 1556.0 Titers | Standard Deviation 4.83 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 1 | 527.6 Titers | Standard Deviation 5.47 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 91 | 2393.6 Titers | Standard Deviation 2.71 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 15 | 10237.9 Titers | Standard Deviation 2.73 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 15 | 5956.0 Titers | Standard Deviation 3.27 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 91 | 3410.5 Titers | Standard Deviation 2.8 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 1 | 381.9 Titers | Standard Deviation 5.21 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 29 | 7582.7 Titers | Standard Deviation 2.98 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 181 | 2040.9 Titers | Standard Deviation 4.05 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 15 | 7229.7 Titers | Standard Deviation 4.9 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.1, Day 1 | 445.8 Titers | Standard Deviation 5.2 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 181 | 1823.2 Titers | Standard Deviation 3.56 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 181 | 1277.6 Titers | Standard Deviation 3.37 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 15 | 9241.4 Titers | Standard Deviation 2.55 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 29 | 15717.3 Titers | Standard Deviation 2.62 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 91 | 3094.9 Titers | Standard Deviation 2.76 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Delta, Day 1 | 500.2 Titers | Standard Deviation 5.21 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | WT, Day 91 | 6861.6 Titers | Standard Deviation 2.71 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.5, Day 181 | 1108.4 Titers | Standard Deviation 4.33 |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint | Omicron BA.2, Day 29 | 7440.6 Titers | Standard Deviation 2.99 |
Secondary
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Seroresponse was defined as post-boost titers \>= 4 times pre-boost (baseline) titers for participants with titer \>= LLOQ at pre-vaccination and as post-booster titer \>= 4 times LLOQ for participants with titer \< LLOQ at pre vaccination.
Time frame: At day 29 (28 days after the booster dose)
Population: The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part B: CV0501 Dose Cohort 6 (3 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.2 | 30.8 Percentage of participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.1 | 38.5 Percentage of participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.5 | 38.5 Percentage of participants |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Ancestral WT | 15.4 Percentage of participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.2 | 28.6 Percentage of participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Ancestral WT | 21.4 Percentage of participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.5 | 28.6 Percentage of participants |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.1 | 21.4 Percentage of participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.1 | 74.1 Percentage of participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.2 | 77.8 Percentage of participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Ancestral WT | 33.3 Percentage of participants |
| Part A: CV0501 Dose Cohort 1 (12 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.5 | 48.1 Percentage of participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Ancestral WT | 69.2 Percentage of participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.1 | 65.4 Percentage of participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.5 | 73.1 Percentage of participants |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.2 | 73.1 Percentage of participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.5 | 73.1 Percentage of participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.2 | 73.1 Percentage of participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.1 | 84.6 Percentage of participants |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Ancestral WT | 69.2 Percentage of participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Ancestral WT | 50.0 Percentage of participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.1 | 76.9 Percentage of participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.2 | 61.5 Percentage of participants |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.5 | 50.0 Percentage of participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.2 | 90.5 Percentage of participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.5 | 81.0 Percentage of participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Ancestral WT | 76.2 Percentage of participants |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29 | Omicron BA.1 | 95.2 Percentage of participants |