COVID-19
Conditions
Brief summary
The primary objectives of the study are: * To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose. * To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. The secondary objectives of the study are: * To describe binding antibody profile from Day 1 to Day 387 of each study intervention group. * To describe the neutralizing antibody profile from Day 91 to Day 387 of each study intervention group. * To describe the occurrence of virologically-confirmed coronavirus disease-2019 (COVID-19)-like illness and serologically-confirmed SARS-CoV-2 infection. * To evaluate the correlation/association between antibody responses to SARS-CoV-2 messenger RNA (mRNA) vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection.
Detailed description
The duration of each participant's participation in the study was approximately 365 days post-last injection: approximately 386 days duration for participants receiving 2 injections and approximately 365 days duration total for participants receiving a single injection.
Interventions
BIOLOGICALSARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 mRNA vaccine formulation 3
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
BIOLOGICALPlacebo (0.9% normal saline)
Pharmaceutical form: Liquid Route of administration: Intramuscular injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
In the FEC: blinding for vaccine group assignment (formulation) of participants, outcome assessors, Investigators, laboratory personnel, and Sponsor study staff. Only study site staff who prepare and administer the vaccine and were not involved with the safety evaluations were unblinded to vaccine group assignment. There was no blinding for injection schedule. The Sentinel Cohort was open-label (no blinding).
Intervention model description
This was a sequential group prevention study consisting of a sentinel cohort followed by the Full Enrollment Cohort. There were 3 dose levels (up to 25 participants 18-49 years of age for each dose level) in the Sentinel Cohort, which were done in an open-label fashion with stepwise safety evaluation for each dose level and each vaccination. All sentinel participants received 2 vaccinations, 21 days apart. For the Full Enrollment Cohort (FEC), which was done in a double-blind design participants were stratified into 2 groups based on age at enrollment: the younger adult age group (140 planned participants 18-49 years of age) and the older adult age group (168 planned participants greater than or equal to \[\>=\] 50 years of age). The FEC Cohort 1 (Groups 1 to 3) received a single injection of study intervention while participants in Cohort 2 (Groups 4 to 6) received 2 vaccinations (to be given 21 days apart).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged \>= 18 years on the day of inclusion. * A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: * Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile. OR * Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. A participant of childbearing potential must had a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the study intervention. * Informed Consent Form had been signed and dated. * Participant not eligible to receive, based on local guidance, or if eligible does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination until completion of the key timepoint of Day 43 of follow-up of this study.
Exclusion criteria
* History of COVID-19 disease or prior SARS-CoV-2 infection confirmed serologically. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. * Known liver disease or fatty liver. * Positive test for chronic active Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody from blood work collected at screening visit. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on Investigator's judgment. * Receipt of immunoglobulins, blood or blood-derived products in the past 3 months. * Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome coronavirus \[MERS-CoV\]). * Receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which might be received at least 2 weeks before and a minimum of 2 weeks after study vaccines. * Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw or planned use of such therapy 72 hours prior to study immunogenicity blood draws at Day 22 and Day 36. * Residence in a nursing home or long-term care facility. * Health care workers providing direct patient care for COVID-19 participants. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | Day 36 (post-vaccination) | Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10. |
| Number of Participants With Solicited Systemic Reactions | Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) | SR was an expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF & considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia & chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. |
| Number of Participants With Unsolicited Adverse Events | Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) | An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. |
| Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) | SAEs: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs: event for which ongoing monitoring & rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol. |
| Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups) | Laboratory tests: hemoglobin (male & female), above & below normal white blood cell, lymphocytes, neutrophils & eosinophils, platelet count, creatinine & blood urea nitrogen, hyponatremia & hypernatremia, hyperkalemia & hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test \[LFT\], bilirubin (normal LFT), prothrombin & partial thromboplastin time (seconds), Urine: protein, glucose & blood. US FDA Toxicity Grading Scale for Healthy Adults & Adolescent Volunteers was used for grading; Grade 1=mild, Grade 2=moderate & Grade 3=severe. In the data table, 'number analyzed'=participants with available data for each specified category & '0'=none of participants were available for assessment for specified Group. |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | Day 1 (pre-vaccination) | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | Day 22 (post-vaccination) | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | Day 36 (post-vaccination) | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. |
| Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | Day 1 (pre-vaccination) and Day 22 (post-vaccination) | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1. |
| Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | Day 1 (pre-vaccination) and Day 36 (post-vaccination) | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1. |
| Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | Day 22 (post-vaccination) | Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10. |
| Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | Day 1 (pre-vaccination) and Day 36 (post-vaccination) | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1. |
| Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | Day 1 (pre-vaccination) and Day 22 (post-vaccination) | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1. |
| Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) | AE: any untoward medical occurrence in clinical investigation participant administered medicinal product & which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis &/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, & any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. |
| Number of Participants With Solicited Injection Site Reactions | Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) | Solicited reaction (SR): expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, & swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) | GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in ELISA unit/mL (ELU/mL). Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
| Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) | Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
| Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) | Binding antibody titers were evaluated by ELISA. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
| Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
| Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 91/Day 1, Day 181/Day 1; Cohort 2: Day 112/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
| Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
| Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) | Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection. LLOQ of the neutralization assay was a titer of 10. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
| Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) | Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness. |
| Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2 | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) | Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection. |
| Number of Participants With Serologically-confirmed SARS-CoV-2 Infection | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) | Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure. |
Countries
Australia, Brazil, Honduras, United States
Participant flow
Recruitment details
The study was conducted at 17 active sites in 4 countries between 12 Mar 2021 and 27 Jun 2022. Study consisted of 2 cohorts: Sentinel Cohort and Full Enrollment Cohort (FEC). For analysis purpose, Baseline, safety and outcome measure data was planned to be collected, analyzed and reported for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Pre-assignment details
Participants (aged 18-49 years) in Sentinel Cohort received two vaccinations, 21 days apart. FEC participants were stratified into 2 age groups: younger adult group (18-49 years) and the older adult group (greater than or equal to \[\>=\] 50 years). FEC Cohort 1 participants received a single injection of study vaccine or placebo, while participants in Cohort 2 received two vaccinations (21 days apart). A total of 182 participants were enrolled, of which 180 were vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1. | 27 |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1. | 26 |
| Cohort 1: Placebo Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. | 13 |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. | 38 |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. | 54 |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. | 10 |
| Cohort 2: Placebo Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. | 14 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Sponsor | 8 | 22 | 9 | 26 | 24 | 11 | 25 | 26 | 11 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 1 | 1 | 1 | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Cohort 1: SARS-CoV-2 Vaccine Low Dose | Cohort 1: Placebo | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Cohort 2: Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.15 years STANDARD_DEVIATION 16.19 | 41.96 years STANDARD_DEVIATION 17.05 | 39.77 years STANDARD_DEVIATION 14.96 | 36.21 years STANDARD_DEVIATION 13 | 34.96 years STANDARD_DEVIATION 13.22 | 31.00 years STANDARD_DEVIATION 8.94 | 38.79 years STANDARD_DEVIATION 16.24 | 38.01 years STANDARD_DEVIATION 14.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 5 Participants | 3 Participants | 12 Participants | 7 Participants | 10 Participants | 3 Participants | 45 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 8 Participants | 0 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 22 Participants | 18 Participants | 10 Participants | 24 Participants | 34 Participants | 0 Participants | 5 Participants | 113 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 5 Participants | 18 Participants | 25 Participants | 3 Participants | 6 Participants | 77 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 8 Participants | 20 Participants | 29 Participants | 7 Participants | 8 Participants | 105 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 / 37 | 0 / 34 | 0 / 18 | 0 / 36 | 0 / 36 | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 31 / 37 | 30 / 34 | 11 / 18 | 34 / 36 | 35 / 36 | 10 / 10 | 7 / 9 |
| serious Total, serious adverse events | 0 / 37 | 0 / 34 | 1 / 18 | 0 / 36 | 0 / 36 | 1 / 10 | 0 / 9 |
Outcome results
Primary
Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22
SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.
Time frame: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | 4.80 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | 5.93 ratio |
| Cohort 1: Group 3: Placebo | Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | 1.36 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | 7.05 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | 5.55 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | 13.6 ratio |
| Cohort 2: Placebo | Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | 1.32 ratio |
Primary
Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36
SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.
Time frame: Day 1 (pre-vaccination) and Day 36 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | 2.84 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | 6.03 ratio |
| Cohort 1: Group 3: Placebo | Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | 1.32 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | 34.9 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | 44.6 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | 83.1 ratio |
| Cohort 2: Placebo | Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | 1.20 ratio |
Primary
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1
GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Time frame: Day 1 (pre-vaccination)
Population: Analyzed on modified full analysis set (mFAS) population that included all participants who received at least one injection of study intervention, analyzed according to the intervention they actually received, and excludes participants with positive pseudovirus neutralization test results against SARS-CoV-2 D614G variant at Baseline (Day 1). Here, overall number of participants analyzed signifies participants with available data for this OM.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | 5.00 titer |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | 5.00 titer |
| Cohort 1: Group 3: Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | 5.00 titer |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | 5.00 titer |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | 5.00 titer |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | 5.00 titer |
| Cohort 2: Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | 5.00 titer |
Primary
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22
GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Time frame: Day 22 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | 24.0 titer |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | 29.7 titer |
| Cohort 1: Group 3: Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | 6.66 titer |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | 35.2 titer |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | 27.7 titer |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | 68.2 titer |
| Cohort 2: Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | 12.8 titer |
Primary
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36
GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Time frame: Day 36 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | 13.6 titer |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | 30.1 titer |
| Cohort 1: Group 3: Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | 6.48 titer |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | 174 titer |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | 223 titer |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | 416 titer |
| Cohort 2: Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | 11.6 titer |
Primary
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
AE: any untoward medical occurrence in clinical investigation participant administered medicinal product & which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis &/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, & any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.
Time frame: Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Population: SafAS: participants who received at least one injection of study vaccine were analyzed by the intervention they actually received. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post Any vaccination | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post Any vaccination | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post Any vaccination | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post Any vaccination | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post Any vaccination | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post Any vaccination | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post vaccination 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post Any vaccination | 0 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
SAEs: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs: event for which ongoing monitoring & rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol.
Time frame: From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)
Population: Analysis was performed on SafAS population. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | MAAEs | 6 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | AESI | 3 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | AESI | 3 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | MAAEs | 2 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | MAAEs | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | AESI | 2 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | MAAEs | 6 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | AESI | 3 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | MAAEs | 6 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | AESI | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | AESI | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | MAAEs | 3 Participants |
| Cohort 2: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | AESI | 1 Participants |
| Cohort 2: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs | 0 Participants |
| Cohort 2: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | MAAEs | 2 Participants |
Primary
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance
Laboratory tests: hemoglobin (male & female), above & below normal white blood cell, lymphocytes, neutrophils & eosinophils, platelet count, creatinine & blood urea nitrogen, hyponatremia & hypernatremia, hyperkalemia & hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test \[LFT\], bilirubin (normal LFT), prothrombin & partial thromboplastin time (seconds), Urine: protein, glucose & blood. US FDA Toxicity Grading Scale for Healthy Adults & Adolescent Volunteers was used for grading; Grade 1=mild, Grade 2=moderate & Grade 3=severe. In the data table, 'number analyzed'=participants with available data for each specified category & '0'=none of participants were available for assessment for specified Group.
Time frame: From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups)
Population: SafAS. Overall number of participants analyzed = participants with available data for this OM. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 2 | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 2 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 2 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 1 | 3 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 3 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 2 | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 1 | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 1 | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 3 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 2 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 3 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 1 | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 1 | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 1 | 5 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 3 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 2 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 1 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 1 | 3 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 3 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 2 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 1 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 1 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 1 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 1 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 1 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 1 | 2 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 1 | 2 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 1 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 1 | 2 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 2 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 3 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 1 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 3 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 2 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 1 | 3 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 3 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 1 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 1 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 2 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 1 | 3 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 2 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 2 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 2 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 2 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 1 | 3 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 2 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 1 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 1 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 2 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 1 | 4 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 1 | 6 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 1 | 3 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 1 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 3 | 1 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 1 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 3 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with any increase in LFT: Grade 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - glucose: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 1 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 1 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - protein: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Aspartate aminotransferase: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Below normal white blood cell: Grade 1 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alkaline phosphate: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 1 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Female): Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Bilirubin - with normal in LFT: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Alanine aminotransferase: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypokalemia: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Eosinophils: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Platelets Decreased: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Partial thromboplastin time: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Urine - blood: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypoproteinemia: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Prothrombin time: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hypernatremia: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hemoglobin (Male): Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperglycemia: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 2 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Above normal white blood cell: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyponatremia: Grade 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Hyperkalemia: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Lymphocytes Decreased: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Blood Urea Nitrogen: Grade 3 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Creatinine: Grade 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Absolute Neutrophils Decreased: Grade 3 | 0 Participants |
Primary
Number of Participants With Solicited Injection Site Reactions
Solicited reaction (SR): expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, & swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.
Time frame: Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Population: SafAS population. Here, overall number of participants analyzed = participants with available data for this outcome measure (OM). Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 28 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 1 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 28 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 28 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 2 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 28 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 5 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 5 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 4 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 29 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 4 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 2 | 28 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 33 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 3 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 3 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 6 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 4 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 5 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 3 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 2 | 32 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 32 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 4 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 33 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 5 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 2 | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Erythema Post-any vaccination | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 2 | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Swelling Post-vaccination 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Pain Post-vaccination 1 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Pain Post-any vaccination | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Swelling Post-any vaccination | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Injection Site Reactions | Erythema Post-vaccination 2 | 0 Participants |
Primary
Number of Participants With Solicited Systemic Reactions
SR was an expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF & considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia & chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.
Time frame: Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Population: SafAS population. Here, overall number of participants analyzed = participants with available data for this OM. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 17 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 5 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 1 | 14 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 17 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 20 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 21 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 20 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-any vaccination | 7 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 21 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-any vaccination | 14 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 5 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 1 | 7 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 8 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 1 | 17 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 8 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 23 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 21 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 21 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 17 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 17 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-any vaccination | 13 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 23 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 1 | 13 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-any vaccination | 17 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 6 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Chills Post-any vaccination | 4 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 5 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 5 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-any vaccination | 2 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 1 | 4 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 1 | 2 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 4 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 1 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 4 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 6 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 6 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 22 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 28 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 2 | 21 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 2 | 7 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 1 | 11 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 2 | 17 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 1 | 15 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-any vaccination | 20 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 2 | 17 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 22 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 26 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 28 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 2 | 22 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 25 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 9 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 23 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-any vaccination | 20 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 2 | 12 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 2 | 19 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-any vaccination | 29 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 1 | 23 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 2 | 25 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 16 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 11 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 24 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 31 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 27 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 2 | 27 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 31 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 28 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 2 | 28 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 28 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 1 | 18 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 25 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-any vaccination | 23 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 2 | 8 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 9 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 8 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 2 | 7 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 1 | 5 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 7 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 2 | 9 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 8 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 1 | 8 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-any vaccination | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Chills Post-any vaccination | 9 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 2 | 7 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 2 | 7 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 9 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 1 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 1 | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-any vaccination | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Malaise Post-vaccination 2 | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 2 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Fever Post-vaccination 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Arthralgia Post-vaccination 2 | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Myalgia Post-any vaccination | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Fever Post-any vaccination | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Headache Post-any vaccination | 5 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 2 | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 1 | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Myalgia Post-vaccination 2 | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Chills Post-vaccination 1 | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Chills Post-any vaccination | 1 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 2 | 3 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Malaise Post-any vaccination | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Solicited Systemic Reactions | Headache Post-vaccination 1 | 3 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.
Time frame: Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Population: Analyzed on SafAS population. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Unsolicited Adverse Events | Post vaccination 1 | 17 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Unsolicited Adverse Events | Post Any vaccination | 17 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Unsolicited Adverse Events | Post vaccination 1 | 4 Participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Unsolicited Adverse Events | Post Any vaccination | 4 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Unsolicited Adverse Events | Post vaccination 1 | 8 Participants |
| Cohort 1: Group 3: Placebo | Number of Participants With Unsolicited Adverse Events | Post Any vaccination | 8 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Unsolicited Adverse Events | Post vaccination 1 | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Unsolicited Adverse Events | Post Any vaccination | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Number of Participants With Unsolicited Adverse Events | Post vaccination 2 | 5 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Unsolicited Adverse Events | Post vaccination 2 | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Unsolicited Adverse Events | Post vaccination 1 | 10 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Number of Participants With Unsolicited Adverse Events | Post Any vaccination | 15 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Unsolicited Adverse Events | Post vaccination 2 | 2 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Unsolicited Adverse Events | Post vaccination 1 | 5 Participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Number of Participants With Unsolicited Adverse Events | Post Any vaccination | 5 Participants |
| Cohort 2: Placebo | Number of Participants With Unsolicited Adverse Events | Post Any vaccination | 3 Participants |
| Cohort 2: Placebo | Number of Participants With Unsolicited Adverse Events | Post vaccination 1 | 2 Participants |
| Cohort 2: Placebo | Number of Participants With Unsolicited Adverse Events | Post vaccination 2 | 1 Participants |
Primary
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22
Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10.
Time frame: Day 22 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | 77.4 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | 66.7 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | 6.7 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | 81.3 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | 74.2 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | 12.5 percentage of participants |
Primary
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36
Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10.
Time frame: Day 36 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | 58.3 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | 77.8 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | 8.3 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | 96.6 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | 12.5 percentage of participants |
Primary
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36
SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.
Time frame: Day 1 (pre-vaccination) and Day 36 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=2-fold rise | 58.3 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=4-fold rise | 45.8 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=2-fold rise | 77.8 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=4-fold rise | 66.7 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=2-fold rise | 8.3 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=4-fold rise | 8.3 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=2-fold rise | 96.6 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=4-fold rise | 96.6 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=4-fold rise | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=2-fold rise | 12.5 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | >=4-fold rise | 12.5 percentage of participants |
Primary
Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22
SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.
Time frame: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=2-fold rise | 77.4 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=4-fold rise | 58.1 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=2-fold rise | 66.7 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=4-fold rise | 58.3 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=2-fold rise | 6.7 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=4-fold rise | 6.7 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=2-fold rise | 81.3 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=4-fold rise | 71.9 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=2-fold rise | 74.2 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=4-fold rise | 54.8 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=4-fold rise | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=2-fold rise | 12.5 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | >=4-fold rise | 12.5 percentage of participants |
Secondary
Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2
Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.
Time frame: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Population: Data was not collected and analyzed for this OM (Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2) due to discontinuation of the development of the mRNA COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.
Secondary
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202
GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in ELISA unit/mL (ELU/mL). Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Time frame: Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in specified Groups for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 22 | 239 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 91 | 185 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 181 | 62.8 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 36 | 188 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 1 | 10.8 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 1 | 10.8 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 181 | 23251 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 22 | 372 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 36 | 310 ELU/mL |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 91 | 1122 ELU/mL |
| Cohort 1: Group 3: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 36 | 14.1 ELU/mL |
| Cohort 1: Group 3: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 1 | 9.45 ELU/mL |
| Cohort 1: Group 3: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 22 | 13.2 ELU/mL |
| Cohort 1: Group 3: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 91 | 31.2 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 1 | 10.1 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 22 | 448 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 36 | 3618 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 202 | 384 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 112 | 4548 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 112 | 1435 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 202 | 1209 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 36 | 4903 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 1 | 10.5 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 22 | 476 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 22 | 1618 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 36 | 10952 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 112 | 2782 ELU/mL |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 1 | 10.3 ELU/mL |
| Cohort 2: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 202 | 17316 ELU/mL |
| Cohort 2: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 1 | 14.4 ELU/mL |
| Cohort 2: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 22 | 34.5 ELU/mL |
| Cohort 2: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 112 | 96.3 ELU/mL |
| Cohort 2: Placebo | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | Day 36 | 34.4 ELU/mL |
Secondary
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202
Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Time frame: Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM and, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1 | 26.8 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1 | 22.5 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1 | 19.5 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 181/Day 1 | 6.65 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1 | 30.2 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 181/Day 1 | 2460 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1 | 36.7 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1 | 135 ratio |
| Cohort 1: Group 3: Placebo | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1 | 1.34 ratio |
| Cohort 1: Group 3: Placebo | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1 | 2.83 ratio |
| Cohort 1: Group 3: Placebo | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1 | 1.28 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1 | 40.6 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1 | 354 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1 | 481 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1 | 44.2 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1 | 101 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1 | 45.3 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1 | 466 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1 | 131 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1 | 1067 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1 | 158 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1 | 271 ratio |
| Cohort 2: Placebo | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1 | 5.40 ratio |
| Cohort 2: Placebo | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1 | 2.38 ratio |
| Cohort 2: Placebo | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1 | 2.39 ratio |
| Cohort 2: Placebo | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1 | 125 ratio |
Secondary
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202
SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 91/Day 1, Day 181/Day 1; Cohort 2: Day 112/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Time frame: Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1 | 3.17 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 181/Day 1 | 4.20 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 181/Day 1 | 599 ratio |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1 | 22.7 ratio |
| Cohort 1: Group 3: Placebo | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1 | 2.18 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1 | 64.4 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 202/Day 1 | 9.00 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 202/Day 1 | 24.1 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1 | 13.9 ratio |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1 | 35.3 ratio |
| Cohort 2: Placebo | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1 | 2.76 ratio |
Secondary
Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202
GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Time frame: Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 91 | 13.7 titers |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 181 | 21.0 titers |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 181 | 2993 titers |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 91 | 113 titers |
| Cohort 1: Group 3: Placebo | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 91 | 9.33 titers |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 112 | 322 titers |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 202 | 45.0 titers |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 112 | 69.5 titers |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 202 | 120 titers |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 112 | 177 titers |
| Cohort 2: Placebo | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 202 | 3490 titers |
| Cohort 2: Placebo | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | Day 112 | 23.1 titers |
Secondary
Number of Participants With Serologically-confirmed SARS-CoV-2 Infection
Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure.
Time frame: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Population: Data was not collected and analyzed for this OM (serologically confirmed SARS-CoV-2 infection) due to discontinuation of the development of the mRNA COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.
Secondary
Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness
Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness.
Time frame: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Population: Data was not collected and analyzed for this OM (virologically confirmed COVID-19 like illness) due to discontinuation of the development of the messenger ribonucleic acid (mRNA) COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.
Secondary
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens
Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection. LLOQ of the neutralization assay was a titer of 10. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Time frame: Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 91 | 71.4 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 181 | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 181 | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 91 | 71.4 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 91 | 25.0 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 112 | 93.3 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 202 | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 202 | 91.7 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 112 | 90.9 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 112 | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Day 112 | 40.0 percentage of participants |
Secondary
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202
Binding antibody titers were evaluated by ELISA. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Time frame: Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=4-fold rise | 90.3 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1: >=4-fold rise | 85.7 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=2-fold rise | 95.8 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 181/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1: >=2-fold rise | 85.7 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=4-fold rise | 87.5 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 181/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=4-fold rise | 86.4 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 181/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 181/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=4-fold rise | 88.9 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=4-fold rise | 6.7 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=2-fold rise | 8.3 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=2-fold rise | 6.7 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1: >=2-fold rise | 25.0 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=4-fold rise | 8.3 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 91/Day 1: >=4-fold rise | 25.0 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=2-fold rise | 93.8 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=4-fold rise | 90.6 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=2-fold rise | 96.9 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=4-fold rise | 93.8 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=4-fold rise | 22.2 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 22/Day 1: >=2-fold rise | 22.2 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=2-fold rise | 22.2 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 202/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 36/Day 1: >=4-fold rise | 22.2 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1: >=4-fold rise | 50.0 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Day 112/Day 1: >=2-fold rise | 50.0 percentage of participants |
Secondary
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202
SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Time frame: Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)
Population: Analyzed on mFAS population. Here, overall number of participants analyzed signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1: >=4-fold rise | 57.1 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 181/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1: >=2-fold rise | 71.4 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 181/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 181/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 181/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1: >=4-fold rise | 71.4 percentage of participants |
| Cohort 1: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1: >=2-fold rise | 71.4 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1: >=4-fold rise | 25.0 percentage of participants |
| Cohort 1: Group 3: Placebo | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 91/Day 1: >=2-fold rise | 25.0 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1: >=4-fold rise | 86.7 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 202/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 202/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1: >=2-fold rise | 93.3 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 202/Day 1: >=4-fold rise | 83.3 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1: >=2-fold rise | 90.9 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1: >=4-fold rise | 77.3 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Low Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 202/Day 1: >=2-fold rise | 91.7 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1: >=4-fold rise | 100 percentage of participants |
| Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1: >=2-fold rise | 100 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1: >=2-fold rise | 40.0 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | Day 112/Day 1: >=4-fold rise | 20.0 percentage of participants |