Corona Virus Infection, Covid19, SARS-CoV Infection
Conditions
Keywords
SARS-CoV-2 Vaccine, Coronavirus Virus Diseases, RNA COVID 19, COVID 19 Vaccine Arcturus, self amplifying RNA vaccine
Brief summary
This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: As 2 doses (at two different dose levels), separated by 28 days or as 1 dose In adults 18 years of age and older
Detailed description
This is a multiregional, multicenter, Phase 2, randomized, observer-blind study designed to evaluate the safety, reactogenicity, and immunogenicity of the study vaccine in younger and older adult participants. Enrolled participants will be randomly assigned to receive either study vaccine ARCT-021 or placebo (sterile saline). Approximately 600 participants (300 each in younger \[18 to \<56 years of age in United States or 21 to \<56 years of age in Singapore\] and older \[≥56 years of age\] participants) will be enrolled (including at least 50% of participants in the older cohort ≥65 years of age). Participants will be stratified by age and then randomly assigned (3 ARCT-021:1 placebo) to receive 2 doses of study vaccine separated by 28 days. At 180 days after second study vaccination (Day 208), participants in Study Groups 1, 2, and 3 will be randomly assigned again to receive a single booster dose of study vaccine (randomly assigned as 1 ARCT-021:1 placebo). Study Group 4 will not be randomized but will receive 1 dose of placebo at Day 208. Study Groups are summarized in Table 1. Study vaccine will be administered in an observer-blind fashion. Participants will be followed for safety and immunogenicity through 180 days after booster vaccination (Day 388). At a subset of clinical sites, all enrolled participants will also undergo blood sampling for evaluation of CMI responses. Vaccine doses will be assigned as follows: Younger Age Cohort: Study Group 1: n= 75 participants, ARCT-021 7.5 µg (first dose), Placebo (second dose Study Group 2: n= 75 participants, ARCT-021 5.0 µg (first dose), 5.0 µg (second dose) Study Group 3: n= 75 participants, ARCT-021 7.5 µg (first dose), 7.5 µg (second dose) Study Group 4: n= 75 participants, Placebo (first dose), Placebo (second dose) Booster Vaccine: Study Groups 1, 2, 3: 113 participants, ARCT-021 5.0 µg or 7.5 µg, 112 participants, Placebo Study Group 4: n= 75 participants, Placebo Older Age Cohort: Study Group 1: n= 75 participants, ARCT-021 7.5 µg (first dose), Placebo (second dose Study Group 2: n= 75 participants, ARCT-021 5.0 µg (first dose), 5.0 µg (second dose) Study Group 3: n= 75 participants, ARCT-021 7.5 µg (first dose), 7.5 µg (second dose) Study Group 4: n= 75 participants, Placebo (first dose), Placebo (second dose) Booster Vaccine: Study Groups 1, 2, 3: 113 participants, ARCT-021 5.0 µg or 7.5 µg, 112 participants, Placebo Study Group 4: n= 75 participants, Placebo A DSMB will be in place to independently review the safety data of participants. Pausing Rules are also utilized in this study to reduce risk to study participants. The expected duration of participation for an individual participant is approximately 14 months, inclusive of the Screening period.
Interventions
BIOLOGICALARCT-021 single dose priming
ARCT-021 higher dose (one dose) + placebo (one dose)
BIOLOGICALARCT-021 two lower dose priming
ARCT-021 lower dose (two doses, Day 0 and Day 28)
BIOLOGICALARCT-021 two higher dose priming
ARCT-021 higher dose (two doses, Day 0 and Day 28)
BIOLOGICALPlacebo (two doses), priming
Placebo (two doses, Day 0 and Day 28)
BIOLOGICALRandomized booster
ARCT-021 (single dose) OR placebo, booster
BIOLOGICALPlacebo booster
Placebo (single dose)
Sponsors
Arcturus Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer blind
Intervention model description
sequential assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Individuals who: 1. are able to provide consent 2. agree to comply with all study visits and procedures 3. are willing and able to adhere to study restrictions 4. are sexually active and willing to adhere to contraceptive requirements 5. are male or female ≥18 or (in Singapore) ≥21 years of age 6. are medically stable
Exclusion criteria
Individuals who: 1. have had SARS-CoV-2 infection or COVID-19 disease. 2. have had cancer except for cancers that were treated and that have low risk of returning 3. have chronic kidney disease 4. have some chronic lung diseases 5. have some heart conditions 6. have compromised immune systems 7. are obese 8. have sickle cell disease or some other blood disorders 9. are current smokers and/or use illegal drugs 10. have Type 2 diabetics 11. are immunocompromised, immunodeficient or have had a transplant 12. have autoimmune disease 13. have other severe or uncontrolled diseases or disease that may interfere with the interpretation of the study 14. have a positive test for hepatitis B or C or human immunodeficiency virus 15. have had a severe reaction to previous investigational vaccines 16. have a fever or are feeling sick close to the time of the first vaccination of the study 17. have positive drug test at screening 18. are pregnant 19. are breastfeeding 20. have a bleeding disorder 21. have previously received an investigational coronavirus vaccine (SARS-CoV(1) or MERS) or who plan to be in other COVID-19 studies 22. have recently been vaccinated with other vaccines 23. have recently received blood products 24. who work at one of the clinic sites participating in this study, work at Arcturus, who work at other companies that monitor the study or close family members to the sites, Arcturus, or partners involved in study monitoring 25. other restrictions may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | Baseline up to Day 236 | — |
| Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | Day 208 | GMFR is reported as a ratio to baseline (Day 0). |
| GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | Day 236 | GMFR is reported as a ratio to baseline (Day 0). |
| Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | Baseline up to Day 56 | — |
| Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | Baseline up to Day 208 | — |
| Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2) | Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module. |
| Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | For 7 days following each dose administration (Day 208 up to Day 215) | Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module. |
| Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2) | Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module. |
| Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | For 7 days post booster dose administration (Day 208 up to Day 215) | Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module. |
| Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | 28 days following each dose administration (Day 0 up to Day 28 for Vaccination 1 and Day 29 up to Day 56 for Vaccination 2) | An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module. |
| Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination | 28 days following each dose administration (Day 208 up to 236 days) | An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module. |
| Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Up to Day 207 | SAEs were defined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as any AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module. |
| Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Day 208 to early termination (up to 396 days) | SAEs were defined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as an AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module. |
| Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination | Day 1 | — |
| GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination | Day 56 | — |
| GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | Day 208 | — |
| Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination | Day 56 | GMFR is reported as a ratio to baseline (Day 0). |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Day 208 and 236 |
| Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Day 56 |
| Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Day 56 |
| Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Days 0 and 56 |
Countries
Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment A Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208. | 145 |
| Treatment B Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208. | 144 |
| Treatment C Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208. | 145 |
| Treatment D Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208. | 146 |
| Total | 580 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 14 | 12 | 8 | 5 |
| Overall Study | Other than specified | 3 | 0 | 1 | 0 |
| Overall Study | Participant unblinded between Day 98 and 198 | 6 | 5 | 4 | 91 |
| Overall Study | Physician Decision | 1 | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 18 | 23 | 12 | 20 |
| Overall Study | Study Terminated by Sponsor | 59 | 59 | 71 | 1 |
| Overall Study | Vaccine not Administered | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 45 | 46 | 46 | 27 |
Baseline characteristics
| Characteristic | Treatment C | Treatment D | Total | Treatment B | Treatment A |
|---|---|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 17.08 | 48.2 years STANDARD_DEVIATION 15.59 | 48.8 years STANDARD_DEVIATION 15.99 | 49.9 years STANDARD_DEVIATION 15.16 | 48.9 years STANDARD_DEVIATION 16.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 12 Participants | 70 Participants | 22 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 134 Participants | 509 Participants | 121 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 23 Participants | 93 Participants | 23 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 15 Participants | 34 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 7 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 14 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 109 Participants | 105 Participants | 429 Participants | 107 Participants | 108 Participants |
| Sex: Female, Male Female | 60 Participants | 65 Participants | 266 Participants | 71 Participants | 70 Participants |
| Sex: Female, Male Male | 85 Participants | 81 Participants | 314 Participants | 73 Participants | 75 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 | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 145 | 0 / 144 | 0 / 145 | 0 / 146 | 0 / 44 | 0 / 41 | 0 / 42 | 0 / 99 | 0 / 142 | 0 / 142 | 0 / 144 | 0 / 146 | 0 / 43 | 0 / 38 | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 49 / 145 | 15 / 144 | 27 / 145 | 11 / 146 | 10 / 44 | 9 / 41 | 11 / 42 | 19 / 99 | 113 / 142 | 107 / 142 | 120 / 144 | 30 / 146 | 35 / 43 | 25 / 38 | 28 / 38 | 10 / 39 |
| serious Total, serious adverse events | 0 / 145 | 3 / 144 | 1 / 145 | 3 / 146 | 0 / 44 | 0 / 41 | 1 / 42 | 0 / 99 | 0 / 142 | 0 / 142 | 0 / 144 | 0 / 146 | 0 / 43 | 0 / 38 | 0 / 38 | 0 / 39 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination
GMFR is reported as a ratio to baseline (Day 0).
Time frame: Day 208
Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | 2.4 Ratio |
| Treatment B | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | 4.2 Ratio |
| Treatment C | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | 3.0 Ratio |
| Treatment D | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | 2.0 Ratio |
Primary
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination
GMFR is reported as a ratio to baseline (Day 0).
Time frame: Day 56
Population: mITT Analysis Set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination | 1.3 Ratio |
| Treatment B | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination | 2.7 Ratio |
| Treatment C | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination | 2.9 Ratio |
| Treatment D | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination | 0.9 Ratio |
Primary
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination
Time frame: Day 1
Population: Modified intent to treat (mITT) analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination | 4.40 IU/mL |
| Treatment B | Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination | 5.14 IU/mL |
| Treatment C | Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination | 5.31 IU/mL |
| Treatment D | Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination | 4.75 IU/mL |
Primary
GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination
GMFR is reported as a ratio to baseline (Day 0).
Time frame: Day 236
Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | 41.3 Ratio |
| Treatment B | GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | 100.8 Ratio |
| Treatment C | GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | 86.1 Ratio |
| Treatment D | GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination | 1.7 Ratio |
Primary
GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination
Time frame: Day 236
Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | 229.70 Titer |
| Treatment B | GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | 503.18 Titer |
| Treatment C | GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | 380.77 Titer |
| Treatment D | GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | 10.73 Titer |
Primary
GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination
Time frame: Day 208
Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | 13.37 Titer |
| Treatment B | GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | 20.71 Titer |
| Treatment C | GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | 14.04 Titer |
| Treatment D | GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination | 11.84 Titer |
Primary
GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination
Time frame: Day 56
Population: mITT Analysis Set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination | 5.47 Titer |
| Treatment B | GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination | 13.37 Titer |
| Treatment C | GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination | 15.31 Titer |
| Treatment D | GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination | 4.21 Titer |
Primary
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: For 7 days following each dose administration (Day 208 up to Day 215)
Population: The Booster Reactogenicity analysis set included all participants who received any dose of booster vaccination (ARCT-021, ARCT-145, ARCT-156 or placebo) and provided at least 1 diary entry for the time period evaluated. Participants were analyzed according to the vaccine actually received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable in specified categories only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Swelling (Hardness) | 11.6 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Erythema (Redness) | 9.3 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Pain | 51.2 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Injection Site Tenderness | 81.4 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Pain | 36.8 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Erythema (Redness) | 7.9 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Swelling (Hardness) | 5.3 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Injection Site Tenderness | 65.8 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Pain | 39.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Swelling (Hardness) | 7.9 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Erythema (Redness) | 7.9 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Injection Site Tenderness | 73.7 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Erythema (Redness) | 2.6 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Swelling (Hardness) | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Injection Site Tenderness | 12.8 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination | Pain | 5.1 percentage of participants |
Primary
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)
Population: The Reactogenicity analysis set included all participants who received any dose of priming study vaccine (ARCT-021 or placebo) and provided at least 1 reactogenicity diary report for the time period evaluated. Here, number analyzed signifies those participants who were evaluable in specified categories only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Pain | 7.9 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Swelling (Hardness) | 4.7 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Erythema (Redness) | 14.8 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Pain | 52.8 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Injection Site Tenderness | 79.6 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Erythema (Redness) | 7.1 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Swelling (Hardness) | 11.3 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Injection Site Tenderness | 15.0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Erythema (Redness) | 14.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Swelling (Hardness) | 11.5 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Pain | 48.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Injection Site Tenderness | 67.7 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Injection Site Tenderness | 75.4 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Erythema (Redness) | 19.7 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Pain | 33.1 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Swelling (Hardness) | 15.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Pain | 44.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Erythema (Redness) | 11.1 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Injection Site Tenderness | 83.3 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Erythema (Redness) | 8.0 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Pain | 57.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Swelling (Hardness) | 9.0 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Injection Site Tenderness | 75.2 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Swelling (Hardness) | 4.4 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Injection Site Tenderness | 15.6 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Pain | 8.2 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Erythema (Redness) | 7.5 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Swelling (Hardness) | 5.5 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Injection Site Tenderness | 19.9 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Pain | 5.9 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Erythema (Redness) | 8.9 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Swelling (Hardness) | 3.0 percentage of participants |
Primary
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: For 7 days post booster dose administration (Day 208 up to Day 215)
Population: The Booster Reactogenicity analysis set included all participants who received any dose of booster vaccination (ARCT-021, ARCT-145, ARCT-156 or placebo) and provided at least 1 diary entry for the time period evaluated. Participants were analyzed according to the vaccine actually received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable in specified categories only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Fever | 11.6 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Headache | 60.5 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Fatigue | 69.8 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Myalgia | 62.8 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Arthralgia | 48.8 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Nausea | 27.9 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Chills | 44.2 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Diarrhea | 25.6 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Dizziness | 32.6 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Vomiting | 7.0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Fatigue | 34.2 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Dizziness | 10.5 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Myalgia | 31.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Arthralgia | 21.1 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Nausea | 7.9 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Chills | 18.4 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Vomiting | 2.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Diarrhea | 18.4 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Fever | 0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Headache | 34.2 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Diarrhea | 10.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Chills | 21.1 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Vomiting | 0 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Fever | 5.3 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Myalgia | 42.1 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Nausea | 10.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Dizziness | 10.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Headache | 31.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Arthralgia | 31.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Fatigue | 50.0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Arthralgia | 12.8 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Diarrhea | 10.3 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Nausea | 2.6 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Vomiting | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Chills | 7.7 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Headache | 25.6 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Fatigue | 25.6 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Myalgia | 12.8 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Fever | 2.6 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination | Dizziness | 2.6 percentage of participants |
Primary
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)
Population: The Reactogenicity analysis set included all participants who received any dose of priming study vaccine (ARCT-021 or placebo) and provided at least 1 reactogenicity diary report for the time period evaluated. Here, number analyzed signifies those participants who were evaluable in specified categories only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Headache | 43.0 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Arthralgia | 21.1 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Nausea | 5.5 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Myalgia | 6.3 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Diarrhea | 7.1 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Nausea | 10.6 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Arthralgia | 3.1 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Chills | 28.9 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Fever | 4.2 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Fatigue | 47.2 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Diarrhea | 12.0 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Fatigue | 14.2 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Fever | 0.8 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Chills | 2.4 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Dizziness | 7.7 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Dizziness | 7.1 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Myalgia | 44.4 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Headache | 12.6 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Vomiting | 1.4 percentage of participants |
| Treatment A | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Vomiting | 0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Vomiting | 0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Arthralgia | 16.9 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Headache | 30.0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Headache | 34.5 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Fatigue | 33.1 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Chills | 16.9 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Myalgia | 34.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Dizziness | 4.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Fatigue | 36.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Myalgia | 28.9 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Diarrhea | 10.0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Arthralgia | 15.5 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Fever | 3.1 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Nausea | 8.5 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Chills | 13.1 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Diarrhea | 12.7 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Fever | 2.1 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Dizziness | 9.9 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Vomiting | 0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Nausea | 6.9 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Myalgia | 39.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Nausea | 6.3 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Fever | 2.8 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Headache | 39.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Fatigue | 40.3 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Arthralgia | 17.4 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Chills | 22.9 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Diarrhea | 16.0 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Dizziness | 9.0 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Vomiting | 0 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Fever | 6.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Headache | 40.9 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Fatigue | 44.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Myalgia | 32.8 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Arthralgia | 24.1 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Nausea | 8.8 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Chills | 22.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Diarrhea | 10.9 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Dizziness | 17.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Vomiting | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Vomiting | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Dizziness | 8.9 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Dizziness | 6.7 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Nausea | 5.2 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Diarrhea | 9.6 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Chills | 2.1 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Fever | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Chills | 5.2 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Arthralgia | 8.2 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Myalgia | 8.2 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Nausea | 7.5 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Diarrhea | 12.6 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Fatigue | 20.5 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Fatigue | 21.5 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 1: Headache | 19.2 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Myalgia | 14.1 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Headache | 16.3 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Fever | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Vomiting | 0.7 percentage of participants |
| Treatment D | Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination | Vaccination 2: Arthralgia | 9.6 percentage of participants |
Primary
Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination
SAEs were defined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as an AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Day 208 to early termination (up to 396 days)
Population: Booster Safety Set included all participants who received at least 1 dose of booster study vaccine (ARCT-021, ARCT-154, ARCT-165, or placebo) or had safety data collected in the period following booster administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any SAEs | 0 percentage of participants |
| Treatment A | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any NOCDs | 2.3 percentage of participants |
| Treatment A | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any MAAEs | 11.4 percentage of participants |
| Treatment B | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any SAEs | 0 percentage of participants |
| Treatment B | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any NOCDs | 4.9 percentage of participants |
| Treatment B | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any MAAEs | 19.5 percentage of participants |
| Treatment C | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any MAAEs | 11.9 percentage of participants |
| Treatment C | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any SAEs | 2.4 percentage of participants |
| Treatment C | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any NOCDs | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any SAEs | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any NOCDs | 0 percentage of participants |
| Treatment D | Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination | Any MAAEs | 12.1 percentage of participants |
Primary
Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination
SAEs were defined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as any AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Up to Day 207
Population: Safety Set included all participants who received at least 1 dose of priming study vaccine (ARCT-021 or placebo). Participants were analyzed according to the vaccine received at the time of priming or booster vaccination. One participant who was randomized to group A received treatment dosing and schedule for group D due to a dosing error. This participant is included in group D for the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any NOCDs | 4.1 percentage of participants |
| Treatment A | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any SAEs | 0 percentage of participants |
| Treatment A | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any MAAEs | 16.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any SAEs | 2.1 percentage of participants |
| Treatment B | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any NOCDs | 7.6 percentage of participants |
| Treatment B | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any MAAEs | 20.8 percentage of participants |
| Treatment C | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any MAAEs | 18.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any SAEs | 0.7 percentage of participants |
| Treatment C | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any NOCDs | 2.8 percentage of participants |
| Treatment D | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any SAEs | 2.1 percentage of participants |
| Treatment D | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any NOCDs | 2.7 percentage of participants |
| Treatment D | Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination | Any MAAEs | 17.1 percentage of participants |
Primary
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination
An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: 28 days following each dose administration (Day 208 up to 236 days)
Population: Booster Safety Set included all participants who received at least 1 dose of booster study vaccine (ARCT-021, ARCT-154, ARCT-165, or placebo) or had safety data collected in the period following booster administration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination | 15.9 percentage of participants |
| Treatment B | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination | 14.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination | 11.9 percentage of participants |
| Treatment D | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination | 9.1 percentage of participants |
Primary
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination
An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: 28 days following each dose administration (Day 0 up to Day 28 for Vaccination 1 and Day 29 up to Day 56 for Vaccination 2)
Population: Safety Set included all participants who received at least 1 dose of priming study vaccine (ARCT-021 or placebo). Participants were analyzed according to the vaccine received at the time of priming or booster vaccination. One participant who was randomized to group A received treatment dosing and schedule for group D due to a dosing error. This participant is included in group D for the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | Vaccination 1 | 20.7 percentage of participants |
| Treatment A | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | Vaccination 2 | 19.1 percentage of participants |
| Treatment B | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | Vaccination 2 | 19.4 percentage of participants |
| Treatment B | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | Vaccination 1 | 22.2 percentage of participants |
| Treatment C | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | Vaccination 2 | 8.6 percentage of participants |
| Treatment C | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | Vaccination 1 | 17.9 percentage of participants |
| Treatment D | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | Vaccination 2 | 20.7 percentage of participants |
| Treatment D | Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination | Vaccination 1 | 19.2 percentage of participants |
Primary
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208
Time frame: Baseline up to Day 208
Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | >=2-fold Increase from Baseline | 53.7 percentage of participants |
| Treatment A | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | >=4-fold Increase from Baseline | 26.8 percentage of participants |
| Treatment B | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | >=4-fold Increase from Baseline | 25.7 percentage of participants |
| Treatment B | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | >=2-fold Increase from Baseline | 74.3 percentage of participants |
| Treatment C | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | >=2-fold Increase from Baseline | 48.6 percentage of participants |
| Treatment C | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | >=4-fold Increase from Baseline | 21.6 percentage of participants |
| Treatment D | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | >=2-fold Increase from Baseline | 53.1 percentage of participants |
| Treatment D | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208 | >=4-fold Increase from Baseline | 14.3 percentage of participants |
Primary
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236
Time frame: Baseline up to Day 236
Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | >=2-fold Increase from Baseline | 90.0 percentage of participants |
| Treatment A | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | >=4-fold Increase from Baseline | 85.0 percentage of participants |
| Treatment B | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | >=4-fold Increase from Baseline | 94.3 percentage of participants |
| Treatment B | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | >=2-fold Increase from Baseline | 97.1 percentage of participants |
| Treatment C | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | >=2-fold Increase from Baseline | 100 percentage of participants |
| Treatment C | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | >=4-fold Increase from Baseline | 100 percentage of participants |
| Treatment D | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | >=2-fold Increase from Baseline | 50.0 percentage of participants |
| Treatment D | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236 | >=4-fold Increase from Baseline | 8.8 percentage of participants |
Primary
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56
Time frame: Baseline up to Day 56
Population: mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | >=4-fold Increase from Baseline | 8.8 percentage of participants |
| Treatment A | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | >=2-fold Increase from Baseline | 15.8 percentage of participants |
| Treatment B | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | >=4-fold Increase from Baseline | 43.1 percentage of participants |
| Treatment B | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | >=2-fold Increase from Baseline | 59.5 percentage of participants |
| Treatment C | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | >=2-fold Increase from Baseline | 62.4 percentage of participants |
| Treatment C | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | >=4-fold Increase from Baseline | 42.7 percentage of participants |
| Treatment D | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | >=4-fold Increase from Baseline | 0.9 percentage of participants |
| Treatment D | Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56 | >=2-fold Increase from Baseline | 2.6 percentage of participants |
Secondary
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
Time frame: Day 208 and 236
Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only and number analyzed signifies those participants who were evaluable at specified time points only.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- N: Day 208 | 0.39 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti-N: Day 236 | 0.67 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- S1: Day 208 | 10.10 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- S1: Day 236 | 236.46 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- RBD: Day 208 | 10.29 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- RBD: Day 236 | 258.97 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- RBD: Day 236 | 715.15 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- S1: Day 236 | 488.81 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- N: Day 208 | 0.38 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- S1: Day 208 | 17.22 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti-N: Day 236 | 0.54 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- RBD: Day 208 | 17.31 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti-N: Day 236 | 0.73 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- S1: Day 208 | 13.36 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- S1: Day 236 | 441.16 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- RBD: Day 236 | 591.87 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- RBD: Day 208 | 12.81 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- N: Day 208 | 0.43 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- RBD: Day 208 | 8.81 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- RBD: Day 236 | 5.38 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti-N: Day 236 | 0.32 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- S1: Day 236 | 5.97 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- N: Day 208 | 0.40 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination | Anti- S1: Day 208 | 9.13 Binding antibody units/milliliters |
Secondary
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
Time frame: Days 0 and 56
Population: mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only and number analyzed signifies those participants who were evaluable at specified time points only.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-N: Day 0 | 0.27 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-N: Day 56 | 0.23 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-RBD: Day 0 | 0.63 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-RBD: Day 56 | 5.19 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-S1: Day 0 | 0.40 Binding antibody units/milliliters |
| Treatment A | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-S1: Day 56 | 7.61 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-S1: Day 56 | 25.91 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-RBD: Day 56 | 22.94 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-N: Day 0 | 0.26 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-RBD: Day 0 | 0.58 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-N: Day 56 | 0.22 Binding antibody units/milliliters |
| Treatment B | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-S1: Day 0 | 0.41 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-N: Day 56 | 0.27 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-RBD: Day 0 | 0.70 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-RBD: Day 56 | 35.71 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-S1: Day 56 | 41.36 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-S1: Day 0 | 0.53 Binding antibody units/milliliters |
| Treatment C | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-N: Day 0 | 0.29 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-S1: Day 0 | 0.35 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-S1: Day 56 | 0.34 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-N: Day 56 | 0.23 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-RBD: Day 56 | 0.55 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-N: Day 0 | 0.29 Binding antibody units/milliliters |
| Treatment D | Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination | Anti-RBD: Day 0 | 0.56 Binding antibody units/milliliters |
Secondary
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56
Time frame: Day 56
Population: mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Treatment A | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-RBD | 8.6 Ratio |
| Treatment A | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-S1 | 19.8 Ratio |
| Treatment A | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-N | 0.9 Ratio |
| Treatment B | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-N | 0.9 Ratio |
| Treatment B | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-S1 | 65.9 Ratio |
| Treatment B | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-RBD | 42.7 Ratio |
| Treatment C | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-RBD | 48.7 Ratio |
| Treatment C | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-N | 0.9 Ratio |
| Treatment C | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-S1 | 77.7 Ratio |
| Treatment D | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-N | 0.9 Ratio |
| Treatment D | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-S1 | 1.0 Ratio |
| Treatment D | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56 | Anti-RBD | 1.0 Ratio |
Secondary
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
Time frame: Day 56
Population: mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-N: >=2 Fold Increase From Baseline | 1.8 percentage of participants |
| Treatment A | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-N: >=4 Fold Increase From Baseline | 0 percentage of participants |
| Treatment A | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-RBD: >=2 Fold Increase From Baseline | 75.4 percentage of participants |
| Treatment A | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-RBD: >=4 Fold Increase From Baseline | 64.0 percentage of participants |
| Treatment A | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-S1: >=2 Fold Increase From Baseline | 90.4 percentage of participants |
| Treatment A | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-S1: >=4 Fold Increase From Baseline | 85.1 percentage of participants |
| Treatment B | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-S1: >=4 Fold Increase From Baseline | 96.5 percentage of participants |
| Treatment B | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-RBD: >=4 Fold Increase From Baseline | 92.2 percentage of participants |
| Treatment B | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-N: >=2 Fold Increase From Baseline | 2.6 percentage of participants |
| Treatment B | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-RBD: >=2 Fold Increase From Baseline | 96.5 percentage of participants |
| Treatment B | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-N: >=4 Fold Increase From Baseline | 1.7 percentage of participants |
| Treatment B | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-S1: >=2 Fold Increase From Baseline | 98.3 percentage of participants |
| Treatment C | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-N: >=4 Fold Increase From Baseline | 0.9 percentage of participants |
| Treatment C | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-RBD: >=2 Fold Increase From Baseline | 88.9 percentage of participants |
| Treatment C | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-RBD: >=4 Fold Increase From Baseline | 84.6 percentage of participants |
| Treatment C | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-S1: >=4 Fold Increase From Baseline | 92.3 percentage of participants |
| Treatment C | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-S1: >=2 Fold Increase From Baseline | 95.7 percentage of participants |
| Treatment C | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-N: >=2 Fold Increase From Baseline | 1.7 percentage of participants |
| Treatment D | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-S1: >=2 Fold Increase From Baseline | 5.2 percentage of participants |
| Treatment D | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-S1: >=4 Fold Increase From Baseline | 0.9 percentage of participants |
| Treatment D | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-N: >=4 Fold Increase From Baseline | 0 percentage of participants |
| Treatment D | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-RBD: >=4 Fold Increase From Baseline | 0.9 percentage of participants |
| Treatment D | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-N: >=2 Fold Increase From Baseline | 2.6 percentage of participants |
| Treatment D | Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels | Anti-RBD: >=2 Fold Increase From Baseline | 3.4 percentage of participants |