Corona Virus Infection, COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
SARS-CoV-2 Vaccine, Coronavirus Virus Diseases, RNA COVID-19, COVID-19 Vaccine Arcturus, Self Amplifying RNA Vaccine, Variants of Concern
Brief summary
This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.
Detailed description
The study will initially enroll approximately 72 adult participants into 2 cohorts (A and B). Cohort A is further sub-divided into two sub-cohorts which include 12 participants who are seronegative, not previously vaccinated at screening (Sub-cohort A1) and 24 participants who are seropositive, not previously vaccinated at screening (Sub-cohort A2). Within the first cohort (Cohort A), Sub-cohort A1 will include a total of 12 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Sub-cohort A2 will include a total of 24 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Study vaccines will be given as 2 doses separated by 28 days. The second cohort (Cohort B) will include a total of 36 adult participants ≥21 to ≤65 years of age who have been previously vaccinated (5 months or longer prior to study enrollment) with SARS-CoV-2 vaccine. Study vaccines will be given as single doses. Additional cohorts may increase the age range of participants up to 80 years of age.
Interventions
Sponsors
Arcturus Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer Blind
Intervention model description
The study will evaluate 3 investigational vaccines in parallel.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
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, female, or transgender ≥21 to ≤80 years of age 6. For the previously vaccinated groups only, received 2 doses of SARS-CoV-2 vaccine 5 months or longer prior to study enrollment
Exclusion criteria
Individuals who: 1. For the unvaccinated groups only, previously received any investigational or authorized MERS-CoV, SARS-CoV, and SARS-CoV-2 vaccines (including ARCT-021) 2. For the previously vaccinated groups only, previously received BNT162b2 but have not received 2 doses within at least 5 months prior to study enrollment 3. Are planning to receive other COVID-19 vaccines during the study period 4. Recently received other vaccines 5. Have a fever or are feeling sick close to the time of the first study vaccination 6. Have a known history of COVID-19 disease or asymptomatic SARS-CoV-2 infection 7. Are pregnant or breastfeeding 8. Have had a severe reaction to previous vaccines 9. Have a severe or uncontrolled disease(s) that may interfere with the interpretation of the study 10. Have some respiratory diseases 11. Have some significant heart diseases 12. Have some neurological conditions 13. Have sickle cell disease or some other blood disorders 14. Have had a major surgery within the past 6 months 15. Have a history of chronic liver disease 16. Have a history of autoimmune disease or immunodeficiency 17. Have received allergy injections, interferon, immunomodulators, cytotoxic drugs or other similar toxic drugs. 18. Have received blood products 19. Have a positive test for hepatitis B or C or human immunodeficiency virus 20. Have uncontrolled hypertension 21. Have had cancer except for cancers that were treated and that have low risk of returning 22. Are obese 23. Are Investigator site staff members, employees of Arcturus or the contract research organization (CRO) directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Up to Day 8 (7 days after first vaccine administration for Cohorts A1, A2 and B), and up to Day 36 (7 days after second vaccine administration for Cohorts A1 and A2) | Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Number of Participants Reporting Unsolicited AEs | Up to Day 29 (28 days after vaccine administration for Cohort B), and up to Day 57 (up to 28 days after each vaccine administration for Cohorts A1 and A2) | Unsolicited AEs were defined as any spontaneously reported or discovered AE. Data are reported for the number of participants with unsolicited AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days | An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) with a health care provider (HCP) (e.g., nurse, nurse practitioner, physician's assistant, physician), including visits to a study site for unscheduled assessments (e.g., rash assessment, abnormal laboratory follow up, coronavirus disease 2019 \[COVID-19\]) and visits to HCPs external to the study site (e.g., urgent care, primary care physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B | Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral D614G variant. Data are reported in international units per milliliter (IU/mL). |
| SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B | Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral B.1.351 (beta) variant. Data are reported in arbitrary units per milliliter (AU/mL). |
| SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B | Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral D614G variant. |
| SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B | Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral B.1.351 (beta) variant. |
| Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B | Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G variant. |
| Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B | Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral B.1.351 (beta) variant. |
| GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B | Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154. Data are reported for the ARCT-165 and ARCT-021 arms (vs ARCT-154 values). |
| GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Days 29, 57, 209, Final Visit (approx. Day 394) for Cohort A1, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B | Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-021 vs ARCT-165. Data are reported for the ARCT-021 arm (vs ARCT-165 values). |
| SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline and Day 57 for Cohorts A1 and A2, Baseline and Day 15 for Cohort B | Spike binding antibody levels expressed as GMCs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibodies for ancestral strain. |
| Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57 for Cohorts A1 and A2, Day 15 for Cohort B | Spike binding antibody levels expressed as GMFRs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibody levels expressed as GMFR for ancestral strain. |
| Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57 for Cohorts A1 and A2, Day 15 for Cohort B | Data are reported for ancestral, D614G, and B.1.351 variants for Spike binding antibodies and ancestral for RBD binding antibodies. |
Countries
Singapore, South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A1: ARCT-021 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain. | 4 |
| Cohort A1: ARCT-165 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant. | 4 |
| Cohort A1: ARCT-154 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation. | 4 |
| Cohort A2: ARCT-021 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain. | 6 |
| Cohort A2: ARCT-154 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation. | 18 |
| Cohort B: ARCT-021 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain. | 12 |
| Cohort B: ARCT-165 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant. | 12 |
| Cohort B: ARCT-154 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation. | 12 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort A1: ARCT-021 | Cohort A1: ARCT-165 | Cohort A1: ARCT-154 | Cohort A2: ARCT-021 | Cohort A2: ARCT-154 | Cohort B: ARCT-021 | Cohort B: ARCT-165 | Cohort B: ARCT-154 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 17 | 34 years STANDARD_DEVIATION 10 | 50 years STANDARD_DEVIATION 17 | 33 years STANDARD_DEVIATION 9 | 31 years STANDARD_DEVIATION 8 | 44 years STANDARD_DEVIATION 16 | 50 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 13 | 41 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 17 Participants | 10 Participants | 12 Participants | 12 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 5 Participants | 16 Participants | 1 Participants | 2 Participants | 0 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 9 Participants | 8 Participants | 10 Participants | 33 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 2 Participants | 4 Participants | 10 Participants | 9 Participants | 6 Participants | 7 Participants | 42 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 8 Participants | 3 Participants | 6 Participants | 5 Participants | 30 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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 6 | 0 / 18 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 3 / 4 | 3 / 4 | 2 / 4 | 4 / 6 | 15 / 18 | 9 / 12 | 9 / 12 | 10 / 12 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 4 | 1 / 6 | 0 / 18 | 1 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs
Spike binding antibody levels expressed as GMFRs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibody levels expressed as GMFR for ancestral strain.
Time frame: Day 57 for Cohorts A1 and A2, Day 15 for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (D614G) | 237 ratio |
| Cohort A1: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (Ancestral) | 231 ratio |
| Cohort A1: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; RBD (Ancestral) | 129 ratio |
| Cohort A1: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (B.1.351) | 136 ratio |
| Cohort A1: ARCT-165 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (D614G) | 667 ratio |
| Cohort A1: ARCT-165 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; RBD (Ancestral) | 286 ratio |
| Cohort A1: ARCT-165 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (Ancestral) | 807 ratio |
| Cohort A1: ARCT-165 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (B.1.351) | 1076 ratio |
| Cohort A1: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; RBD (Ancestral) | 110 ratio |
| Cohort A1: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (D614G) | 84 ratio |
| Cohort A1: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (B.1.351) | 32 ratio |
| Cohort A1: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (Ancestral) | 76 ratio |
| Cohort A2: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (B.1.351) | 4.0 ratio |
| Cohort A2: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; RBD (Ancestral) | 4.1 ratio |
| Cohort A2: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (Ancestral) | 4.1 ratio |
| Cohort A2: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (D614G) | 4.0 ratio |
| Cohort A2: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (D614G) | 4.1 ratio |
| Cohort A2: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (Ancestral) | 4.2 ratio |
| Cohort A2: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; RBD (Ancestral) | 4.9 ratio |
| Cohort A2: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 57; Spike (B.1.351) | 3.6 ratio |
| Cohort B: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (B.1.351) | 7 ratio |
| Cohort B: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; RBD (Ancestral) | 10 ratio |
| Cohort B: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (Ancestral) | 8 ratio |
| Cohort B: ARCT-021 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (D614G) | 8 ratio |
| Cohort B: ARCT-165 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (B.1.351) | 15 ratio |
| Cohort B: ARCT-165 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (Ancestral) | 13 ratio |
| Cohort B: ARCT-165 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (D614G) | 13 ratio |
| Cohort B: ARCT-165 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; RBD (Ancestral) | 19 ratio |
| Cohort B: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; RBD (Ancestral) | 21 ratio |
| Cohort B: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (D614G) | 14 ratio |
| Cohort B: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (Ancestral) | 14 ratio |
| Cohort B: ARCT-154 | Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs | Day 15; Spike (B.1.351) | 13 ratio |
Primary
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-021 vs ARCT-165. Data are reported for the ARCT-021 arm (vs ARCT-165 values).
Time frame: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohort A1, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Day 57 | 1.26 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | NA ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Day 57 | 0.48 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Day 209 | NA ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Day 209 | NA ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Final Visit Cohorts A1 and A2 (approx. Day 394) | NA ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Final Visit Cohorts A1 and A2 (approx. Day 394) | NA ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Day 209 | NA ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Day 29 | 1.45 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Day 57 | 0.12 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Day 29 | 0.54 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Day 29 | 4.00 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Day 209 | NA ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Day 29 | 3.16 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Final Visit Cohorts A1 and A2 (approx. Day 394) | NA ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Day 57 | 0.05 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Day 271 | 0.31 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Final Visit Cohort B (approx. Day 366) | 0.27 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Day 15 | 0.29 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Day 29 | 0.34 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Day 91 | 0.43 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Day 181 | 0.27 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Day 271 | 0.15 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Day 15 | 0.70 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral BA.1 Variant; Final Visit Cohort B (approx. Day 366) | 0.12 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Day 29 | 0.79 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Day 91 | 1.06 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Day 181 | 0.70 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Day 271 | 0.28 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 0.29 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Day 15 | 0.37 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Day 29 | 0.41 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Day 91 | 0.52 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Day 181 | 0.56 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Day 271 | 0.21 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.351; Final Visit Cohort B (approx. Day 366) | 0.14 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Day 15 | 0.63 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Day 29 | 0.70 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Day 91 | 0.68 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) | Pseudoviral B.1.617.2; Day 181 | 0.56 ratio |
Primary
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154. Data are reported for the ARCT-165 and ARCT-021 arms (vs ARCT-154 values).
Time frame: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Final Visit Cohorts A1 and A2 (approx. Day 394) | 3.69 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Final Visit Cohorts A1 and A2 (approx. Day 394) | 4.37 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 57 | 0.78 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 29 | 1.52 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 209 | 4.65 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Final Visit Cohorts A1 and A2 (approx. Day 394) | 2.18 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 209 | 3.26 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 4.20 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 57 | 1.78 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 29 | 1.03 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 29 | 2.45 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 209 | 8.15 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 209 | 6.77 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 57 | 0.60 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 29 | 1.38 ratio |
| Cohort A1: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 57 | 1.15 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 57 | 16.96 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 29 | 1.05 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 29 | 1.92 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 29 | 0.77 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 57 | 1.23 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 29 | 0.35 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 57 | 9.73 ratio |
| Cohort A1: ARCT-165 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 57 | 1.42 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 209 | 0.59 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 29 | 1.01 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 57 | 0.57 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 209 | 0.96 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 29 | 1.51 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 57 | 0.71 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 209 | 0.95 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Final Visit Cohorts A1 and A2 (approx. Day 394) | 1.77 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 29 | 1.17 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 57 | 0.92 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Final Visit Cohorts A1 and A2 (approx. Day 394) | 0.84 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 29 | 1.18 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 57 | 0.74 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 209 | 1.38 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Final Visit Cohorts A1 and A2 (approx. Day 394) | 1.91 ratio |
| Cohort A1: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 0.76 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 15 | 0.43 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 29 | 0.38 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 29 | 0.41 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 29 | 0.47 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 15 | 0.33 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 0.23 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 91 | 0.68 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 181 | 0.46 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 15 | 0.41 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 271 | 0.41 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 271 | 0.31 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Final Visit Cohort B (approx. Day 366) | 0.11 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Final Visit Cohort B (approx. Day 366) | 0.35 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 15 | 0.34 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 181 | 0.35 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 29 | 0.36 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 91 | 0.52 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 91 | 0.35 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 181 | 0.22 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 181 | 0.33 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 91 | 0.41 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 271 | 0.20 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 271 | 0.16 ratio |
| Cohort A2: ARCT-021 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Final Visit Cohort B (approx. Day 366) | 0.14 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 91 | 0.78 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 15 | 0.69 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 271 | 0.73 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 15 | 0.87 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Final Visit Cohort B (approx. Day 366) | 0.87 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 181 | 0.59 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 29 | 0.66 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 29 | 1.06 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 0.78 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 91 | 0.50 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Day 29 | 0.91 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 91 | 0.61 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 15 | 0.58 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 181 | 0.82 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 271 | 1.10 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 271 | 1.27 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 91 | 0.82 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Day 271 | 1.30 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.351; Final Visit Cohort B (approx. Day 366) | 0.97 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 181 | 0.82 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral BA.1 Variant; Day 15 | 1.18 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 29 | 0.52 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral D614G; Day 181 | 0.50 ratio |
| Cohort A2: ARCT-154 | GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) | Pseudoviral B.1.617.2; Final Visit Cohort B (approx. Day 366) | 1.30 ratio |
Primary
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels
Data are reported for ancestral, D614G, and B.1.351 variants for Spike binding antibodies and ancestral for RBD binding antibodies.
Time frame: Day 57 for Cohorts A1 and A2, Day 15 for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed =participants evaluable for endpoint. Number analyzed =participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; RBD (Ancestral) | 4 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (Ancestral) | 4 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (D614G) | 4 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (B.1.351) | 4 Participants |
| Cohort A1: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (B.1.351) | 2 Participants |
| Cohort A1: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (D614G) | 2 Participants |
| Cohort A1: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (Ancestral) | 2 Participants |
| Cohort A1: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; RBD (Ancestral) | 2 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (B.1.351) | 4 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (Ancestral) | 4 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; RBD (Ancestral) | 4 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (D614G) | 4 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (B.1.351) | 3 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (D614G) | 3 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (Ancestral) | 3 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; RBD (Ancestral) | 3 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; RBD (Ancestral) | 9 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (Ancestral) | 8 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (D614G) | 8 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 57; Spike (B.1.351) | 6 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (B.1.351) | 9 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; RBD (Ancestral) | 11 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (Ancestral) | 9 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (D614G) | 9 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (B.1.351) | 11 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; RBD (Ancestral) | 11 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (D614G) | 11 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (Ancestral) | 10 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (B.1.351) | 10 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (Ancestral) | 10 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; Spike (D614G) | 10 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels | Day 15; RBD (Ancestral) | 10 Participants |
Primary
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral B.1.351 (beta) variant.
Time frame: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 57 | 1 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 29 | 0 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394) | 2 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 209 | 2 Participants |
| Cohort A1: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 29 | 1 Participants |
| Cohort A1: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 57 | 2 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394) | 0 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 29 | 0 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 57 | 1 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 209 | 0 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394) | 1 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 29 | 3 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 57 | 3 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 209 | 1 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394) | 1 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 57 | 9 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 209 | 5 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 29 | 9 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 91 | 9 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 271 | 2 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 3 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 29 | 11 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 181 | 4 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 15 | 11 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 181 | 8 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 4 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 91 | 10 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 29 | 11 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 271 | 5 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 15 | 11 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 181 | 8 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 29 | 11 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 91 | 12 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 15 | 10 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Day 271 | 9 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 7 Participants |
Primary
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G variant.
Time frame: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 29 | 1 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 2 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 209 | 2 Participants |
| Cohort A1: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 57 | 2 Participants |
| Cohort A1: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 57 | 1 Participants |
| Cohort A1: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 29 | 0 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 29 | 2 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 0 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 209 | 0 Participants |
| Cohort A1: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 57 | 2 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 57 | 4 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 209 | 1 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 29 | 3 Participants |
| Cohort A2: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 1 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 209 | 5 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 57 | 11 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 29 | 10 Participants |
| Cohort A2: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 1 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 3 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 91 | 10 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 181 | 5 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 29 | 11 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 15 | 11 Participants |
| Cohort B: ARCT-021 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 271 | 3 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 271 | 6 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 5 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 29 | 11 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 91 | 10 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 181 | 8 Participants |
| Cohort B: ARCT-165 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 15 | 11 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 181 | 9 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 15 | 10 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 91 | 12 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 29 | 11 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Day 271 | 8 Participants |
| Cohort B: ARCT-154 | Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 6 Participants |
Primary
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs)
An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) with a health care provider (HCP) (e.g., nurse, nurse practitioner, physician's assistant, physician), including visits to a study site for unscheduled assessments (e.g., rash assessment, abnormal laboratory follow up, coronavirus disease 2019 \[COVID-19\]) and visits to HCPs external to the study site (e.g., urgent care, primary care physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days
Population: Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Cohort A1: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal | 0 Participants |
| Cohort A1: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any MAAEs | 0 Participants |
| Cohort A1: ARCT-165 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Cohort A1: ARCT-165 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any MAAEs | 1 Participants |
| Cohort A1: ARCT-165 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal | 0 Participants |
| Cohort A1: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal | 0 Participants |
| Cohort A1: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any MAAEs | 0 Participants |
| Cohort A1: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Cohort A2: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| Cohort A2: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any MAAEs | 1 Participants |
| Cohort A2: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal | 0 Participants |
| Cohort A2: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any MAAEs | 3 Participants |
| Cohort A2: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Cohort A2: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal | 0 Participants |
| Cohort B: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| Cohort B: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal | 0 Participants |
| Cohort B: ARCT-021 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any MAAEs | 2 Participants |
| Cohort B: ARCT-165 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal | 0 Participants |
| Cohort B: ARCT-165 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Cohort B: ARCT-165 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any MAAEs | 1 Participants |
| Cohort B: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Cohort B: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal | 0 Participants |
| Cohort B: ARCT-154 | Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) | Any MAAEs | 0 Participants |
Primary
Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs)
Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Up to Day 8 (7 days after first vaccine administration for Cohorts A1, A2 and B), and up to Day 36 (7 days after second vaccine administration for Cohorts A1 and A2)
Population: Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received. Number analyzed for Cohort B arms for AEs after Dose 2 = 0 as participants in this Cohort received only a single dose of treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 2 | 2 Participants |
| Cohort A1: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 1 | 3 Participants |
| Cohort A1: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 1 | 3 Participants |
| Cohort A1: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 2 | 2 Participants |
| Cohort A1: ARCT-165 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 1 | 3 Participants |
| Cohort A1: ARCT-165 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 2 | 2 Participants |
| Cohort A1: ARCT-165 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 2 | 2 Participants |
| Cohort A1: ARCT-165 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 1 | 4 Participants |
| Cohort A1: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 1 | 1 Participants |
| Cohort A1: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 1 | 3 Participants |
| Cohort A1: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 2 | 3 Participants |
| Cohort A1: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 2 | 4 Participants |
| Cohort A2: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 2 | 5 Participants |
| Cohort A2: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 2 | 6 Participants |
| Cohort A2: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 1 | 5 Participants |
| Cohort A2: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 1 | 5 Participants |
| Cohort A2: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 2 | 10 Participants |
| Cohort A2: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 2 | 10 Participants |
| Cohort A2: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 1 | 9 Participants |
| Cohort A2: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 1 | 10 Participants |
| Cohort B: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 1 | 12 Participants |
| Cohort B: ARCT-021 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 1 | 12 Participants |
| Cohort B: ARCT-165 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 1 | 10 Participants |
| Cohort B: ARCT-165 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 1 | 9 Participants |
| Cohort B: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Systemic AE After Dose 1 | 11 Participants |
| Cohort B: ARCT-154 | Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) | Any Solicited Local AE After Dose 1 | 10 Participants |
Primary
Number of Participants Reporting Unsolicited AEs
Unsolicited AEs were defined as any spontaneously reported or discovered AE. Data are reported for the number of participants with unsolicited AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Up to Day 29 (28 days after vaccine administration for Cohort B), and up to Day 57 (up to 28 days after each vaccine administration for Cohorts A1 and A2)
Population: Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A1: ARCT-021 | Number of Participants Reporting Unsolicited AEs | 3 Participants |
| Cohort A1: ARCT-165 | Number of Participants Reporting Unsolicited AEs | 3 Participants |
| Cohort A1: ARCT-154 | Number of Participants Reporting Unsolicited AEs | 2 Participants |
| Cohort A2: ARCT-021 | Number of Participants Reporting Unsolicited AEs | 4 Participants |
| Cohort A2: ARCT-154 | Number of Participants Reporting Unsolicited AEs | 15 Participants |
| Cohort B: ARCT-021 | Number of Participants Reporting Unsolicited AEs | 9 Participants |
| Cohort B: ARCT-165 | Number of Participants Reporting Unsolicited AEs | 9 Participants |
| Cohort B: ARCT-154 | Number of Participants Reporting Unsolicited AEs | 10 Participants |
Primary
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs
Spike binding antibody levels expressed as GMCs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibodies for ancestral strain.
Time frame: Baseline and Day 57 for Cohorts A1 and A2, Baseline and Day 15 for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (D614G) | 0.0 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (Ancestral) | 0.0 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; RBD (Ancestral) | 0.0 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (B.1.351) | 0.0 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; RBD (Ancestral) | 3.4 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (Ancestral) | 10.6 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (D614G) | 10.7 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (B.1.351) | 5.0 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (Ancestral) | 0.0 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (D614G) | 0.1 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (B.1.351) | 0.0 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (D614G) | 55.8 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (Ancestral) | 52.4 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (B.1.351) | 61.1 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; RBD (Ancestral) | 0.1 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; RBD (Ancestral) | 34.5 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; RBD (Ancestral) | 0.1 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (B.1.351) | 0.2 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (B.1.351) | 5.8 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (D614G) | 19.8 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (Ancestral) | 19.1 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (D614G) | 0.2 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; RBD (Ancestral) | 8.2 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (Ancestral) | 0.3 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (B.1.351) | 30 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (D614G) | 187 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; RBD (Ancestral) | 34 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (D614G) | 47 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (Ancestral) | 44 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (B.1.351) | 119 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; RBD (Ancestral) | 138 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (Ancestral) | 181 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (D614G) | 52 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (Ancestral) | 265 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; RBD (Ancestral) | 186 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (B.1.351) | 32 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; RBD (Ancestral) | 29 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (D614G) | 277 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (Ancestral) | 49 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 57; Spike (B.1.351) | 147 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (D614G) | 142 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (Ancestral) | 18 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (D614G) | 19 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (B.1.351) | 57 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (B.1.351) | 8 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; RBD (Ancestral) | 91 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (Ancestral) | 138 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; RBD (Ancestral) | 9 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (B.1.351) | 8 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; RBD (Ancestral) | 171 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; RBD (Ancestral) | 9 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (Ancestral) | 231 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (D614G) | 235 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (D614G) | 18 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (Ancestral) | 17 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (B.1.351) | 117 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (B.1.351) | 9 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (D614G) | 20 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; RBD (Ancestral) | 10 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (B.1.351) | 123 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; RBD (Ancestral) | 221 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (D614G) | 296 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Baseline; Spike (Ancestral) | 19 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs | Day 15; Spike (Ancestral) | 290 AU/mL |
Primary
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR)
Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral D614G variant.
Time frame: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 209 | 11.4 ratio |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 57 | 5.4 ratio |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 7.7 ratio |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 29 | 4.6 ratio |
| Cohort A1: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 57 | 10.1 ratio |
| Cohort A1: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 29 | 1.0 ratio |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 29 | 2.2 ratio |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 0.8 ratio |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 57 | 5.9 ratio |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 209 | 1.4 ratio |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 2.7 ratio |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 29 | 4.7 ratio |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 209 | 3.2 ratio |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 57 | 4.8 ratio |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 57 | 6.2 ratio |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 209 | 2.7 ratio |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 1.9 ratio |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 29 | 4.4 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 91 | 20 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 15 | 16 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 6 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 29 | 20 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 271 | 5 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 181 | 11 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 15 | 22 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 181 | 12 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 91 | 17 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 271 | 13 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 27 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 29 | 24 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 15 | 28 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 25 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 91 | 30 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 29 | 37 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 181 | 31 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) | Pseudoviral D614G; Day 271 | 20 ratio |
Primary
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC
Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral B.1.351 (beta) variant. Data are reported in arbitrary units per milliliter (AU/mL).
Time frame: Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Baseline | 14 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 29 | 17 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Final Visit Cohort A1 and A2 (approx. Day 394) | 61 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 209 | 97 AU/mL |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 57 | 21 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 57 | 452 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Baseline | 14 AU/mL |
| Cohort A1: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 29 | 32 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 57 | 27 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 209 | 14 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Baseline | 14 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Final Visit Cohort A1 and A2 (approx. Day 394) | 14 AU/mL |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 29 | 17 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 57 | 2292 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 209 | 1372 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Baseline | 402 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 29 | 1926 AU/mL |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Final Visit Cohort A1 and A2 (approx. Day 394) | 1502 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 209 | 1438 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 29 | 1273 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Baseline | 442 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Final Visit Cohort A1 and A2 (approx. Day 394) | 847 AU/mL |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 57 | 3237 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 29 | 664 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 271 | 175 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Baseline | 38 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 15 | 554 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 91 | 560 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 181 | 400 AU/mL |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 213 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 181 | 708 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 91 | 1079 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 29 | 1608 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 271 | 829 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 15 | 1479 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 1532 AU/mL |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Baseline | 44 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Baseline | 60 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 91 | 1376 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 181 | 1202 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 29 | 1768 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 1578 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 15 | 1692 AU/mL |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC | Pseudoviral B.1.351 (Beta); Day 271 | 1129 AU/mL |
Primary
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR
Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral B.1.351 (beta) variant.
Time frame: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 29 | 1.2 ratio |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 57 | 1.5 ratio |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 209 | 6.9 ratio |
| Cohort A1: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394) | 4.4 ratio |
| Cohort A1: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 57 | 32.3 ratio |
| Cohort A1: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 29 | 2.3 ratio |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 57 | 1.9 ratio |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 29 | 1.2 ratio |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 209 | 1.0 ratio |
| Cohort A1: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394) | 1.0 ratio |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 57 | 5.7 ratio |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 209 | 2.8 ratio |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 29 | 4.8 ratio |
| Cohort A2: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394) | 3.0 ratio |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 57 | 5.6 ratio |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 29 | 3.2 ratio |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 209 | 2.9 ratio |
| Cohort A2: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394) | 1.7 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 91 | 14 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 181 | 10 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 29 | 17 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 271 | 4 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 5 ratio |
| Cohort B: ARCT-021 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 15 | 14 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 29 | 37 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 91 | 23 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 271 | 12 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 46 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 181 | 12 ratio |
| Cohort B: ARCT-165 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 15 | 34 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 181 | 24 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 15 | 25 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 271 | 23 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 91 | 23 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366) | 31 ratio |
| Cohort B: ARCT-154 | SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR | Pseudoviral B.1.351 (Beta); Day 29 | 29 ratio |
Primary
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC)
Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral D614G variant. Data are reported in international units per milliliter (IU/mL).
Time frame: Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 29 | 36 IU/mL |
| Cohort A1: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 57 | 42 IU/mL |
| Cohort A1: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 60 IU/mL |
| Cohort A1: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 209 | 90 IU/mL |
| Cohort A1: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Baseline | 8 IU/mL |
| Cohort A1: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 29 | 9 IU/mL |
| Cohort A1: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Baseline | 8 IU/mL |
| Cohort A1: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 57 | 87 IU/mL |
| Cohort A1: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Baseline | 12 IU/mL |
| Cohort A1: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 14 IU/mL |
| Cohort A1: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 57 | 70 IU/mL |
| Cohort A1: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 209 | 19 IU/mL |
| Cohort A1: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 29 | 26 IU/mL |
| Cohort A2: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 57 | 2038 IU/mL |
| Cohort A2: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 1000 IU/mL |
| Cohort A2: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 29 | 1966 IU/mL |
| Cohort A2: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Baseline | 421 IU/mL |
| Cohort A2: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 209 | 1340 IU/mL |
| Cohort A2: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 57 | 3563 IU/mL |
| Cohort A2: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 29 | 1949 IU/mL |
| Cohort A2: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394) | 1324 IU/mL |
| Cohort A2: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Baseline | 455 IU/mL |
| Cohort A2: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 209 | 1402 IU/mL |
| Cohort B: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 181 | 1072 IU/mL |
| Cohort B: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Baseline | 87 IU/mL |
| Cohort B: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 15 | 1415 IU/mL |
| Cohort B: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 29 | 1741 IU/mL |
| Cohort B: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 91 | 1796 IU/mL |
| Cohort B: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 271 | 611 IU/mL |
| Cohort B: ARCT-021 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 564 IU/mL |
| Cohort B: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Baseline | 94 IU/mL |
| Cohort B: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 1924 IU/mL |
| Cohort B: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 91 | 1697 IU/mL |
| Cohort B: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 271 | 2158 IU/mL |
| Cohort B: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 15 | 2019 IU/mL |
| Cohort B: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 181 | 1534 IU/mL |
| Cohort B: ARCT-165 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 29 | 2202 IU/mL |
| Cohort B: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 181 | 3041 IU/mL |
| Cohort B: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 29 | 4200 IU/mL |
| Cohort B: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Baseline | 114 IU/mL |
| Cohort B: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 271 | 1965 IU/mL |
| Cohort B: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Final Visit Cohort B (approx. Day 366) | 2463 IU/mL |
| Cohort B: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 15 | 3474 IU/mL |
| Cohort B: ARCT-154 | Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) | Pseudoviral D614G; Day 91 | 3427 IU/mL |