Covid19
Conditions
Keywords
enveloped virus-like particle (eVLP), SARS-CoV-2 spike, neutralizing antibody, cell-mediated immune responses
Brief summary
VBI-2902a and VBI-2905a are investigational vaccine candidates that use enveloped virus-like particle (eVLP) expression of a modified version of the SARS-CoV-2 spike (S) glycoprotein and are designed to induce neutralizing antibody and cell-mediated immune responses against the SARS-CoV-2 spike protein. VBI-2902a expresses the spike protein of SARS-CoV-2 Wuhan isolate (the first virus variant isolated in 2019 in Wuhan, China), while VBI-2905a expresses the spike protein of SARS-CoV-2 variant Beta (B.1.351 variant, first isolated in 2020 in South Africa). The Phase 1a portion of this study tests one- and two-dose regimens of VBI- 2902a with 5 μg S protein content and aluminum phosphate (alum) adjuvant or placebo delivered by intramuscular (IM) injection. The Phase 1b portion of the study tests a one-dose regimen of VBI-2905a with 5 μg S protein content and alum adjuvant or placebo delivered by IM injection in participants previously vaccinated with an authorized mRNA COVID-19 vaccine.
Detailed description
Phase 1a: The primary objective is to evaluate the safety and tolerability of VBI-2902a containing 5 μg of S protein in one- or two-dose regimens in healthy adults of 18-54 years of age. The secondary objective is to evaluate the immunogenicity of VBI-2902a containing 5 μg of S protein in one- or two-dose regimens in healthy adults 18-54 years of age. * Group G1 - 20 participants will receive VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28. * Group G2 - 20 participants will receive VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28. * Group G3 - 20 participants will receive placebo at Days 1 and 28. An Independent Data Safety Monitoring Board (DSMB) will review blinded safety data (reactogenicity, adverse events (AEs) and safety laboratory assessments) at Day 7 after the first vaccination. The second vaccination will only be given if the DSMB confirms that Day 7 safety is acceptable and that stopping rules were not met. The DSMB will further review blinded post-vaccination safety through Day 35, 7 days after the second vaccination and through Day 56, 28 days after the second vaccination. The study will be unblinded following DSMB review of safety data collected through Day 56. Study participants will continue with study visits as planned up to 12 months of follow up after the first dose of study vaccine. Phase 1b: The primary objective is to evaluate the safety and tolerability of a one-dose regimen of VBI-2905a at a 5 μg dose level of S protein in healthy adults (age 18-54 years) who had been previously vaccinated with mRNA vaccines. The secondary objective is to evaluate the immunogenicity of a one-dose regimen of VBI-2905a at a 5 μg dose level of S protein in healthy adults (age 18-54 years) who had been previously vaccinated with mRNA vaccines. A total of 54 healthy adults, age 18-54 years, with no history of clinical or laboratory diagnosis of SARS-CoV- 2 infection or COVID-19 illness, will be enrolled in the Phase 1b part of the study. All participants in Phase 1b will have been previously vaccinated with an authorized mRNA COVID-19 vaccine, including the second dose administered at least 4 months prior to enrollment, will be randomized at a 1:1 ratio to receive, in a blinded fashion, one dose of VBI-2905a or placebo: * Group G4 - 27 participants will receive VBI-2905a at a dose of 5 μg of S protein at Day 1 * Group G5 - 27 participants will receive placebo at Day 1 The DSMB will review blinded post-vaccination safety data 7 days after each vaccination (reactogenicity, AEs and safety laboratory assessments). In Phase 1b, the DSMB will review blinded Day 7 safety data after the first 10 participants in groups G4 and G5 have received the first dose. Only after the DSMB confirms that safety is acceptable and that stopping rules were not met will the enrollment in the respective study groups continue to its completion.
Interventions
BIOLOGICALVBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
BIOLOGICALPlacebo
0.9% sodium chloride
BIOLOGICALVBI-2905a
VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Sponsors
VBI Vaccines Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This is an observer-blinded study. Both participants and the study center staff performing outcome measurement are blinded; vaccines will be administered by qualified unblinded study personnel who have no other role in the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
To be eligible for the study, each participant must satisfy all of the following criteria: 1. Healthy female and male participants 18 -54 years of age. 2. If female: 1. is of childbearing potential and must have a negative pregnancy test prior to study vaccinations and agree to use an effective method of birth control as deemed appropriate by the investigator (e.g., hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) beginning \>30 days prior to the first study vaccine administration and continuing until the end of the study. OR 2. is not of childbearing potential, defined as postmenopausal (12 months with no menses without an alternative medical cause) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy orhysterectomy). 3. Phase 1b: previously received a full course (2 doses) of an authorized S protein mRNA COVID-19 vaccine (e.g. COVID-19 vaccines produced by Pfizer/BioNTech or Moderna) at least 4 months prior to enrollment. 4. Sign an informed consent document indicating understanding of the purpose of and procedures required for the study and willingness to participate in the study.
Exclusion criteria
Participants with any of the following criteria will be excluded: 1. History of clinical or laboratory diagnosis of COVID-19 or SARS-CoV-2 infection. 2. Phase 1b: Previous receipt of an experimental or authorized SARS-CoV-2 (COVID-19) vaccines other than an S-protein mRNA vaccine. 3. Phase 1a: Previous receipt of an experimental or authorized SARS-CoV-2 (COVID-19) vaccine. 4. Positive PCR or rapid antigen test for SARS-CoV-2 at screening. 5. Individuals with chronic medical conditions, including any of the following: 1. Diabetes mellitus Type 1 or Type 2 2. Chronic pulmonary disease (e.g., COPD or Asthma) 3. Hypertension (e.g., SBP \>140 mmHg or DBP \>90 mmHg) 4. Chronic kidney disease (e.g., GFR \<60 mL/min/1.73 m2) 5. Chronic liver disease 6. Obesity (e.g., BMI \>30 kg/m2) 6. Any history of cancer requiring chemotherapy or radiation within 5years. 7. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 8. Lack of participant's capacity (mental, social, behavioral), in the investigator's judgement, to provide informed consent for participation in the study. 9. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases: 1. autoimmune diseases (e.g. multiple sclerosis, type 1 diabetes, myasthenia gravis, Crohn disease and other inflammatory bowel diseases, celiac disease, systemic lupus erythematosus, scleroderma, including diffuse systemic form and CREST syndrome, systemic sclerosis, dermatomyositis polymyositis, rheumatoid arthritis, juvenile idiopathic arthritis, autoimmune thyroiditis - including Hashimoto thyroiditis, Grave's or Basedow's disease, immune thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune hepatitis, psoriasis, vitiligo, vasculitis, Guillain- Barré syndrome, Transverse myelitis, Addison's disease, Bell's Palsy and Alopecia Areata); 2. secondary immunodeficiency disorders (e.g., Acquired Immunodeficiency Syndrome caused by Human Immunodeficiency Virus infection (HIV/AIDS), solid organ transplant,splenectomy); 3. primary immunodeficiency disorders (e.g., common variable immune deficiency (CVID), Defective phagocytic cell function and neutropenia syndromes, complement deficiency). 10. History of allergic reactions or anaphylactic reaction to any vaccine component. 11. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). 12. Pregnant or breastfeeding or plans to conceive from 2 weeks before the study until the end of study. 13. Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, serum chemistry or urinalysis at screening as determined by the investigator. 14. Any laboratory test abnormality that would be considered of Grade 1 severity or above (as per FDA grading guidelines) and is considered as clinically significant by the investigator. Grade 2 severity or above is exclusionary, regardless of clinical assessment. 15. Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period. 16. Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug within six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and topical steroids are allowed. 17. Immunization with attenuated vaccines (e.g., measles, mumps, and rubella vaccine) within 4 weeks prior to enrollment. 18. Immunization with inactivated vaccines (e.g., influenza) within 2 weeks prior to enrolment. 19. Participation in another clinical study within 30 days. 20. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment. 21. Family members of study site personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Local Solicited Adverse Events After Each Study Vaccination | Through 7 days after each study vaccination | The occurrence of local (near injection site) adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. |
| Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Through 7 days after each study vaccination | The occurrence of systemic adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. |
| Rate of Unsolicited Adverse Events After Each Study Vaccination | Through 28 days after each study vaccination | Any adverse event reported in addition to those solicited during the clinical study. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Study Days 1, 7, 28, 35 and 56 | Virus-neutralizing antibody titers in serum were determined at baseline and post-vaccination using a pseudovirus neutralization assay (PNA). Titers are expressed as the highest serum dilution neutralizing 50% of viral infectivity (PNA50). Neutralization was tested against pseudoviruses expressing the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus as well as Beta and Delta variants. |
| Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Study Days 1, 7,14, 28, 56, 84,168 and 336 | Binding of serum antibody to SARS-CoV-2 spike protein was determined at baseline and post-vaccination by enzyme-linked immunosorbent assay (ELISA). Antibody levels are expressed as ELISA laboratory units (ELU)/mL. Binding antibody was tested against the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus. |
| Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Study Days 1, 7, 28, 35, 56 and 112 | Binding of serum antibody to SARS-CoV-2 spike protein was determined at baseline and post-vaccination by enzyme-linked immunosorbent assay (ELISA). Antibody levels are expressed as ELISA laboratory units (ELU)/mL. Binding antibody was tested against the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus. |
| Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Study Days 1, 7, 14, 28, 56, 84 and 168 | Virus-neutralizing antibody titers in serum were determined at baseline and post-vaccination using a pseudovirus neutralization assay (PNA). Titers are expressed as the highest serum dilution neutralizing 50% of viral infectivity (PNA50). Neutralization was tested against pseudoviruses expressing the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus as well as Beta and Delta variants. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1a, Group G1 Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride | 21 |
| Phase 1a, Group G2 Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant. | 20 |
| Phase 1a, Group G3 Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride | 20 |
| Phase 1b, Group G4 Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant. | 27 |
| Phase 1b, Group G5 Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride | 26 |
| Total | 114 |
Baseline characteristics
| Characteristic | Phase 1a, Group G1 | Phase 1a, Group G2 | Phase 1a, Group G3 | Phase 1b, Group G4 | Phase 1b, Group G5 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 9.37 | 32.9 years STANDARD_DEVIATION 9.45 | 30.8 years STANDARD_DEVIATION 9.03 | 36.3 years STANDARD_DEVIATION 11.03 | 36.6 years STANDARD_DEVIATION 9.87 | 33.68 years STANDARD_DEVIATION 9.77 |
| Age, Customized 18 to 39 | 17 Participants | 15 Participants | 18 Participants | 14 Participants | 15 Participants | 79 Participants |
| Age, Customized 40 to 55 | 4 Participants | 5 Participants | 2 Participants | 13 Participants | 11 Participants | 35 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 20 Participants | 19 Participants | 19 Participants | 26 Participants | 26 Participants | 110 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race First Nations | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Multiple | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Race White | 16 Participants | 17 Participants | 12 Participants | 24 Participants | 21 Participants | 90 Participants |
| Region of Enrollment Canada | 21 participants | 20 participants | 20 participants | 27 participants | 26 participants | 114 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 11 Participants | 16 Participants | 16 Participants | 57 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 9 Participants | 11 Participants | 10 Participants | 57 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 | 0 / 20 | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 16 / 21 | 17 / 20 | 15 / 20 | 27 / 27 | 23 / 26 |
| serious Total, serious adverse events | 1 / 21 | 0 / 20 | 1 / 20 | 0 / 27 | 0 / 26 |
Outcome results
Primary
Rate of Local Solicited Adverse Events After Each Study Vaccination
The occurrence of local (near injection site) adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Time frame: Through 7 days after each study vaccination
Population: Safety Set: subjects who received a study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a, Group G1 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Tenderness | 10 Participants |
| Phase 1a, Group G1 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Pain | 11 Participants |
| Phase 1a, Group G1 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Erythema/redness | 0 Participants |
| Phase 1a, Group G1 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Itchiness | 2 Participants |
| Phase 1a, Group G1 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Any local solicited adverse event | 13 Participants |
| Phase 1a, Group G1 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Induration/swelling | 0 Participants |
| Phase 1a, Group G2 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Tenderness | 13 Participants |
| Phase 1a, Group G2 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Any local solicited adverse event | 17 Participants |
| Phase 1a, Group G2 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Pain | 17 Participants |
| Phase 1a, Group G2 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Erythema/redness | 0 Participants |
| Phase 1a, Group G2 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Induration/swelling | 1 Participants |
| Phase 1a, Group G2 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Itchiness | 0 Participants |
| Phase 1a, Group G3 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Pain | 10 Participants |
| Phase 1a, Group G3 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Induration/swelling | 0 Participants |
| Phase 1a, Group G3 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Any local solicited adverse event | 11 Participants |
| Phase 1a, Group G3 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Tenderness | 9 Participants |
| Phase 1a, Group G3 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Itchiness | 2 Participants |
| Phase 1a, Group G3 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Erythema/redness | 0 Participants |
| Phase 1b, Group G4 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Induration/swelling | 1 Participants |
| Phase 1b, Group G4 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Tenderness | 19 Participants |
| Phase 1b, Group G4 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Itchiness | 2 Participants |
| Phase 1b, Group G4 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Erythema/redness | 0 Participants |
| Phase 1b, Group G4 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Pain | 20 Participants |
| Phase 1b, Group G4 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Any local solicited adverse event | 23 Participants |
| Phase 1b, Group G5 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Pain | 4 Participants |
| Phase 1b, Group G5 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Tenderness | 6 Participants |
| Phase 1b, Group G5 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Induration/swelling | 0 Participants |
| Phase 1b, Group G5 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Erythema/redness | 1 Participants |
| Phase 1b, Group G5 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Itchiness | 1 Participants |
| Phase 1b, Group G5 | Rate of Local Solicited Adverse Events After Each Study Vaccination | Any local solicited adverse event | 8 Participants |
Primary
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
The occurrence of systemic adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Time frame: Through 7 days after each study vaccination
Population: Safety Set: subjects who received a study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a, Group G1 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Nausea/vomiting | 1 Participants |
| Phase 1a, Group G1 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Any systemic solicited adverse event | 15 Participants |
| Phase 1a, Group G1 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Diarrhoea | 5 Participants |
| Phase 1a, Group G1 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fever | 0 Participants |
| Phase 1a, Group G1 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Myalgia | 8 Participants |
| Phase 1a, Group G1 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Headache | 9 Participants |
| Phase 1a, Group G1 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fatigue | 12 Participants |
| Phase 1a, Group G2 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Diarrhoea | 1 Participants |
| Phase 1a, Group G2 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Any systemic solicited adverse event | 15 Participants |
| Phase 1a, Group G2 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fatigue | 12 Participants |
| Phase 1a, Group G2 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Nausea/vomiting | 1 Participants |
| Phase 1a, Group G2 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Myalgia | 6 Participants |
| Phase 1a, Group G2 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Headache | 10 Participants |
| Phase 1a, Group G2 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fever | 0 Participants |
| Phase 1a, Group G3 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Diarrhoea | 4 Participants |
| Phase 1a, Group G3 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Any systemic solicited adverse event | 15 Participants |
| Phase 1a, Group G3 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fatigue | 10 Participants |
| Phase 1a, Group G3 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Nausea/vomiting | 3 Participants |
| Phase 1a, Group G3 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Headache | 8 Participants |
| Phase 1a, Group G3 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Myalgia | 6 Participants |
| Phase 1a, Group G3 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fever | 2 Participants |
| Phase 1b, Group G4 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Nausea/vomiting | 2 Participants |
| Phase 1b, Group G4 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Headache | 7 Participants |
| Phase 1b, Group G4 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Myalgia | 4 Participants |
| Phase 1b, Group G4 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Any systemic solicited adverse event | 15 Participants |
| Phase 1b, Group G4 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Diarrhoea | 1 Participants |
| Phase 1b, Group G4 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fatigue | 10 Participants |
| Phase 1b, Group G4 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fever | 0 Participants |
| Phase 1b, Group G5 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Any systemic solicited adverse event | 16 Participants |
| Phase 1b, Group G5 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Nausea/vomiting | 3 Participants |
| Phase 1b, Group G5 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Diarrhoea | 4 Participants |
| Phase 1b, Group G5 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Headache | 10 Participants |
| Phase 1b, Group G5 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fever | 0 Participants |
| Phase 1b, Group G5 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Fatigue | 8 Participants |
| Phase 1b, Group G5 | Rate of Systemic Solicited Adverse Events After Each Study Vaccination | Myalgia | 4 Participants |
Primary
Rate of Unsolicited Adverse Events After Each Study Vaccination
Any adverse event reported in addition to those solicited during the clinical study. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Time frame: Through 28 days after each study vaccination
Population: Safety Set: subjects who received a study vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaginal haemorrhage | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Haemoglobin decreased | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Cough | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthralgia | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspnoea | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nasal congestion | 2 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alcohol poisoning | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinorrhoea | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Throat tightness | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alopecia | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eustachian tube obstruction | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Abdominal pain | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Tinnitus | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Flatulence | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vertigo | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nausea | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pyrexia | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Heavy menstrual bleeding | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site pain | 3 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Any unsolicited AE | 11 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Palpitations | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oropharyngeal pain | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eye pruritus | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Paraesthesia oral | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspepsia | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain in extremity | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site reaction | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pharyngitis | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinitis | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neck pain | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Urinary tract infection | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthropod bite | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | COVID-19 | 2 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chest pain | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Musculoskeletal stiffness | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chills | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oligomenorrhoea | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oral herpes | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscle fatigue | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site bruising | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site haemorrhage | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site pain | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Bone pain | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Limb injury | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Liver function test increased | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Lymph node palpable | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Fatigue | 2 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Joint stiffness | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | White blood cell count decreased | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscular weakness | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Aspartate aminotransferase increased | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Myalgia | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dizziness | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Menstruation irregular | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neutrophil count decreased | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Headache | 2 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Blood bilirubin increased | 0 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Anxiety | 1 Participants |
| Phase 1a, Group G1 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Gamma-glutamyltransferase decreased | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Liver function test increased | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain in extremity | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Limb injury | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Urinary tract infection | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Cough | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oral herpes | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspepsia | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site reaction | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site bruising | 2 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Haemoglobin decreased | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspnoea | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthropod bite | 2 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthralgia | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alcohol poisoning | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dizziness | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nasal congestion | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oligomenorrhoea | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Joint stiffness | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Paraesthesia oral | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Myalgia | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinorrhoea | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Lymph node palpable | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscular weakness | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | White blood cell count decreased | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site haemorrhage | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Throat tightness | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Musculoskeletal stiffness | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Anxiety | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chest pain | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pharyngitis | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alopecia | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | COVID-19 | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaginal haemorrhage | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Abdominal pain | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oropharyngeal pain | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eustachian tube obstruction | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Menstruation irregular | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Tinnitus | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Bone pain | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eye pruritus | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chills | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site pain | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Headache | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Palpitations | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vertigo | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Flatulence | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Blood bilirubin increased | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Any unsolicited AE | 12 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Heavy menstrual bleeding | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Aspartate aminotransferase increased | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pyrexia | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neck pain | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Fatigue | 1 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neutrophil count decreased | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site pain | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nausea | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscle fatigue | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Gamma-glutamyltransferase decreased | 0 Participants |
| Phase 1a, Group G2 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinitis | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Fatigue | 3 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Palpitations | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Joint stiffness | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain in extremity | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eye pruritus | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspepsia | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oligomenorrhoea | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | White blood cell count decreased | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nausea | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | COVID-19 | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dizziness | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oral herpes | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neck pain | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pharyngitis | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site reaction | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Lymph node palpable | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinitis | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Limb injury | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthralgia | 2 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Urinary tract infection | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chills | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Musculoskeletal stiffness | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Aspartate aminotransferase increased | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Paraesthesia oral | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chest pain | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Anxiety | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscle fatigue | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Blood bilirubin increased | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Headache | 2 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Gamma-glutamyltransferase decreased | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oropharyngeal pain | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Liver function test increased | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neutrophil count decreased | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaginal haemorrhage | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Cough | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Heavy menstrual bleeding | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alcohol poisoning | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site bruising | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspnoea | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthropod bite | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nasal congestion | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Bone pain | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinorrhoea | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Flatulence | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Throat tightness | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscular weakness | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Abdominal pain | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site haemorrhage | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alopecia | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eustachian tube obstruction | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Myalgia | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Tinnitus | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vertigo | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site pain | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Menstruation irregular | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pyrexia | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site pain | 1 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Any unsolicited AE | 10 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain | 0 Participants |
| Phase 1a, Group G3 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Haemoglobin decreased | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nausea | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chills | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site pain | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site reaction | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinitis | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthropod bite | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Limb injury | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pyrexia | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Any unsolicited AE | 7 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Palpitations | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eye pruritus | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspepsia | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | COVID-19 | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oral herpes | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pharyngitis | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Urinary tract infection | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Aspartate aminotransferase increased | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Paraesthesia oral | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chest pain | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Fatigue | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Blood bilirubin increased | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Gamma-glutamyltransferase decreased | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site bruising | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site haemorrhage | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site pain | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Liver function test increased | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Lymph node palpable | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthralgia | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Joint stiffness | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscular weakness | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Myalgia | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dizziness | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Headache | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Anxiety | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaginal haemorrhage | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Cough | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Abdominal pain | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspnoea | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nasal congestion | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinorrhoea | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Throat tightness | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alopecia | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eustachian tube obstruction | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Tinnitus | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vertigo | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Flatulence | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alcohol poisoning | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Haemoglobin decreased | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neutrophil count decreased | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | White blood cell count decreased | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Bone pain | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscle fatigue | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Musculoskeletal stiffness | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neck pain | 0 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain in extremity | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Heavy menstrual bleeding | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Menstruation irregular | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oligomenorrhoea | 1 Participants |
| Phase 1b, Group G4 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oropharyngeal pain | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaginal haemorrhage | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Anxiety | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Headache | 1 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nausea | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Haemoglobin decreased | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dizziness | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Myalgia | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscular weakness | 1 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Menstruation irregular | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neutrophil count decreased | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Joint stiffness | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthralgia | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Liver function test increased | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | COVID-19 | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | White blood cell count decreased | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site pain | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site haemorrhage | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Injection site bruising | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site reaction | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Bone pain | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Gamma-glutamyltransferase decreased | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Blood bilirubin increased | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Fatigue | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vaccination site pain | 4 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Muscle fatigue | 1 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chest pain | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Paraesthesia oral | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Urinary tract infection | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oropharyngeal pain | 1 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Musculoskeletal stiffness | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinitis | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pharyngitis | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oral herpes | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Oligomenorrhoea | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Neck pain | 1 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspepsia | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eye pruritus | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Palpitations | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pain in extremity | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Pyrexia | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Any unsolicited AE | 7 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Lymph node palpable | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Chills | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Heavy menstrual bleeding | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Tinnitus | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Aspartate aminotransferase increased | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Vertigo | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Eustachian tube obstruction | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alopecia | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Throat tightness | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Abdominal pain | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Rhinorrhoea | 1 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Limb injury | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Flatulence | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Nasal congestion | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Dyspnoea | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Cough | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Arthropod bite | 0 Participants |
| Phase 1b, Group G5 | Rate of Unsolicited Adverse Events After Each Study Vaccination | Alcohol poisoning | 0 Participants |
Secondary
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Virus-neutralizing antibody titers in serum were determined at baseline and post-vaccination using a pseudovirus neutralization assay (PNA). Titers are expressed as the highest serum dilution neutralizing 50% of viral infectivity (PNA50). Neutralization was tested against pseudoviruses expressing the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus as well as Beta and Delta variants.
Time frame: Study Days 1, 7, 28, 35 and 56
Population: Full Analysis Set: Includes all subjects from the Intent-to-Treat (ITT) set who received the prescribed study vaccine and underwent immunogenicity assessment at baseline and at least one time point after baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 35 | 9.7 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 56 | 5.0 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 1 | 5.4 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 28 | 13.3 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 35 | 7.8 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 28 | 8.8 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 1 | 6.0 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 7 | 6.7 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 28 | 10.8 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 35 | 12.6 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 56 | 5.7 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 1 | 5.4 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 56 | 5.4 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 28 | 7.3 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 1 | 5.0 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 7 | 5.6 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 28 | 18.0 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 35 | 99.0 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 56 | 329.1 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 1 | 5.0 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 35 | 16.3 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 56 | 28.0 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 1 | 5.0 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 28 | 14.3 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 35 | 27.6 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 56 | 49.4 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 56 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 35 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 35 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 1 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 28 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 1 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 28 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 28 | 5.2 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 1 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 7 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Beta, Day 35 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Ancestral, Day 56 | 5.0 50% neutralization titer |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a) | Delta, Day 56 | 5.0 50% neutralization titer |
Secondary
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Virus-neutralizing antibody titers in serum were determined at baseline and post-vaccination using a pseudovirus neutralization assay (PNA). Titers are expressed as the highest serum dilution neutralizing 50% of viral infectivity (PNA50). Neutralization was tested against pseudoviruses expressing the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus as well as Beta and Delta variants.
Time frame: Study Days 1, 7, 14, 28, 56, 84 and 168
Population: Full Analysis Set: Includes all subjects from the Intent-to-Treat (ITT) set who received the prescribed study vaccine and underwent immunogenicity assessment at baseline and at least one time point after baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 28 | 138.5 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 56 | 110.9 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 84 | 221.2 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 168 | 151.4 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 1 | 247.9 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 7 | 353.5 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 14 | 476.6 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 28 | 404.3 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 56 | 474.4 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 84 | 323.7 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 168 | 382.5 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 1 | 100.9 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 7 | 215.1 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 28 | 388.0 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 56 | 267.9 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 84 | 351.1 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 168 | 264.8 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 1 | 65.0 50% neutralization titer |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 7 | 102.7 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 1 | 57.1 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 168 | 429.8 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 56 | 39.6 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 84 | 79.6 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 84 | 82.7 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 1 | 62.2 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 168 | 201.9 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 28 | 49.8 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 1 | 196.3 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 7 | 63.8 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 7 | 184.0 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 168 | 139.6 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 14 | 209.9 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 28 | 63.9 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 28 | 154.4 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Delta, Day 7 | 54.3 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 56 | 194.5 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Beta, Day 56 | 50.7 50% neutralization titer |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b) | Ancestral, Day 84 | 264.2 50% neutralization titer |
Secondary
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Binding of serum antibody to SARS-CoV-2 spike protein was determined at baseline and post-vaccination by enzyme-linked immunosorbent assay (ELISA). Antibody levels are expressed as ELISA laboratory units (ELU)/mL. Binding antibody was tested against the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus.
Time frame: Study Days 1, 7, 28, 35, 56 and 112
Population: Full Analysis Set: Includes all subjects from the Intent-to-Treat (ITT) set who received the prescribed study vaccine and underwent immunogenicity assessment at baseline and at least one time point after baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 112 | 127.0 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 28 | 161.5 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 56 | 96.6 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 1 | 28.4 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 35 | 186.8 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 7 | 33.4 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 35 | 793.8 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 56 | 4046.6 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 7 | 25.2 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 112 | 766.3 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 1 | 25.2 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 28 | 123.9 ELISA laboratory units per mL |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 28 | 25.2 ELISA laboratory units per mL |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 1 | 25.2 ELISA laboratory units per mL |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 7 | 25.2 ELISA laboratory units per mL |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 112 | 25.2 ELISA laboratory units per mL |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 35 | 25.2 ELISA laboratory units per mL |
| Phase 1a, Group G3 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a) | Day 56 | 25.2 ELISA laboratory units per mL |
Secondary
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Binding of serum antibody to SARS-CoV-2 spike protein was determined at baseline and post-vaccination by enzyme-linked immunosorbent assay (ELISA). Antibody levels are expressed as ELISA laboratory units (ELU)/mL. Binding antibody was tested against the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus.
Time frame: Study Days 1, 7,14, 28, 56, 84,168 and 336
Population: Full Analysis Set: Includes all subjects from the Intent-to-Treat (ITT) set who received the prescribed study vaccine and underwent immunogenicity assessment at baseline and at least one time point after baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 14 | 8716.8 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 56 | 8223.0 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 7 | 6952.7 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 84 | 10090.9 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 28 | 8915.0 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 168 | 8340.2 ELISA laboratory units per mL |
| Phase 1a, Group G1 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 1 | 5169.1 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 168 | 6736.9 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 1 | 3979.4 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 7 | 3894.4 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 14 | 3771.4 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 28 | 3269.2 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 56 | 3177.6 ELISA laboratory units per mL |
| Phase 1a, Group G2 | Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b) | Day 84 | 4718.2 ELISA laboratory units per mL |