Cytomegalovirus Infections
Conditions
Keywords
VBI-1501A, VBI-1501, prophylactic vaccine, virus diseases, cytomegalovirus (CMV), cytomegalovirus infections, cytomegalovirus vaccines, Herpesviridae Infections, Phase 1, Human Herpesvirus 5 (HHV5), Vaccines, virus-like particle (VLP), enveloped virus-like particle (eVLP)
Brief summary
The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.
Detailed description
This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.
Interventions
DRUGVBI-1501A 0.5 μg
VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
DRUGVBI-1501A 1.0 μg
VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
DRUGVBI-1501A 2.0 μg
VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
DRUGVBI-1501 1.0 μg
VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
DRUGPlacebo
buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
Sponsors
Clinical Trial Data Services, LLC
VBI Vaccines Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Generally healthy adult female and male 18 to 40 years of age, inclusive; 2. Serologically confirmed to be CMV seronegative at screening; 3. Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator 4. Sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study
Exclusion criteria
1. History of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results 2. Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator 3. Previous receipt of any cytomegalovirus vaccine 4. History of allergic reactions or anaphylactic reaction to any vaccine component 5. Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine 6. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS 7. Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with 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 8. Participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study 9. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment 10. Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease 11. Are family members of study center staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Through Day 336 or early withdrawal | Blood and urine samples were collected at screening for all evaluations with additional blood samples obtained on Days 28, 56, 84, 168, 196, 280, and 336. The following clinical laboratory evaluations were performed: Biochemistry: alanine aminotransferase; aspartate aminotransferase; creatinine; blood urea nitrogen; Hematology: neutrophils, lymphocytes, eosinophils, hemoglobin, platelet count, white blood cell count; Infection status: HIV, hepatitis B, hepatitis C, and cytomegalovirus; and Urinalysis: blood, glucose, protein. |
| Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Day of vaccine administration (days 0, 56, 168) and six subsequent days | — |
| Number of Participants With Any Adverse Event | Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal. | — |
| Number of Participants With Any Serious Adverse Event | Through Day 336 or early withdrawal | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of Antibody Binding to CMV gB | Through Day 336 or early withdrawal | — |
| Geometric Mean Titer of Antibody Avidity Index Value Against gB | Through Day 336 or early withdrawal | To measure the avidity of responses against CMV gB protein, a standard ELISA assay using recombinant gB protein which did or did not include treatment with 5M urea for 30 minutes of samples after sera had been incubated with recombinant protein. The reported value, or Avidity Index, represents the percent of signal measured in ELISA after treatment with urea relative to samples not exposed to urea. |
| Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Through Day 196 or early withdrawal | — |
| Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Through Day 336 or early withdrawal | — |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VBI-1501A: 0.5µg With Adjuvant Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | 25 |
| VBI-1501A: 1.0µg With Adjuvant Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | 26 |
| VBI-1501A: 2.0 µg With Adjuvant Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | 26 |
| VBI-1501: 1.0µg Without Adjuvant Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | 25 |
| Placebo Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | 26 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous Mean (standard deviation) | 26.4 years STANDARD_DEVIATION 4.58 | 27.0 years STANDARD_DEVIATION 5.38 | 26.5 years STANDARD_DEVIATION 4.6 | 26.8 years STANDARD_DEVIATION 5.99 | 28.3 years STANDARD_DEVIATION 5.58 | 27.0 years STANDARD_DEVIATION 5.22 |
| Race/Ethnicity, Customized Alaskan Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Chinese | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Filipino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized North American Indian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized West Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White, Caucasian | 22 Participants | 24 Participants | 23 Participants | 22 Participants | 24 Participants | 115 Participants |
| Region of Enrollment Canada | 25 participants | 26 participants | 26 participants | 25 participants | 26 participants | 128 participants |
| Sex: Female, Male Female | 12 Participants | 18 Participants | 17 Participants | 14 Participants | 15 Participants | 76 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 9 Participants | 11 Participants | 11 Participants | 52 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 / 25 | 0 / 26 | 0 / 26 | 0 / 25 | 0 / 26 |
| other Total, other adverse events | 18 / 25 | 23 / 26 | 20 / 26 | 21 / 25 | 22 / 26 |
| serious Total, serious adverse events | 0 / 25 | 2 / 26 | 1 / 26 | 2 / 25 | 0 / 26 |
Outcome results
Primary
Number of Participants With Any Adverse Event
Time frame: Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.
Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 1 | 12 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 2 | 8 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Adverse Event | Through Day 336 or Early Withdrawal | 18 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 3 | 7 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 1 | 11 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Adverse Event | Through Day 336 or Early Withdrawal | 22 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 3 | 13 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 2 | 11 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 1 | 10 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 3 | 8 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Adverse Event | Through Day 336 or Early Withdrawal | 19 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 2 | 10 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Adverse Event | Through Day 336 or Early Withdrawal | 19 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 1 | 10 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 3 | 8 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Adverse Event | Post-Dose 2 | 8 Participants |
| Placebo | Number of Participants With Any Adverse Event | Post-Dose 2 | 8 Participants |
| Placebo | Number of Participants With Any Adverse Event | Post-Dose 3 | 7 Participants |
| Placebo | Number of Participants With Any Adverse Event | Post-Dose 1 | 15 Participants |
| Placebo | Number of Participants With Any Adverse Event | Through Day 336 or Early Withdrawal | 22 Participants |
Primary
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Blood and urine samples were collected at screening for all evaluations with additional blood samples obtained on Days 28, 56, 84, 168, 196, 280, and 336. The following clinical laboratory evaluations were performed: Biochemistry: alanine aminotransferase; aspartate aminotransferase; creatinine; blood urea nitrogen; Hematology: neutrophils, lymphocytes, eosinophils, hemoglobin, platelet count, white blood cell count; Infection status: HIV, hepatitis B, hepatitis C, and cytomegalovirus; and Urinalysis: blood, glucose, protein.
Time frame: Through Day 336 or early withdrawal
Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 28 | 14 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 168 | 16 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 84 | 13 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 280 | 14 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 196 | 12 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 56 | 13 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 336 | 14 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 168 | 11 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 28 | 10 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 56 | 13 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 84 | 11 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 196 | 13 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 280 | 13 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 336 | 14 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 28 | 15 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 336 | 16 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 196 | 15 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 56 | 15 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 168 | 14 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 84 | 13 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 280 | 13 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 196 | 13 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 56 | 14 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 168 | 13 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 84 | 13 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 28 | 8 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 336 | 13 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 280 | 13 Participants |
| Placebo | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 84 | 14 Participants |
| Placebo | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 280 | 16 Participants |
| Placebo | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 28 | 11 Participants |
| Placebo | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 168 | 14 Participants |
| Placebo | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 196 | 11 Participants |
| Placebo | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 56 | 11 Participants |
| Placebo | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | Day 336 | 14 Participants |
Primary
Number of Participants With Any Serious Adverse Event
Time frame: Through Day 336 or early withdrawal
Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Any Serious Adverse Event | 0 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Any Serious Adverse Event | 2 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Any Serious Adverse Event | 0 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Any Serious Adverse Event | 2 Participants |
| Placebo | Number of Participants With Any Serious Adverse Event | 0 Participants |
Primary
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Time frame: Day of vaccine administration (days 0, 56, 168) and six subsequent days
Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 1 | 11 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 1 | 1 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 1 | 2 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 1 | 6 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 1 | 9 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 1 | 8 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 3 | 0 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 3 | 4 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 2 | 2 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 1 | 9 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 3 | 1 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 2 | 9 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 2 | 2 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 3 | 2 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 3 | 7 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 2 | 1 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 2 | 10 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 1 | 6 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 1 | 4 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 2 | 11 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 3 | 10 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 2 | 2 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 3 | 5 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 2 | 2 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 3 | 10 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 3 | 1 Participants |
| VBI-1501A: 0.5µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 2 | 5 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 2 | 8 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 3 | 2 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 3 | 0 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 1 | 7 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 1 | 11 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 1 | 1 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 3 | 12 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 2 | 8 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 1 | 8 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 3 | 2 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 2 | 7 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 2 | 1 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 3 | 7 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 2 | 15 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 1 | 3 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 1 | 4 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 1 | 14 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 3 | 5 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 2 | 3 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 2 | 0 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 2 | 8 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 3 | 1 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 1 | 11 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 1 | 2 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 3 | 6 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 2 | 4 Participants |
| VBI-1501A: 1.0µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 3 | 13 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 2 | 10 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 1 | 13 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 2 | 14 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 3 | 13 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 1 | 5 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 2 | 8 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 3 | 7 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 1 | 2 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 2 | 1 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 3 | 3 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 1 | 2 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 2 | 4 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 3 | 3 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 1 | 7 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 3 | 9 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 1 | 4 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 2 | 7 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 3 | 4 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 1 | 1 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 2 | 3 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 3 | 2 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 1 | 2 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 2 | 1 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 3 | 3 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 1 | 1 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 2 | 0 Participants |
| VBI-1501A: 2.0 µg With Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 3 | 0 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 2 | 0 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 2 | 3 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 1 | 2 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 3 | 4 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 3 | 2 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 2 | 5 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 1 | 4 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 2 | 0 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 3 | 1 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 2 | 3 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 1 | 4 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 2 | 2 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 3 | 1 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 3 | 7 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 1 | 0 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 2 | 8 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 2 | 2 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 1 | 11 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 1 | 5 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 3 | 2 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 3 | 4 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 2 | 10 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 1 | 10 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 3 | 10 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 3 | 0 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 1 | 0 Participants |
| VBI-1501: 1.0µg Without Adjuvant | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 1 | 7 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 3 | 0 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 1 | 2 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 1 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 2 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 1 | 1 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 2 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 2 | 4 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 2 | 2 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 3 | 2 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 3 | 0 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 1 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 1 | 7 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 2 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 1 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 2 | 1 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 1 | 6 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Nausea/Vomiting, Dose 2 | 0 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 3 | 1 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 2 | 1 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Diarrhea, Dose 1 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Malaise, Dose 1 | 4 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Neck Swelling, Dose 3 | 1 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Pain at injection site, Dose 3 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Myalgia, Dose 3 | 2 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Fatigue, Dose 3 | 3 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Headache, Dose 3 | 5 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Armpit Swelling, Dose 2 | 1 Participants |
Secondary
Geometric Mean Titer of Antibody Avidity Index Value Against gB
To measure the avidity of responses against CMV gB protein, a standard ELISA assay using recombinant gB protein which did or did not include treatment with 5M urea for 30 minutes of samples after sera had been incubated with recombinant protein. The reported value, or Avidity Index, represents the percent of signal measured in ELISA after treatment with urea relative to samples not exposed to urea.
Time frame: Through Day 336 or early withdrawal
Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 28 | 38.98 Avidity index | Standard Deviation 1.79 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 84 | 64.56 Avidity index | Standard Deviation 1.2 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 196 | 77.17 Avidity index | Standard Deviation 1.14 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 336 | 74.82 Avidity index | Standard Deviation 1.18 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 28 | 41.83 Avidity index | Standard Deviation 1.47 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 336 | 75.86 Avidity index | Standard Deviation 1.13 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 84 | 64.77 Avidity index | Standard Deviation 1.22 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 196 | 79.58 Avidity index | Standard Deviation 1.13 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 336 | 80.81 Avidity index | Standard Deviation 1.09 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 84 | 71.91 Avidity index | Standard Deviation 1.15 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 196 | 83.43 Avidity index | Standard Deviation 1.07 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 28 | 33.81 Avidity index | Standard Deviation 1.52 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 28 | 35.53 Avidity index | Standard Deviation 2.72 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 84 | 57.73 Avidity index | Standard Deviation 1.55 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 336 | 66.43 Avidity index | Standard Deviation 1.39 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 196 | 69.71 Avidity index | Standard Deviation 1.29 |
| Placebo | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 336 | 44.20 Avidity index | Standard Deviation 2.09 |
| Placebo | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 196 | 36.39 Avidity index | Standard Deviation 2.84 |
| Placebo | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 84 | 47.55 Avidity index | Standard Deviation 2.1 |
| Placebo | Geometric Mean Titer of Antibody Avidity Index Value Against gB | Day 28 | 38.67 Avidity index | Standard Deviation 1.85 |
Secondary
Geometric Mean Titer of Antibody Binding to CMV gB
Time frame: Through Day 336 or early withdrawal
Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. The group means and standard deviations of positive samples are shown, except where no samples tested positive (neither mean nor standard deviation could be calculated) or only one sample tested positive (standard deviation could not be calculated).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 0 | 1126.00 Titer | — |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 28 | NA Titer | — |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 56 | 1461.82 Titer | Standard Deviation 1.15 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 84 | 7410.59 Titer | Standard Deviation 2.59 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 168 | 2578.32 Titer | Standard Deviation 2.04 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 196 | 24832.80 Titer | Standard Deviation 3.56 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 280 | 8736.27 Titer | Standard Deviation 4.24 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 336 | 4977.61 Titer | Standard Deviation 3.09 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 56 | 933.07 Titer | Standard Deviation 1.16 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 196 | 32600.15 Titer | Standard Deviation 3.27 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 0 | NA Titer | — |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 84 | 10378.98 Titer | Standard Deviation 2.87 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 28 | 863.00 Titer | — |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 336 | 9543.19 Titer | Standard Deviation 3.58 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 168 | 3554.05 Titer | Standard Deviation 2.48 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 280 | 13564.41 Titer | Standard Deviation 3.06 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 280 | 25574.36 Titer | Standard Deviation 3.65 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 336 | 12351.83 Titer | Standard Deviation 3.79 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 84 | 15212.90 Titer | Standard Deviation 2.54 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 196 | 48189.54 Titer | Standard Deviation 2.73 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 56 | 691.90 Titer | Standard Deviation 1.21 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 28 | NA Titer | — |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 0 | NA Titer | — |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 168 | 5344.20 Titer | Standard Deviation 3.38 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 28 | 1493.80 Titer | Standard Deviation 2.05 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 56 | 1468.22 Titer | Standard Deviation 1.93 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 84 | 3097.78 Titer | Standard Deviation 3.24 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 168 | 1901.01 Titer | Standard Deviation 2 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 196 | 12579.63 Titer | Standard Deviation 5.79 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 336 | 3719.56 Titer | Standard Deviation 3.8 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 0 | 1077.29 Titer | Standard Deviation 1.85 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Antibody Binding to CMV gB | Day 280 | 5877.74 Titer | Standard Deviation 5.45 |
| Placebo | Geometric Mean Titer of Antibody Binding to CMV gB | Day 84 | 1306.99 Titer | Standard Deviation 1.01 |
| Placebo | Geometric Mean Titer of Antibody Binding to CMV gB | Day 336 | 2907.15 Titer | Standard Deviation 5.73 |
| Placebo | Geometric Mean Titer of Antibody Binding to CMV gB | Day 56 | 1072.06 Titer | Standard Deviation 1.41 |
| Placebo | Geometric Mean Titer of Antibody Binding to CMV gB | Day 280 | 3115.63 Titer | Standard Deviation 1.35 |
| Placebo | Geometric Mean Titer of Antibody Binding to CMV gB | Day 0 | 505.00 Titer | — |
| Placebo | Geometric Mean Titer of Antibody Binding to CMV gB | Day 196 | 2086.94 Titer | Standard Deviation 1.91 |
| Placebo | Geometric Mean Titer of Antibody Binding to CMV gB | Day 28 | 580.3 Titer | Standard Deviation 1.15 |
| Placebo | Geometric Mean Titer of Antibody Binding to CMV gB | Day 168 | 1241.41 Titer | Standard Deviation 3.21 |
Secondary
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
Time frame: Through Day 336 or early withdrawal
Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. The group means and standard deviations of positive samples are shown, except where no samples tested positive (neither mean nor standard deviation could be calculated) or only one sample tested positive (standard deviation could not be calculated).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 28 | NA Titer | — |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 84 | NA Titer | — |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 168 | 151.00 Titer | — |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 196 | 159.69 Titer | Standard Deviation 1.11 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 280 | NA Titer | — |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 336 | 151.00 Titer | — |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 280 | 152.00 Titer | — |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 336 | NA Titer | — |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 28 | NA Titer | — |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 168 | NA Titer | — |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 196 | 281.00 Titer | — |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 84 | NA Titer | — |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 196 | 287.24 Titer | Standard Deviation 1.45 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 280 | 288.17 Titer | Standard Deviation 1.69 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 28 | NA Titer | — |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 168 | NA Titer | — |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 84 | 221.28 Titer | Standard Deviation 1.57 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 336 | 234.80 Titer | Standard Deviation 1.82 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 196 | 261.95 Titer | Standard Deviation 1.17 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 84 | NA Titer | — |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 168 | 177.00 Titer | — |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 336 | NA Titer | — |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 280 | NA Titer | — |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 28 | NA Titer | — |
| Placebo | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 280 | NA Titer | — |
| Placebo | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 168 | NA Titer | — |
| Placebo | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 84 | NA Titer | — |
| Placebo | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 336 | NA Titer | — |
| Placebo | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 196 | NA Titer | — |
| Placebo | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | Day 28 | NA Titer | — |
Secondary
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells
Time frame: Through Day 196 or early withdrawal
Population: Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. Samples with antibody titers below the assay cut point were not included in the calculation of geometric mean or standard deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 84 | 77.48 Titer | Standard Deviation 1.98 |
| VBI-1501A: 0.5µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 196 | 139.40 Titer | Standard Deviation 2.67 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 196 | 165.25 Titer | Standard Deviation 2.29 |
| VBI-1501A: 1.0µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 84 | 88.80 Titer | Standard Deviation 2.19 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 196 | 254.31 Titer | Standard Deviation 2.73 |
| VBI-1501A: 2.0 µg With Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 84 | 140.38 Titer | Standard Deviation 2.35 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 84 | 107.06 Titer | Standard Deviation 2.41 |
| VBI-1501: 1.0µg Without Adjuvant | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 196 | 101.10 Titer | Standard Deviation 3.35 |
| Placebo | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 84 | NA Titer | — |
| Placebo | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | Day 196 | NA Titer | — |