Zika Virus Infection
Conditions
Keywords
Zika virus, mosquito-borne pathogen, Zika fever
Brief summary
This study is designed to investigate, at first, safety and tolerability of a novel liquid vaccine formulation named MV-ZIKA-RSP, in healthy adults aged 18 to 55 years
Detailed description
This is an observer-blinded, block-randomized, dose-finding, phase I trial, comparing different dose levels of MV-ZIKA-RSP to evaluate the safety, tolerability, and immunogenicity, of this novel ZIKA-RSP vaccine. Placebo (physiological saline solution) will be applied to blind the different treatment schedules. After the screening procedures, 48 healthy male and female volunteers aged 18-55 years will be randomly assigned to one of four treatment groups (A, B, C or D). Participants will be assessed for immunogenicity on days 0, 28 and 56 (treatment period), as confirmed by the presence of functional anti-zika-rsp antibodies determined by (PRNT50) and by ELISA, at the same time safety will be also assessed. After the treatment period, participants will be called by phone (day 182) for evaluation of safety follow-up. The investigator and site personnel assessing AEs, all participants, as well as one of the sponsor's representatives involved in the monitoring and conduct of the study will be blinded to which vaccine was administered. Only the unblinded monitor, site personnel performing randomization, preparation and administration of IMP will be unblinded.
Interventions
BIOLOGICALTwo MV-ZIKA-RSP vaccinations (high dose)
In this arm of the study, 14 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose). 2. V2= day 28; dose vaccination with MV-ZIKA-RSP (high dose). Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (high dose)
BIOLOGICALTwo MV-ZIKA-RSP vaccination (low dose)
In this arm of the study, 14 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose). 2. V2= day 28; dose vaccination with MV-ZIKA-RSP (low dose). Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (low dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (low dose)
BIOLOGICALOne MV-ZIKA-RSP vaccination (high dose) and one placebo
In this arm of the study, 12 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose). 2. V2= day 28; treatment with placebo Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second treatment with placebo
OTHERTwo placebo injection
In this arm of the study, 8 participants will receive: 1. V1= day 0; placebo treatment 2. V2= day 28; placebo treatment Description: Visit 1: Participants will receive their first treatment with placebo Visit 2: Participants will receive their second treatment with placebo
Sponsors
Themis Bioscience GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent obtained before any trial-related activities 2. Healthy men or women aged 18 to 55 years on the day of consenting 3. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study 4. All female participants must have a negative urine pregnancy serum pregnancy test at screening 5. Willingness not to become pregnant or to father a child during the entire study period by practising reliable methods of contraception as specified in protocol section 8.11.4 6. Availability during the duration of the trial 7. Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant 8. Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in
Exclusion criteria
)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56 | Up to Day 56 | An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. As specified by the protocol, the percentage of participants who experience an AE up to study Day 56 was presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced an Unsolicited AE up to Day 182 | Up to Day 182 | An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Unsolicited or spontaneous AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experienced an unsolicited AE up to study Day 182 was presented. |
| Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182 | Up to Day 182 | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect or is another important medical event deemed as much by medical or scientific judgement. As specified by the protocol, the percentage of participants who experience an SAE up to study Day 182 was presented. |
| Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 0, Day 28 and Day 56 | The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of a VNT, an immunoassay that detects and quantifies antibodies in serum samples that can neutralize infectious Zika virions. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by the VNT on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the lower limit of quantification (LLOQ) were set to the half of the true LLOQ value and values above the upper limit of quantification (ULOQ) were set to the true ULOQ value for calculations. |
| GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 0, Day 28 and Day 56 | The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of Immunoglobulin G (IgG) ELISA, an immunoassay that quantifies anti-ZIKA-RSP IgG. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by ELISA on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations. |
| T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56 | Day 56 | Immune response mediated by functional T-cells was investigated using an IFNγ enzyme-linked immune adsorbent spot (ELISpot) assay. This is an immunoassay that quantifies IFNγ producing cells by assessing the number of SFCs per 10\^6 PBMCs stimulated with a peptide pool containing the viral protein prM\*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IFNγ SFCs per 10\^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations. |
| T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56 | Day 56 | Immune response mediated by functional T-cells was investigated using an IL-2 ELISpot assay. This is an immunoassay that quantifies IL-2 producing cells by assessing the number of SFCs per 10\^6 PBMCs stimulated with a peptide pool containing the viral protein prM\*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IL-2 SFCs per 10\^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations. |
| Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Day 28 and Day 56 | Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 28 and Day 56 | Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of erythrocytes on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Percentage of Participants Who Experienced a Solicited AE up to Day 182 | Up to Day 182 | An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Solicited AEs include local solicited AEs (e.g. injection site pain, tenderness, erythema/redness, swelling, itching and induration) and systemic solicited AEs (e.g. nausea, vomiting, arthralgia, headache, fatigue, myalgia, fever, pain in limb, rash and flu-like symptoms). Solicited AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experience a solicited AE up to study Day 182 was presented. |
| Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 28 and Day 56 | Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hemoglobin on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Day 28 and Day 56 | Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Day 28 and Day 56 | Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of sodium, calcium and potassium on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Day 28 and Day 56 | Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of bilirubin and creatinine on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 28 and Day 56 | Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the pH on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 28 and Day 56 | Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the specific gravity on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Day 28 and Day 56 | Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein levels were defined as negative by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants negative for bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Day 28 and Day 56 | Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Glucose and urobilinogen were defined as normal by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants normal for glucose and urobilinogen on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
| Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 28 and Day 56 | Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hematocrit on Day 28 (second dose) and Day 56 (follow-up assessment) was presented. |
Countries
Austria
Participant flow
Pre-assignment details
Participants were screened within two weeks prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) Participants receive V187 at a high dose of 1x10\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection. | 14 |
| Group B: V187 (Low Dose) - V187 (Low Dose) Participants receive V187 at a low dose of 2.5x10\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection. | 14 |
| Group C: V187 (High Dose) - Placebo Participants receive V187 at a high dose of 1x10\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection. | 12 |
| Group D: Placebo - Placebo Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection. | 8 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Inclusion / exclusion criteria not fulfilled | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group D: Placebo - Placebo | Total | Group A: V187 (High Dose) - V187 (High Dose) | Group B: V187 (Low Dose) - V187 (Low Dose) | Group C: V187 (High Dose) - Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 39.3 Years STANDARD_DEVIATION 12.41 | 36.5 Years STANDARD_DEVIATION 10.32 | 38.5 Years STANDARD_DEVIATION 9.15 | 35.5 Years STANDARD_DEVIATION 10.09 | 33.4 Years STANDARD_DEVIATION 10.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 47 Participants | 14 Participants | 14 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 31 Participants | 10 Participants | 9 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 17 Participants | 4 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 12 | 0 / 8 |
| other Total, other adverse events | 13 / 14 | 13 / 14 | 11 / 12 | 5 / 8 |
| serious Total, serious adverse events | 0 / 14 | 1 / 14 | 0 / 12 | 0 / 8 |
Outcome results
Primary
Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56
An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. As specified by the protocol, the percentage of participants who experience an AE up to study Day 56 was presented.
Time frame: Up to Day 56
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56 | 92.9 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56 | 92.9 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56 | 91.7 Percentage of Participants |
| Group D: Placebo - Placebo | Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56 | 62.5 Percentage of Participants |
p-value: =0.2003Fisher-Freeman-Halton Test
Secondary
Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56
The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of a VNT, an immunoassay that detects and quantifies antibodies in serum samples that can neutralize infectious Zika virions. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by the VNT on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the lower limit of quantification (LLOQ) were set to the half of the true LLOQ value and values above the upper limit of quantification (ULOQ) were set to the true ULOQ value for calculations.
Time frame: Day 0, Day 28 and Day 56
Population: All randomized participants without protocol deviations that could impact immune response, who had anti-ZIKA-RSP antibody VNT data available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 0 | 10.0 Titers | 95% Confidence Interval 10 |
| Group A: V187 (High Dose) - V187 (High Dose) | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 56 | 10.0 Titers | 95% Confidence Interval 10 |
| Group A: V187 (High Dose) - V187 (High Dose) | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 28 | 10.0 Titers | 95% Confidence Interval 10 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 0 | 10.0 Titers | 95% Confidence Interval 10 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 56 | 10.0 Titers | 95% Confidence Interval 10 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 28 | 10.0 Titers | 95% Confidence Interval 10 |
| Group C: V187 (High Dose) - Placebo | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 28 | 10.0 Titers | 95% Confidence Interval 10 |
| Group C: V187 (High Dose) - Placebo | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 0 | 10.0 Titers | 95% Confidence Interval 10 |
| Group C: V187 (High Dose) - Placebo | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 56 | 10.0 Titers | 95% Confidence Interval 10 |
| Group D: Placebo - Placebo | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 0 | 10.0 Titers | 95% Confidence Interval 10 |
| Group D: Placebo - Placebo | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 56 | 10.0 Titers | 95% Confidence Interval 10 |
| Group D: Placebo - Placebo | Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56 | Day 28 | 10.0 Titers | 95% Confidence Interval 10 |
Secondary
GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56
The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of Immunoglobulin G (IgG) ELISA, an immunoassay that quantifies anti-ZIKA-RSP IgG. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by ELISA on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.
Time frame: Day 0, Day 28 and Day 56
Population: All randomized participants without protocol deviations that could impact immune response, who had anti-ZIKA-RSP antibody ELISA data available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 0 | 2107.0 Titers | 95% Confidence Interval 579.6 |
| Group A: V187 (High Dose) - V187 (High Dose) | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 56 | 5908.4 Titers | 95% Confidence Interval 2210.4 |
| Group A: V187 (High Dose) - V187 (High Dose) | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 28 | 4084.2 Titers | 95% Confidence Interval 1348.4 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 0 | 2310.9 Titers | 95% Confidence Interval 829.1 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 56 | 4600.6 Titers | 95% Confidence Interval 2386.1 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 28 | 3529.3 Titers | 95% Confidence Interval 1570.9 |
| Group C: V187 (High Dose) - Placebo | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 28 | 4219.7 Titers | 95% Confidence Interval 2008.3 |
| Group C: V187 (High Dose) - Placebo | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 0 | 2780.8 Titers | 95% Confidence Interval 1269.3 |
| Group C: V187 (High Dose) - Placebo | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 56 | 3485.9 Titers | 95% Confidence Interval 1783.3 |
| Group D: Placebo - Placebo | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 0 | 1759.2 Titers | 95% Confidence Interval 408.9 |
| Group D: Placebo - Placebo | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 56 | 2059.0 Titers | 95% Confidence Interval 435.5 |
| Group D: Placebo - Placebo | GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56 | Day 28 | 1821.1 Titers | 95% Confidence Interval 421.3 |
Comparison: Day 56p-value: =0.847195% CI: [0.3, 9.6]ANOVA
Comparison: Day 0p-value: =0.99995% CI: [0.2, 5.5]ANOVA
Comparison: Day 0p-value: =0.979895% CI: [0.1, 5.2]ANOVA
Comparison: Day 0p-value: =0.995895% CI: [0.1, 10.1]ANOVA
Comparison: Day 0p-value: =0.993595% CI: [0.1, 5.5]ANOVA
Comparison: Day 0p-value: =0.985295% CI: [0.2, 10.7]ANOVA
Comparison: Day 0p-value: =0.94495% CI: [0.2, 14.4]ANOVA
Comparison: Day 28p-value: =0.994395% CI: [0.2, 5.5]ANOVA
Comparison: Day 28p-value: =0.999995% CI: [0.2, 5.1]ANOVA
Comparison: Day 28p-value: =0.647695% CI: [0.4, 14.3]ANOVA
Comparison: Day 28p-value: =0.991195% CI: [0.2, 4.3]ANOVA
Comparison: Day 28p-value: =0.764795% CI: [0.3, 12]ANOVA
Comparison: Day 28p-value: =0.644795% CI: [0.3, 15.8]ANOVA
Comparison: Day 56p-value: =0.963895% CI: [0.3, 5.3]ANOVA
Comparison: Day 56p-value: =0.783795% CI: [0.4, 7.7]ANOVA
Comparison: Day 56p-value: =0.342795% CI: [0.5, 15.3]ANOVA
Comparison: Day 56p-value: =0.957895% CI: [0.3, 5.8]ANOVA
Comparison: Day 56p-value: =0.563795% CI: [0.4, 11.7]ANOVA
Secondary
Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56
Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of erythrocytes on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available hematology data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 28 | 4.73 Trillions of cells per liter | Standard Deviation 0.44 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 56 | 4.67 Trillions of cells per liter | Standard Deviation 0.4 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 56 | 4.56 Trillions of cells per liter | Standard Deviation 0.44 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 28 | 4.49 Trillions of cells per liter | Standard Deviation 0.49 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 28 | 4.59 Trillions of cells per liter | Standard Deviation 0.19 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 56 | 4.63 Trillions of cells per liter | Standard Deviation 0.23 |
| Group D: Placebo - Placebo | Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 28 | 4.80 Trillions of cells per liter | Standard Deviation 0.42 |
| Group D: Placebo - Placebo | Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 | Day 56 | 4.83 Trillions of cells per liter | Standard Deviation 0.62 |
Secondary
Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56
Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hematocrit on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available hematology data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 28 | 0.41 Liter of cells per liter of blood | Standard Deviation 0.03 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 56 | 0.41 Liter of cells per liter of blood | Standard Deviation 0.03 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 56 | 0.40 Liter of cells per liter of blood | Standard Deviation 0.05 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 28 | 0.39 Liter of cells per liter of blood | Standard Deviation 0.05 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 28 | 0.40 Liter of cells per liter of blood | Standard Deviation 0.02 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 56 | 0.41 Liter of cells per liter of blood | Standard Deviation 0.02 |
| Group D: Placebo - Placebo | Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 28 | 0.43 Liter of cells per liter of blood | Standard Deviation 0.03 |
| Group D: Placebo - Placebo | Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56 | Day 56 | 0.43 Liter of cells per liter of blood | Standard Deviation 0.05 |
Secondary
Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56
Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hemoglobin on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available hematology data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 28 | 14.06 Grams per deciliter | Standard Deviation 1.09 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 56 | 13.89 Grams per deciliter | Standard Deviation 1.02 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 56 | 13.64 Grams per deciliter | Standard Deviation 2 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 28 | 13.57 Grams per deciliter | Standard Deviation 2.11 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 28 | 13.82 Grams per deciliter | Standard Deviation 0.7 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 56 | 13.79 Grams per deciliter | Standard Deviation 0.74 |
| Group D: Placebo - Placebo | Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 28 | 14.63 Grams per deciliter | Standard Deviation 1.19 |
| Group D: Placebo - Placebo | Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 | Day 56 | 14.63 Grams per deciliter | Standard Deviation 1.6 |
Secondary
Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56
Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alanine Aminotransferase Day 28 | 35.00 Units per liter | Standard Deviation 21.91 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alanine Aminotransferase Day 56 | 35.21 Units per liter | Standard Deviation 19.86 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alkaline Phosphatase Day 28 | 65.29 Units per liter | Standard Deviation 14.62 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alkaline Phosphatase Day 56 | 65.50 Units per liter | Standard Deviation 15.81 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Aspartate Aminotransferase Day 28 | 29.21 Units per liter | Standard Deviation 19.26 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Aspartate Aminotransferase Day 56 | 29.43 Units per liter | Standard Deviation 12.02 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Aspartate Aminotransferase Day 56 | 19.36 Units per liter | Standard Deviation 5.47 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alkaline Phosphatase Day 56 | 65.14 Units per liter | Standard Deviation 20.72 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alanine Aminotransferase Day 28 | 20.14 Units per liter | Standard Deviation 8.79 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alkaline Phosphatase Day 28 | 63.43 Units per liter | Standard Deviation 20.63 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alanine Aminotransferase Day 56 | 22.29 Units per liter | Standard Deviation 13.75 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Aspartate Aminotransferase Day 28 | 21.64 Units per liter | Standard Deviation 6.45 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alanine Aminotransferase Day 56 | 22.18 Units per liter | Standard Deviation 8.32 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alkaline Phosphatase Day 28 | 63.18 Units per liter | Standard Deviation 16.14 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alkaline Phosphatase Day 56 | 59.73 Units per liter | Standard Deviation 16.63 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Aspartate Aminotransferase Day 56 | 22.55 Units per liter | Standard Deviation 4.32 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Aspartate Aminotransferase Day 28 | 22.36 Units per liter | Standard Deviation 3.29 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alanine Aminotransferase Day 28 | 21.09 Units per liter | Standard Deviation 7.38 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Aspartate Aminotransferase Day 28 | 24.57 Units per liter | Standard Deviation 8.04 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Aspartate Aminotransferase Day 56 | 23.71 Units per liter | Standard Deviation 6.26 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alanine Aminotransferase Day 56 | 22.14 Units per liter | Standard Deviation 8.36 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alkaline Phosphatase Day 56 | 77.43 Units per liter | Standard Deviation 23.78 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alanine Aminotransferase Day 28 | 26.00 Units per liter | Standard Deviation 13.66 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56 | Alkaline Phosphatase Day 28 | 79.86 Units per liter | Standard Deviation 23.36 |
Secondary
Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56
Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of bilirubin and creatinine on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Bilirubin Day 28 | 0.40 milligrams per deciliter | Standard Deviation 0.22 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Bilirubin Day 56 | 0.42 milligrams per deciliter | Standard Deviation 0.13 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Creatinine Day 28 | 0.83 milligrams per deciliter | Standard Deviation 0.18 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Creatinine Day 56 | 0.82 milligrams per deciliter | Standard Deviation 0.13 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Bilirubin Day 56 | 0.41 milligrams per deciliter | Standard Deviation 0.24 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Creatinine Day 28 | 0.71 milligrams per deciliter | Standard Deviation 0.15 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Creatinine Day 56 | 0.76 milligrams per deciliter | Standard Deviation 0.13 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Bilirubin Day 28 | 0.39 milligrams per deciliter | Standard Deviation 0.27 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Creatinine Day 28 | 0.77 milligrams per deciliter | Standard Deviation 0.13 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Bilirubin Day 56 | 0.42 milligrams per deciliter | Standard Deviation 0.13 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Creatinine Day 56 | 0.79 milligrams per deciliter | Standard Deviation 0.12 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Bilirubin Day 28 | 0.44 milligrams per deciliter | Standard Deviation 0.16 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Creatinine Day 56 | 0.81 milligrams per deciliter | Standard Deviation 0.17 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Bilirubin Day 56 | 0.46 milligrams per deciliter | Standard Deviation 0.19 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Bilirubin Day 28 | 0.50 milligrams per deciliter | Standard Deviation 0.35 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56 | Creatinine Day 28 | 0.84 milligrams per deciliter | Standard Deviation 0.13 |
Secondary
Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56
Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of sodium, calcium and potassium on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Sodium Day 28 | 139.57 Millimoles per liter | Standard Deviation 1.65 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Sodium Day 56 | 139.64 Millimoles per liter | Standard Deviation 1.95 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Calcium Day 28 | 2.39 Millimoles per liter | Standard Deviation 0.08 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Calcium Day 56 | 2.38 Millimoles per liter | Standard Deviation 0.09 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Potassium Day 28 | 4.72 Millimoles per liter | Standard Deviation 0.44 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Potassium Day 56 | 4.61 Millimoles per liter | Standard Deviation 0.47 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Potassium Day 56 | 4.58 Millimoles per liter | Standard Deviation 0.42 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Calcium Day 56 | 2.36 Millimoles per liter | Standard Deviation 0.09 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Sodium Day 28 | 139.5 Millimoles per liter | Standard Deviation 1.95 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Potassium Day 28 | 4.63 Millimoles per liter | Standard Deviation 0.34 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Calcium Day 28 | 2.37 Millimoles per liter | Standard Deviation 0.08 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Sodium Day 56 | 139.86 Millimoles per liter | Standard Deviation 2.07 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Sodium Day 56 | 139.45 Millimoles per liter | Standard Deviation 2.02 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Calcium Day 28 | 2.36 Millimoles per liter | Standard Deviation 0.09 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Calcium Day 56 | 2.36 Millimoles per liter | Standard Deviation 0.08 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Potassium Day 56 | 4.67 Millimoles per liter | Standard Deviation 0.54 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Potassium Day 28 | 4.35 Millimoles per liter | Standard Deviation 0.29 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Sodium Day 28 | 139.82 Millimoles per liter | Standard Deviation 1.78 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Potassium Day 28 | 4.53 Millimoles per liter | Standard Deviation 0.26 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Potassium Day 56 | 4.70 Millimoles per liter | Standard Deviation 0.3 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Sodium Day 56 | 140.29 Millimoles per liter | Standard Deviation 1.8 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Calcium Day 56 | 2.34 Millimoles per liter | Standard Deviation 0.08 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Sodium Day 28 | 141.43 Millimoles per liter | Standard Deviation 1.62 |
| Group D: Placebo - Placebo | Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56 | Calcium Day 28 | 2.40 Millimoles per liter | Standard Deviation 0.08 |
Secondary
Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56
Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available hematology data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Monocytes Day 28 | 0.54 Giga cells per liter | Standard Deviation 0.1 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Lymphocytes Day 56 | 1.94 Giga cells per liter | Standard Deviation 0.39 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Leukocytes Day 28 | 7.11 Giga cells per liter | Standard Deviation 1.3 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Platelets Day 56 | 273.21 Giga cells per liter | Standard Deviation 73.62 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Lymphocytes Day 28 | 2.01 Giga cells per liter | Standard Deviation 0.57 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Leukocytes Day 56 | 6.81 Giga cells per liter | Standard Deviation 1.56 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Neutrophils Day 56 | 4.11 Giga cells per liter | Standard Deviation 1.39 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Basophils Day 28 | 0.05 Giga cells per liter | Standard Deviation 0.05 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Eosinophils Day 28 | 0.19 Giga cells per liter | Standard Deviation 0.12 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Platelets Day 28 | 275.0 Giga cells per liter | Standard Deviation 82.43 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Neutrophils Day 28 | 4.29 Giga cells per liter | Standard Deviation 1.02 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Monocytes Day 56 | 0.51 Giga cells per liter | Standard Deviation 0.09 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Eosinophils Day 56 | 0.20 Giga cells per liter | Standard Deviation 0.13 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Basophils Day 56 | 0.04 Giga cells per liter | Standard Deviation 0.05 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Neutrophils Day 28 | 4.74 Giga cells per liter | Standard Deviation 3.09 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Basophils Day 28 | 0.06 Giga cells per liter | Standard Deviation 0.06 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Basophils Day 56 | 0.07 Giga cells per liter | Standard Deviation 0.06 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Eosinophils Day 28 | 0.17 Giga cells per liter | Standard Deviation 0.14 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Eosinophils Day 56 | 0.16 Giga cells per liter | Standard Deviation 0.13 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Leukocytes Day 28 | 7.47 Giga cells per liter | Standard Deviation 3.82 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Leukocytes Day 56 | 7.21 Giga cells per liter | Standard Deviation 2.58 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Lymphocytes Day 28 | 1.99 Giga cells per liter | Standard Deviation 0.77 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Lymphocytes Day 56 | 1.96 Giga cells per liter | Standard Deviation 0.83 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Monocytes Day 28 | 0.52 Giga cells per liter | Standard Deviation 0.13 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Monocytes Day 56 | 0.51 Giga cells per liter | Standard Deviation 0.11 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Neutrophils Day 56 | 4.49 Giga cells per liter | Standard Deviation 1.72 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Platelets Day 28 | 290.93 Giga cells per liter | Standard Deviation 74.22 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Platelets Day 56 | 286.93 Giga cells per liter | Standard Deviation 75.68 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Neutrophils Day 28 | 3.15 Giga cells per liter | Standard Deviation 1.21 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Platelets Day 28 | 236.45 Giga cells per liter | Standard Deviation 45.65 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Basophils Day 56 | 0.02 Giga cells per liter | Standard Deviation 0.04 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Eosinophils Day 56 | 0.13 Giga cells per liter | Standard Deviation 0.13 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Neutrophils Day 56 | 3.20 Giga cells per liter | Standard Deviation 1.12 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Basophils Day 28 | 0.03 Giga cells per liter | Standard Deviation 0.05 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Monocytes Day 56 | 0.43 Giga cells per liter | Standard Deviation 0.12 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Lymphocytes Day 56 | 1.76 Giga cells per liter | Standard Deviation 0.44 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Leukocytes Day 56 | 5.55 Giga cells per liter | Standard Deviation 1.48 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Eosinophils Day 28 | 0.15 Giga cells per liter | Standard Deviation 0.12 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Leukocytes Day 28 | 5.51 Giga cells per liter | Standard Deviation 1.58 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Platelets Day 56 | 229.55 Giga cells per liter | Standard Deviation 47.98 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Lymphocytes Day 28 | 1.74 Giga cells per liter | Standard Deviation 0.43 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Monocytes Day 28 | 0.45 Giga cells per liter | Standard Deviation 0.1 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Lymphocytes Day 28 | 2.03 Giga cells per liter | Standard Deviation 0.93 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Lymphocytes Day 56 | 1.85 Giga cells per liter | Standard Deviation 1.02 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Platelets Day 28 | 274.86 Giga cells per liter | Standard Deviation 60.78 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Monocytes Day 28 | 0.49 Giga cells per liter | Standard Deviation 0.22 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Eosinophils Day 28 | 0.17 Giga cells per liter | Standard Deviation 0.14 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Monocytes Day 56 | 0.52 Giga cells per liter | Standard Deviation 0.17 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Basophils Day 56 | 0.07 Giga cells per liter | Standard Deviation 0.05 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Neutrophils Day 28 | 4.73 Giga cells per liter | Standard Deviation 2.22 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Platelets Day 56 | 281.17 Giga cells per liter | Standard Deviation 60.5 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Neutrophils Day 56 | 5.28 Giga cells per liter | Standard Deviation 2.68 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Leukocytes Day 28 | 7.49 Giga cells per liter | Standard Deviation 2.96 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Basophils Day 28 | 0.06 Giga cells per liter | Standard Deviation 0.05 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Leukocytes Day 56 | 7.83 Giga cells per liter | Standard Deviation 3.53 |
| Group D: Placebo - Placebo | Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56 | Eosinophils Day 56 | 0.16 Giga cells per liter | Standard Deviation 0.08 |
Secondary
Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56
Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein levels were defined as negative by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants negative for bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available urinalysis data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Nitrite Day 56 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Protein Day 56 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Leukocytes Day 56 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Bilirubin Day 28 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Nitrite Day 28 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Erythrocytes Day 28 | 85.7 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Erythrocytes Day 56 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Bilirubin Day 56 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Protein Day 28 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Ketones Day 28 | 92.9 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Ketones Day 56 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Leukocytes Day 28 | 92.9 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Bilirubin Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Leukocytes Day 28 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Erythrocytes Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Nitrite Day 28 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Nitrite Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Leukocytes Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Bilirubin Day 28 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Ketones Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Ketones Day 28 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Erythrocytes Day 28 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Protein Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Protein Day 28 | 92.9 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Leukocytes Day 56 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Bilirubin Day 28 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Bilirubin Day 56 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Erythrocytes Day 28 | 90.9 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Erythrocytes Day 56 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Ketones Day 28 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Ketones Day 56 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Leukocytes Day 28 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Nitrite Day 28 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Nitrite Day 56 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Protein Day 28 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Protein Day 56 | 81.8 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Ketones Day 56 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Ketones Day 28 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Bilirubin Day 28 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Nitrite Day 56 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Erythrocytes Day 56 | 85.7 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Erythrocytes Day 28 | 71.4 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Protein Day 56 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Protein Day 28 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Leukocytes Day 56 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Leukocytes Day 28 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Bilirubin Day 56 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56 | Nitrite Day 28 | 100 Percentage of Participants |
Secondary
Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56
Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Glucose and urobilinogen were defined as normal by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants normal for glucose and urobilinogen on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available urinalysis data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Glucose Day 28 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Glucose Day 56 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Urobilinogen Day 28 | 100 Percentage of Participants |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Urobilinogen Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Glucose Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Urobilinogen Day 28 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Urobilinogen Day 56 | 100 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Glucose Day 28 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Urobilinogen Day 28 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Glucose Day 56 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Urobilinogen Day 56 | 100 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Glucose Day 28 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Urobilinogen Day 56 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Glucose Day 56 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Glucose Day 28 | 100 Percentage of Participants |
| Group D: Placebo - Placebo | Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 | Urobilinogen Day 28 | 100 Percentage of Participants |
Secondary
Laboratory Parameter (Urinalysis): pH on Days 28 and 56
Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the pH on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available urinalysis data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 28 | 5.79 pH | Standard Deviation 1.05 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 56 | 5.71 pH | Standard Deviation 1.07 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 56 | 5.79 pH | Standard Deviation 0.89 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 28 | 5.43 pH | Standard Deviation 0.65 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 28 | 5.82 pH | Standard Deviation 0.6 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 56 | 5.82 pH | Standard Deviation 0.87 |
| Group D: Placebo - Placebo | Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 28 | 5.57 pH | Standard Deviation 0.79 |
| Group D: Placebo - Placebo | Laboratory Parameter (Urinalysis): pH on Days 28 and 56 | Day 56 | 5.14 pH | Standard Deviation 0.38 |
Secondary
Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56
Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the specific gravity on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Time frame: Day 28 and Day 56
Population: All randomized participants who received at least one dose of study treatment and had available urinalysis data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 28 | 1.014 grams per milliliter | Standard Deviation 0.005 |
| Group A: V187 (High Dose) - V187 (High Dose) | Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 56 | 1.013 grams per milliliter | Standard Deviation 0.009 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 56 | 1.012 grams per milliliter | Standard Deviation 0.007 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 28 | 1.011 grams per milliliter | Standard Deviation 0.007 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 28 | 1.010 grams per milliliter | Standard Deviation 0.008 |
| Group C: V187 (High Dose) - Placebo | Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 56 | 1.013 grams per milliliter | Standard Deviation 0.004 |
| Group D: Placebo - Placebo | Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 28 | 1.011 grams per milliliter | Standard Deviation 0.009 |
| Group D: Placebo - Placebo | Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 | Day 56 | 1.009 grams per milliliter | Standard Deviation 0.005 |
Secondary
Percentage of Participants Who Experienced an Unsolicited AE up to Day 182
An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Unsolicited or spontaneous AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experienced an unsolicited AE up to study Day 182 was presented.
Time frame: Up to Day 182
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Percentage of Participants Who Experienced an Unsolicited AE up to Day 182 | 57.1 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Percentage of Participants Who Experienced an Unsolicited AE up to Day 182 | 71.4 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Percentage of Participants Who Experienced an Unsolicited AE up to Day 182 | 58.3 Percentage of Participants |
| Group D: Placebo - Placebo | Percentage of Participants Who Experienced an Unsolicited AE up to Day 182 | 62.5 Percentage of Participants |
p-value: =0.9111Fisher-Freeman-Halton Test
Secondary
Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect or is another important medical event deemed as much by medical or scientific judgement. As specified by the protocol, the percentage of participants who experience an SAE up to study Day 182 was presented.
Time frame: Up to Day 182
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182 | 0.0 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182 | 7.1 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182 | 0.0 Percentage of Participants |
| Group D: Placebo - Placebo | Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182 | 0.0 Percentage of Participants |
p-value: =1Fisher-Freeman-Halton Test
Secondary
Percentage of Participants Who Experienced a Solicited AE up to Day 182
An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Solicited AEs include local solicited AEs (e.g. injection site pain, tenderness, erythema/redness, swelling, itching and induration) and systemic solicited AEs (e.g. nausea, vomiting, arthralgia, headache, fatigue, myalgia, fever, pain in limb, rash and flu-like symptoms). Solicited AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experience a solicited AE up to study Day 182 was presented.
Time frame: Up to Day 182
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | Percentage of Participants Who Experienced a Solicited AE up to Day 182 | 92.9 Percentage of Participants |
| Group B: V187 (Low Dose) - V187 (Low Dose) | Percentage of Participants Who Experienced a Solicited AE up to Day 182 | 78.6 Percentage of Participants |
| Group C: V187 (High Dose) - Placebo | Percentage of Participants Who Experienced a Solicited AE up to Day 182 | 83.3 Percentage of Participants |
| Group D: Placebo - Placebo | Percentage of Participants Who Experienced a Solicited AE up to Day 182 | 50.0 Percentage of Participants |
p-value: =0.1448Fisher-Freeman-Halton Test
Secondary
T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56
Immune response mediated by functional T-cells was investigated using an IL-2 ELISpot assay. This is an immunoassay that quantifies IL-2 producing cells by assessing the number of SFCs per 10\^6 PBMCs stimulated with a peptide pool containing the viral protein prM\*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IL-2 SFCs per 10\^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.
Time frame: Day 56
Population: All randomized participants without protocol deviations that could impact immune response, who had IL-2 SFC data available.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56 | 7.5 SFC/10^6 PBMC | Inter-Quartile Range 0 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56 | 0.0 SFC/10^6 PBMC | Inter-Quartile Range 0 |
| Group C: V187 (High Dose) - Placebo | T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56 | 0.0 SFC/10^6 PBMC | Inter-Quartile Range 0 |
| Group D: Placebo - Placebo | T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56 | 1.0 SFC/10^6 PBMC | Inter-Quartile Range 0 |
Secondary
T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56
Immune response mediated by functional T-cells was investigated using an IFNγ enzyme-linked immune adsorbent spot (ELISpot) assay. This is an immunoassay that quantifies IFNγ producing cells by assessing the number of SFCs per 10\^6 PBMCs stimulated with a peptide pool containing the viral protein prM\*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IFNγ SFCs per 10\^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.
Time frame: Day 56
Population: All randomized participants without protocol deviations that could impact immune response, who had IFNγ SFC data available.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Group A: V187 (High Dose) - V187 (High Dose) | T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56 | 0.0 SFC/10^6 PBMC | Inter-Quartile Range 0 |
| Group B: V187 (Low Dose) - V187 (Low Dose) | T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56 | 0.0 SFC/10^6 PBMC | Inter-Quartile Range 0 |
| Group C: V187 (High Dose) - Placebo | T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56 | 10.0 SFC/10^6 PBMC | Inter-Quartile Range 3 |
| Group D: Placebo - Placebo | T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56 | 2.5 SFC/10^6 PBMC | Inter-Quartile Range 1 |