Trial Outcomes & Findings for Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001) (NCT NCT04033068)

NCT ID: NCT04033068

Last Updated: 2021-12-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

48 participants

Primary outcome timeframe

Up to Day 56

Results posted on

2021-12-06

Participant Flow

Participants were screened within two weeks prior to randomization.

Participant milestones

Participant milestones
Measure	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.	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.	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.	Group D: Placebo - Placebo Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Overall Study STARTED	14	14	12	8
Overall Study First Dose	14	14	12	8
Overall Study Second Dose	14	14	11	7
Overall Study COMPLETED	14	13	11	7
Overall Study NOT COMPLETED	0	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	Group D: Placebo - Placebo Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Overall Study Withdrawal by Subject	0	1	0
Overall Study Lost to Follow-up	1	0	0
Overall Study Inclusion / exclusion criteria not fulfilled	0	0	1

Baseline Characteristics

Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.	Total n=48 Participants Total of all reporting groups
Age, Continuous	38.5 Years STANDARD_DEVIATION 9.15 • n=5 Participants	35.5 Years STANDARD_DEVIATION 10.09 • n=7 Participants	33.4 Years STANDARD_DEVIATION 10.74 • n=5 Participants	39.3 Years STANDARD_DEVIATION 12.41 • n=4 Participants	36.5 Years STANDARD_DEVIATION 10.32 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	31 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	17 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	47 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to Day 56

Population: All randomized participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56	92.9 Percentage of Participants	92.9 Percentage of Participants	91.7 Percentage of Participants	62.5 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 182

Population: All randomized participants who received at least one dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Percentage of Participants Who Experienced a Solicited AE up to Day 182	92.9 Percentage of Participants	78.6 Percentage of Participants	83.3 Percentage of Participants	50.0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 182

Population: All randomized participants who received at least one dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Percentage of Participants Who Experienced an Unsolicited AE up to Day 182	57.1 Percentage of Participants	71.4 Percentage of Participants	58.3 Percentage of Participants	62.5 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 182

Population: All randomized participants who received at least one dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182	0.0 Percentage of Participants	7.1 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=12 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=13 Participants 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.	Group C: V187 (High Dose) - Placebo n=10 Participants 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.	Group D: Placebo - Placebo n=7 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0
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 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0
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 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0	10.0 Titers 95% Confidence Interval 10.0 • Interval 10.0 to 10.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=12 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=13 Participants 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.	Group C: V187 (High Dose) - Placebo n=10 Participants 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.	Group D: Placebo - Placebo n=7 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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 • Interval 579.6 to 7659.7	2310.9 Titers 95% Confidence Interval 829.1 • Interval 829.1 to 6440.8	2780.8 Titers 95% Confidence Interval 1269.3 • Interval 1269.3 to 6092.5	1759.2 Titers 95% Confidence Interval 408.9 • Interval 408.9 to 7568.2
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 • Interval 1348.4 to 12370.5	3529.3 Titers 95% Confidence Interval 1570.9 • Interval 1570.9 to 7929.5	4219.7 Titers 95% Confidence Interval 2008.3 • Interval 2008.3 to 8866.3	1821.1 Titers 95% Confidence Interval 421.3 • Interval 421.3 to 7872.4
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 • Interval 2210.4 to 15792.8	4600.6 Titers 95% Confidence Interval 2386.1 • Interval 2386.1 to 8870.4	3485.9 Titers 95% Confidence Interval 1783.3 • Interval 1783.3 to 6813.9	2059.0 Titers 95% Confidence Interval 435.5 • Interval 435.5 to 9734.7

SECONDARY outcome

Timeframe: Day 56

Population: All randomized participants without protocol deviations that could impact immune response, who had IFNγ SFC data available.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=12 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=13 Participants 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.	Group C: V187 (High Dose) - Placebo n=10 Participants 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.	Group D: Placebo - Placebo n=7 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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 0.0 • Interval 0.0 to 9.0	0.0 SFC/10^6 PBMC Inter-Quartile Range 0.0 • Interval 0.0 to 6.0	10.0 SFC/10^6 PBMC Inter-Quartile Range 3.0 • Interval 3.0 to 30.0	2.5 SFC/10^6 PBMC Inter-Quartile Range 1.0 • Interval 1.0 to 10.5

SECONDARY outcome

Timeframe: Day 56

Population: All randomized participants without protocol deviations that could impact immune response, who had IL-2 SFC data available.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=12 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=13 Participants 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.	Group C: V187 (High Dose) - Placebo n=10 Participants 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.	Group D: Placebo - Placebo n=7 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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 0.0 • Interval 0.0 to 15.5	0.0 SFC/10^6 PBMC Inter-Quartile Range 0.0 • Interval 0.0 to 18.0	0.0 SFC/10^6 PBMC Inter-Quartile Range 0.0 • Interval 0.0 to 5.0	1.0 SFC/10^6 PBMC Inter-Quartile Range 0.0 • Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available hematology data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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	1.96 Giga cells per liter Standard Deviation 0.83	1.76 Giga cells per liter Standard Deviation 0.44	1.85 Giga cells per liter Standard Deviation 1.02
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 0.10	0.52 Giga cells per liter Standard Deviation 0.13	0.45 Giga cells per liter Standard Deviation 0.10	0.49 Giga cells per liter Standard Deviation 0.22
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	0.51 Giga cells per liter Standard Deviation 0.11	0.43 Giga cells per liter Standard Deviation 0.12	0.52 Giga cells per liter Standard Deviation 0.17
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	4.74 Giga cells per liter Standard Deviation 3.09	3.15 Giga cells per liter Standard Deviation 1.21	4.73 Giga cells per liter Standard Deviation 2.22
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	4.49 Giga cells per liter Standard Deviation 1.72	3.20 Giga cells per liter Standard Deviation 1.12	5.28 Giga cells per liter Standard Deviation 2.68
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	290.93 Giga cells per liter Standard Deviation 74.22	236.45 Giga cells per liter Standard Deviation 45.65	274.86 Giga cells per liter Standard Deviation 60.78
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	286.93 Giga cells per liter Standard Deviation 75.68	229.55 Giga cells per liter Standard Deviation 47.98	281.17 Giga cells per liter Standard Deviation 60.50
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	0.06 Giga cells per liter Standard Deviation 0.06	0.03 Giga cells per liter Standard Deviation 0.05	0.06 Giga cells per liter Standard Deviation 0.05
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	0.07 Giga cells per liter Standard Deviation 0.06	0.02 Giga cells per liter Standard Deviation 0.04	0.07 Giga cells per liter Standard Deviation 0.05
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	0.17 Giga cells per liter Standard Deviation 0.14	0.15 Giga cells per liter Standard Deviation 0.12	0.17 Giga cells per liter Standard Deviation 0.14
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	0.16 Giga cells per liter Standard Deviation 0.13	0.13 Giga cells per liter Standard Deviation 0.13	0.16 Giga cells per liter Standard Deviation 0.08
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 1.30	7.47 Giga cells per liter Standard Deviation 3.82	5.51 Giga cells per liter Standard Deviation 1.58	7.49 Giga cells per liter Standard Deviation 2.96
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	7.21 Giga cells per liter Standard Deviation 2.58	5.55 Giga cells per liter Standard Deviation 1.48	7.83 Giga cells per liter Standard Deviation 3.53
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	1.99 Giga cells per liter Standard Deviation 0.77	1.74 Giga cells per liter Standard Deviation 0.43	2.03 Giga cells per liter Standard Deviation 0.93

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available hematology data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 Day 28	4.73 Trillions of cells per liter Standard Deviation 0.44	4.49 Trillions of cells per liter Standard Deviation 0.49	4.59 Trillions of cells per liter Standard Deviation 0.19	4.80 Trillions of cells per liter Standard Deviation 0.42
Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56 Day 56	4.67 Trillions of cells per liter Standard Deviation 0.40	4.56 Trillions of cells per liter Standard Deviation 0.44	4.63 Trillions of cells per liter Standard Deviation 0.23	4.83 Trillions of cells per liter Standard Deviation 0.62

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available hematology data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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	0.39 Liter of cells per liter of blood Standard Deviation 0.05	0.40 Liter of cells per liter of blood Standard Deviation 0.02	0.43 Liter of cells per liter of blood Standard Deviation 0.03
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	0.40 Liter of cells per liter of blood Standard Deviation 0.05	0.41 Liter of cells per liter of blood Standard Deviation 0.02	0.43 Liter of cells per liter of blood Standard Deviation 0.05

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available hematology data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 Day 56	13.89 Grams per deciliter Standard Deviation 1.02	13.64 Grams per deciliter Standard Deviation 2.00	13.79 Grams per deciliter Standard Deviation 0.74	14.63 Grams per deciliter Standard Deviation 1.60
Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56 Day 28	14.06 Grams per deciliter Standard Deviation 1.09	13.57 Grams per deciliter Standard Deviation 2.11	13.82 Grams per deciliter Standard Deviation 0.70	14.63 Grams per deciliter Standard Deviation 1.19

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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	20.14 Units per liter Standard Deviation 8.79	21.09 Units per liter Standard Deviation 7.38	26.00 Units per liter Standard Deviation 13.66
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	22.29 Units per liter Standard Deviation 13.75	22.18 Units per liter Standard Deviation 8.32	22.14 Units per liter Standard Deviation 8.36
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	63.43 Units per liter Standard Deviation 20.63	63.18 Units per liter Standard Deviation 16.14	79.86 Units per liter Standard Deviation 23.36
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	65.14 Units per liter Standard Deviation 20.72	59.73 Units per liter Standard Deviation 16.63	77.43 Units per liter Standard Deviation 23.78
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	21.64 Units per liter Standard Deviation 6.45	22.36 Units per liter Standard Deviation 3.29	24.57 Units per liter Standard Deviation 8.04
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	19.36 Units per liter Standard Deviation 5.47	22.55 Units per liter Standard Deviation 4.32	23.71 Units per liter Standard Deviation 6.26

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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	139.5 Millimoles per liter Standard Deviation 1.95	139.82 Millimoles per liter Standard Deviation 1.78	141.43 Millimoles per liter Standard Deviation 1.62
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	139.86 Millimoles per liter Standard Deviation 2.07	139.45 Millimoles per liter Standard Deviation 2.02	140.29 Millimoles per liter Standard Deviation 1.80
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	2.37 Millimoles per liter Standard Deviation 0.08	2.36 Millimoles per liter Standard Deviation 0.09	2.40 Millimoles per liter Standard Deviation 0.08
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	2.36 Millimoles per liter Standard Deviation 0.09	2.36 Millimoles per liter Standard Deviation 0.08	2.34 Millimoles per liter Standard Deviation 0.08
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	4.63 Millimoles per liter Standard Deviation 0.34	4.35 Millimoles per liter Standard Deviation 0.29	4.53 Millimoles per liter Standard Deviation 0.26
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	4.58 Millimoles per liter Standard Deviation 0.42	4.67 Millimoles per liter Standard Deviation 0.54	4.70 Millimoles per liter Standard Deviation 0.30

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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	0.39 milligrams per deciliter Standard Deviation 0.27	0.44 milligrams per deciliter Standard Deviation 0.16	0.50 milligrams per deciliter Standard Deviation 0.35
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	0.41 milligrams per deciliter Standard Deviation 0.24	0.42 milligrams per deciliter Standard Deviation 0.13	0.46 milligrams per deciliter Standard Deviation 0.19
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	0.71 milligrams per deciliter Standard Deviation 0.15	0.77 milligrams per deciliter Standard Deviation 0.13	0.84 milligrams per deciliter Standard Deviation 0.13
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	0.76 milligrams per deciliter Standard Deviation 0.13	0.79 milligrams per deciliter Standard Deviation 0.12	0.81 milligrams per deciliter Standard Deviation 0.17

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available urinalysis data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Laboratory Parameter (Urinalysis): pH on Days 28 and 56 Day 56	5.71 pH Standard Deviation 1.07	5.79 pH Standard Deviation 0.89	5.82 pH Standard Deviation 0.87	5.14 pH Standard Deviation 0.38
Laboratory Parameter (Urinalysis): pH on Days 28 and 56 Day 28	5.79 pH Standard Deviation 1.05	5.43 pH Standard Deviation 0.65	5.82 pH Standard Deviation 0.60	5.57 pH Standard Deviation 0.79

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available urinalysis data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 Day 28	1.014 grams per milliliter Standard Deviation 0.005	1.011 grams per milliliter Standard Deviation 0.007	1.010 grams per milliliter Standard Deviation 0.008	1.011 grams per milliliter Standard Deviation 0.009
Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56 Day 56	1.013 grams per milliliter Standard Deviation 0.009	1.012 grams per milliliter Standard Deviation 0.007	1.013 grams per milliliter Standard Deviation 0.004	1.009 grams per milliliter Standard Deviation 0.005

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available urinalysis data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	90.9 Percentage of Participants	71.4 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	85.7 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	92.9 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	81.8 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: Day 28 and Day 56

Population: All randomized participants who received at least one dose of study treatment and had available urinalysis data.

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.

Outcome measures

Outcome measures
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 Participants 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 Participants 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.	Group C: V187 (High Dose) - Placebo n=12 Participants 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.	Group D: Placebo - Placebo n=8 Participants Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 Glucose Day 28	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 Glucose Day 56	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 Urobilinogen Day 28	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56 Urobilinogen Day 56	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants

Adverse Events

Group A: V187 (High Dose) - V187 (High Dose)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Group B: V187 (Low Dose) - V187 (Low Dose)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Group C: V187 (High Dose) - Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Group D: Placebo - Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group A: V187 (High Dose) - V187 (High Dose) n=14 participants at risk 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.	Group B: V187 (Low Dose) - V187 (Low Dose) n=14 participants at risk 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.	Group C: V187 (High Dose) - Placebo n=12 participants at risk 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.	Group D: Placebo - Placebo n=8 participants at risk Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
Injury, poisoning and procedural complications Injury	0.00% 0/14 • Up to 182 Days The analysis population included all randomized participants who received at least one dose of study treatment. Per protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	7.1% 1/14 • Number of events 1 • Up to 182 Days The analysis population included all randomized participants who received at least one dose of study treatment. Per protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/12 • Up to 182 Days The analysis population included all randomized participants who received at least one dose of study treatment. Per protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/8 • Up to 182 Days The analysis population included all randomized participants who received at least one dose of study treatment. Per protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.

Other adverse events

Additional Information

Clinical Trials Disclosure

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigators may not submit the results for publication or presentation without prior written permission of the sponsor. Authorship for any publication will be determined in mutual agreement.
Publication restrictions are in place

Restriction type: OTHER