Safety and Immunogenicity of a Novel Vaccine Formulation... | NCT04033068

ID	Type	Description	Link
2019-000840-93	EudraCT Number
MV-ZIKA-RSP	Other Identifier	Themisbio

Label	Type	Description	Intervention Names
Two MV-ZIKA-RSP vaccinations (high dose)	Experimental	14 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and day 28	Biological: Two MV-ZIKA-RSP vaccinations (high dose)
Two MV-ZIKA-RSP vaccination (low dose)	Experimental	14 Participants will receive MV-ZIKA-RSP 2,5 x10E4 /dose on day 0 and day 28	Biological: Two MV-ZIKA-RSP vaccination (low dose)
One MV-ZIKA-RSP vaccination (high dose) and one placebo	Experimental	12 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and placebo on day 28	Biological: One MV-ZIKA-RSP vaccination (high dose) and one placebo
Two placebo injection	Placebo Comparator	8 Participants will receive placebo on day 0 and placebo on day 28	Other: Two placebo injection

Name	Type	Description	Arm Group Labels	Other Names
Two MV-ZIKA-RSP vaccinations (high dose)	Biological	In this arm of the study, 14 participants will receive: V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose). 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)

Measure	Description	Time Frame
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.	Up to Day 56

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent obtained before any trial-related activities
Healthy men or women aged 18 to 55 years on the day of consenting
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
All female participants must have a negative urine pregnancy serum pregnancy test at screening
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
Availability during the duration of the trial
Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant
Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)

Exclusion Criteria:

Participation in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period (day 56)
History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
Strong anamnestic evidence for or confirmed the history of or current infection with Zika- or Dengue-virus
History of drug addiction including alcohol dependence within the last 2 years
Inability or unwillingness to avoid intake of more than around 20g alcohol per day during 48 hours after each vaccination (equals roughly 0.5 L beer or 0.25 L of wine)
Vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until the end of the treatment period (day 56)
Prior receipt of any Zika or Chikungunya vaccine
History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit
Recent infection within 1 week prior to Screening Visit (possibility of deferral)
Blood donations including plasma donations, 90 days prior to Screening Visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until the end of the treatment period (day 56)
Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study
History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any haematological malignancy
Behavioural, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine
History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer
Abnormal laboratory values which, at the discretion of the investigator should lead to the exclusion of the subject
Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants. (Prior to taking any medication within 72 h before study vaccination, the subject should consult the investigator)
Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to first IMP administration, or anticipated use until completion of the end of treatment visit Receipt of blood products or immunoglobulins within 120 days prior to the Screening Visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period (day 56)
Pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
Unreliable contraception methods (for details please refer to protocol section 8.11.4)
Persons in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Specific Prophylaxis and Tropical Medicine		Vienna		1090	Austria

PubMed Identifier	Type	Citation	Retractions
31053842	Result	Rossi SL, Comer JE, Wang E, Azar SR, Lawrence WS, Plante JA, Ramsauer K, Schrauf S, Weaver SC. Immunogenicity and Efficacy of a Measles Virus-Vectored Chikungunya Vaccine in Nonhuman Primates. J Infect Dis. 2019 Jul 31;220(5):735-742. doi: 10.1093/infdis/jiz202.

Label	URL
Sponsor Web Page	View source

ID	Title	Description
FG000	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.
FG001	Group B: V187 (Low Dose) - V187 (Low Dose)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 28, 2020

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Group D: Placebo - Placebo	Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00014 BG00114 BG00212 BG0038 BG00448

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56

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

Posted

Number

Percentage of Participants

Up to Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	Group D: Placebo - Placebo	Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.

Units	Counts
Participants	OG00014 OG00114 OG00212 OG003

Title

Denominators

Categories

Title	Measurements
	OG00092.9 OG00192.9 OG00291.7 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003		Fisher-Freeman-Halton Test		= 0.2003														Superiority

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.

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

Posted

Number

Percentage of Participants

Up to Day 182

ID	Title	Description
OG000	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.
OG001	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.
OG002

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.

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

Posted

Number

Percentage of Participants

Up to Day 182

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Number

Percentage of Participants

Up to Day 182

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

All randomized participants without protocol deviations that could impact immune response, who had anti-ZIKA-RSP antibody VNT data available.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

All randomized participants without protocol deviations that could impact immune response, who had anti-ZIKA-RSP antibody ELISA data available.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	Group C: V187 (High Dose) - Placebo

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.

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

Posted

Median

Inter-Quartile Range

SFC/10^6 PBMC

Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

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

Posted

Median

Inter-Quartile Range

SFC/10^6 PBMC

Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

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

Posted

Mean

Standard Deviation

Giga cells per liter

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Mean

Standard Deviation

Trillions of cells per liter

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Mean

Standard Deviation

Liter of cells per liter of blood

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Mean

Standard Deviation

Grams per deciliter

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Mean

Standard Deviation

Units per liter

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Mean

Standard Deviation

Millimoles per liter

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Mean

Standard Deviation

milligrams per deciliter

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Mean

Standard Deviation

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Mean

Standard Deviation

grams per milliliter

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

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

Posted

Number

Percentage of Participants

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	Group C: V187 (High Dose) - Placebo

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.

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

Posted

Number

Percentage of Participants

Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG0030 events0 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0021 events1 affected12 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0021 events1 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0022 events2 affected12 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0011 events1 affected14 at risk EG0021 events1 affected12 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0021 events1 affected12 at risk EG003
Face oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0008 events3 affected14 at risk EG0012 events1 affected14 at risk EG0021 events1 affected12 at risk EG003
Inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Influenza like illness	General disorders	MedDRA 23.0	Systematic Assessment	EG0006 events2 affected14 at risk EG0013 events3 affected14 at risk EG0025 events2 affected12 at risk EG003
Injection site erythema	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0023 events2 affected12 at risk EG003
Injection site haematoma	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0021 events1 affected12 at risk EG003
Injection site induration	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0024 events3 affected12 at risk EG003
Injection site pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00031 events13 affected14 at risk EG00117 events9 affected14 at risk EG00210 events8 affected12 at risk EG003
Injection site pruritus	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Injection site swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0022 events2 affected12 at risk EG003
Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected14 at risk EG0015 events4 affected14 at risk EG0023 events2 affected12 at risk EG003
Oral herpes	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0013 events3 affected14 at risk EG0023 events2 affected12 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0021 events1 affected12 at risk EG003
Viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Body temperature increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0022 events2 affected12 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected14 at risk EG0020 events0 affected12 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0021 events1 affected12 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected14 at risk EG0022 events2 affected12 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events1 affected14 at risk EG0021 events1 affected12 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected14 at risk EG0017 events5 affected14 at risk EG00214 events8 affected12 at risk EG003
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected14 at risk EG0021 events1 affected12 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0021 events1 affected12 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected14 at risk EG0020 events0 affected12 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected14 at risk EG0020 events0 affected12 at risk EG003

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections
D014777	Virus Diseases
D018177	Flavivirus Infections
D018178	Flaviviridae Infections
D012327	RNA Virus Infections

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	14	13	14
EG001	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	1	14	13	14
EG002	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	0	12	11	12
EG003	Group D: Placebo - Placebo	Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.	8	0	8	5	8